late daughter. her lawyer daughter's -- her late daughter's name was anise fornay from hagerstown, maryland. 16 years old. this young girl, with no history or no warning, drank two 24-ounce monster energy drinks in a 24-hour period of time. and it killed her. there was almost 500 milligrams of caffeine in those two drinks. she died of cardiac arrest. those were billed not as sodas but as die dietary supplement ey drippings. i have an amendment that i am going to offer. this will come up i hope on the food and drug administration bill. here's what it says: every dietary supplemental manufacturer who wanted to sell their product in america has to register with the f.d.a., tell the f.d.a. the name of the

product, the ingredients in the product and a copy of the label. that's it. no requirement for testing. just so we know what's out there. and let me add, dietary supplements are coming in from all over the world into the united states. you walk into that vitamin store, nutrition store, you think everything in there has been tested? no. virtually nothing has been tested. do you still have a right to buy it? yes, and i will fight to defend your right to buy t but i also think we have a responsibility, too. if people get sick and die because of a dietary supplement, we ought to do something about it. it starts with registration, simple registration. so the food and drug administration knows what's out there. a few years ago there was a picture from the baltimore -- there was a pitcher from the baltimore orioles who in an effort to lose a few pounds took a dietary supplement that included a compound called ephedra, a stimulant. he died as a result of that compound that he took. we ended up basically banning

ephedra from dietary supplements as a result of it. i think it is important for the food and drug administration to have a list of the dietary supplements, the ingredients in when they're selling and a copy of the label. and some future ephedra, some future compound that we find that can be dangerous can then be traced to the die territory supplement products to -- the dietary supplement products. the dietary supplement industry hates my amendments like the devil hates holy water. the notion that they would have to register and disclose the name of their product and its ingredients? no way. you can't do that. it is a violation of basic rights. baloney. you want to sell in america? tell us what you're selling. and if you live in china and want to sell in the united states, is it too much to ask that you register with the f.d.a. and tell us what you're portinputting on the shelves acs america? that's basic. so we have a choice:

i'm fighting now mutt this amendment on there. let's have a choice on it, let's have a vote. should the dietary supplement industry have to register their products? it is pretty basic. this amendment is based on a recommendation for 2009 g.a.o. report which said the f.d.a. has insufficient information to regulate dietary supplements and analyze adverse event reports. that's what happened when people get sick and die. facilitiefacilities -- the ament requires that facility that manufacture, package or sell dietary supplements register the product with the f.d.a., provide a description and a list of the ingredients and a copy of the label. facilities notify the f.d.a. within 30 days and require the registration of a product. they have 30 days to do it. any product that's not registered is to be considered misbranded and illegal to sell. you've got to do t it is a real law. that's it.

that's it. just register. tell us what you're selling to americans. give us the name, give us the ingredients, give us a copy of the label. well, get ready because the dry is coming in here to say this is an outrage. i think it is outageious that they would not comply with this basic, basic amendment. and i say this to them: i am not opposed to people buying vitamins. i've gone to these nutrition stores and they've -- about every other month they put out "stop the latest durbin amendment." well, i buy vitamins, i take vitamins much it is ofnlg you shouldn't have to have a prescription for t but americans have a right know what they're taking, and they have a right to know what, if nirks the government is doing -- what, if anything, the government is doing protect them. i yield the floor. the presiding officer: the senator from missouri. mr. blunt: i thank you for the

time on the floor. i'm supportive of the bill that's comin come out of the hep committee to reauthorize user fees for the food and drug administration. we've tried these user fees in the past. they would be reauthorized for prescription drugs, for medical devices. this seems to be a way to help get these items to the consumer faster, to get them through the approval process more quickly, to allow the companies that develop new medical devices or new prescription drugs to recoup their investment in a quicker way, which also allows them to get to the generic market flay -- to the generic market in a quicker way. i think it serves the purposes of health care well and the community that pays the user fees appears to be in support of their continued use, and i am,

too. this adds generics for faster verification of generics and it adds a product called biosimilars to the process where fees would be paid and for all of the same reasons it seems that those fees would also make sense for health care and make sense for health care costs. it allows, again, recouping the investment that's made to develop a new drug quicker. that allowse allows it to go toe generic market quicker. i hope this bill can be approved and be approved even before we leave here for the memorial day work period. like senator harkin and senator enzi and their committee, the help committee, have worked hard -- i don't serve on that committee. i am on the appropriating committee for the food and drug administration, agriculture, rural development and f.d.a.

i am glad to be o on that committee and have the contacts because of being on that committee. but certainly i support this amendment. there will be amendments and we'll look at those amendments as they're offered. i do think the committee has worked in a bipartisan way to bring a bill to the floor that is legislated the way we should legislate. the committee dozen their work. it is a bipartisan approach. it seeks input, continues current policies, and improves on those policy in a way that i would hope that the senate and then the house can be supportive of. i know one of the areas where we're likely to have amendments would be the debate that we've had over and over again on whether or not prescription drugs can be imported into the country p. p and if that amendment is there, i'll have the same position that i've had in the past as long as

someone from gowfort is willing to say that those -- from our government is willing to say that those prescription drugs are what they appear to be. think of they've been out of thf custody, out of the closed pharmaceutical chain supply system that we have believed ha- is always essential to make sure that the drug you're getting is the drug you're getting. the vitamins that mr. durbin talked about earlier, i don' i t know what's in that capsule unless someone has verified what's purr appellate courted t the to be in there is real in there. there are all kinds of examples of that all over the world. we want to be sure that american consumers, they're taking a health product, take that product for good cause. the senator from illinois even mention that he had thought dietary supplements should be filed with the f.d.a. well certainly anyone who would think that should think that

prescription medicines, pharmaceutical med singsz, that someone would need to verify that that medicine is the medicine you believe it to be because you're not taking it some additional dietary ran. you're taking it because your doctor has told you that's a medicine you need to take. that means there must be some health care reason you're taking it and you need to be certain, in my view, that that health care reason is being met. will mr. president, i reaalso, s week that the a a time of trillion-dollar deficits, the department of health and human services announced that it would go forward with a provision in the affordable health care act that apparently allows the department to spend $20 million of taxpayer money to launch a p.r. campaign to convince americans that they should like the afford baling health care

act -- the affordable health care act better than they apparently do. $20 million at a time when we have these trillion-dollar deficits, at a time when in fact the health care law has even been challenged in court and we'll find out within the next month what the court thinks about the potential constitutionality of the health care law. now, this is, i will say, the same department of health healtd human services that during the health care debate told insurance companies that they could not -- that they could not tell their customers -- they could not communicate with their customers in any way that suggested any possible negative impact that this law might create. i thought that was an incredible position for the government to take at the time, so maybe i shouldn't be surprised that now the government would spend $20 million on a health care -- on a p.r. contract to convince people

that they should like this health care plan better than they do. in fact, poll after poll shows that the more that people know about the health care proposal, the less they like it. two years after its passage, opposition to the health care larks i believe, is stronger than it's ever been. a recent rasmussen poll said that 56% of voters favor a repeal of the affordable health care act believing that it is neither all that affordable or all that tabooe good for health. according to a "usa today"/gallup poll, 72% of madam president, think in this bill will make things worse or won't help their health care situation. it's clear in my view that this is a bad law that we can't afford, bad for families. it's bad for seniors, bad for

job creators, and i guess maybe that's why we're going to spend $20 million to convince me and others that it's not nearly as bad as we think it is. it's not the first time that the administration has used taxpayer money to roll out publicity initiatives or to move forward in a way that will try to encourage the use of this law. last year the health and human services department asked congress to quadruple the budget for its public affairs office to another $20 million, so the request was, let's have $20 million in public affairs to double the staff, quadruple the budget, let's have another $20 million to hire a p.r. firm to convince the american people that the affordable health care act is going to be good for th

them, let's sway seniors by using $3 million for an ad campaign featuring andy griffith, who is one of my favorite actors of all time, who took on the role that would convince people that the health care law was good for seniors. the nonpartisan factcheck.org concluded that that ad used -- they said -- quote -- "-- "weasel words" -- unquote -- to mislead seniors. i certainly would no not imagine that andy griffith would say "weasel words." they used taxpayer paid-for words to talk about why this plan would be good for them. then the administration recently decided to spend $8.35 billion -- now, mr. president, we're talking about real money. we're not talking about $20 million or $3 million, we're

talking about $8.35 billion to postpone the vast majority of the medicare advantage cuts until after the end of this year. coincidentally, after election day as well. this is supposedly out of money that would usually go for a demonstration project. now, as i understand demonstration projects, this is to take an idea and prove whether it will work or not. well apparently this demonstration project is merely to not allow these provisions of the affordable health care act to go into effect until after the election. i think we can all see twha demonstrates. that democrat tax rates that there must be something -- that demonstrates that there must be something that the administration believes the american people and seniors would not like, if they found out before the election that that $8.35 billion was scheduled

to be taken out of medicare and put into another health care program. in fact, the affordable health care act will spend $500 billion that will come out of medicare at the time when medicare, we all know, is about to be in real trouble. if you made this argument anywhere but washington, d.c., i think you'd be laughed out of the room. we've got this one fund that's about to to be in big trouble, o we're going to take money from it and we're going to start another program that we also don't quite know how we're going to fund. the government accounting office has said that that demonstration project, i think they've identified it as a sham as a demonstration project because it doesn't demonstrate anything. this isn't a health care system

proving that if you take care of seniors on a per capita basis that you do a better job keeping them well than if you wait until everybody gets sick for them to be able to see a doctor under medicare. this just simply demonstrates that the administration would not like people to know what the impact of the law is going to be during this even-numbered year. government spending out of control, federal debt at a record high; it's unacceptable to me that the administration has decided to waste money on a p.r. campaign or to waste money to see that the impact of the law is not evident until after election day. instead of spending time and tax-paying dollars to try to convince people that unpopular things should be liked, i'd like to see the president work with the congress to help us get the

23 million men and women who are either unemployed or underemployed back to work. if we're going to spend money, let's spend money for purposes like that. i would yield back and note, mr. president, the absence of a quorum. the presiding officer: the clerk will call the roll. quorum call:

the presiding officer: the senator from iowa. mr. grassley: i ask that the calling of the quorum be suspended. the presiding officer: without objection. mr. grassley: mr. president, today we will be considering, and are considering a vital piece of legislation that not only includes all four user fee agreements, but also includes policy proposals to improve food and drug administration review and approval of medical products, particularly in the pharmaceutical supply chain. in 2008, when senator kennedy was still in the senate, he and i introduced the drug and device accountability act. this legislation was largely in response to the stiff oversight i conducted on the food and drug

administration. during these investigations, i identified serious problems including delays of intpofrplg the public of -- informing the public of emergency safety problems and lack of informed authority. based on these findings, the kennedy-grassley legislation included provisions to ensure the safety of drugs, including foreign manufactured drugs. it would have expanded f.d.a.'s authority to inspect foreign manufacturers and importers on a risk-based schedule. it would have required all manufacturers to register with the agency so they can properly identify the number of manufacturers and where they're located. this would have also ensured that when a crisis occurred, we can quickly locate the questionable facilities.

and it would have increased civil and criminal penalties with respect to the violations. unfortunately, senator kennedy and i never had an opportunity to debate this legislation, let alone cast a vote on it. however, roughly a year ago senator harkin and enzi forged a bipartisan working group to address these challenges. the group has worked tirelessly to produce a bipartisan bill that modernizes f.d.a.'s authority to ensure that drug products coming in to the united states are safe for american patients. this bill incorporates many provisions introduced in the drug and device accountability act senator kennedy and i introduced. it increases penalties for knowingly and intentionally counterfeiting drug products. it requires electronic submission of certain key information by a drug importer

as a condition for grant entry. i would like to have seen additional enforcement tools included in the legislation. for example, granting f.d.a. the authority to destroy unsafe products that are refused admission into our country. that would enhance f.d.a.'s ability to protect the public from tainted products. likewise, i think f.d.a. should have been granted subpoena authority and have it on a par with other federal law enforcement authorities because currently, f.d.a. lacks subpoena authority and has to go through the department of justice, which is time-consuming and burdensome. ultimately, this legislation is needed -- is a needed step in the right direction towards securing our supply chain. this legislation did not address a top priority of mine and that is ensuring whistle-blowers have adequate protections.

four months ago, my office learned of an abusive treatment by the food and drug administration towards whistle-blowers due to their protected communication with congress, more specifically with the office of this senator. once the agency learned of the communication, it began actively monitoring and observing employees' personal e-mail accounts for two years until the agency was able to have the employee fired. regrettably, i was not shocked to learn that the f.d.a. was mistreating whistle-blowers within its agency, as it has done so on more than one occasion in the past that i've identified. what makes the example different and worse is that the f.d.a. intentionally went after an employee because that -- they knew that that employee had no

protection under the whistle-blower protection act. the employee in question happened to be a member of the public health service and the -- the title is the public health service commission corps. and because of a decision from the court of federal claims, those employees in the public health service, along with other members of uniformed service, are not covered by the federal employee whistle-blower protections. in 2009, the court of federal claims held in ferbeck v. u.s. that an officer in the public health service commissioned corps is a member of the uniformed services and, as such, is not covered under the civilian whistle-blower protection act nor the military whistle-blower protection act. this same logic extends to the commission corps of the

national -- of noaa. so under this precedent, officers of -- of the public health service and noaa currently have no whistle-blower protection under federal law. this is particularly problematic when you consider that the public health service and noaa officers can be detailed to agencies like the food and drug administration or the center for disease control -- and that's the case here, where that public health service officer was working with f.d.a. there they happened to work side-by-side with civilian employees doing critical work to review and approve drugs, oversea medical devices, and even -- oversee medical devices, and even work on infectious diseases. however, unlike their civilian colleagues sitting right beside them, if these employees uncover wrongdoing, waste, fraud and abuse, they can be retaliated against by the agency and have no recourse for it.

this is wrong and needs to be fixed. without whistle-blowers -- whistle-blowers point out waste, fraud and abuse when no one else will and they do so while risking their professional careers. whistle-blowers have played a critical role in exposing government failures and retaliation against whistle-blowers should never be tolerated, whether you're with the public health service or otherwise. for this reason, i offer an amendment that expands whistle-blower protection for uniformed employees of the public health service. it corrects the anomaly pointed out in the court of federal claims and ensures that officers in the public health service have some baseline whistle-blower protections. it expressly includes the commission's corps of the public health service within the protections of the military whistle-blower protection act. this is consistent with the

structure of the commissioned corps functioning like a military organization and matches the fact that these officers receive military-like benefits and retirement. all federal employees should feel comfortable expressing their opinion, both inside and agency and to those of us in congress. the inclusion of this language will ensure those opinions receive appropriate protections. i want to take this opportunity to express my appreciation to senator harkin and senator enzi and -- for their commitment and effort over the years to reform and improve the food and drug administration. we've got to do what we can to protect whistle-blowers. they know where the skeletons are buried. they and enterprising journalists come to us in congress so we can investigate. we need those sources of information. i yield the floor. the presiding officer: the majority leader.

mr. reid: i ask unanimous consent that the execution of the previous order with respect to s. 3187 be delayed until 2:15 today. that at 2:15 p.m., the majority leader be recognized prior to execution of the order and that all provisions of the previous order remain in effect at that time. the presiding officer: without objection, so ordered. mr. reid: mr. president, we're close to a way to move forward on the f.d.a. bill. i do say this, however. we have -- on this side, we've cleared everything. so the disputes now are with the republicans on a republican amendment. we -- we are willing to do whatever's necessary on that amendment. so i hope we can get this worked out. it would sure be to the -- as we've heard all of the speeches about this important bill, it really is important. as i indicated today talking about some of the shortages we've had in nevada where people die as a result of not having

the medicine. and we're -- we're nearing a time where we can't prolong this anymore. this legislation is necessary because the bill -- i'm sorry, the information that we have in this bill, everything we need expires at the end of this month ms. klobuchar: mr. president? the presiding officer: the senator from minnesota. ms. klobuchar: mr. president, i rise today to talk about the importance of passing the food and drug administration safety and innovation act, more commonly known as the user fee reauthorization bill. this bipartisan legislation would reauthorize the user fee programs for the medical device industry, incredibly important in our home state of minnesota, as well as the pharmaceutical industry. this bill represents over a year of negotiations between the f.d.a., congress, and the

industry. i believe we have achieved a good balance in terms of the improved performance incentives through increased accountability, more meaningful goals, important process improvements, better metrics, and additional resources. not only does this legislation include the user fee agreements negotiated between the industry and the f.d.a., it also includes several reforms that will benefit the entire health care system and improve public health. the bill will make medicines safer for children, it will protect the global drug supply chain, it will improve access to safe, innovative medical devices and treatments, and it will tackle the drug shortage crisis that is spreading across the country. on monday, i talked about the work of -- that i did leading the effort on drug shortage and i'm so pleased that senator harkin and senator enzi included this provision in this bill, but i also today believe it's important to talk about the guts of the bill and that is the

improvements with the f.d.a. and the work that needs to be done. i want to commend the help committee, on which you serve, mr. president, and specifically chairman harkin and ranking member enzi, for being dedicated to ensuring that this process was open, transparent and bipartisan. at a time when congress has been deeply divided, this legislation shows that we can still overcome our differences and address the needs of the country through strong bipartisan cooperation. for our state of minnesota, passing this bill is vital to our continued economic growth and strength. with strong institutions like the mayo clinic and the university of minnesota and innovative companies like 3m and boston scientific and medtronic and san diego jude, minnesota's -- and st. jude, minnesota's job numbers have fared better than the national average, with our unemployment rate now 2 1/2 points below the national average. that is 5.6% compared to 8.1%.

that is also attributed to the fact that minnesota has one of the largest and most dynamic pockets of medical device companies in the country. i mentioned a few of the big ones but there are also many small thriving companies and many of our biggest innovations have come from the small companies, adding up to about 400 firms employing over 35,000 people across our state. and we can't forget that it was minnesota that brought the world one of the biggest innovations in the country. i'm not talking about the post-it note, mr. president, although that is true, that did come from our state. i am talking about the pacemaker. which we give thanks to a company called medtronic that started out in a garage in minneapolis. so our roots really do run deep in this industry. but medical technology is not just important to minnesota, it is important to our country, putting billions of dollars into our economy each year. and it's important to the world. the devices we make here in the

united states don't just save lives locally, they save lives globally. and as you look at potential exports and how we're going to reach the president's goal of doubling our exports in five years and how we're going to get out of the economic rut that we've been in, a lot has to do with exports. new markets, a rising middle class in countries like china and india, where people are finally going to the hospital, will use our medical devices, will bring jobs to the united states. but that only works if these medical devices get approved and if we're able to make them, have the skilled workers to make them and can beat out our competition basically of companies in other countries that may be growing unless we make sure that we have a proper approval process here that keeps things safe but also moves smoothly and quickly. the kind of meaningful, innovative work that our country needs more of is really this kind of work. it is high-tech manufacturing and that's what we need more of in this country. as cochair of the bipartisan

med-tech caucus in the senate, i've had several conversations with the f.d.a. about ways to improve this regulatory environment. i've introduced bills, as you have as well, mr. president, and looked at the importance of putting in things that guarantee safety but also make sure that we improve the process so we get more innovation and more jobs in this country. if we're not careful, mr. president, as we know, countries like europe, if they move faster than us, as they have in some instances, then we have a problem because then the venture capital money goes europe, with china requiring country-of-or begin approvals, you can -- country-of-origin approvals, you can decide companies can get things done quick fur they move to places like europe so they get the approvals in place so they can sell in china. we don't want that to happen. the f.d.a. will now be responsible for total review time goals. that is an important part of this. this measures the time from submission of a new application to the time the technology is

available to patients, putting the f.d.a. on the hook for this measure will streamline the approval process and help get innovative and lifesaving devices and treatments to patients. in addition to improved review times and performance standards, the one thing i hear about the most from our medical device companies, both small and large, is that they need better communication between the f.d.a. and industry. this agreement takes significant steps to address this issue by opening clear lines of discussion before a submission is made. this helps provide companies with clear direction and requires the f.d.a. to stick to their commitments. it also requires interaction between the f.d.a. and the applicant during the review process to keep everyone on the same page, avoid miscommunication, and costly delays. and the agreement also requires the f.d.a. to work with companies to find the best path forward if goals are not met. and most importantly, this legislation will give the f.d.a. the tools necessary to meet

these goals. this agreement provides for $595 million in user fees over the next five years. this is meant to provide for additional reviewers, enhanced training and increased efficiencies to help improve f.d.a. performance and keep -- help patients get access to the most innovative and safest products available. but a positive user fee agreement does not guarantee success. we must also focus on the execution and administration of these new resources and new guidelines. that is why i introduced a bipartisan bill with republican richard burr of north carolina and democrat michael bennet of colorado that would significantly improve the regulatory process. it would tackle three important things related to the approval process. first it would increase efficiency by strengthening the agency's lead burdensome principles which have been continuously overlooked by f.d.a.'s reviewers. the average time to approve a

