'significant numbers of settlements potentially involving pay for delay. " in 2004 the f.t.c. identified zero. 2006 up to 14. in 2011 that doubled to 28. clearly it's a big trend. -- quote -- "28 final settlements that contain both compensation to the generic manufacturer and a restriction on the generic manufacturer's ability to market its product." pay for delay. this fair generics bill, through this amendment, fixes the problem. that was the intent of the original hatch-waxman language, but there was a loophole there that has been kphroeuted in this -- exploited in this pay for delay deal, because the first filer is granted

exclusivity even if the first filer is paid off and settles and doesn't pursue its ability to enter the market. the fair generics act would fix that, and it would basically outlaw that sort of parking of generics. and so it would realign and reaffirm the incentive and reward not stkwruft -- just for filing first but for successfully challenging and invalidating a patent. so we would move the first filing exclusivity to a reward for filing and also successfully invalidating a patent. realistic proposal. it would allow the first filer certainly to follow through on that filing. it would incent it, encourage it, but also if that's not going to happen, it would allow subsequent filers to litigate, invalidate the patent and thereby gain ability to enter the marketplace.

i really think this was the intent of hatch-waxman. unfortunately, there is a loophole that's been exploited in hatch-waxman that has led to the serious pay-for-delay cases. and, again, this is an escalating trend and it's growing and growing and growing. i have no doubt that when we get the numbers for 2012, it's going to be significantly above the 2011 number of 28. so to simplify it, if a first filer does not enter into a settlement with the restricted and delayed market entry date, and if it does diligently challenge and invalidate a patent, nothing changes under present law. the current six-month market exclusivity reward remains. so that incentive, that reward absolutely remains. however, if that doesn't happen

and the first filer just wants to settle or park its filing and its generic, a subsequent filer would have an ability to step up and challenge the patent. and if it won, it would have market access. this solution provides more litigation certainty. we propose basically a use it or lose it statute for the brand name to sue the generic within the 45-day window. current law provides a brand manufacturer a 30-month stay if they sue the generic within the 45-month wen dough. but -- window but still allows a suit after. so, again, i believe this is a reasonable and measured approach this is not as draconian and dramatic a approach as other proposals in the senate. i believe this is a middle grounds and i believe this honors and gets us back to the original intent on this subject

of hatch-waxman. but it is a measured response to this escalating trend we clearly see, that the f.t.c. has objectively identified and measured of so-called pay-for-delay arrangements. so, in conclusion, mr. president , again, the goal of hatch-waxman was to bring generics to the market more quickly. this approach, the fair generics act, will do that. there are anticompetitive deals that are being struck more and more often. pay-for-delay. and they're becoming much more prevalent and they're hurting american families. the megalobbyist pharmaceutical industry, of course, opposes this reform because, quite frankly, those pay-for-delay deals with a way to buy more exclusivity and keep generics off the market longer. but that's not in the interest of the consumer.

it's time to stand up to them, to have some courage to stand up to big pharma and say, we're going to preserve your exclusivity for developing a drug but we're not going to let you buy off generics and unfairly extend that time period we're going to let generics come to market in a reasonable time. we're going to create incentives to make sure that happens. i urge all of my colleagues to support that proposal which is embodied in the bingaman-vitter amendment, the fair generics act. thank you, madam president. i yield back the floor. the presiding officer: there is now time equally divided on the bingaman vote for the -- on the bingaman amendment. mr. harkin: madam president, first i ask for the yeas and nays on the bingaman amendment. the presiding officer: is there a sufficient second? there appears to be. the yeas and nays are ordered.

mr. bingaman: madam president, first let me thank my colleague, senator vitter, for his comments and his strong support for this amendment and thank all the other cosponsors of the legislation. if you're interested in -- in promoting competition in the health care field so that we can keep prices down, then you need to support this amendment. that's exactly what this does. under -- under our law in this country, we provide exclusive rights to a company that develops a drug to sell that drug during the time that that patent is in effect. but what we're concerned with here is that after that patent is no longer valid, companies are still extending their exclusivity, extending their time when they don't have any competition by entering into these agreements. so we think that they can settle

their -- their disputes, we don't have a problem there, but they cannot keep other generic manufacturers from coming to market who also have demonstrated the not validity of the patent. if you're worried about the cost of health care to the federal government, the federal government's paying too much for prescription drugs because of this flaw in the hatch-waxman act that we're trying to correct. if you're worried about keeping prices down for hospitals and insurance companies and consumers, this amendment will help to do that. i urge my colleagues to support the amendment. mr. enzi: madam president? the presiding officer: the senator from wyoming. mr. enzi: madam president, i rise today to oppose the amendment addressing the patent settlements for generic drugs. i'm sympathetic to the intent of the sponsors of this amendment. i believe that the drug patent settlements can be improper and could be unfairly increasing drug prices for consumers. if that's happening, in fact, we should stop the bad settlements and encourage the ones that do work. the problem with this amendment is that its scope is much