510 application has increased 43% from 2003 to 2007 time period to 2010. this is simply unacceptable. second it would improve conflict of interest provisions making it easier for the f.d.a. to recruit topline experts to take part in the review process. this would allow the f.d.a. to protect the integrity of the review from undue conflicts of interest but also take advantage of available expertise. third, it would require the f.d.a. to use an independent consulting organization to assess the management processes at the center on devices. this would encourage the agency to consider the impact of its decisions on innovation while also considering the balance between the risk and the benefits of the new devices. i'm thankful that in working with senator harkin and senator enzi we were able to include these improvements in this legislation.

equally as important as improving the regulatory process at the f.d.a., the legislation also includes my provision on drug shortages. i've come to the floor several times in the past year to talk about the crisis that has impacted individuals all acrewsl across our country. the story of a 4-year-old boy who was going to get treatment for leukemia. the parents put in a panicked little bald boy and found out that the drug he needed was missing in action, not in the hospital or the pharmacy. they were looking into booking g flights to dan di -- they were looking into book being flights to canada. at the last minute someone located that drug. we have had people come forward talking about missing breast cancer treatments. people have died because drugs were not available. the fact that physicians and nurses are spending hours and

hours of time looking for pharmaceuticals is an outrage. we know there are many reasons for this. we are glad that the industry was willing to work with us to come up with at least a short-term patch here where the f.d.a. will be alerted as a result of the provisions in this bill when the pharmaceutical companies believe that there's going to be a shortage. right now they're only required to do it for orphan drugs. now they're going to be required to do it for all drugs. and these can be shortages as a result of raw materials that aren't there, shortages as a result of mergers in the pharmaceutical industry, shortages as a result of decisions not to produce a drug because it may not be as profitable, shortages because of all kind of things that could happen in the course of commerce. the key point is here, when the f.d.a. finds about things early, they have been able to avert drug crises. they find another drug abroad that's safe. they get the drugs in. they've done it over 200 times in two years. this will simply give them more tools to be able to avert what

is in an he is a -- what is an escalating crisis in this country where we're seeing more and more short afnlings drugs hon a wokely -- more and more shortages of drugs on a weekly basis. i'm so glad that this is a bipartisan provision. senator casey originally introduced it with me. it has support from susan collins and others. this has very good prospects in the house under the leadership of a bill led by congres congren deeing et of colorado. i want to thank my colleagues for two reasons. this is better for jobs in america as we become a country that makes stuff, that invents things, that exports to the world. do that you need to get the regulatory process working. secondly, this bill is good because it contains this drug shortage provision toally get at something -- to finally get at something that is long overdue.

that is the escalating crisis of drugs that have gone miss, that should be in the hand of patients across this country. now we've put them in a much better position in terms of being able to find alternative drugs in either our own country or others so we don't have these shortages, as we're seeing every single day. that is why i thits very important that we get this bill done and that we get it done soon. thank you, mr. president. i yield the floor. mr. president, i note the absence of a quorum. the presiding officer: the clerk will call the roll. quorum call:

mr. whitehouse: mr. president? the presiding officer: the senator from rhode island. mr. whitehouse: mr. president, are we present any a quorum call? the presiding officer: yes, we are. white house may i ask that the quorum call d. mr. whitehouse: may i ask that the quorum call be lifted. the presiding officer: without objection. mr. whitehouse: thank you, mr. president. i rise today to speak about a subject that i know is dear to the presiding officer's heart, and that is the sorry state of our campaign finance system and the need for the disclose act of 2012. we call disclose 2.0. the supreme court's 2010 decision in citizens united v. the federal elections commission

opened the floodgates to unlimited corporate and special interest money in our elections, bringing about an era in which corporations and other wealthy interests can drown out the voices of individual voters in our political system. worse still, much of this spending is anonymous, so we don't even know who is spending millions to influence our elections. here's how my home state newspaper, the providence journal, explained it when the ruling came down: "the ruling will mean that more than ever big-spending economic interests will determine who gets elected. more money will especially pour into relentless attack campaigns. free speech for most individuals will suffer, because their voices will count for even less than they do now. they will simply be drowned out

by the big money." the "providence journal" had a lot of foresight with that warning. what has happened since then has proven them right. senator john mccain recently said, "i predicted when the united states supreme court with their absolute ignorance of what happens in politics struck down" -- he was reversio referring toe mccain-feingold campaign finance law -- "that there would be a flood of money into campaigns unaccounted for and this is exactly what is happening." senator mccain, is it ever? in the 2010 midterm elections, the first after citizens united, there was more than a fourfold increase in expenditures from superpacs and other outside groups compared to 2006. with near three-quarters of political advertising coming from sources were prohibited

from spending money in 2006. also in 2010, 501-c-4 and c-6 not-for-profit organizations, spent more than $135 million in unlimited and secret contributions. this anonymous secret spending rose from 1% of outside spending in 2006 to 44% in 2010. we are already seeing the influence of money on the 2012 elections. super pacs and other outside groups spent around $140 million in this election cycle. that's about twice of what was spend during the same period in 2008 during the last presidential election. in the two weeks leading up to

super tuesday, outside pacs that supported the republican presidential candidate spent three times as much on advertising as the campaigns did themselves. there are already signs that things are going to get even worse. as reported by "the washington post," groups that do not reveal their funding sources have spent $28.5 million on advertising related to the november presidential matchup or about 90% of the total. 90%. and these groups that don't reveal their funding sources. our campaign finance system is broken. action is required to fix it. americans of all political stripes are disgusted by the influence of unlimited anonymous corporate cash in our elections, and disgusted by campaigns that

succeed or fail, depending on how many billionaires the candidates have in their pockets. more and more people feel that their government responds only to wealthy and corporate interests as they see their jobs disappear and their wages stagnate and bailouts and special deals for the big guys, they lose evermore faith that their elected officials are actually listening to them. and over the deafening roar of secret special interest spending, they get harder and harder to listen to. this growing consensus across the political spectrum was reflected in the brief that senator john mccain and i filed last week in american traditional partnership versus bullock. in that brief, we urged the court to reconsider the flawed central premise of its decision in citizens united. the proposition that independent

expenditures do not lead to corruption or the appearance of corruption. as the statistics about anonymous spending and public perception that i cited make clear, this premise is discredited. i'm proud to have worked on the brief with senator mccain, who has long been a leader in congress on campaign finance issues, and i hope that our partnership will mark the beginning of greater cooperation across party lines on this issue of vital importance to the integrity of our great american democracy. i also hope that the supreme court will take heed of the nearly universal opinion that the system that they've unleashed in citizens united puts our very democracy in jeopardy. until the court acts or until we enact a constitutional amendment to repair what they have done, we are left with one weapon in the fight against the overwhelming tidal wave of money

from special interests, and that is disclosure. at least make them fess up to who they are. that's why i stand here today in support of the disclose act of 2012. as i he said, disclose 2.0 in recognition of senator schumer's great work with the first disclose act. this legislation will shine a bright light on these powerful interests and their spending. with this legislation which now has 43 cosponsors in the senate, every citizen will know who is spending these great sums of money to get their candidates elected and to influence those candidates. particular thanks to the previous presiding officer when i began, senator franken; the current presiding officer, senator tom udall, as well as senators schumer and jeanne shaheen. senator schumer has been leading

the charge on disclosure since citizens united up ended and followed our campaign system. in 2010 with senator schumer's leadership we came within one vote of passing the original disclose act. and since then the problem of anonymous unaccountable special interest money has become much, much worse. we must redouble our efforts and pass disclose 2.0. disclose 2.0 says very two very simple things. first, if you're an organization such as a cooperation, a super pack, a 501-c-4 and spending money in an election campaign, you have to tell the public where that money came from and what you are spending it on in a timely manner. that should not be a controversial idea to anyone, at least to anyone who is not seeking secret special influence. this chart shows how easy it is under our current system for wealthy interests to anonymously spend millions on election ads.

this amounts to a form of legalized money laundering or identity laundering. super pacs are supposed to disclose their donors under current law, but if you want to avoid that disclosure, you can set up a shell corporation which may be nothing more than a p.o. pwofplt and send the money -- p.o. box and send the money through that. you can pass the money through a 501-c-4, so-called social welfare organization set up for that purpose, spending money in elections. think about that. the i.r.s. gives nonprofit status to groups whose primary purpose in many cases is to shield billionaires and corporations spending money in elections from having their identities disclosed. in many cases, the 501-c-4 groups are so closely affiliated with their super pacs that they have all the same staff, all the

same office space, and the c-4 groups still don't have to disclose the identities of their donors. on this chart, we see the money raised through the end of 2011 by two political groups started after citizens united by republican political operatives. these two organizations have the same staff and the same office space, and they run negative ads against many of the same candidates. one, american crossroads, is a super pac and is supposed to disclose its donors. the other, crossroads g.p.s., is a 501-c-4 group and doesn't have to disclose donors. guess which one has raised more money? of course it's the 501-c-4 group which doesn't have to disclose its donors. that group has raised $76.8 million as compared to only $46.4 million by its sister super pac. this is no unique situation.

for corporations trying to buy influence through spending in elections -- quote -- "nondisclosure is always preferred." close quote. as an unnamed corporate lobbyist recently told "politico." why? well, for one thing, there is no accountability, not to the company shareholders, not to their customers and not to the public. nondisclosure is -- quote -- "preferred because it makes it impossible for the public and for law enforcement to track the corrupting influence of the money that these corporations spend in elections." disclose 2.0 would put an end to using 501-c-4 groups and shell corporations to shield the identities of big campaign contributors. one thing that shouldn't be lost in this discussion of anonymous spending is the fact that there is one person to whom this spending is virtually certainly not anonymous, and that's the

candidate, that's the elected official. the donors manage to hide their identities from the public, but they can sure tell the candidate how much money they put in to that candidate's super pac and what positions they want the candidate to take on issues. what this creates is a perfect formula for corruption. wealthy corporations and individuals spending millions of dollars to influence a candidate without any oversight or public accountability or scrutiny. also, as a former attorney general, i know that the presiding officer can appreciate this as well, a well-heeled donor doesn't have to make the contribution necessarily, doesn't have to launch the ad necessarily. they can also secretly threaten a massive expenditure against a candidate if the candidate doesn't vote right on their issue.

political scientist norm ornstein recently said -- quote -- "i've had this tale told to me by a number of lawmakers. you're sitting in your office and a lobbyist comes in and says i'm working with americans for a better america, and i can't tell you whose funding them, but i can tell you they really, really want this amendment in this bill. and who knows what they'll do. they've got more money than god." if the candidate complies and does the right thing by the amendment or the right thing by the bill, the expenditure is never made. there will be no paper trail, no trace that that threat that drove a vote that corrupted that vote was ever made. the whole rationale for unlimited spending was that it was going to be done independently of the candidate's campaign. that has proven false. the reality is that super pacs are anything but independent. campaigns and super pacs share fund-raising lists, donors, former staff, consultants,

candidates appear at fund-raisers for their super pacs, and super pacs recycle ads originally run by the candidates. they are free to act as the -- quote -- "evil twins of candidate campaigns" as one f.e.c. commissioner put it raising unlimited anonymous money and then spending it on massive amounts of advertising, most of it negative, which further hides the identity of the interests behind the ad, because if all you're doing is trashing a candidate, you don't have to even show what your interest is let alone what your identity is. about 70% of ads in this election cycle have, as a result, been negative ads. up from only 9% in 2008. this brings us to the second thing that disclose 2.0 does. if you're a top executive or a major donor of an organization spending millions of dollars on

campaign ads, you have to take responsibility for your ad, just the way we do as candidates. these are reasonable provisions that should have wide support from democrats and republicans alike. as trevor potter, a republican former chairman of the federal election commission, said in a statement submitted to the rules committee of the senate, "disclose 2.01, quote, appropriately targeted, narrowly tailored, clearly constitutional, and desperately needed." we have made every effort to craft an effective and fair proposal while imposing the least possible burden on covered organizations. in passing this law would remove a dark cloud of unlimited anonymous money from our elections, and it would prove to the american people that congress is capable of fairness,

equality, and following the fundamental principle of government of the people, by the people, and for the people. i urge my colleagues to support the disclose act of 2012, and i yield the floor. i will suggest the absence of a quorum so that i may switch with the presiding officer and you may then take the floor. the presiding officer: the clerk will call the roll. quorum call: quorum call:

mr. udall: mr. president? the presiding officer: the senator from new mexico. mr. udall: i ask to vitiate the quorum call. the presiding officer: without objection. mr. udall: mr. president, i -- i was just listening to senator whitehouse who is now in the chair, and i just want to congratulate him on filing that amicus brief with senator mccain and the supreme court. i really believe that the supreme court should heed the good advice that both senator mccain and senator whitehouse have given them, and i think if they do not heed that advice, they will be -- the authority

that they have undertaken themselves would be taken away from them by the people, the people that are urging a constitutional amendment to give this back to the congress and back to the state legislatures, and i -- i join my colleagues today to highlight what i consider a significant problem in our country, the unprecedented flow of money into our democratic elections. over the past several months, a group of us have been working together to address this problem. we have asked the f.e.c., the i.r.s. and the f.c.c. to take actions that would help curb the impact of money on our elections. led by senator whitehouse, we have introduced the disclose act. this bill would shine a light into the dark corners of the campaign finance system. and senator bennet and i have introduced a constitutional amendment which currently has 22 cosponsors to overturn the disastrous judicial opinions that have led to the broken

system we have today. in january, 2010, the supreme court issued its opinion in citizens united verizon f.e.c. two months -- versus f.e.c. two months later, the speech now versus f.e.c. case was decided. these two cases gave rise to the super pacs. millions of dollars now bore into negative and misleading campaign ads and often without disclosing the true source of the donations. but our campaign finance system was hardly a model of democracy before these disastrous opinions. the citizens united and speech now decisions renewed our concerns about campaign finance, but the court laid the groundwork many years ago. we can go all the way back to 1976. that year the court held in buckley versus falleo that

restricting independent campaign expenditures violates the first amendment right to free speech. in effect, that money and speech are the same thing. the damage is clear. elections become more about the quantity of the cash and less about the quality of ideas. more about the special interests and less about public service. we cannot truly fix this broken system until we undo the flawed premise that spending money on elections is the same thing as exercising free speech. that only can be achieved in two ways. the court could overturn buckley and subsequent decisions based on it, something the current court seems highly unlikely to do, or we amend the constitution to not only overturn the previous bad court decisions but also to prevent future ones. until then, we will fall short of the real reform that is

needed. in federalist number 49, james madison argued the u.s. constitution should be amended only on great and extraordinary occasions. i believe we have reached one of those occasions. in today's political campaigns, our free and fair elections, are founding principle of our great democracy, are for sale to the highest bidder. i know amending the constitution is difficult, and it should be, but we didn't start this effort last year or even in the last congress. others before us have urged that this long-standing problem needs a long-term solution. many of our predecessors understood the corrosive effect money has on our political system. they spent years championing the cause. senator fritz hollings introduced bipartisan constitutional amendments similar it our amendment in

every congress from the 99th congress to the 108th congress. senators schumer and cochran introduced one in the 109th congress, and those were all before the citizens united decision, before things went from bad to worse. the out-of-control spending since that decision has further poisoned our elections, but it is also -- it has also ignited a broad movement to amend the constitution. i participated in a panel discussion in january with several activists in this movement. one of the panelists, maryland state senator jamie raskin was asked about overcoming the difficulty of amending the constitution. jamie said, and i quote -- "a constitutional amendment always seems impossible until it becomes inevitable. i think we are finally reaching the point of inevitability. across the country, more than 200 local resolutions have

passed calling for a constitutional amendment to overturn citizens united. legislatures in four states -- hawaii, vermont, rhode island and my home state of new mexico -- have all called on congress to send an amendment to the states for ratification. many more states have similar resolutions pending. over a million citizens have signed petitions in support of an amendment, and more than 100 organizations under the banner of united for the people are advocating for constitutional remedies. this grassroots movement is yielding progress. in addition to our amendment, several other campaign finance related amendments have been introduced in the house and the senate. senators leahy and durbin recently announced the chairman durbin judiciary subcommittee on the constitution will hold a hearing on the senate proposals on july -- will hold a hearing

on the senate proposals in july. i thank them for their support. the hearing will be a great opportunity to examine the different approaches to solicit input from constitutional experts and to have a national discussion about the need to return our elections to the american people. i hope this dialogue will convince some of my republican colleagues to join me. fixing our campaign finance system is only a partisan issue in washington. a recent "washington post"/abc news poll found that nearly 70% of registered voters would like superpacks to be illegal. among independent voters, that figure rose to 78%. but the court in its misguided reading of the first amendment told the congress that we can't rein in superpacs. in doing so, it give millionaires and billionaires unchecked power to influence our

elections. it has allowed a flood of pac money to drown out the voices of average americans. this is a fatal misreading of the real world of political campaigns, and it is wrong. supporters of superpacs and unlimited campaign spending claim they are promoting the democratic process, but the public knows better. wealthy individuals and special interests are buying our elections. citizens united has really meant citizens denied. our nation cannot afford a system that says come on in to the rich and powerful and says don't bore -- bother to everyone else. the faith of the american people and their electoral system is shaken by big money. it is time to restore that faith. it's time for congress to take back control. and, mr. president, just let me say i know the senator from rhode island, senator

whitehouse, has worked very hard on this issue, has pulled us together. we're going to have others, i believe, join us in this power. the crucial thing we're trying to say is we need reform, we need disclose, we need to get to the bottom of what's happening in this broken system and get our democracy back for the american people. so with that, i would note the absence of a quorum. the presiding officer: the clerk will call the roll. quorum call:

mr. whitehouse: mr. president? the presiding officer: the senator from rhode island is recognized. mr. whitehouse: mr. president, may i ask that the quorum call be lifted? the presiding officer: without objection. mr. whitehouse: thank you, mr. president. while we are waiting for the next speaker to arrive, i wanted to take a moment and discuss the brief that we filed in the

supreme court. senator mccain and i last week. let me first ask unanimous consent that a copy of the brief be admitted into the record. the presiding officer: without objection. mr. whitehouse: at the conclusion of our colloquy of remarks here so that people can refer to it if they are looking at those at the congressional record. the supreme court in the citizens united decision was in a difficult situation. no member of the court had ever run for office, run in an election. it may be the first time in the history of the country that no member of the supreme court had ever run for office, so it's a supreme court that has a -- as a corporate group was uniquely

inexperienced in the actual ins and outs of elections and politics. moreover, the way that the citizens united case came up to the court, the question that they ended up deciding was one that they asked for additional briefing on. it's a question that in many respects the court raised itself. and so it did not have the benefit -- the court did not have the benefit of the usual process of a case beginning in the trial court and amassing a record of evidence of testimony, of witnesses, of review of all of that at the appellate court level and then final review by the supreme court, so they did something very unusual. they actually made a finding of fact. now, a finding of fact is not something that supreme courts are supposed to do in the first instance.

that's the job of the trial judge and the jury if it's a jury trial. those are the fact finders in our system of law. and certainly, a supreme court that has an appellate tribunal between it and the trial branch as our federal system does, it's very unusual for them to be making findings of fact. they made findings of fact in this case, and unfortunately because they had no experience in elections, any of them, because they had no record, they made a finding of fact that was not in fact a fact. they made a finding of a false fact. and the mistake that they made was to determine that no amount of corporate spending in an election could create either the risk or the appearance of corruption. and i think the practical facts of that are pretty easy to

rebut. they stood that finding of fact, that premise on two subordinate premises, and we rebut both of them in the brief. if i have further time, i will come back to that, but i see that the senator from new hampshire is here and i do not wish to cut into her time. so i will yield to the distinguished senator from new hampshire and appreciate her great work through the long period of discussion and draftsmanship that brought disclose 2.0 to the floor, now with its 43 cosponsors. i yield. the presiding officer: the senator from new hampshire is recognized. mrs. shaheen: i'm pleased i could be here today to join you, to join senator whitehouse and our colleagues who have been working to try to bring to light for the public the really serious and ongoing problem of excessive campaign spending.

and i want to congratulate senator whitehouse for all of his work in leading this effort. it's been very important. this excessive spending has really been a problem for the last two years since the supreme court's decision in citizens united. because their decision has allowed for the formation of what's been called super pac's which are really organizations that can spend unlimited amounts of money without ever having to disclose where that money came from so the public doesn't know who's spending the money. doesn't know how that money -- the decisions about spending are being made. and now we're actually in the middle of the first presidential election since that supreme court decision, and we can really see the dramatic impact of that spending. there are now more than 500

super pac's registered with the federal election commission. they're permitted to raise and spend unlimited amounts of secret money to fund political advertisements. and, again, i want to emphasize the fact that we don't know where this money's coming from. we don't know if it's coming from corporations, we've heard a lot of stories, seen a loft stories that there are very wealthy individuals who are putting up money for these super pac's. but the amount of money that has been spent by these super pac's so far this election cycle alone has just topped $100 million. and nearly $80 million of that came from just five groups. so i think as we're looking at this money being spent, it's important for all of to us reflect on our national priorities. what does it say about our

country that we allow this kind of deluge of money to flood our electoral process? who is really being represented? are average voters in america being represented in this process? to provide some perspective, mr. president, i think it might be useful to examine what else this amount of money could pay for. in the past few weeks we've been discussing the importance of providing providers -- survivors of domestic violence and sexual assault with the resources they need by reauthorizing the violence against women act. well, $100 million, what's already been spent so far in this -- by knees super pac's, that $100 million could fund all of the domestic violence and sexual assault assistance in the entire state of new hampshire for 20 years. it could serve more than 320,000

victims. the new hampshire job training program provides workers with valuable instruction at community colleges across our state. it prepares workers for high-skilled jobs and creates a stronger economy. with $100 million, what's been spent by these super pac's, we could train 288,434 workers in new hampshire. $100 million would provide low-income heating assistance to more than 135,000 households. that's enough to keep new hampshire's neediest families warm for three winters. the starting salary for a police officer in the city of manchester, our largest city in new hampshire, is $50,000. with $100 million we could put an additional 2,000 police officers on the street. but instead, this money is being spent on political advertisements. millions of dollars from groups who refuse to disclose their donors, and most of these

expenditures are being made on attack ads. according to a study by the wesleyan media project, at this point during the last presidential campaign in 2008, just 10% of the ads were negative. now in this presidential campaign, 70% of those ads are negative. it's no wonder that americans are becoming increasingly disillusioned with our political process. the challenges confronting this country are significant. we need americans to be engaged and invested in our political process, not throwing up their hands in frustration as the attack ads pile up. we need campaign finance reform. and i've been he pleased to work with the presiding officer, with senator whitehouse, with all of those of our colleagues in developing the disclose act which makes some important changes to our current system

and senator whitehouse described the disclose act very well. but it will make sure that voters know who is really paying for all of these campaign ads, it doesn't eliminate super pac's, but it's a very important step in the right direction. i urge all of our colleagues to join us in calling for change and urging reform of our campaign finance system. i urge everyone in this body to support the disclose act. thank you very much, mr. president. i yield the floor. a senator: mr. president? the presiding officer: the senator from oregon is recognized. mr. merkley: i ask unanimous consent to ask a question of my

colleague from rhode island. the presiding officer: without objection. mr. merkley: thank you very much, mr. president. i was very engaged by the comments you were making a short period of time ago, senator whitehouse, and i was very struck as i have been all along about the substantial challenge posed by citizens united. and you were speaking to the impact on our constitutional system, and when i think about this, i often think about those first three words of our constitution, "we the people." is it your sense that this phrase, "we the people" that starts out the constitution is more than simple window dressing? does it go to the heart hoff and what we are as a society, as a nation? mr. whitehouse: the great experiment that the founders of this country embarked upon when they founded this country was to

allow for a democratic form of government that was governed by the people. not kings, not lords, not pharaohs, by the people. and it has been a consistent thread throughout threw our history -- through our history and at important times, as the civil war came to a close and our beloved president lincoln stood at gettysburg to give his great address, he talked about the importance of a government of the people, by the people, and for the people that has always been the core, heart, and hallmark of the american form of government and it has lit a blaze, really, that has illuminated the rest of the world as well. it's not just an american value. people have around -- from around the world look at this and say, you know, it can be that way. mr. merkley: if any three words were to summarize the heart of

the constitution, it would be those three words, "we the people." and we have a supreme court decision, citizens united, that essentially unleashes a flood of special interest money. is that fundamentally in con flift with the notion of we the people? mr. whitehouse: i believe it is. we operate in a modern world in which we are bombarded by media, and the average person, the average, ordinary member of the people does not have much access to that media, cannot get his or her voice much heard in that bombardment. but if you have enormous amounts of money, either because you're a corporation with a vast treasury or because you're a billionaire, you can take a big chunk of that media and you can use it to broadcast your view. and that will drown out other

voices that don't have that power. so it really does attack the basic premise of we the people. mr. merkley: so citizens united goes right against the very heart of our constitution. how is it possible that the supreme court found in this 5-4 decision that this has no corrupting impact on our -- on our electoral process? mr. whitehouse: i think three things went wrong. first of all, this is a supreme court that unlike most if not all other supreme courts has no political experience, none has ever run for office so they don't have the practical sense of how politics engages in an election. second, because they sort of invented this question, they didn't have a record where people who did know about politics and did know about elections and did know about corruption could assemble a record they could then learn from. so they were operating in a much

greater vacuum than the supreme court usually does and finally, they made two presumptions that supported it. one was that the super pac's and all these big entities would be independent from the candidates. as we've seen, that was a false assumption. that was a wrong premise. now the super pac's are connected to a candidate, they have one purpose, to get the candidate elected, they have funds raised by the candidate, they share staff with the candidate, they share consultants with the candidate, they use the same footage as the candidate. the idea that they are independent is really been made preposterous by the facts and the second was that there would be disclosure. so the public could at least evaluate, okay, this is the coal mining industry coming after somebody who is fighting for climate change, we get that, we can make an appropriate judgment about that use of corporate money to attack a candidate.

they were wrong about that as well and that's why we're here on disclose 2.0 and why you've worked so hard to get the floor in the good shape it has been. mr. merkley: so the supreme court envisioned this steel wall, between an independent campaign and a candidate's campaign and thereby saw fit to unleash unlimited money on of that wall while saying the other side has campaign caps and all that made sense together but their fundamental premise was wrong. mr. whitehouse: absolutely dead wrong as proven out by reality. it's not a theoretical wrongness, it's a factual wrongness, an actual wrongness. mr. merkley: most of our campaigns for u.s. senate involve millions of dollars, some are $2 million, some are $20 million, some are more. there are super pac's that have that much money. did the supreme court wrestle with the type of intimidation

that that creates, that presensorship impact on this body when someone is thinking about what should i say, do i want to offend someone who has not just $1 million but millions and millions of dollars to bring to bear? did they wrestle with the impact in corrupting the dialogue and the debate and the decisionsmaking of this body? mr. whitehouse: not only did they not wrestle about with it, senator, it's not clear they even thought of it. when you have nine people who come out of what people have call the judicial monastery, not quite the right word because they're men and women alike, but out of the sort of separate province of high-end adjudication, they're not familiar with this. they didn't think of that. the other thing they never thought of was that the threat of launching a multimillion-dollar negative attack against a candidate could have a corrupting effect even if no dollars were ever spent.

if the threat is successful, if the scheme works, then there's no trail left to it. before citizens united if you wanted to threaten that your threat was limited to a big pac contribution, having a fundraiser, things like that. it was not a real threat in tense the sense it could knock somebody out of their offense. now the idea that a corporate entity can hide its identity, can launder its identity through 501-c-4's and launch a multimillion-dollar attack in somebody's home state is a credible threat and that i think is danger among others that they overlooked threat completely. mr. merkley: i thank my colleague from rhode island very much for championing this bill and the work he's done to help folks understand this issue. i'll just make a few remarks. my colleague from vermont is standing by and i think would like to make some remarks as well. i wanted to have the key words that we're talking about put up before us here.

this is a picture of the constitution. at least the top of the front page, if you will. and i was always struck that our founders saw fit to start this document that lays out the framework for our nation, the framework for our system of governance with three simple words: "we the people." they got to it right from the very beginning. they didn't put in three paragraphs of polite this and that and then get to the heart of it. they started with the heart, we the people. and they didn't put it in small print. they put it in supersized print. you can see it's written in a font that's probably ten times the size of the rest of the constitution.. they deliberately said this is the premise on which our nation will operate, this is the

foundation on which we stand. now, these words are not, "we, the powerful." there's a huge distinction between "we, the people" and "we, the powerful." but the supreme court, in citizens united, attacked the very hearted of our -- very heart of our constitution by saying that the most powerful companies with vast sums of money can flood our political system, can buy up the airwaves and completely dominate the conversation. now, free speech wasn't about one side buying up the airwaves. of course, airwaves didn't exist then. but it wasn't about one side buying up the airwaves anddom anything the conversation, it was -- and dominating the conversation, it was about all ideas depaying with -- debating so the citizens could debate the pros and cons, who they would like to elect.

who would work best for "we, the people." the supreme court did not benefit from seeing the republican primaries of this year in prayer, they didn't see how a super pac would sweep into a state, buy up the airwaves, dominate the conversation and determine the outcome. no. they had some other vision. and my colleague has referred to the fact that none of the members of the supreme court had the political experience to understand the impact of this flood of money. now, you may be thinking to yourself, well, how much money can we be talking about? well, money beyond an amount that a working man or woman could ever envision. if you took it in dollar bills and stacked it in a room in your house, it would fill the room in your house plus. you couldn't get all those dollar bills into a room. we are talking about such an enormous amount of money that it completely controls the sound and the airwaves. let me give you an example. in 2008, if one of the rather

well-off companies in america -- and i'm going to use them as an example, they made a lot of money that year, the exxon corporation -- if they had spent just 3%, three dollars out of a hundred, of our they profits on the presidential race, they would have spent as much as the rest of america put together. that's the type of flood we're talking about washing across the cities and the countrysides of america, buying up the newspapers, buying up the airwaves and dominating the debate. that is not a competition of ideas envisioned in our constitution. that is, "we, the powerful." that is not, "we, the people." now, it is my hope that the members of the supreme court will stand back and realize that they're finding of facts was wrong, their finding of fact that there was no corruption from this flood of money was

wrong, their argument that it didn't attack the heart of the constitution was wrong, the fact that they didn't consider the precensor ship that this type of flood -- precensorship that this type of flood of money creates was an error and that they'll change their decision. but we can't be sure that this activist, right-wing court will consider the facts and reach a finding consistent with the constitution, the very heart of our constitution, we can't be sure of that so we have to do what we can in this chamber and that's the disclose act. the disclose act that says, at least at a minimum, this huge flood of money will be identified by the donor and it will be identified promptly so the citizens will be able to find out where it came from. and that the advertiselyments that are purchased by -- and that the advertisements that are purchased by this money will have debt claimers, they will say who the major contributors are so that citizens can see it in realtime. so when the group says that we

are the group america for green forests and blue skies and it's really by a very powerful group that is against blue skies and against green forests, you can find out who it is. that's the heart of this. citizens united is a dagger poised at the heart of the american constitution. we must reverse it and we must use every tool at our disposal to make that happen. i encourage citizens, summon your full instincts about what we value in our democracy and make your voices heard. let's get this disclose act passed and let's go further to reverse. thank you very much, mr. president. and i yield the floor to my colleague. the presiding officer: the

senator from vermont is recognized. mr. sanders: thank you, mr. president. i want to thank senator whitehouse and senator merkley and everybody else for the very hard work they've done on this monumentally important issue. it's hard for me to think of an issue that is more important. senator merkley a moment ago used the word "precensorship," which is an interesting concept and i want to give you an example of this. mr. president, i would ask unanimous consent to submit into the record an article that appeared in the "american banker" fairly recently. the presiding officer: without objection. mr. sanders: and let me read you what this article says. there is a member of the banking industry who contrasts what the old rules would have allowed and that is under the old rules, there are limits to how much people can contribute into a pac and that is $5,000 before the

primary, $5,000 after, a total of $10,000. and what this gentleman, mr. packard says, from the banking industry, he says, "if someone says i'm going to give your opponent $5,000 or $10,000, you might say, 'yeah, okay.' but if you say the bankers are going to put in $100,000 or $500,000 or $1 million into your opponents' campaign, that starts to draw some attention." what that gentleman is saying and what this whole issue is about is that if a member of congress is prepared to stand up to wall street, you better watch out. if you're going to vote for a bill that protects consumers, you better watch out because, as

this banker just said, there may be $500,000 or $1 million going to your opponent, going against the television and radio ads. so when members of the house and senate are thinking about how they want to address the recklessness and irresponsibility on wall street, if they are thinking, as i am thinking, about the need to break up these huge banks which have so much power and have done so much harm to our country, if you want to bring about reform of the fed so you don't have representatives of the largest banks in america sitting on regional feds, you know what? you're going to think twice about going forward because you're going to worry that when you go home on the weekend, there are going to be all kinds of ads, unlimited amounts of ads from the banking industry. or maybe you're concerned as to why in america we spend almost

twice as much per person on health conclude as any other nation. maybe you want to move, as i do, to a single-payer health care system. well, private insurance companies are not going to like that. they're going to pour huge amounts of money into advertising. or maybe you're concerned in america that we pay the highest prices in the world for prescription drugs. are you going to really take on the pharmaceutical industry if they now have the ability to spend unlimited sums of money? so, mr. president, i come to the floor this afternoon to express my profound disgust with the current state of our campaign finance supreme court and to call for more disclosure until we can finally overturn citizens united. and i know the presiding officer from -- the presiding officer from new mexico has a very good constitutional amendment to do just that. i have one. there are other good amendments.

long term, no question in my mind we need to overturn citizens united. in my view, it will go down in history as one of the worst decisions ever to come from the supreme court by a 5-4 decision. five members of the court came to the bizarre conclusion that corporations should be treated as if they were people and that they have a first amendment right to spend as much money as they want in elections even though corporations can't vote. so the average american, with pride, on election day goes out and votes. studies the issues, votes for the candidate of his or her choice. there are many people in this country who make campaign contributions. maybe they'll contribute $25, maybe they'll contribute $50. maybe if they have a lot of money, they may contribute $1,000 or $2,000.

but what citizens united is saying is that a small number of people who run large multinational corporations can spend as much as they want on campaigns. and if that is what american democracy is supposed to be about, you surely could have fooled me and i think many americans who put their lives on the line to defend american democracy. what american democracy is -- one person, one vote. we're all in this together. you may be rich and you may be poor, but under our constitution you have one vote. and this country has had to go through a very rocky process to ensure one person, one vote. in the beginning, poor whites couldn't vote, women couldn't vote, african-americans couldn't vote. and we struggled and we

struggled and we struggled and we said, in america, every citizen of this country is going to have their say on election day. that's what we learned when we were in election -- when we were in elementary school. that's what democracy is about. and by a 5-4 supreme court vote the supreme court said, hey, yeah, everybody has one vote, but if you're rich, if you're the head of a corporation, you can go into corporate treasuries and spend as much money as you want. the average joe, one vote. corporate america can spend unlimited sums of money buying the airwaves. and we're seeing this today. this it is -- this is no academic intellectual debate. people all over america are seeing the results of citizens united today on their television stations and on their radio stations. in the past few months, the american people have seen what

citizens united means. super pacs alone have spent over $112 million on this election, according to the center for responsive politics, and we're still more than five months away from election day. and if two weeks before the election you've got a billionaire out there, head of some corporation, who is to say that person cannot take hundreds of millions of dollars out of a large corporation and spend it on an election? totally legal. but not what america is supposed to be about. now, mr. president, i know you are aware of it, once again because of your excellent constitutional amendment, what we are seeing through our grass-roots -- throughout grass-roots america is that people are beginning to stand up and they're saying, no, we don't want citizens united. we want to overturn it. we want real democracy in this country. and i'm very proud that in the state of vermont and in four

other states, state legislatures now have gone on record saying overturn citizens united. 209 cities have passed resolutions to that effect, including some 50 or 60 in the state of vermont. and people are organizing all over america on this issue. and i just want to thank senator whitehouse and others for the work they are doing on this disclose bill. this is the very least that we can do, the very least that we can do, and i'm eagerly awaiting to hear the arguments from those people who oppose it. if i put an ad on as a candidate, if you put an ad on as a candidate, senator whitehouse puts an ad on television as a candidate, we have to say, as we should, "i approve this ad." if you're saying something nasty, you're saying something dishonest, the viewers have the right to know that you are behind that ad, you're not

hiding. but right now ads going on all over this country, who's paying for them? we don't know who's paying for them. we don't see their pretty face on the tv saying, i am the c.e.o. of this corporation, i approved this ad. we don't get the immediate disclosure that we should as to who's paying for that ad, and that's all that this disclose legislation does. so long -term, no question -- so, long-term, we need a constitutional amendment to overturn citizens united. it would be awfully nice if maybe our friends on the supreme court realized the error of their ways and acted accordingly. but, at the very least, here in the congress we need to pass a close piece of legislation and minimize the severe damage that citizens united is doing to our democracy. and with that, mr. president, i would yield the floor.

mr. roberts: mr. president? mr. president, it is my understanding i am to be recognized at 2:00, and we're at about 2:01, for ten minutes, and i know the leader will have something to say about 2:15 in regards to the progress of this bill. the presiding officer: the senator is recognized cht. mr. roberts: i appreciate that so much. mr. president, i rise today to speak on the legislation that is actually before us, as opposed to the topic before. the food and drug administration safety and innovation act we are currently debating. notiothis legislation includes y other important provisions members should know what's in this bill and just how important these provisions are. language to permanently reauthorize pediatric research incentives, programs to incentive antibiotic research and development, and more transparency and accountability

for the f.d.a. and stakeholders, which we hope will address drug shortages. that is a big problem not only in urban areas but in the rural health care delivery system, every state, every senator rot to be aware of that. i'm sure they're hearing about it. in play i joined senators reid, murray, alexander in introducing the better pharmaceuticals and devices for children act. that's the bpdca -- i don't think that makes a very good acronym, so i'm not even going to try it. back in 1997, congress passed the best pharmaceutical for children act, which acknowledged the importance of ensuring medications were effective and safe for children by providing an incentive for pharmaceutical companies to invest in pediatric research. and in 2003, with the passage of the pediatric research equity act, why, congress required that the pharmaceutical companies to

engage in these studies. now, these bills are often referred to as the carrot and the stick approach for pediatric drug development. now, i prefer carrots to sticks around here, especially mandates. but they have proven over time to work, the carrot-and-stick are approach. since the enactment of these laws, approximately 426 drug labels have been revised with important pediatric information, and the number of off-label drugs used in children has declined from 80% to 50%. that's certainly good news. in 2007, a complementary initiative to promote the development of pediatric medical devices -- that's the pediatric medical device safety and improvement act was enacted. now, this law has resulted in a fivefold increase in the number of small-market medical devices designated for pediatric use. now, the better pharmaceuticals

and devices for children act will permanently extend these worthwhile programs while providing some real predictability and accountability for pediatric drug and medical device development. the legislation also includes the generating -- pardon me, the generating antibiotic incentives act. i joined with senators blumenthal and corker in supporting this bill as of last year. this title contains provisions that aim to boost development of products to treat serious and life-threatening infections, something that is a growing problem in all of our hospitals. it provides meaningful market incentives and reduces -- get this -- reduces regulatory burdens. glory be. here's a bill that actually reduces regulations, to encourage development of new antibiotics. why? well, the antibiotic pipeline has slowed, mr. president, to an

alarming rate. according to the f.d.a., the approval of such drugs has decreased by 70% since the mid-1980's. this is unacceptable. the development of just one new antibiotic can take upwards of ten years. we must act now to avoid a potential health care crisis. now, when i'm back in kansas -- and i know when other senators are back in their states -- and talking to folks about health care, i often hear about the problem with short druggages. now, when a problem exists in an urban set, simply multiply that ten times and that's what we have in our rural areas. this is a crisis. as difficult as it is to hear from my hospital administrators and pharmacists in kansas about the difficulties they are having in e getting drugs to fill prescriptions, nothing compares

to the patients who can't get their drugs, who can't get their treatment, who are scared about their future and they can't get their lifesaving medication due to shortages. this is unacceptable. this is why i join the together with number of my colleagues to work together to see if we could come to a bipartisan consensus on a way to alleviate at least some of the burden that drug shortages do create. the legislation now requires reporting on drug shortages but also -- also -- it does provide some transparency and accountability in the hope that we can get to the root cause of this problem. now, not everything in this legislation is what i would have done if i had my choice. that's obviously the case with every senator on every major bill that we must make decisions on. but i am certain that many of my colleagues on the help committee are thinking the same thing, but i think we are pleased that we were able to come to a bipartisan consensus on this legislation, and in addressing

many of the issues that are affecting kansans and the rest of americans. i just talked to a fellow on the telephone last night that said, why can't you all work thought? why can't you pass something in a bipartisan way? this legislation is a good example of exactly what that gentleman was talking about, what a lot of americans are concerned about. in that regard, i really want to thank chairman harkin, ranking member enzi for awful their work -- for all of their work, for all of the work by their staffs and our staffs in putting together in important piece of legislation. this took a long time. it took a lot of effort, a lot of hard work. their commitment to a bipartisan process and their willingness to communicate with all the members of the help committee has led us through a relevantly noncontentious markup and i hope the same will happen as we consider this legislation on the floor. i yield back my time.

mr. president, i note the absence of a quorum -- oh. mr. schumer: thank you, mr. president. i thank my colleague for finishing his speech in a timely manner. i'm here to talk about little bit about the close act and citizens united. you've heard us talk about the need for full disclosure of money donated to campaigns. it is time for congress to stop stalling and let the american voters find out where the money being spent on elections is exphg from once and for all -- is coming from once and for all. all of our predictions of the aftermath of the flawed citizens united decision are coming true. this decision hand add megaphone to the wealthiest voices among us and strapped a muzzle on every other american. sure, average americans can talk to one another but not spending $10 million on tv ads, and we

know what kind of affect that has. if anything, the situation is even worse than we could have possibly anticipated because unlimited spending by just a handful of just the wealthiest americans has made true democracy in danger, a true democracy of one person, one vote, of true equality -- worrisome when you have such huge amounts of money being spent by so few people who seem to speak with one voice and one concerted point of view. the list of the top donors to supesuper pacs reads like a whos who of the richest people in america. the contributions to superpacs that were released in the most recent disclosure reports are astonishing. six-figure sums seem like pocket change now compared with today's trend of seven- and eight-figure donations. let's take bob perry, the top tp

donor to the group that ran smear ads questioning john kerry's military service in 2004. when you add up his donations to super pacs this cycle, we have almost $14 million of political influence from just one man. another example is harold simmons. when you combine his person aldo nations with the corporation he owns with his wife, you get contributions of $17 million to six different super pacs. and because disclosures to the federal election commission are only made publicly available once a month, this paints a fraction of the picture of total super pac spending and the reports don't even address spending through so-called nonprofit organizations organiz. as we all know, 501-c-4

organizationorganizations are ae as conduits for huge sums of anonanonymous funding. they function the same as the super pacs except they can't say vote for or vote against. but their effect on campaigns obviously intended is just as real. it doesn't stop at the federal level. we're also seeing the concern over corporate spending at the state level through the montana case, american tradition partnership v. attorney general bullock. this case hinges on a challenge to montana' montana's century-od campaign law. in fact, the fund raisers in this case, a group called american tradition partnership, solicits contributors by actually bragging about their secrecy. in their promotional literate a tour they promise donors "we're not required it promote the name

or the amount of any contribution we receive." so if you decide to support this program, no politician, no bureaucrat, no radical environmentalist will ever know you helped make this program possible." it is no surprise, given mounting concern about the corrupting effect of unlimit and often anonymous campaign spending on our democracy, that so much individuals and groups have filed amicus briefs in this case, including senators whitehouse and mccain, several house democrats, and dozens of others urging the court to uphold montana's 100--year-old law. we cannot sit idly buy and watch our democracy go for sale to the highest bidders. full disclosure, the kind that the disclose act of 2012 requires, is so necessary to shed light on which groups and individuals are funding or elections. to keep some mo modicum of faith that the voters at least know

what's going on. in 2010, the original disclose act passed the house, had widespread support from the senate and from the president but failed to gain cloture by one vote because not one republican was willing to step across the aisle and do what clearly the american people regard is the right thing. well, now there's no excuse. we've removed the original provisions that my republican colleagues most objected to. all tharm that remains is discl. the time to act is now while america's richest billionaires can atoured to keep contributing millions of dollars to super pacs and 501-c's, america cannot afford to be kept in the dark any longer. mr. president, i yield the floor.

the presiding officer: the clerk will call the roll. quorum call:

quorum call:

mr. reid: mr. president? the presiding officer: the majority leader is recognized. mr. reid: i ask unanimous consent the call for the quorum be terminated. the presiding officer: without objection. the majority leader is recognized. mr. reid: mr. president, the first thing we're going to talk about, i've had conversations over the last few days, in fact a longer period of time than that, with senators vitter and senator coburn, senator johnson, senator shelby and others on flood insurance. like a lot of things that happen, this has become critical that we do something on flood insurance. it affects almost six million people, and we need to get

something done on a more permanent basis. there's been a general agreement -- we don't have it in writing yet but i want to make sure the record is clear here on the floor what my intention is. is that we would have a 60-day short-term extension, and that extension there would be language for the duration of 60 days that would include in that the second-home subject that's part of the underlying bill that senator coburn has focused on. that would be for 60 days. then i would be happy to make a statement here on the floor today during the next work period that we will move to that bill, the flood insurance bill, so that we would have the opportunity to make it permanent. it's very important we do that, with the economy being such as it is, we can't in this area,

and probably others, but this one, we can't have short-term extensions that doesn't allow people to do what they need to do. 40,000 homes a day go through a process where they have to have flood insurance. if there is no flood insurance, that's 40,000 loans every day that will not be approved. so, senators johnson and shelby have done good work to narrow down the list of amendments that we would have to consider when the senate takes up this long-term flood insurance bill. it's my understanding there are a dozen or so amendments, six, eight on each side. i hope we can do that. if we can't do that, we're going to have to go to the bill anyway, and i want to make sure that senator vitter, who is on the floor today, understands that that's my understanding of things that he and i have talked about the last couple of weeks.

mr. vitter: mr. president? the presiding officer: the senator from louisiana. mr. vitter: mr. president, i thank the distinguished majority leader very much for this important announcement and this plan, and it certainly meets -- mr. reid: mr. president, it's my understanding that he was going to ask me a question, because i don't want to lose the floor. mr. vitter: i have no intention of his losing the floor. i just want to thank him for the announcement, and from my perspective, it meets the two main goals we've been in search of. first of all, making sure in the short term there is not a lapse of the program. that would be disastrous. that would cancel, as the majority leader suggested, thousands of good closings, really put a hiccup in the economy for no good reason. and in addition, get to a permanent bill in the next work period. so i appreciate the leader's announcement, and i would also note, as he did, that there's

been great work and great progress in narrowing the field of relevant amendments. i certainly hope that leads to a limited and reasonable number of amendment votes, as he does, on the floor. i understand what he said about if that becomes unwieldy, we'll just proceed with the bill as is. but certainly it's my expectation -- i'll continue to work on that amendment list so that we have a reasonable opportunity for relevant amendments. mr. reid: mr. president? the presiding officer: the majority leader. mr. reid: i'm glad the republican leader is on the floor. we've worked very hard to arrive at this point, i'm going to ask this consent agreement. i appreciate everyone's help, and it takes everyone's help to get to where we are. that's why we call them unanimous consent agreements. i ask unanimous consent that the only first-degree amendments in order to the bill that's now pending before the senate be the following: bingaman 2111, mccain 2107 --

the presiding officer: under the previous order the motion to proceed to s. 3187 is agreed to. the clerk will report. the clerk: calendar number 400, s. 3187, a bill to amend the federal food, drug and cosmetic act to revise and extend the user fee programs for prescription drugs and medical devices, and so forth and for other purposes. the presiding officer: under the previous order, amendment number 2122 is agreed to. the majority leader. mr. reid: thank you very much, mr. president. i'm sorry i got ahead of chair a little bit. i ask unanimous consent that the only first-degree amendments in order to the bill be the following: bingaman 2111, mccain 2107, sanders 2108

murkowski, cardin 2141, grassley 21221, 2129, manchin 2151, portman 2146 as modified. portman 2141 as modified. reed of rhode island 2126, coburn 2131, durbin 2137, paul 4143 and burr 2130, that there be no second-degree amendments in order prior to the votes or relation there to. that there be no points of order, motions or points of order to the amendments of the bill other than the budget points of order and applicable motions to waive or motions to table. that there be up to 30 minutes of debate on each of the amendments with the exception of the mccain amendment which will have two hours of debate, 60 minutes on the bill, with all time equally divided in the usual form. and at 2:00 p.m. on thursday, may 24 all debate paoeupl be

considered is -- time be considered expired and the senate proceed to votes, that there be two minutes of debate equally divided in the you're form prior to each vote -- in the usual form prior to each vote, that all after the first sroebt ten minutes -- vote be ten minutes. 60-affirmative vote threshold bingaman 2111, sanders 2109, murkowski 2108. upon disposition of the amendments the senate proceed to vote on passage of the bill as amended. that upon disposition of s. 3187 the senate proceed to the consideration of calendar number 365, 2343, that the only amendment in order to the bill be an amendment for the republican leader or his designee, the text of which is identical to 2366, that there be

ten minutes of debate on the amendment and the bill equally divided between the two leaders or their designees prior to a vote on the mcconnell or designee amendment, and no amendment be in order to the mcconnell or designee amendment, that no motions or points of order be in order to the amendment or the bill other than the budget points of order and the applicable motions to waive. that upon disposition of the amendment the senate proceed to vote on passage of the bill as amended, if amended, that the amendment and the bill be subject to a 60-vote threshold, that if the bill does not receive 60 affirmative votes s. 2343 be returned to the calendar and the motion with respect to s. 2343 be withdrawn. the presiding officer: is there objection? without objection, so ordered. mr. reid: so, mr. president, we're going to have votes on these amendments. it's my understanding that there's time, 30 minutes per amendment.

and we need to get as much of that done today as possible. we have an event for spouses tonight, so we're going to have to -- we're not going to be working late into the night. we have tomorrow to finish this. we should be able to do that. i hope we can. i hope it doesn't spill in -- there is no reason it should spill over until the next day. we're going to also have votes on the republican student loan legislation and on ours. that's what we're doing the next 36 hours. the presiding officer: the republican leader. mr. mcconnell: let me just add i think this is a good agreement that allows us to go forward on the f.d.a. bill with appropriate amendments and also allows an opportunity for the senate to express itself on the issue of the student loans. i would join the majority leader in encouraging people to do their debate today or in the

morning, because once we get into the votes tomorrow afternoon, they'll be dealt with in rapid succession. a senator: mr. president? the presiding officer: the senator from utah. mr. hatch: mr. president, i rise to discuss my amendment that would repeal the costly counterproductive medical device tax in president obama's health care law. in the mad scramble to find money to pay for his $2.6 trillion health spending law, the president and his democratic allies created a number of new taxes that serve no purpose other than to fuel

this new spending. economically, these taxes are a disaster. they will undercut job creation and they will increase costs for patients. the new 2.3% tax on medical device manufacturers which kicks in at the beginning of next year is particularly onerous. for that reason, last year i introduced legislation to repeal it. that bill, the medical device act, says an innovation protection act, s. 17, has been cosponsored by 25 of my colleagues. they understand that all of obamacare needs to go. the president's health care law is now over two years old and it is not aging well. even before obamacare became law, the american people made themselves absolutely clear that they wanted nothing to do with this washington takeover of the nation's health care system. the president and his advisors refuse to face reality, telling reluctant democrats that all is well in spite of the tea party town halls. according to the president and congressional democrat

leadership, as soon as the legislation became law, americans would come to embrace the wonderful benefits bestowed on them by the department of health and human services. it has not quite turned out that way. poll after poll shows that substantial majorities of americans continue to oppose the law and favorites full repeal. the majority of democrats think that the law is unconstitutional. in a matter of weeks, the supreme court might issue a coup to the government. whatever the supreme court does, i want to be clear about something -- all of obamacare needs to go. it needs to be pulled out root and branch. the entire thing needs to be repealed. that said, some parts of the law stand out for their wrong-headedness. the individual mandate and medicaid expansions are flat out unconstitutional. the ipab, the class act, the medicare cuts and employer

mandate all deserve honorable mention for being bad public policy. and among the most counterproductive parts of the law are the over $500 billion in new taxes and penalties. the medical device tax sits at the top of a list of foolish new obamacare taxes and my colleagues who have supported s. 17 and this amendment understand the critical importance of eliminating it. i want to thank in particular my colleague senator brown from massachusetts and senator toomey from pennsylvania who have spoken on this issue and understand completely the devastation that this tax will create for patients and for employers that provide good jobs for communities in their states. thanks to obamacare, medical devices will get hit with a $28 billion tax. and so we are clear about what these medical devices are. they include surgical tools, bed pans, wheelchairs, stethoscopes and countless other projects that patients and doctors rely on every day.

surgical masks, gloves, blood pressure monitors, scissors, needles, lights, stents, pacemakers, scales, scalpels, ankle, knee and hip braces and a lot more. the cost of all these products is going up, thanks to this tax. somebody is going to have to pay for it, and that somebody is the already overburdened american taxpayer and middle-class breadwinner. the president and his supporters seem to think you can simply tax corporations and individuals with impunity and face no adverse economic consequences. yet, economists understand that when you tax these companies, employees will pay for it in lower wages, the unemployed will pay for it with a job that was never created and patients will pay for it with higher health care costs. whatever economic circumstances, this tax is bad news but it is particularly foolish given the precarious state of our economic recovery. the president once liked to tout all of the jobs created or saved by his over $800 billion

stimulus bill, yet by supporting the medical device tax, the president and his allies have shown a real disregard for good, high-paying american jobs. medical device companies employ nearly half a million people. they pay a salary that is nearly 40% higher than the national average. these manufacturers are small businesses that we must be cultivating in our economy is going to recover and we're going to bring -- and we're going to be successful in bringing down unemployment. roughly 80% of medical device companies have fewer than 50 employees. 98% have fewer than 500 employees. obamacare's $28 billion tax hike on these manufacturers will do nothing to improve health care, but it will do plenty to undercut the viability of these companies that provide good wages and good opportunities for american families. according to one recent analysis, the medical device industry provided jobs to

409,000 employees in 2009, yet this tax could result in job losses in excess of 43,000. and it will hit certain states harder than others -- california, florida, illinois, massachusetts, minnesota, new jersey, new york, ohio, pennsylvania and wisconsin. my state as well, the state of utah. the presence of medical device manufacturers is significant in all of these states. this new tax will roughly double the device industry's total tax bill and raise its average effective corporate income tax rate to one of the highest effective tax rates faced by any industry in the world. the president and his allies frequently attack industries that choose to move their operations overseas, but they do not seem to grasp that their policies are driving these industries to do just that. with the onset of this new tax, u.s. device manufacturers are increasingly likely to choose plants in the united states and replace them with plants in

foreign countries. according to another report by the lewen group, the american technology industry contributes contributes $382 billion in economic output to the u.s. economy every year. and president obama in the middle of the weak economy, facing high rates of joblessness, has decided to attack that industry. it's bewildering to me. and industry that pays workers on average $84,156, 1.85 times the national average, has become a victim of the president's desire to pay for his new health spending law. or better put, those workers and the families they support become the victims of the president's health spending law. in my own home state of utah, the device tax is an issue of great importance. there are over 120 medical device companies in my home state of utah. as the utah technology council wrote in a letter to me, these

companies -- quote -- "are a vibrant part of the utah economy, providing high-paying, high-tech jobs for citizens of our great state." unquote. they certainly are all of that. they are under assault as a result of this tax. targeted for nothing other than their success and the fact that they were a so-called stakeholder that could pay its so-called fair share to subsidize the president's health spending bonanza. mr. president, i request that that letter be included in the record at this point. the presiding officer: without objection. mr. hatch: just yesterday, the governor of utah, the honorable gary herbert, sent a letter to congress addressing the negative economic impact this tax will have on our state. he wrote -- quote -- "as the governor of a state with a significant concentration of medical technology manufacturers, i believe this tax could harm u.s. global competitiveness, stunt medical innovation and result in the loss of tens of thousands of good-paying jobs." unquote. now, there is little doubt that

the president's medical device tax, one that unfortunately received the vote of every democrat in the senate, will do just that. kill jobs and undercut our economy. mr. president, i ask that governor herbert's letter be included in the record at this point. the presiding officer: without objection, so ordered. mr. hatch: mr. president, the president's health care law is a travesty. the american people know it. they think that it is fundamentally illegitimate, unconstitutional to its core and enacted over the deep and loud objections of citizens and taxpayers. all 2,700 pages of that law must be stricken from the u.s. code one way or another. eliminating its medical device tax is absolutely essential. it is critical for our states, for our economy and for america's families and workers. i ask for my colleagues to join the repeal effort, and i thank my colleagues who have already joined as cosponsors. mr. president, i would like to briefly touch on one other issue that is of great importance to me and to the people of utah and others all over the country.

over 150 million americans regularly consume dietary supplements as a means of improving and maintaining their health. the passage of the dietary supplement health and education act or dshea, in 1994 brought clarity, predictability and a better understanding of what the f.d.a. expected from industry and vice versa. dshea provides an appropriate structure that balances the risks and benefits to consumers with continued access and affordability. unfortunately, my colleague from illinois, senator durbin, has filed an amendment to the current bill that would undo that well-balanced approach. as the author of dhea, along with my dear friend and colleague, senator harkin in the senate, i strongly oppose his amendment. it would require facilities engaged in the manufacturing, processing, packaging and

holding of dietary supplements to register with the f.d.a., provided with a list of all ingredients as well as a copy of the labeling for each dietary supplement product. additionally, the facilities must also register with respect to new, reformulated and discontinued dietary supplement products. while i appreciate my colleague's commitment, his amendment is based on the misguided presumption that the current regulatory framework for dietary supplements is flawed and that the f.d.a. lacks authority to regulate these products. this is simply not the case. previous f.d.a. commissioners, including doctors jane henney, mark mcclelland, mark crawford and andy vonashenbach and dr. josh sharpsting have all agreed that dshea provides a sufficient level of oversight for this industry. under dshea, congress set out a legal definition of what could be marketed as a dietary

supplement and safety standards that products have to meet. it allowed the f.d.a. to develop good manufacturing practice standards and clarified what types of claims could be made. and it provided the secretary of health and human services with the authority to impose an immediate ban on any dietary settlement that poses an imminent risk to public health. dsea already provides the secretary with enforcement tools of seizure, injunction or criminal prosecution for ingredients that pose an unreasonable risk of illness or injury, are poisonous or deleterious, contain unapproved drugs or food additives or fail to meet good manufacturing practice standards. furthermore, under the dietary supplement and nonprescription drug consumer protection act, a manufacturer, packer or distributor whose name appears on the label is required to report a serious adverse event related to the use of a

supplement within 15 business days to h.h.s., submit any related medical information received within one year of the initial report within 15 business days, maintain records related to each report for six years and permit inspection of such records. to me, that sounds like a whole lot of regulation. the f.d.a. already has a tremendous amount of regulatory oversight and enforcement tools when it comes to dietary supplements. yesterday, instead of urging f.d.a. to use its current enforcement authority to find and publish those companies that are not following the law, senator durbin's amendment serves to punish all responsible companies with its overreaching mandate. should i say mandates. finally, i would be remiss if i did not mention another obvious point. senator durbin's amendment would have the devastating effect of piling on more work for an

underfunded agency already struggling to keep above water with its current core responsibilities. let me just say this. before we passed dshea, there basically was no regulation over this industry. we brought together, senator harkin and i, the whole dietary supplement industry to get behind dshea. they are behind it. it took over ten years to get the good manufacturing practices completed by f.d.a. more than ten years, as a matter of fact. but we provided for them and had agreement. we provide all the tools that are necessary to supervise and regulate dietary supplements, and to now add other obligations onto this industry is just plain not right. i hope my colleagues in the united states senate and the house of representatives will recognize that this is an overreach and not put up with

it. i'm going to be voting against senator durbin's amendment and i urge all our colleagues to do the same. i'd like to pay tribute to my colleague, senator harkin from iowa. he worked assiduously on this bill along with me. we worked all the way through the senate on a number of occasions, we've improved the bill from time to time, we've gone along with the improvements, we've done everything we can to protect the american citizens, everything that should be done, nothing further needs to be done. this is an industry that really deserves support, not condemnation. and senator harkin has been there every step of the way. he's a champion for the dietary supplement industry, as am i. and a lot of others in this body. i think it's time to quit trying to overregulate everything to death and cause the cost to go

up by leaps and bounds. dietary supplements are not inexpensive today although they are a lot less expensive than they would be if we keep piling on these regulations. and frankly, we believe that we have all of the necessary language in law today to protect the american public from deleterious dietary supplements and we've again f.d.a., the food and drug administration, all the authority they need, and every f.d.a. commissioner has met with me, as i recall, since dshea was passed in 1994 and have said that they have enough tools to be able to supervise this industry properly and that they don't really need anything more. to make a long story short, again, this is an overreach by our colleague, sincere though he may be, it's important to -- and as important as he may be and i hope he will withdraw his amendment so we don't have to go through this

again. but if he won't, and i -- then i hope all of our colleagues on both sides of the aisle, because this is a bipartisan effort, on both sides of the aisle will rise up and say we've had enough of this and let's vote these kind of amendments down. with that i yield the floor to -- i yield the floor. mr. harkin: mr. president? the presiding officer: the senator from iowa. mr. harkin: i want to thank the senator from utah for his concluding remarks regarding the amendment that will, i assume will be offered, it's clear to be offered by the senator from illinois. i just want to, again, thank senator hatch for his great leadership on the issue of making sure that the american people can have access to healthy, life-supporting vitamins, minerals, supplements, without having it to go through untold processes

and reviews and approvals by f.d.a. and all that kind of regulation. senator hatch was the leader on the dshea bill when we passed it in 1994. i was happy to work in tandem with him on that. and it has proven through the years to be of great success for the american people. the american people all over this country take vitamins and supplements, they're healthier, they want to take charge of their own health and they're living healthier because of this. i just -- i say to my friend from utah, i heard the senator from illinois yesterday here on the floor, give a very impassioned speech about a very sad case, a young woman who evidently consumed some energy drinks with a lot of caffeine, had heart arrest and died, very sad story. a very sad story. but as sad as that is, you

know, you can't -- you just can't keep people that abuse things. i've said there are people who die every year from aspirin poisoning, they take too many aspirin. so, you know, a reasonableness has to enter into this. we have -- we've worked together to make sure that the labels are good on all of these things, that people know what's in them, that f.d.a. has the authority as the senator said. the f.d.a., every commissioner said they have the authority to keep dangerous products off the shelves and removal themselves -- remove them from the shelves. they have all that authority. so, you know, these cases like senator durbin brought up, they're sad, very sad and you wish it weren't so. but i don't think that that lends itself then to overturning what has been working now for 18

years -- no, 17 going on 18 years. working well for the american people. so i -- i just join with the senator from utah. i would hope that the amendment might be -- might not come up. but if it does, it does. and i'm sure there will be some debate on it. but i would join with the senator from utah in urging all members of the senate to -- to vote that amendment down if the amendment does come up, i would -- i would move to table that amendment, by say to my friend from utah, and hopefully that we can approach this in a much more judicious, responsible, thinking manner. i would just say to my friend from utah and i know he agrease -- agrees with me on this. i'm sure we're not taking the position nothing can ever be changed and we've changed dshea to make it work better but we've done it after due deliberation

and thoughtfulness and committee hearings and going through the process to see just what this means in terms of access to these products by the american people to make sure that we keep the intent of dshea there. so, again, i'm more than willing as chairman of the committee, senators -- used to be chairman of the committee, was chairman at that time and ranking member. that we're always willing to look at these things and take a hearing on it and get information. so, again, i just thank the senator from utah, he's been a great leader on this and i appreciate his -- mr. hatch: i appreciate his leadership on this matter. i know senator durbin is very sincere but my gosh, there's enough regulation and regulatory authority in this bill and including the amendments that we've added voluntarily over the years to resolve any problem that exists. and frankly, i hope everybody will vote against the durbin

amendment. thank you. mr. harkin: i thank the senator from utah. mr. president, i -- mr. harkin: how much time is

remaining on the bill? the presiding officer: on general debate, 24 1/2 minutes. mr. harkin: i reserve the balance of my time on the bill. i would ask if senator durbin is on the floor, if you'd like to bring up your amendment then and we could begin debate on the amendment. the presiding officer: the senator from iowa has the floor. mr. harkin: mr. president, again consuming my time on the bill, i understand i have 24 minutes left. the presiding officer: that is correct. mr. harkin: i would just make a short general statement about the bill. i've talked about it in the past, i don't mean to take too much time but i want every senator to know that we are now on the f.d.a. reauthorization bill. this is reauthorizing the prescription drug user fee, the medical device user fees, then we are authorizing a new program, the generic drug user fee, the biosimilar user fee,

and -- and so we're on the bill now. there are 30 minutes of debate on each amendment that has been listed, senators know who they are and what those amendments are. i just want to make it very clear that the unanimous consent that we just adopted says that all debate time will expire at 2:00 p.m. tomorrow. at 2:00 p.m. tomorrow. so i say to senators if you want to take your 30 minutes and debate your amendment, now is the time to do it. if you wait too long, 2:00 will come tomorrow, you won't have the time and you'll be limited to one minute. there will be two minutes on each amendment after that, so you'd be limited to just one amendment. those who have amendments and wish to discuss them, you're guaranteed at least 30 minutes but all time runs out at 2:00 p.m. tomorrow. i say to senators, again, if you'd like to talk on your

amendment and make your points, now's the time to do it, this afternoon. so, mr. president, i yield the floor. mr. durbin: madam president? the presiding officer: the senator from illinois. mr. durbin: i have an amendment pending and i call up amendment 2124. the presiding officer: the clerk will report. the clerk: the senator from illinois, mr. durbin, proposes amendment numbered 2127. the presiding officer: the senator is recognized. mr. durbin: this amendment is very straightforward. i'm not going to ask for a show of hands among monica senators or staff, how many of us got up and took a vitamin pill but i'll say this senator did. i didn't have a prescription for my vitamin pill, i bought it voluntarily, i don't know if it does any good but it's my decision. i think that's a good thing. the food and drug administration is an agency which takes a look at what we buy and what we consume. and it has an important responsibility. when it comes to certain things

like prescription drugs, they test them. maybe the pharmaceutical company actually does the testing but the f.d.a. monitors to make sure that what is given to you by your doctor is safe, won't kill you, and effective, does what it says it's going to do. same thing true for over-the-counter drugs. the food and drug administration has that responsibility. and when it comes to the ingredients, the dosage, those sorts of things are established through the food and drug administration based on disclosures by the companies, testing, experience, it's all there. but there's another world out there, completely different world called dietary supplements which includes the vitamin pill i took this morning as did the chairman. that isn't much -- is a much different world. it is a world with less disclosure, less transparency, and far less regulation. in fact, in fact, there is no requirement in the law today,

none, that the people who sell us dietary supplements have to register with the food and drug administration the name of their product, the ingredients it contains, and a copy of the label. that's what my amendment says. we don't require any testing by dietary supplement companies. we don't require any assertions of safety. just simply that they register with the f.d.a. that they're selling in america. so that to me seems like a pretty basic thing. and it isn't my idea. it isn't an original idea. it comes from a report from the general accountability office in 2009. here's what they recommended after they made a review of the safety issues with the food and drug administration. to improve the information available to f.d.a. for identifying safety concerns and better enable f.d.a. to meet its responsibility to promote the public health, we, the g.a.o., recommend that the

secretary of department of health and human services direct the commissioner of the f.d.a. to request authority to require dietary supplement companies to identify themselves as a dietary supplement company, as part of existing registration requirements and update this information annually, provide a list of all dietary supplement products they sell and a copy of the laibilities and update this information annually and report all adverse events related to the dietary supplements. in other words, did you take the pill and get sick. does that seem like an onerous, hef-handed, big-government, overregulation of an industry? remember, the dietary supplement companies are not all based in the united states. there are products sitting on the shelf which if you don't look carefully you may not know come from a lot of other countries, including china. so do we want to know? when you go in the vitamin store, would you like to know that the company that's selling

you whatever it is is at least registered in the united states? is that too much to ask, that if you're going to sell the product in the united states, you have to register with the f.d.a. and tell was the ingredients are? that to me seems pretty basic and i'll bet you 99% of american people thought i thought they already did that. no, they don't. no requirement in the law. dietary supplement is outside the law. let me tell you dietary supplements go beyond the vitamin pill. yesterday i told the story on the floor, 16-year-old girl in hagerstown, maryland, she drank two monster energy drinks. ever seen them? when you go in the store you see cokes and all those things and there's a monster energy drink. there are all kinds of them out there. she drank two of them and died. killed her. cardiac arrest. i met with her mom yesterday. she said i ran in there, her boyfriend said she stopped breathing while weechg tv. they took her to the hospital,

got her back to life for a little while and she lingered and died a few days later. it was a dietary supplement. is it too much to ask the company making the monster energy drink to register with the f.d.a. and tell us what the ingredients are in that drink? is that the heavy hand of government? i don't think so. because here's a what we found. sometimes ingredients that may appear to be benign and okay today turn out to be dangerous when you look at them more carefully and more closely and maybe more dangerous for people who are younger or pregnant or in a compromised immune situation. so this amendment basically says american consumers have the right to know that the dietary supplement sitting on the shelf has at least shown up and registered with the f.d.a. i heard senator hatch and senator harkin say this just goes too far. it's too much to ask. i think they're wrong. manufacturers already, some say, already voluntarily

provide product labels this to the national institutes of health. it's true but it's a voluntary system. good actors share their labels with the n.i.h. but the bad actors don't. n.i.h. is in the process of building a label data base that currently has 7,500 -- 7,500 -- dietary supplement labels. do you know how many products are on the market? they have 7,500 be labels. 75,000. 75,000. so 10% of volunteering this information. so to say the n.i.h. already has the information is 90% wrong. requiring registration they say of these labels is just too much work for the f.d.a. as a matter of fact, the f.d.a. responded to the g.a.o. recommendation and said we agree the agency's abuilt to ensure the safety of dietary supplements used by consumers would be improved if f.d.a. had more information on the identity of firms marketing dietary supplements as well as the

identity and compositions of the products they market. the f.d.a. said we want this information to keep americans safe. so to argue that this is a burden we shouldn't put on the f.d.a., they asked for it. the other thing is about how many supplements are being said in the united states. i said 5,000. that was the estimate in -- i said 75,000. that was the estimate in 2008. the number i'm afraid is much larger. and in terms of how many come on the market each year, it's just a guess -- it's a wild guess because it's the wild west, it's an open market. any country that wants to export their dietary supplement to the united states, whether it's from china or india or africa or europe or mexico, be my guest. you don't even have to show up and register with 9 f.d.a. it's a -- register with the f.d.a. it's a simple amendment. it just says if you want to do business in the u.s., sell your dietary supplement, tell us who you are, tell us what it looks like, tell us what your label says. it's not too much to protect families from harmful

consequences. i reserve the balance of my time. mr. president, i ask unanimous consent that the time senator hatch used be counted retroactively against the time in opposition to my amendment number 2127. the presiding officer: without objection. so ordered. a senator: mr. president? the presiding officer: the senator from wyoming. mr. enzi: speaking on this amendment, i appreciate the concern and the interest and the effort that the senator from illinois has gone to on this bill, but in looking at it, there's still a couple of steps that are missing if this were to become law. yes, it would provide a lot of information at the f.d.a. it would, in fact, flood them with information. and i think it would food them with more information than they could possibly process. but that part doesn't even bother me. what bothers me is, how do you get that information to the consumer? it's the consumer that needs to

know what they're drinking, eating, everything else and that's why we provided labeling on a lot of things. but even the things that we already provide labeling on, the consumer doesn't necessarily pay a attention to it. and probably the people that need to pay the most attention to it don't pay any attention to it. and so just making this information available to the f.d.a. doesn't get it to the point where the consumer can know. and, of course, any time we start talking in this area, people get really worried about the amount of regulation that we put on -- on things that they consider to be very important to them and do know harm. so -- do no harm. so i think the right way to address this issue would for the help committee to hold hearings and to work together, weaves done on this bill, to find common ground -- as we've done on this bill, to find common ground on the policy. and when we have common ground, like we have on this f.d.a. bill, then we can get something done. i think this is a bit premature so i would hope people would not support this amendment at this

time. i yield the floor and reserve the balance of our time. mr. harkin: mr. president, how much time -- the presiding officer: the senator from ohio. mr. hark iin: n: how much time s remaining on this amendment? the presiding officer: seven minutes in favor of the amendment. mr. harkin: mr. president, i just want to say, first of all, i have the greatest respect, as he knows, for the senator from illinois of the he is -- from illinois. is he one of the true consumer champions in the entire congress and has been for all of his time here. and so it's kind of hard to argue against senator durbin when he is such a champion of consumers. but on this issue, i think we part a little company. i just -- i want to make it very clear that it's -- it's -- that under deshea, already supplement labels must disclose their ingredients. must disclose their ingredients. even when a product is

reformulated, if the supplement contains new ingredients, then the label must reflect that change. these were all added, that we added for consumer protection. now, again, it's not as though f.d.a. doesn't know what's out there. under current law, supplement manufacturers have to biannually register their stuff. there's a biannual registration requirement right now so that -- really, the concern is that the agency just -- f.d.a. just doesn't have the resources to do anything. i've tried -- the senator knows, he's on the appropriations committee -- to get more funds for the f.d.a. to do this but we haven't been able to do it, to get the funds necessary for the f.d.a. to even do what jobs they're supposed to do now. and i repeat, for emphasis sake, every f.d.a. commissioner, that was reported by democratic presidents or republican presidents, as said that deshea gives them adequate authority to

keep dangerous products off the shelves. so the authority is already there. what f.d.a. needs is the resources. that's money and that's appropriations. and, quite frankly, i don't see that happening this year, that we're going to get anything more. we're just going to give them more of a burden to do and i think it's going to give a false sense of security to people because f.d.a. simply won't be able to do this. lastly, as the senator did say, we do have a voluntary registration program of ingredients and stuff with the office of dietary supplements at the national institute of health so that's already there. that coupled with the biannual reporting requirements plus the fact that every dietary supplement has to have the ingredients listed on the label. so there's plenty of consumer protections out there. it's just that you can't protect a consumer who doesn't want to follow directions, who doesn't want to follow the guideline as that are listed on the labels themselves. i don't know how you protect people from that. sometimes you just have to

continually tell people, follow directions. follow the directions, you'll fine. so i -- that's why i think this amendment is ill-timed. i said to the senator -- and i mean this -- i said it with the senator from utah, our committee would be more than happy to have hearings on this, again, to flush it out a little bit more and to see just what might be possible. but i come down to this. bottom line -- the f.d.a. needs more money and they need more personnel to do this job. i yield the floor. mr. durbin: how much time is remaining on the amendment? the presiding officer: seven minutes. mr. durbin: on my side? the presiding officer: on your side. mr. durbin: any time remaining on the opposite? the presiding officer: one minute. mr. durbin: one minute. let me just say -- and i respect the senator from iowa. he and i work on so many things, and the senator from wyoming as w. they're two excellent colleagues, good people, and this is a tough bill. and the underlying bill is a masterpiece of bipartisan accomplishment that they can both be proud of.

what i'm saying here about dietary supplements is no reflection on you, senator harkin, or senator enzi. this is an industry which i've been watching for a long, long time for a variety of reasons, and i would say the argument that senator enzi made that merely disclosing the label ingredients and name of the product to the f.d.a. doesn't get the information to the consumer really argues for a much bigger amendment than i'm offering. it argues for a web site and access and so forth, and i -- i understand that going in. i agree with is that right harkin. it's an overreach in this time of budgetary problems. i wish we could do it. i think we should. i think we have an obligation to. but i didn't put it in here because i knew the first thing they'd say was, we can't afford it. we went to the f.d.a. and said, if -- do you want this information? they said, not only do we want it, we've already publicly stated we want it in reply to the g.a.o. report. and we said, can you handle it if we send you the basic information of the products

presently being sold. they said, yes. now, you can go further and say more can be done. that calls for a bigger role of government than even this amendment suggests, but how do you argue -- how do you argue, when the institute of medicine tells us there are a thousand new products a year coming in called dietary supplements on the shelves all across america, in stores and drugstores, where families and children are walking in buying them, how do you argue that we don't want to know you're here, we don't want your chinese product that just made it to the shelf in springfield, illinois, to register with the f.d.a. before you do business here? how do you make that argument? wouldn't you assume as a consumer, a family member, when you walk in the store that somebody, somewhere knows this company exists, that this product exists? right now they don't. the only disclosure to the government is voluntary. and as i said, about one out of ten products, companies, volunteer the information.

that, to me, is not the way to protect consumers. why do we need this information? simply said, when an ingredient turns out to be dangerous, we want to know if that ingredient is in more than one product and go after it to protect american consumers. if you don't know the product's in the united states and you don't know the ingredients, how are you going to find that out? wouldn't we want that basic information? god forbid something happens with one of these products, someone loses their life, like this poor young woman in hagerstown, maryland, drinking that monster energy drink -- two of them. she had two of them and it killed her. cardiac arrest. god forbid that happens again and we say, you know, we didn't even know that product was in america. they don't have to tell anybody anything. now, the argument made by senator harkin is, they have to put a label on the product. that's a good thing. we also find out that sometimes the ingredients that are listed

aren't the actual ingredients. i won't get into that. it's a whole other issue that the f.d.a.'s working o. but that isn't enough. you ought to see some of the claims that being made on the labels of these dietary supplements. they are preposterous. not for all of them. some of them are basic and good. but some of them go way overboard. don't we owe it to consumers across america to give them the basic information, to at least let them know we know the name of the company and the ingredients and the product being sold? some people say that's just too much to ask, they ought to be able to sell whatever they want in america and never tell a soul. i don't buy it. i think we have a responsibility in congress to protect these families. i reserve the balance of my time. mr. harkin: mr. president? the presiding officer: the senator from iowa. mr. harkin: just one minor correction i would make and that is that under deshea law, that the f.d.a. must approve any health claims made by any dietary supplement or vitamins. and the only health claims that they can make are structure

function claims. but they have to be approved by the f.d.a. i just wanted to clear up -- clear up that point. i would also say further that i honestly don't know of any vitamin or supplement out there that's out in the market now that is dangerous to you if taken as directed. if taken as directed. as i said, anybody can abuse things. but if taken as directed, i, quite frankly, don't know of any supplement out there that is dangerous. quite frankly, if taken as directed, they help you maintain your health and keep you healthy rather than -- rather than being injurious to your health. i yield the floor. mr. durbin: how much time is remaining? the presiding officer: three minutes. mr. durbin: i'll just close. i thank the senator from iowa. he will acknowledge, i hope, that no one tests dietary supplements. no one tests them. companies that make these products may test them if they

wish. there is no requirement under law that they test them. and there's certainly no agency of government that tests the dietary supplements. so to say they're perfectly safe as they instruct to you take them on the label, how would you know that? how could you possibly know that? there's no testing involved. when it comes to prescription drugs and over-the-counter drugs, there's testing involved. and at least we can point to the tests to say whether it's safe, whether it's effective. dietary supplements -- a whole different world. and i will just tell ya, if we are conscientious enough on behalf of consumers to limit the amount of caffeine that you can put in a cola and then a company like this monster drink company decides to call theirs a dietary supplement, not a beverage, not a food, no hold's barred, they can put as much as they want in, that's why that poor girl died. two monster energy drinks, 480 milligrams, i believe, of caffeine, and she died from cardiac arrest. is it too much to ask that we know the ingredients and know the company?

the next time there's another tragedy, i would like to be sure that we can say we at least made this modest, tiny, small step forward to say to the industry, if you're a good actor, don't be threatened. but when it comes to bad actors and things coming in from overseas, we're going to make you show up and at least identify who you are and what you're selling, period. that's it. so at this point i yield the floor and yield back the balance of my time. i suggest the absence of a quorum. the presiding officer: the clerk will call the roll. quorum call: mr. harkin: mr. president, i ask unanimous consent that further proceedings under the quorum call being dispensed with. the presiding officer: without objection. mr. harkin: i have to ask, how much time left on the bill for

both sides? the presiding officer: the majority has 19 minutes. the minority has 29 minutes. mr. harkin: again, i see that senator sanders is on the floor, and i assume ready to call up his amendment. i yield the floor. and sanmr. sanders: mr. chairma, thank you -- the presiding officer: the senator from vermont. mr. sanders: mr. chairman, thank you very much for your hard worng this legislation, for the opportunity to talk about what i consider to be a very important amendment. the amendment is -- i would like to call up amendment 2109. the presiding officer: the clerk will report. the clerk: the senator from vermont, mr. sanders, proposes an amendment numbered 2109. at the end of title 11, add the following:

section -- san mr. sanders: i would ask that the amendment be considered as read. the presiding officer: without objection. mr. sanders: this amendment, to my mind, is an exstrombly important amendment -- extremely important amendment, and it has the support of some of the major consumer organizations in our country, including public citizen, u.s. pirg, the consumer federation of america, consumers union, the national committee to preserve social socia social sed medicare and the national women's health network. these really are some of the large consumer organizations that are in america representing tens and tens of millions of our people. mr. president, when we talk about prescription drugs, it's important to understand that in our country we pay, by far, the highest prices in the world for prescription drugs.

that's simple -- that's simply the reality. and that causes enormous problems because millions of our people go to the doctor, the doctor writes a prescription, and then the person can't afford to fill that prescription. so that's pretty crazy because doctors are doing their diagnosis, telling the patients what they need, the patients can't afford to pay for the drugs because they have the highest prices in the world in this country. so, mr. president, this is an issue that we have got to deal with. now, there are a number of reasons why prices in this country are higher than in canada, europe, scandinavia, and certainly one of them is that we are the only major country on earth that doesn't have a national health care program so that the government can negotiate prices with the drug companies. so what happens in this country

is the drug companies simply charge us what the market will bear, any price they can come up with by which they can make money, and the end result is that we pay -- in 2009, prices in this country were 85% higher than canada, 150% higher than france, italy, sweden, and switzerland and so forth and so on. but the reason the drug prices are high in this country is not just that we don't have a flat health care program -- a national health care program, it's because of the enormous amount of fraud that takes place within the pharmaceutical industry. in fact, every single year the major drug companies are ripping off the american people to the tune of billions of dollars a year because of fraudulent practices.

well, i do not have enough time here today to recite every example of fraud that have been caught and prosecuted in the last ten years. i would ask unanimous consent to enter into the record my full statement, which catalogs a a lg list of the most egregious examples. but here is the bottom line, and i am going to list some of the cases of fraud. virtually every major pharmaceutical company in this country has either been convicted of fraud -- i.e., ripping off federal government, state government or individuals -- or else has reached a settlement. and we have got to get a handle on this crisis. now, i want to read -- i am going to bore some people because it is a long list. sadly, it is a long list. but it is a list that has to get outer, and it is an issue that -- that has to get out, and it

is an issue that we have got to deal with. here we go. abbott labs is one of the top ten pharmaceutical companies in the world. it had $4.7 billion in profits in 2011. just last month, abbott reached an agreement with the u.s. department of justice to pay $1.6 billion for illegally marketing the antiseizure drug depicodium. according to "the new york times," "as part of the agreement, abbott said that it would pay $800 million to resolve civil cases brought by federal and state authorities, $700 million in criminal penalties ands is 0 and $100 min connection with consumer matters." that was just last month. they're going to pay $1.6 billion. in 2010, two years ago, abbott

and two smaller companies collectively agreed to pay $429 million to settle charges that they deliberately misreported drug pricing in order to hike reimbursements from medicare and medicaid. that's abbott just in recent years. pfizer is the largest pharmaceutical company in the world, $67.9 billion in revenues and $10 billion in profits in 23011. pfizer in 2012, this year, pfizer alleged willed avoided paying hundreds of billions in rebates due to state medicaid programs for aprontonix. pfizer holds four different exclusives for aprontotnix. talks are under way to settle the charnls for up to $2 billion. and this is for ripping off medicaid. in 2009, pfizer agreed to plead

goilt a felony of misbranding dextra and pay $1 bhl to resolve allegations your honor the civil false claims. 2004, a division of pfizer pled guilty to two felonies and agreed to pay $430 million to settle charges that it fraudulently promoted the drug nurontin for a string of unapproved uses. uses johnson & johnson is the second-largest pharmaceutical company in the world which had almost $10 billion in profits in 2011. in 2012, this year, johnson & johnson illegally marketed an antipsychotic medication to nursing home patients and paid over $2 billion in fines which constituted a mere 6 230eu% of

sales from the drugs. in 2010, two subsidiaries of johnson & johnson illegally marketed the drug topomax for off-label psychiatric use. okay, that's johnson & johnson. now, we go to america. -- now we go to merck. merck is the third-largest pharmaceutical company in the world. in 2011 merck pleaded gil guilto a criminal misdemeanor charge and paid a $950 million settlement for illegally promoting vioxx for rheumatoid arthritis before that use was approved. in 2011, merck will pay the state of massachusetts $24 million to settle claims that former subsidiary warwick pharmaceuticals caused the state's medicaid program to

overpay. in 2008, merck reached a $670 million settlement for fraud on patients and medicare-medicaid involving a conspiracy with hospitals to give the elderly cheaper drugs by charging them for the more expensive product. that's merck. now we'll go to glaxosmithkline. glaxo smith compline is, again, one of the largest pharmaceutical companies in the world. made profits of almost $44 billion in 2011. glaxosmithkline in 2011 announced that it had reached -- quote -- "an agreement in principle" with the u.s. government to pay $3 billion -- $3 billion -- to conclude the company's most significant ongoing federal government investigations; specifically, illegal sales and marketing practices in colorado and

massachusetts, overcharge the medicaid rebate program and illegal development in marketing of avandia, a diabetes drug. 2006, glaxosmithkline agreed to pay $14 million to settle allegations that it engaged in patient fraud. in 2005, glaxosmithkline paid $150 million to settle claims it overcharged the government for two antinausea drugs. in 2003, glas glaxosmithkline sn greanlt and paid a fine for overcharge medicaid. and on and on and on it goes. so when we talk about the high cost of health care, when we talk about the fact that the united states has the highest prices in the world for prescription drugs, it is important for us to address the crisis in terms of fraud within

the pharmaceutical industry and the fact -- the fact that virtually every major drug company has been found guilty of fraud or reached a settlement in terms of fraud charges. mr. president, in 2010, the pharmaceutical industry achieved a dubious distinction: it surpoosed the knower to cuss corrupt defense contracting industry in defrawrding the government. the pharmaceutical industry accounted for nearly half -- $1.8 billion -- of a total of $4.1 billion of the pen flalts collected in 2011ably the department of justice, health, and human services health care afraud and abuse control program. in 2012 -- and this is really quite amazing -- the pharmaceutical industry is expected to pay out up to four times the amount of last year's

penalty between $8 billion to $9 billion -- $8 billion to $9 billion -- in penalties due to pending fraud settlements with the department of justice. and those are the penalties for fraud that has been discovered. who knows what type of fraud is taking place on behalf of the drug companies that has not been discovered? so let me reexit rate. -- so let me recapitulate. virtually every major drug company has either been found guilty of or settled charges of significant fraud over the last ten years. the question arises -- and this really is an important question -- is fraud within the pharmaceutical industry the exception, does it just happen here or there, or is it, simply

put, their business model? is fraud the business model of the pharmaceutical industry, who think that in most cases they can get away with the fraud, make huge profits, and in some cases when they get caught they will in fact pay a penalty, but the penalty will in no way match the kind of huge profits they are making from their fraudulent activity? now, the question that the senate has got to address is, do we look away from this issue? do we ignore this issue? or do we finally address the very important issue of fraud within the pharmaceutical country, fraud being practiced by virtually every major drug company in our country? since it is obvious to anyone paying attention to the prevalence of pharmaceutical industry fraud that it is of course, i think, that the prevalence of pharmaceutical fraud -- it is clear that the

punishments that we now have on the books have not done enough to address this problem. because apparently the drug companies are not too intimidated by the laws on the books. they think it makes business sense for them to continue going forward on their fraudulent activities. the amendment that i am offering would send a strong and clear message to the drug industry. illegal behavior will not be rewarded with continued government-granted monopolies. there are some things -- patient safety, the devotion of scarce public resources to provide health care to needy patients -- that are more important than drug company profits. this amendment is designed to effectively deter pharmaceutical fraud by making government-granted monopolies contingent on good corporate behavior.

and i think that is the least that we can do. mr. president, our amendment, this amendment would penalize any instance of pharmaceutical fraud resulting in a civil or criminal judgment or a settlement with an acknowledgement of fault by revoking any applicable data or marketing exclusivity for the particular drug or product involved in the fraud, giving pharmaceutical companies another factor to consider when weighing whether or not to violate the law in their sales or billing practices. so, if a company violated federal or state law by inflating the price of a drug in medicare or medicaid billing or illegally marketing a medication, under my amendment that company would lose the remainder of any exclusivity period for that medication. companies would be required to self-report, qualifying

violations to the tp*d within 30 -- to the f.d.a. within 30 days. let me conclude, mr. president, by saying this: our people are paying the highest -- the presiding officer: the senator's time has expired. mr. sanders: i would ask unanimous consent for one minute more. the presiding officer: without objection. mr. sanders: i thank my colleagues. our people are paying the highest prices in the world for prescription drugs. one of the reasons is widespread: fraudulent activey on the part of every major drug company in our country. it is no longer acceptable to turn a blind eye to that crisis. the time to act is now. this amendment would go a long way forward to ending that outrageous fraud. and i would ask the support of my colleagues for this amendment. i would yield the floor. a senator: mr. president? the presiding officer: the senator from wyoming. mr. enzi: mr. president, i appreciate the concern by the senator from vermont, but i have to oppose the amendment number

2109 because of some of the unintended consequences it will have. this amendment would require drug companies to forfeit exclusivity for certain violations of the federal drug and cosmetic act and other laws. exclusivity means exclusive market rights granted by the food and drug administration upon approval of a drug to encourage people to develop drugs. it may or may not run concurrently with the patent. exclusivity is a very important type of intellectual property protection. without it innovators can't predictably obtain returns on their drug development investments. the stated purpose of the amendment is to combat health-related fraud. the premise is that companies know their profits are at risk they'll be discouraged from engaging in fraudulent activity. but this amendment is counter productive. it will make it more costly for hraurplt to fight fraud -- law enforcement to fight fraud. in a reece oepbt letter to the health care community, six members of the finance committee led by chairman baucus and

ranking member hatch announced a bipartisan effort to solicit ideas from the health care community on ways to reduce health care waste, fraud and abuse. estimates of the amount of fraud and misspending in medicare and medicaid vary widely from $20 billion to as much as $100 billion. to address this problem the six senators solicited ideas on program integrity and fraud and abuse enforcement reforms. this constructive search for real solutions is long overdue. health care fraud is a serious problem and i agree congress should develop substantial solutions to it. the problem here is that the pending amendment tkphots really tack -- does not tackle the problem of fraud. the amendment use as blunt ininstrument, revocation and exclusivity to punish legal violations. the amendment would discourage settlements in fraud cases. a settlement agreement, mostly listed there, concerning illicit violation would trigger

forfeiture. if the company knows it would trigger a result that would koftd hundreds of millions of dollars or billions, it would less likely to settle. this will make it harder for the government to settle cases and increase the backlog of cases waiting for trial. it also creates the risk that a fraud ster would prevail or appeal and prevent the prosecutor from pursuing other cases. settlement is an important tool. it enables prosecutors to obtain a higher volume of cases. in fiscal 2011 the department jd billions of dollars. the ability to settle claims contributed substantially to this khaoefplt by allowing the government to pursue a higher volume of cases within the federal, food, drug and cosmetic act itself, there are robust standards and enforcement tools concerning industry marketing and communications and interactions with health care

providers and professionals. the false claims act and strong antikick-back laws are also on the books already. the amendment will also discourage manufacturers from developing new cures. it creates tremendous uncertainty about whether investors can obtain returns on their drug development investments if a trivial violation of f.d.a.'s detailed elaborate regulations could put the entire investment in a drug at risk. it will discourage investment in new treatments. this would severely threaten biomedical investment and jobs. more importantly, it would lead to fewer lifesaving therapies for patients. this amendment could produce absurd results. for example, the amendment would revoke exclusivity for a civil judgment considering adult racial of a drug adulteration of a drug. a drug is adulterated if a manufacture violates the current manufacturing program practices known as g.m.p.'s. there is no intent requirement and no minimum number of inspection requirements that

would trigger that liability. some examples of the violations include washing and toilet facilities are not easily accessible to work areas. adequate lighting is not provided in all areas. laboratory records do not include complete records of the periodic calibration of laboratory instruments. it obviously doesn't make sense to strip drug companies of exclusivity for violations like this which do not reflect fraudulent intent. it is disproportionate and counterproductive. i agree health care fraud is a significant problem. the best way to solve it is through robust enforcement of the current laws on point and continuing to work with the health care community to find effective solutions. that would be going through some committee hearings as women. the pending amendment -- as women. the pending amendment would from you the current's -- it would

frustrate the government's current antifraud practices. i yield the floor. a senator: mr. president? the presiding officer: the senator from oklahoma. mr. coburn: i ask unanimous consent the pending amendment be set aside and coburn amendment 2131 be called up. a senator: mr. president, i would like to object. how much time is left on the sanders amendment? the presiding officer: the senator from vermont has no time left. the senator from wyoming controls ten minutes. mr. harkin: would the senator from oklahoma withhold? we have some people that want to speak on this. once the time is run, we automatically move on to another amendment and you can bring up the senator's amendment at that point. mr. coburn: it is my understanding the time is under our control. at the present there's ten minutes left. mr. harkin: there's ten minutes in opposition to the amendment. mr. coburn: i'd be happy to yield to the ranking member if he has people that want to speak

in opposition. that's fine. har -- mr. harkin: just wanted to speak on this amendment. if we wait five minutes, we can get to that. ms. mikulski: mr. president? the presiding officer: the senator from maryland. ms. mikulski: mr. president, first of all, i want to thank my colleague from oklahoma for this. i just wanted to take a few minutes, if i could, to talk about an important issue. i guess -- mr. harkin: i'm sorry. i was wrong. i thought the senator wanted to speak on the sanders amendment. you wanted to speak on the underlying bill itself? ms. mikulski: yes. mr. harkin: and the senator just wishes for five minutes? ms. mikulski: yes. or less. mr. harkin: since it is my time, i would yield the senator from maryland five minutes on the underlying bill. ms. mikulski: and i'll be very

brief. the presiding officer: the senator from maryland. ms. mikulski: thank you very much, mr. president. to our colleague from oklahoma, himself a physician, he would be very keenly interested in this issue of prescription drug shortages. this is a problem that's been brought to my attention by marylanders, leaders of great institutions like the university of maryland and hopkins as well as family members who care for someone and find that though there's been the right diagnosis and there's even the right drug to care for that problem, like the dreaded cancer word, the drug is not vague. so you can imagine the worst thing that you want to hear is that your child has cancer. then the worst thing you want to hear is that there is a shortage of that drug to take care of that child not because it hasn't been developed, not because there hasn't been a scientific

breakthrough. but because there's been a manufacturing problem or because the company stopped making the drug when it was no longer profitable. mr. president, that is inexcusable, and the bill before us does something about it. i ask unanimous consent that my full statement be included in the record. the presiding officer: without objection. ms. mikulski: i want to make a few points, that in 2007 we had more than -- in 2011 we had more than 250 drug shortages, incidents. that's 250 drugs that were on shortage. and half of the drugs experience a shortage that goes in to multiple times. this drug shortage threatens public health by preventing patients and physicians from accesses needed medications. it forces doctors to often delay medical he procedures, use alternative products that carry on one its side effects to rely

on foreign versions of drugs that might not have been reviewed by f.d.a. or it sends their very able pharmacist in their institutions to spend endless hours and hour on the phone to be able to come up with the needed drug. as i said, this was brought to my attention by letters, some famous constituents, meaning well-known, in our community with great health insurance, who had a child, who had leukemia and then found the drug was in short supply. we heard from doctors who were forced to delay. hospitals scrambling to manage these shortages. pharmacists trying to track down needed treatments. even then we heard about gouging and we heard about a gray market. the gouging was for pumping up the price where there is a shortage and then for gray

market where you can buy these drugs but might not be the drug you wanted or might have been on somebody's shelf a long time and were flawed and even dangerous, or they hadn't been refrigerated. i could go through one horror story after another. but, phr-bs, i wanted to bring this to the attention of the full senate because as we work on this excellent bipartisan bill on user fees, what we also have is a way for dealing in a very commonsense way with the drug shortage issue. it has the support of the private sector and certainly those who care for patients as well as parents themselves. i hope we pass this underlying bill, and i hope we don't tie up this bill with amendments that could either derail or detour this bill. mr. president, i thank my colleagues for being so generous. i yield the floor and thank them for their kind attention.

is mr. harkin: mr. president, how much time is remaining on the sanders amendment? the presiding officer: 7 minutes in opposition remaining on the sanders amendment. mr. harkin: mr. president, i yield myself a couple of minutes on that. i just want to join with my colleague, senator enzi, in opposition to the sanders amendment. look, we're all disturbed by a lot of what we're reading in these big settlements. i know the one of abbott labs where part of the prosecution case was actually that this was part of their business model. and then they had to settle it. so this is all very disturbing. however, that cries out more for perhaps looking at the criminal

charges and perhaps strengthening some of those things but not taking away exclusivity. if you do that, a lot of times you could take away exclusivity from somebody that just committed a misdemeanor. a lot of these settlements are misdemeanors where no intent has to be shown. a lot of times if you did this, you might penalize someone who had maybe done something wrong in the past, maybe they have new leadership, new company and reformed themselves, but then they still have to lose their exclusivity. you wouldn't want to do that. and third, if you do this, i think senator enzi pointed this out very correctly, if there is no reason to settle, then people are going to go to the wall on terms of defending themselves and d.o.j. doesn't have all that kind of personnel and that time to do that. i think we would then have even a worse situation of people committing fraud because then

they would know they would not have any reason to settle whatsoever. settlement is a good tool to be used by prosecutors to get cases to justice, to make sure that consumers were made whole and to let people know that they are being watched in what they do. so i think the sanders amendment, while maybe well intentioned, i know it's well intentioned. i snow the senator has all good intentions what he wants to do on this, but i think it goes too far and is not the right -- not the right solution to that problem. so i would oppose the sanders amendment also. i yield the floor. a senator: mr. president? the presiding officer: the senator from oklahoma. mr. coburn: i ask that the pending amendment be set aside and that amendment 213 1 be called up. the presiding officer: without objection, the clerk will report. the clerk: the senator from oklahoma, mr. coburn, for himself and mr. burr, proposes amendment numbered 2131. mr. coburn: i ask unanimous consent the amendment be

considered as read. the presiding officer: without objection. mr. coburn: let me say how proud i am of the ranking member and all the members of the help committee on this very difficult and complicated issue that they are bringing before us. f.d.a. having been in business and under the control of the f.d.a. as a medical device manufacturer, this is a very complicateed area of law that if it's done right will have tremendous positive effects on this company, and i think you have put out a very good bill, and i congratulate you and all the members on doing that. i have two amendments i'm going to speak a very period of time on both of them, and then i will work with the ranking member and chairman to see if we can't get them so we don't have to vote on them. just a little history with padufa and madufa. the reason they were set up in the first place was to help fund the f.d.a. and the reap the manufacturers did that was to

get more timeliness in response to their applications. that was the whole basis for it. what we have before us today is some improvement in terms of the f.d.a.'s response but really not everything that we should have gotten. i along with senator burr asked for a g.a.o. study to the f.d.a. in terms of meeting stated performance goals, and we found out a whole lot about that, and that's my next amendment, but i say that to preface why i have this amendment. in this bill is a wonderful requirement that causes the f.d.a. to contract with an independent management company to assess the management of the missions and resources of the device regulation component of f.d.a. what is missing is that same independent review in terms of

drugs. it's one of those things where we would invest in something that is going to pay us additional big dividends. i know it's going to pay us big dividends in the device area. it's also going to pay us big dividends in the drug area. i don't know the workings of the committee, why they decided not to put this in as far as the drug review process, but having a second look at a very complicated regulatory and approval structure could be very beneficial in terms of improving both the quality of the outcome as well as the timeliness. so this amendment simply says that what we're going to do for the device in the bill already, we're also going to do for the drug side of the f.d.a. it's about gathering knowledge, both for the f.d.a. and for us, as we help this agency perform very needed things. i read a lot about new science on new drugs as a physician. i want to tell you, the things

that are coming into this country are going to be phenomenal in terms of new treatments and new drugs and new capabilities. we need in terms of our competitiveness worldwide but also in terms of how we address these diseases to have the most efficient regulatory agency we can. so all i'm asking is that we treat all of f.d.a. the same in terms of taking a look, how well are they doing, what could they do better, how could they do it better? that report comes to us and the f.d.a. we haven't been through every area of the f.d.a. as members of the senate, and to have an independent assessment of the drug side as well as the device side will pay huge benefits to the f.d.a., but mostly it will pay huge benefits to the people of this country in terms of timeliness of drug presentation. so with that, i won't speak any more to that. it's a commonsense good government amendment. part of it is already in the bill. part of it is not in the bill.

it's something that will pay us big dividends both in terms of health care, both in terms of improving the operation of the f.d.a., but also in terms of improving our competitiveness worldwide. i would ask that that amendment be set aside and call up 2132. the presiding officer: without objection. the clerk will report. the clerk: the senator from oklahoma, mr. coburn, for himself and mr. burr proposes an amendment numbered 2132. at the end -- mr. coburn: i ask unanimous consent the amendment be considered as read. the presiding officer: without objection. mr. coburn: this is an amendment that comes out of a study of g.a.o.'s findings, and g.a.o. did a wonderful job looking at the f.d.a. what we found out, part of it will be covered if, in fact, we do this other study on the management, but what g.a.o. is telling us is there is an irregular pattern of performance review at the f.d.a.

about 40% of the people who are involved in the drug and device approval process, part of their evaluation in terms of their performance review has to do with the timeliness of their work product. and it's only a small component but it's yet still a component of it, and what this amendment does is just said f.d.a., make this a part of your component on the people that are actually reviewed in the review process. not to try to push them to do it better but to have a management tool with which to evaluate individual employees doing this. the fact that they are already doing this on some and what g.a.o. really said is just a lack of management effectiveness that they haven't installed it everywhere else, all this amendment says is this should be a component, as they evaluate

their employees that are associated, as one component of their performance review, how did you do on timeliness? was your work product timely? the idea behind this is not to push drugs out that shouldn't be approved. it's not to push out devices that shouldn't be approved, but remember the purpose for pdufa in the first place and mdufa. the purpose was to find f.d.a. with more money so they would be more timely. the opposition that i hear to this amendment is that we're afraid if this is a component of review that they might review a product and let it go when they shouldn't doesn't make sense since already 40% of the employees that are doing this are being evaluated on this performance standard anyway. so i would raise the question if we're in opposition to this amendment, why in the world haven't we eliminated this as a part of all the review process already if, in fact, it's a concern. and there isn't a concern with it. it's a good management tool.

it's used in all other sorts of government agencies. i would commend and ask unanimous consent to put the g.a.o. report in the record that backs up exactly what i'm saying, and their recommendation. these aren't tom coburn's recommendation. these are the g.a.o. recommendations for f.d.a., and they address the concerns of inappropriate pressure for early approval or inappropriate approval for drugs or devices. so, again, it's good government, it's common sense, it's how you would manage a private organization. you would put every component that the employee is involved with as a component of part of their review process. and my hope is that we don't have to vote on this, when you actually thoroughly study the g.a.o. report, you will embrace what they are saying as common sense with sound judgment that will actually improve the f.d.a. with that, i would yield the floor.

mr. harkin: would the senator yield for a question? a senator: i would be happy to. mr. harkin: i think the senator is making a lot of sense. the only question i would ask -- i don't know a lot about this. i haven't read the g.a.o. report, i would be the first to admit. if, in fact, every employee says i know they are going to get me on this timeliness, so it's the balance of safety, safety and -- and -- and quickness, safety and expediency. in other words, we try to get a balance. we want devices and drugs approved as quickly as possible but we don't want to jeopardize safety. those are the two things. we always try to balance it here. safety being the foremost. we want things to be safe. i just -- i guess i ask the question would enshrining this in law rather than the administration, would this somehow put more undo pressure

on reviewers and things to do something quickly and jeopardize the safety aspect? mr. coburn: well, my answer to the chairman through the chair is the f.d.a. does nothing quickly now, and he knows that because he has been sitting in oversight over him for years. that's number one. number two, the answer to that is they have no explanation if you will read the g.a.o. report on why they do it on some employees and not others. so the fact is if this is a bad thing, why are they doing it on 40% of the employees now? it's not. the number one and number two things that the f.d.a. is charged with is safety and efficacy, safety and efficacy. safety comes first. they get graded on how well they do on that. so you have this counterbalance, but what we have is a lack of responsiveness even though billions of dollars are going to the f.d.a. from the device companies and the drug companies. part of the deal was is to make them more timely.

that means in no way do you ignore safety and in no way do you ignore efficacy. the fact is they do deserve answers, and what has happened is a lot of times they are not. i fully support the bureaucracy of the f.d.a. in terms of doing their job. i think they do an awfully good job. they are just awfully slow at it. when you ask why, there is not a good answer. and so the point is if there is a large number of employees that are already reviewed, a small component, it doesn't have to be a major one, but it ought to have to be something you think about. you know, do i push this one off my desk because i'm bored with it? does the time frame mean anything? we're not going after eliminating safety and efficacy. we're going after smart management. and those two things, safety and efficacy reign supreme at the f.d.a. that's why we spend so much in this country. that's why most of the drugs are approved outside of this country way ahead of when they get

approved here, because our drugs and devices are safe and we're slow to approve and rightly so but we shouldn't be like frozen ice slowly slipping down a hill, and all this says is let's make one component of many in terms of the review, do it. again, i would tell the chairman, this is not my recommendation. this is the g.a.o.'s recommendation. so i would appreciate the consideration by the chairman and regular member for these amendments. i think they are common sense. we can look at them again. if you think there is a problem, we can put a caveat. let's look at them in a year and say have there been problems because we have done this. but it is good management, it does make sense. they are already doing it on 40% of their employees who are involved in the approval of both drugs and devices. i thank the chair for his question and i yield the floor and i will be back.

the presiding officer: the senator from iowa. mr. grassley: i rise for the purpose of calling up amendment 2129. the presiding officer: the clerk will report the amendment. the clerk: the senator from iowa, mr. grassley, proposes an amendment numbered 2129. mr. grassley: i ask that we suspend reading of the amendment. the presiding officer: without objection. mr. grassley: mr. president, first of all, i congratulate my colleagues from -- my colleague from iowa and my colleague from wyoming for the bipartisanship of this legislation. the f.d.a. amendments of 2007 mandated basic public results,

reporting for all clinical trials supporting f.d.a.-approved drugs and devices, clinical trials result help both patient and doctors understand the benefits and efficacy of a particular medical product. more moreover, a july, 2007 report stated -- quote -- "understanding characteristics in clinical trial sites is extremely important because of the international nature of current clinical trials. the sources of differences in efficacy results between the united states and foreign clinical trial sites have yet to be determined, but differences rooted in the conduct of the clinical trial should be evaluated" -- end of quote. it has been five years now since the passage of the f.d.a. amendment act, and the national institute of health is still in

the process of writing proposed regulations. the clinical trials dot gov program and the title 7 of the f.d.a. amendments act were considered major reforms in health science information advances. if they're not being implemented well or adequately enforced, society will fail to reap full benefits of the billions of dollars in good medical science research. this amendment before the senate will impose a deadline by which the n.i.h. will finalize both the proposed and final regulations. further, two years after the regulation has been in place, the government accountability office will conduct a study on compliance with the regulations and will look at, among other things, whether the applicable

clinical trial is conducted domestically, in foreign sites, or in a combination of sites. the rapid increase in trials being run overseas makes it imperative that the government accountability office investigate this matter. currently, 80 -- currently 80% of approved marketing applications for drugs and biologicals contained data from foreign clinical trials. and the f.d.a. inspected 1.9% of domestic clinical triel sites and .7% of foreign clinical trial sites. we need stronger reporting requirements to make sure we understand what the implications are of this move to having so many trials conducted overseas. i encourage my colleagues to support this important

amendment. before i move on, i'd like to talk about another amendment that i'm a cosponsor of. the amendment offered by senator portman that will make dangerous synthetic drugs like k-2 and bath salts schedule one narcotics. i've worked for over a year now to get this legislation passed through the senate after a constituent of mine named david razga committed suicide shortly after smoking some k-2 with some friends now nearly two years ago. i introduced the david mitchell razga act in march of 2011, and the senate judiciary committee unanimously passed it out of committee along with two other related bills sponsored by senator schumer and senator klobuchar last july. since that time, the use of synthetic drugs has grown very rapidly with the number of calls

into poison control centers going from a few -- as few as 19 in the year 2009 to over 6,000 in the year 2011. the house passed their version of this bill last december on a strong bipartisan vote, but one senator has blocked consideration of this legislation in this chamber up to now. and so i am grateful that we're finally able to have a vote on this issue, and i would urge passage of the portman amendment as well. madam president, i'd like to go to another amendment if that would be appropriate at this time. the presiding officer: without objection. mr. grassley: by call up -- i would call up amendment 2121. the presiding officer: the clerk will report. the clerk: the senator from iowa, mr. grassley, proposes amendment 2121 -- mr. grassley: i ask that we suspend the reading of the

amendment. the presiding officer: without objection, so ordered. mr. grassley: madam president, the bill before us, s. 3187, did not address a top priority of mine, and that is ensuring whistle-blowers having adequate protections. four months ago, my office learned of a very abusive treatment by the f.d.a. on certain whistle-blowers due to those whistle-blowers protected communications with congress. more specifically, with this senator's office. once the agency learned of the communications, even though they were on personal email, it began actively monitoring and observing employees' personal email as you might expect, and they -- and they observed those email accounts for two years, for a whole two years, until the agency was able to have the

employee fired. well, you know, whistle-blowers shouldn't be fired for doing what's patriotic, and that is reporting to congress wrongdoing regret tbli bli, i -- regrettably, i was shocked to learn that the f.d.a. was mistreating whistle-blowers within its agency as it has done -- i said that wrong. i was not shocked to learn that the f.d.a. was mistreating whistle-blowers within its agency, as i pointed out to my colleagues on so many occasions that the f.d.a. has done that, and i've been reporting those things ever since the vioxx situation of 2004, i believe. what makes this example different, though, and even worse is that the f.d.a. intentionally went after an employee because it knew that that employee was not covered by

the whistle-blower protection act. now, it might surprise some of you that all employees aren't covered by the whistle-blower protection act. but this employee in question was a member of the public health service commission corps, and because of a decision from the court of federal claims, these employees, meaning the public health service along with other members of the union formed services, are not -- uniformed services, are not covered by the whistle-blower proakdzle. i think the court case was wrong, but anyway, that's the way the court of federal claims ruled and that came in the verbec versus united states case that an officer in the public health commission corps is a member of the union foample services and is not covered by the civilian whistle-blower protectionth act or even the

military whistle-blower protection act. the same logic extends to the commission corps of the national oceanic and atmospheric administration as well. so under the precedent of this verbeck case, the officers of both the public health service and noaa currently have no whistle-blower protection under federal law. this is particularly problematic when you consider that the public health service and noaa officers can be detailed to agencies like the f.d.c. or the centers for disease control. there these officers working in another agency happen to work side by side with civilian employees of that agency, doing very critical work to review and approve drugs, oversee medical devices, and even work on infectious diseases.

however, unlike their civilian colleagues, employees of that agency that are sitting right next to them, if these employees uncover wrongdoing, waste, fraud, and abuse, they can be retaliated against by the agency and have no recourse for it, and that's exactly what happened to this public health service employee working in the food and drug administration when they reported to congress wrongdoing there. and they did it by personal email, and the f.d.a. got onto it, and then fired the one employee that was reporting to congress but not firing the employees that were protected by the whistle-blower protection act. so that's why i say this is wrong, and it needs to be fixed, and this amendment will fix that. whistle-blowers point out fraud, waste, and abuse when

no one else will, and they do so while risking their professional careers. whistle-blowers have played a critical role in exposing government failures and retaliation against whistle-blowers should never be tolerated. for this reason, i offered an amendment that expands whistle-blower protection for uniform employees of the public health service. it corrects the anomaly pointed out by the court of federal claims and ensures that officers in the public health service have some baseline whistle-blower protection. it expressly includes the commission corps of the public health service within the protections of the military whistle-blower protection act. this is consistent with the structure of the commissioned corps' functioning like a military organization and matches that -- the fact that these officers receive militarylike benefits and

retirement. unfortunately, this amendment, which i was able to get into this legislation, only covers employees of the public health service. it does not address the commission corps of noaa because of other senators' concern that is not related to the underlying bill, so i hope to be able to address that remaining gap in whistle-blower protections in the near future so that all employees of the federal government are so covered. all federal employees should feel comfortable expressing their opinions both inside the agency they work on as well as to congress. the inclusion of this language will ensure those opinions receive appropriate protections. i want to take this opportunity as i did opening my comments on these two amendments to express my appreciation to senators harkin and enzi and their commitment and efforts over the years to reform and improve the

f.d.a. i yield the floor. the presiding officer: the senator from north carolina is recognized. mr. burr: what's the pending business on the senate floor? the presiding officer: it is grassley amendment number 2121. mr. burr: i ask unanimous consent to set aside the pending amendment and to call up amendment 2130. the presiding officer: without objection, so ordered. the clerk will report. the clerk: the senator from north carolina, mr. burr, for himself and mr. coburn -- mr. burr: i ask unanimous consent it be considered as read. the presiding officer: without objection, so ordered. mr. burr: madam president, let me also reiterate what my colleague just said, that chairman harkin and ranking member enzi have done a wonderful job with a very complicated bill, navigating what was a negotiation that members of congress never played a part of, negotiation that

happens between the food and drug administration and the pharmaceutical industry for one piece, the device industry for another piece, and the generic drug industry for a third piece and i might say that third piece, this is first the first time that congress will consider this. i think it's important that members of the united states senate, members of congress, the american people understand that typically all legislation is crafted in the congress of the united states. it's not negotiated in the back room of the food and drug administration and the device or pharmaceutical or generic drug manufacturers, except for this. and, in fact, my amendment gets at the heart of it. it's called the amendment to ensure transparency in the

f.d.a. user fee agreement negotiations. it's straightforward. it would ensure that transparency in the f.d.a. and drug and device user agreements, negotiations would allow members of congress or their designated staff to attend the negotiations between the f.d.a. and the industry. now, what a novel thing to say that those that are responsible to actually implement the policy could sit in the room and listen. i'm not talking about playing a role in negotiating. let me just say, why is this amendment necessary? the bottom line is that while the f.d.a. may consult with many of the stakeholders at various points in the process, the drug -- the drug and device user fee agreements are not negotiated where members of congress and where the general public knows exactly what's in

it. congress is effectively shut out of the process until the negotiated deal behind closed doors is announced. in other words, we're presented what they have negotiated, and basically told here's what we want to you pass. at no other point in the legislative process does it happen like this in the congress of the united states. the drug and device user fee agreements have significant implications for the american people as well as congress' ability to do oversight. the number-one role of the congress of the united states is to serve on behalf of the american people as an oversight tool on federal agencies. congress should not have to read between the lines of the minutes of a negotiation to try figure out, in fact, the spirit of those negotiations. the ability for congress and the american people to fully understand and weigh the negotiated agreements and the implications they present for

patients, taxpayers, the f.d.a. and for congress would be in greatly -- would greatly be improved by ensuring that congress might attend the negotiations. now, some of my colleagues will probably come down and suggest that this amendment would put congress at the negotiating table and potentially it would jeopardize negotiations. it's not true. it's not what i'm attempting to do with this amendment. the amendment merely states that if a member of congress wants to attend or if they want to have their designated staff attend in their place, that they may. this amendment does not call for members of congress to participate in the negotiation or certainly staff. the negotiations would still be between the f.d.a. and the industry. but it does not ensure that members of congress or their

staff may be in the room and be informed of the negotiations in realtime. congressional staff may be required to comply with all the applicable confidentiality agreements. the f.d.a.'s negotiations with the industry would not be jeopardized. let me say that again to my colleagues, would not be jeopardized, because the members of congress or the staff would be there just for observation purposes. let me suggest that if us being in the room jeopardizes the outcome, then we wouldn't be allowed to attend the supreme court when some of the most important cases are tried across the street. but members of congress and their staff regularly sit in and listen to the arguments that are made. the fact is, congress should not have to wait to be informed of how f.d.a.'s public health

mission could be strengthened and improved on behalf of patients. by having the option to attend the negotiations, congress and their staff would gain invaluable insight into how congress can work with the f.d.a. to ensure that the agency is fulfilling its public health mission on behalf of patients. now, congress has a critical role to play in the process. when negotiated user fee agreements arrive on our doorstep, we're expected to take them up and we're expected to pass them quickly without change. let me say that again. we're expected to take them up, we're expected to take them up quickly -- because we don't want to break the continuity of the user fee agreements -- and we're expected to do it without change because to change those agreements would be to break what was negotiated. well, let me suggest to my colleagues, this is the only

time in the legislative process where congress is asked to take somebody else's negotiated product and not to provide the input of two senators from every state or every member of the house of representatives. it completely goes around the structure, the legislative structure of the congress of the united states, something that has been tested and tested for over hundreds of years. so congress is told to tiptoe around the agreements. and we focus our efforts on belt-and-suspenders policies to complement the agreement. this doesn't make for the most deliberative process in considering how congress can work with the f.d.a. and industry to strengthen and improve f.d.a.'s drug and device work. as a matter of fact, i'd say to my colleagues, as we talk about health care policy in this

institution, where our goal today is how we reduce the overall cost of health care, remember as we sign off on this user fee agreement that every dime that's transferred from the industry to an agency means that that industry's going to have to raise the price of their products to accommodate what they're paying. what are we here doing? we're raising the cost of pharmaceutical products, devices, and for the first time we're raising the cost of generics because an industry as negotiated something outside of the walls of the congress of the united states. f.d.a. faces an unprecedented challenge today, challenges we could have not envisioned generations ago. the agreements and many of the provisions in the senate bill are intended to help address these real challenges the agency's facing. but i ask my colleagues this, in closing: what if they don't?

what if they don't address the challenges? what if now generic drugs become more expensive than some people can pay because of this agreement? that's why it's absolutely crucial that congress play a part in this role to balance this policy. where will we be in five years? when it's time renegotiate this agreement? well, madam president, i hope that we're in a much better situation than we are today, that we actually have the right matrix in place through this legislation, not something that was negotiated between the f.d.a. and the industry but something that the senate of the united states put into this language that gives people on both sides of the aisle the ability to have a yardstick of measurement of success. did the agency live up to what they promised this industry and, more importantly, does that compute to a beneficial product

for patients across the country? i hope that's what we'll find five years from now. it's what we've tried to construct in a very difficult and challenging piece of legislation. i will tell my colleagues, this is not an amendment i will ask for a vote on. at the end of the day, the reality is that this probably upsets the apple cart a little too much. but i think it's absolutely crucial that somebody asks the questions of how can congress legitimately stand here and allow something this complex and this important to be negotiated without the input, the full input, of the congress of the united states? again, i conclude the same way i started, that i think that chairman harkin and ranking member enzi have done a

magnificent job of navigating a very difficult issue and they deserve a tremendous amount of credit for taking the negotiated product and incorporating what i think are some very, very positive changes that make this a better product than was negotiated by the private sector and by the agency. my only wish is that next time we do this, that we won't have to try to figure out why certain things happened in the negotiations, we'll be privy to those negotiations and we'll better understand how collectively we can take an agency and an industry and public policy and move it in a situation where the american patients are the beneficiaries of it in a much more effective way than i think we have today. i yield the floor. mr. enzi: madam president? the presiding officer: the

senator from wyoming is recognized. mr. enzi: thank you. i want to thank the senator for his comments and his insight and his idea. i appreciate that we're not going to be voting on this one right away because i think this needs a little time to germanate. i think it is something that as people look at it and think about it, they'll recognize the value that there would be if we had more insight into what the negotiations were. not just on this but perhaps on regulation as that are being done as well. and i really want to thank the senator, though, for the way that he's -- that he's dug into the entire user fee bill and made some very substantial changes in a number of other places. i don't know of anybody that works as hard on the medical issues as senator burr does and understands it and gets into some of the -- the details.

and, of course, he's worked all of these when he was in the house and now works them when he's in the senate and is our foremost expert on any of the pandemic issues and was very successful earlier in the year in getting that bill through the united states senate. and he's been very cooperative on the other amendments which are now part of the bill that we won't be voting on because they're already in there. and i appreciate this -- this one more suggestion and suggest that that's something that we should take a look at. i'd yield the floor and reserve the balance of the time. mr. harkin: madam president? the presiding officer: the senator from iowa is recognized. mr. harkin: madam president, i just. to join senator enzi in thanking -- madam president, i just want to join senator enzi in thanking senator burr for not only being a very valuable member of the committee but i would say that the senator's fingerprints are a lot on this bill that we have before us here. he's really worked very hard on this bill and helped i think improve it every step of the way over the last year. i was just looking through the list of different things here and senator burr was one of the

leaders on our working group on the supply chain, which we have in this bill, to make sure that those things are coming from other countries, that we have good manufacturing practices on them and we can keep track of those. the provision of clarifying the least burdensome standard on clinical data for device approvals was also the result of the senator's hard work. the senator was also on the working group on the gain bill in terms of -- of -- an addition regarding antibiotics incentives, getting new incentives for new antibiotics. and there was a burr-coburn bill regarding enhanced reporting requirements for f.d.a. and that basically was also included into the bill that we have in front of us. so in just every respect, the senator from north carolina has been a -- a -- is a great member of our committee, a very valuable member of our committee as i said, we're looking at the amendment that -- that he's now brought up and i'm sure, as

senator enzi said, we'll be talking about this in the next few hours and going into tomorrow. but i just again want to pay my respects to the senator from north dakota and thank him, thank him so much, for all the hard work he's done on this -- on this bill. i yield the floor.

mr. franken: madam president? the presiding officer: the senator from minnesota is recognized. mr. franken: thank you, madam president. madam president, i'd like to thank my friends on both sides -- the presiding officer: senator, who yields time? mr. harkin: ahmadinejad, an inquiry. is the senator bringing -- mr. harkin: madam president, an inquiry. is the senator bringing up -- oh, no, the senator does not have an amendment pending.

does the senator wish to speak on which amendment? mr. franken: not on an amendment, just for the bill overall. mr. harkin: madam president, how much time is remaining on the grassley amendments, the amendments offered by the senator from iowa? the presiding officer: the senator from iowa has nine minutes and the time in opposition is 15 minutes. mr. harkin: i would ask, how much time does the senator wish to take? mr. frank he be -- mr. franken: well, it's about 10 minutes. mr. harkin: i would ask that 10 minutes of time from the opposition to the grassley amendment be allocated to the senator from minnesota. the presiding officer: is there objection? no objection, so ordered. mr. franken: i object to the grassley amendment -- i don't know. i'm joking. the presiding officer: the senator from minnesota. mr. franken: thank you. [laughter] i'd like to thank the senator from iowa for that.

mr. president -- madam president, i'd like to thank my friends on both sides of the aisle for their work on the legislation that we are considering today, the food and drug administration safety and improvement act is not only among the most important pieces of legislation that we will consider this year, it's also the product of more than a year's hard work and negotiation. this legislation will help support a culture of innovation in this country. it will help millions of americans access the lifesaving medications and devices they need when they need them, and as a member of the help committee i'm proud of the bipartisan bill before us today. i look forward to passing it into law. and let me tell you why, and of course the presiding officer spoke so eloquently about this bill earlier. the presiding officer doesn't really have to know why, but let me tell you a story about a

little girl in minnesota, our state, named josie. josie seemed perfectly healthy when she was born, but at nine months of age josie's parents found out she had a rare congenital heart disorder, a condition with the scary name of a tree atrial sceptal defect, a hole between the two chambers in her heart. when the doctors tested her they found josie had three holes in her heart and it became clear that what was originally a fairly simple surgery to repair the hole was actually a lot more complicated. but josie is lucky. josie's parents live in minnesota, and josie's doctor, dr. daniel gruenstein works at the university of minnesota. he was able to operate on

josie's heart because he had a brand-new device that the f.d.a. had approved only months before. the device, which was also developed in minnesota, saved josie's life. because of this procedure, josie was acting like her same old silly self the very night of her operation, and she walked out of the hospital the next day. a few years later when josie's little sister jenna was born with the same congenital heart defect, dr. gruenstein repaired her heart using the very same device. but too too many children like e and jenna aren't so lucky. too many children don't have access to the medical technology they needed to save their lives or to prevent their illness or to help them recover from their rare condition. that's because too many medical devices get stuck or delayed in

the agency that regulates our medical technologies. and it's because we don't do enough to support a culture of innovation in this country. look, the food and drug administration has a tough job. the technologies they regulate are moving at the speed of light, and they don't have the workforce or the expertise to know everything about every new treatment. in fact, the number of annual 510-k submissions, the most common kind of new device application the f.d.a. receives, has quadrupled since 1976. that's why when the help committee sat down, we had to agree we had to streamline the f.d.a.'s processes and make them more efficient. we agree that we had to do more to support a culture of innovation which will help manufacturers get safe

technologies and treatments to patients. and that's exactly what the bill does. and i thank both the chairman and the ranking member. it requires the f.d.a. to stop using vague f.d.a. days and start using regular calendar days, like everyone else. it lists restrictive constraints on the f.d.a.'s consultation with outside experts, something that the presiding officer knows well about. outside experts like at the university of minnesota. and it creates new incentives for manufacturers to develop treatments for people with rare diseases and conditions like josie and jenna. these provisions will support innovation and will remove red tape from the process. three provisions that i championed are included in this legislation in addition to the base bill, which we negotiated as a committee.

the first provision will strengthen the food and drug administration's workforce by removing overly restrictive requirements that keep the f.d.a. from consulting with outside is experts. again, something that the presiding officer has been a leader on as well. this provision will change the rules that keep the f.d.a. from talking with many outside experts. it will make these rules consistent with those of all other agencies, including the national institutes of health, so as the f.d.a.'s experienced workforce retires, the f.d.a. will be able to consult with leading experts when they are reviewing a new technology or a new treatment for a rare disease. this provision will give the f.d.a. the flexibility it needs to consult with experts and keep patients safe and at the end of the day that means more patients will get the health care that they need.

the second provision will require the f.d.a. to remove new and burdensome guidance on the industry that could triple the number of required new submissions for existing devices. this provision which senator burr also championed, from north carolina, will prevent this guidance from overburdening both the industry and the f.d.a., which could have caused innovation to come to a screeching halt. and my third provision will help companies develop innovative new products for patients across the country with rare conditions. according to the national institutes of health, 25 million americans struggle with a rare disease, and these patients have to jump hurdle after hurdle to get the care that they need. many of them will go from doctor to doctor for years before they find a specialist who understands their condition. now, if you live in rural minnesota, you may have to drive hundreds of miles to find a

doctor who can help you. even for patients who find the right doctor, too often treatment for their condition doesn't exist or hasn't been approved. so my provision will reward companies that choose to develop treatments for patients with rare diseases. we did this in 2007 to help companies develop devices for children with rare conditions, and we saw the number of devices that companies develop quadruple in a few years. this provision will help get treatments to adult patients with rare conditions in minnesota and around the country, and really around the world. minnesotans know what it means to foster a culture of innovation. our manufacturers have developed new treatments for everything from skin lacerations to brain aneurysms. and this bill will go further to support this kind of innovation. by streamlining the processes that are currently impeding

investment in new technologies and making the f.d.a. more efficient and predictable. this legislation will help patients in minnesota access the medical technologies they need just like josie and jenna, and in a time of economic hardship, it's an investment in one of our country's strongest industries, one of our state's strongest industries. this bill is a step toward a healthier future for our country, and i look forward to making sure that it becomes part of our law. thank you. i yield the floor and, again, i thank the senator from iowa, the chair of this committee. i thank the ranking member for his leadership as well.

a senator: madam president? the presiding officer: the senator from alaska is recognized. ms. murkowski: thank you, madam president. at this time i would ask unanimous consent to call up amendment number 2108. the presiding officer: is there objection? without objection, the clerk will report. the clerk: the senator from alaska, mrs. murkowski, for herself and others proposes amendment numbered 2108. at the end of title 11 -- ms. murkowski: request that further reading of the amendment be dispensed with. the presiding officer: without objection, so ordered. ms. murkowski: thank you, madam president. i rise today to speak to an amendment that we will have on the floor tomorrow afternoon. this is an amendment that certainly has generated a fair amount of interest within my state. in fact, really most of our coastal states, anywhere where we have an interest in seafood and seafood industry. it has been kind of unceremoniously dubbed the franken fish amendment. so my apologies to my colleague

who just yielded the floor to me. certainly no affront to him. but what we are speaking about today is a genetically-engineered salmon. and it has been somewhat affectionately dubbed franken fish because of the images that this genetically-engineered fish conjures up. a fish that would literally be growing in size, doubling in size, unlike the fish that we see in our streams and in our waters. so what is happening today is the f.d.a. is on path to approve an application for this genetically engineered fish. and i want to discuss the amendment that i have filed which would require noaa to

conduct a full environmental assessment and analysis of economic impacts to affected fisheries before the f.d.a. approves any of these genetically engineered fish. so i start my comments by saying i am not looking to pull the plug on the f.d.a. i am not looking to insert congress's judgment into the f.d.a. process. i am asking that when we are talking about a -- basically a new fishery for a modified salmon, i'm asking that the agency that is tasked with our fisheries have some role in what is moving forward. so let me give you a little bit of background in terms of what we're talking about with this genetically engineered fish, this franken fish.

this is -- this would be a fish, an atlantic salmon that has d.n.a. spliced from a chinook salmon with that of what they call an ocean pout, which is some kind of an eel type of a fish that apparently is in colder waters. but the technology that f.d.a. is looking at that would allow for this genetic engineering would essentially provide for a fish that would grow to market size in about half the time of a conventional salmon. so, in other words, a salmon out in the wild takes about 30 months to gain full maturity. with this franken fish, or this genetically modified salmon,

they could be of good market size, basically good eating size within about 15 to 18 months. so you're thinking, okay, how can this be bad? we get a salmon that looks like a salmon, and it comes to us in half the time. so, how can this be a bad thing? and i would like to share with you why i feel this is a bad thing. you will hear me talking about salmon because that's what the f.d.a. process is engaged with right now. but i will tell you that we understand that similar efforts are underway to develop a genetically modified trout as well as genetically modified tilapia, again, designed to grow faster than occurs in nature, out in the wild. the pending application for the salmon would be the very first

food from a transgenic animal that's been approved by the f.d.a. so this is really precedent-setting. people have suggested that, well, we see this in other forms of agriculture, but the fact is this would be the first food from a transgenic animal application that has been approved by the f.d.a. so this is really quite precedent-setting. what is happening is this approval process for the genetically engineered fish continues to move forward as a new animal drug rather than what it really is, what i mentioned before, which is a new fishery for this modified salmon, this salmon that has been tinkered with. basically a test tube salmon. so the reasons why i think this is a bad thing to be messing with mother nature and to

encourage this unnatural growth, we heard on the floor this morning the senator from new jersey, the senator from new york both stood and talked about a measure that's out there, the march that was out on the capitol yesterday, mothers concerned about toxins in the food supply, toxins in the world around us, and knowing what is out there, knowing what we are exposed to. well, i, along with many consumers out there, am concerned about genetically-engineered animal products that are intended for human consumption, including those that are in our marine resources. now, i'm -- i'm not the best cook in the family. my husband is. but i want to know -- he wants to know, our kids with a nts to know that what -- our kids want to know that what we're eat something good and safe to eat. at home we eat a lot of salmon. i can tell my kids, eat this,

this is loaded with omega-3 fatty acids. it is as good a as you can possibly get. and i can say that with certainty. we won't be able to say that with this genetically engineered fish. as a mornlings i'm not going to say -- as a mom, i'm not going to say, eat this frankenfish. not sure if they made it sterile or not. go ahead eat it because it came to market quick and we're going to be able to get a cheaper price on it. i think we care, we want to know -- we want to know the process here. and the scary thing with the f.d.a. right now, they are very reluctant, madam president, to label genetically engineered products, even though it allows the public to know what they're eth. the data out there is pretty

clear. higher human aletter general effects with genetically engineered fish. if you are a mom and your kids s have allergies, are you going to look at this fish and say, hmmm, i wonder if this will set your allergies off? no, you're going to stayway from t you're not going to serve that to your kids and family. even though you know the wild tough is good, is healthy, but how do you know which is which, if the f.d.a. isn't moving forward to label and you're not quite sure whether or not what you're buying in the grocery store is as advertised? how are we helping the consumer here? how are we helping them at all? so the first problem that i have is, this is -- this is, again, a product that's intended for human consumption and we've got some real concerns about the safety of the food, the safety

of it in the first place. second -- and this is one that, as an alaskan, where we have very strong fisheries, a very healthy fisheries, i worry about what will happen if in fact there is escape into the wild by these genetically engineered fish. you've got a frankenfish that et goes loose. they'll tell you, they are going to be in pens. we will make sure there is no escapement. but how can they guarantee that, how can they make sure that we're not going to see escapement? we've seen escapement from the farm fish that come and mingle with the wild stock? we've seen the disease that can be transmitted. how is any of this good? even though this genetically engineered fish is supposedly going to be kept in a closed system, on-shore pens, the possibility of escape, it is recognized, is still out there,

it still exists. and then what you're going to have, you're going to have these genetically engineered fish that are going to breed year-round. they are also going to be eating year-round. they are real estat going to bes year-round and what you can very possibly see is this competition with the wild stock. they will compete with one another for the food -- for the food that the species feed on. they'll wreak havoc with the ecosystem. so you are introducing -- and, granded, nogranted, not essentia fish that just doesn't work with our wild stock. these genetically engineered fish would reportedly be sterilized and their hormones altered. many scientists that the f.d.a. testing to confirm the safety

and sterilization of the fish is sufficient. we see that in the c.r.s. report that has looked specifically to this issue. so unlike -- unlike other agricultural products, if you've got an escape of frankenfish, it would be to an uncontrolled marine environment exposing the ecosystems to associated risks. if you have a cow that has been genetically modified, the cow is on land, gets out of the pen, you have more ability to control. you don't have the ability to control in a marine environment. it's just not possible. so what is happening is we are putting at risk the health and the safety of our wild stocks, unacceptable. third, many find the f.d.a. process for approving an animal

product intended for human consumption, as it would a veterinary drug, to be insufficient. it lacks the robustness and transparency that one would expect for a product that would be treated as a substitute for fish that's currently on our dinner plates in this country today. the c.r.s. report, which i just mentioned -- and i'd like to introduce to the record a report by c.r.s. dated june 7 of last year "generagenetically engineed fish and wildlife: environmental concerns." one of the concerns raised is, "a national research council report stated that transgenetic fish posed the greatest concerns associated with animal biotechnology in large part due to the certainty inherent in

identifying environmental problems early on and the difficulty of remediation once a problem has been identified." madam president, our fishermen, are highly regulated. any change to a federal fishery, including a new g.e. fish rirks should bage isled for environmental effects and economic impacts to environmental impacts and fishing communities. that's what we are doing in this amendment. we are bringing noaa in to say, be part of this process. and then the last point that i'd like to make on this is the very significant economic consequences of approving a genetically engineered fish. historically, the entrance and the growth of farm salmon in the marketplace has had negative impacts on our salmon industry. we've got -- we've got incredible, abundant wild stocks. we're very proud of it. it is -- the seafood industry in the state of alaska is our second-largest employer, 500

vessels deal with salmon alone. but the concern is although we have very strong wild stocks, we could see the market respond with fear, unreasonable but still respond with fear and confusion to the introduction and the growth of engineered fish, particularly if it is not labeled. this, in my opinion, could have devastating impact on our fish industry, the jobs that it supports, and clearly at a time that it can't afford it. now, some will come back and say, hey, this is a new industry, it's going to create new jobs. well, i'll take you back to that c.r.s. report, and one of the things that i find kind of interesting, "to address the concerns that have been raised, this aqua bounty company is proposing producing all the salmon eggs in canada, then they ship them to panama, they grow and process in panama, and then

they ship this fish, this frankenfish to the united states for resale. so basically we get all the harm, we don't get any jobs, but what we're doing is we're putting at risk -- we're putting at risk the existing jobs within the seafood industry in this country, priority number one. madam president, i see that my time has expired. as imansed, i would ask that -- as i mentioned, i would ask that the c.r.s. report be made part of the record as well as several letters of support that -- support for my amendment that i would ask to be included as part of the record, and with that, i will yield the floor. the presiding officer: without objection. thank you. the senator from maryland is recognized. mr. cardin: thank you, madam president. i would ask consent that the pending amendment be set aside so that i can call up amendment 2125. the presiding officer: without objection. so ordered. the clerk will report.

the clerk: the senator from maryland, mr. cardin, proposes amendment numbered 2125. mr. cardin: madam president, i now ask consent that that settlemenamendmentbe set aside l up amendment 2141. the presiding officer: without objection, the clerk will report. the clerk: mr. cardin proposes amendment numbered 2141. mr. cardin: thank you, madam president. i would ask consent that my entire 125eu78 statement be madf the record. the presiding officer: without objection, so ordered. mr. cardin: first let me thank and congratulate senator harkin and senator enzi for their incredible work in bringing forward this bill that is so important to the public health of our nation. we're dealing with the safety of drugs, biologics, medical devices, our nation's food supply, vaccines, cosmetics and

the list goes on and on. and it is important that we have the proper authorization so that the f.d.a. has the resources it needs to advance innovation into the marketplace, products that fall within the jurisdiction of the f.d.a. we know that the basic research is done at n.i.h., but then to get products to market, it is important that f.d.a. has the resources in order to move the process forward. i am proud of the 11,000 workforce that are headquartered in silver spring, maryland, for the f.d.a. and we know that they work very hard. i think this legislation, this reauthorization of the user fees, will give them the tools in order to get the job done, and i'm particularly impressed that this is a five-year reauthorization bill that will give the predictability that's needed in order to get the job done. so i do want to applaud senator harkin and senator enzi.

we don't see enough of these bills moving forward with the type of process that our leaders have brought forward. you have brought -- you've resolved a lot of the issues, and we thank you for that. you've brought us forward a bill that enjoys brought, bipartisan support understan and is in thet interests of our nation, and i'm proud to sponso support this legislation and thank you for the manner in which you have proceed in committee and on the floor. i also want to point out that this bill deals with the drug shortage issues. madam president, i applaud your efforts, senator klobuchar's efforts, with dealing with the drug shortage issues. we need more effective notification of potential shortages so that we can have appropriate action to make sure that the people of this nation have an adequate supply of medicines. let me just share with my colleagues a letter that i received from kerry fitz morris

of bethesda, maryland, who is undergoing treatment for ovarian cancer. "my doctor put me on ovment doxo try to get rid of some tumors. doxil was chosen because it works especially well with brca gene. i have four treatments and was responding very, very well. i have noe now missed three doses of doxil due to shortage. i am treading water wit but am frustrated that i am no longer making progress towards remission. then there is all of the stress involved with the shortage, not knowing if there is anything that i can do or what will happen next or how long i will be in treatment. i am trying to continue to be a wife, a mother, to hold down a job. i wonder why we are being asked to raise money to find cures when we can't even get access to the cures that exist now."

that's the frustration that's out there on drug shortages. i am very please pleased in a ts legislation will move us in the right direction on answering that question. i might tell you that it doesn't only affect those that are under active treatment. it also affects those -- the number of clinical trials that we can participate in. there are currently about 150 clinical trials at n.i.h. involving cancer and trying to find the answers to and cures for cancer. the problem is they don't use placebos. they use the current drug therapy that is known for the treatment against an experimental process. well, there's not enough drugs available to treat people for the current protocols, how can those drugs can be used in a clinical trial? and as a result we're finding it very challenging to move forward with the clinical trials that are needed. once again, this legislation