broader and could lead to unintended consequences that could harm consumers and increase costs, and that's why i have to oppose it. not all patent settlements are abusive. they do not all lead to higher costs. in fact, according to one recent study by r.d.c. capital market, patent settlements helped expedite 24 of 37 most recent generic drug approvals. if it works in 24 out of 37 of the cases, we ought to figure out the way to eliminate the other 13 but not all of them. so i would ask that we oppose this amendment and continue to work on it. i yield the floor. the presiding officer: the question is on the amendment. the yeas and nays were previously ordered. this is a 60-vote threshold. the clerk will call the roll. vote:

vote:

vote: the presiding officer: are there any senators in the chamber wishing to vote or change their vote? seeing none, on this vote, the

yeas are 28, the nays are 67. under the previous order requiring 60 votes for the adoption of this amendment, the amendment is not agreed to. mr. harkin: madam president? the presiding officer: the senator from iowa. mr. harkin: madam president, i understand -- the presiding officer: the senator from iowa. mr. harkin: madam president, might i inquire what the next vote would be on. the presiding officer: the murkowski amendment number 23108. mr. harkin: madam president, i ask unanimous consent that that vote be a ten-minute vote. the presiding officer: that is already the order. mr. harkin: and there will twok minutetwo minutes you divided prior to the vote. the presiding officer: there are now two minutes divided. ms. murkowski: madam president, i ask for support -- the presiding officer: if we could have order in the chamber,

please. the senator from alaska. ms. murkowski: madam president, i ask for support of the amendment that's before us. this is an amendment that will actually strengthen the role of noaa as the federal agency that has oversight over our fisheries. we're talking -- the presiding officer: senators, please take your conversationed out of the well of the senate. ms. murkowski: madam president, currently the f.d.a. is considering an application for a genetically engineered fish, a fish that takes d.n.a. from one salmon and an eel pout to accelerate the growth unnaturally. the faf.d.a. is not looking at labeling this fish. the f.d.a. is not considering the environmental impact of a statement on this fish into the marine environment. what we're asking for with this

amendment is, as the f.d.a. proceeds in its process, that the agency that has oversight of our fisheries be allowed to participate and weigh in as to whether or not there's any environmental consequences that may come about as a consequence of a release into a marine environment. this is a situation where people have a right to know about the quality of their fish, where it comes from, what it's made of, and what i'm asking is for the agency that has oversight of our fisheries to have a role in this process. i urge members to support the amendment. the presiding officer: the majority leader. mr. reid: madam president -- madam president, the time, as usual, doesn't run as quickly as we want. and so i ask unanimous consent that we only have two votes prior to lunch today and that the next vote start at 1:5

today, after we -- at 1:55 today after we complete this vote. the presiding officer: is there objection? without objection, so ordered. mr. roberts: madam president? the presiding officer: the senator from kansas. mr. roberts: madam president, can we've order? mr. harkin: madam president, regular order, please. the presiding officer: for what purpose is the senator seeking recognition? the senator from kansas. mr. roberts: i rise in opposition to speak for one minute. the presiding officer: there's one minute in opposition. the senator ^s recognized. mr. roberts: i thank you, madam president. i fear this legislation would insert congress in the scientific process of approving a. applications that we have

entrusted the f.d.a. this application has been pending at f.d.a. for over 15 years. we should allow the -- the presiding officer: could with we have order in the senate, please. mr. roberts: i appreciate that madam president. the presiding officer: the senator from kansas. mr. roberts: we should allow the f.d.a. to complete their scientific review of the product and not interfere with the ongoing reviews. we have a science-based system that allows for a complete review. we should allow for that rerue to continue. this sets up a two-tier, two-agency system. we know the f.d.a. has already conferred with noaa. basically members of the senate should not put on lab coats and tell the f.d.a. to approve or deny the pending application. we should allow them to act on the statutory authority that is given to them. i reluctantly oppose the amendment from my colleague -- my disappearing colleague from alaska. i yield back.

mr. kerry: does any time remain? the presiding officer: the senator from massachusetts, ten seconds remains. mr. kerry: this would be the first time congress has ever interfered in an f.d.a.-based, science-based approval process, and if we open that up, we would be opening up an extraordinary can of worms. i urge my colleagues to oppose this amendment of. mr. merkley: madam president, is there time left on the affirmative? the presiding officer: there is not. mr. merkley: i ask for the yeas and nays. the presiding officer: is there a sufficient second? there appears to be. there is. the clerk will call the roll. vote:

vote:

the presiding officer: are there any senators wishing to vote or to change their vote? seeing none, on this vote the yeas are 46 and the nays are 50. under the previous order requiring 60 votes for the adoption of this amendment, the amendment is not agreed to. a senator: madam president?

the presiding officer: the senator from tennessee. may we have order in the chambers, please. mr. corker: i understand i have three or four minutes to speak about the gain act. the presiding officer: on whose time does the senator wish to speak? mr. corker: how much time, about hour minutes. the presiding officer: on an amendment or on the bill? the senator is recognized. mr. corker: madam president, i rise to --. a senator: parliamentary inquiry, if the senator would yield for a second. the presiding officer: the senator from iowa. mr. harkin: i wants to ask -- there is a lot of commotion going on here. the presiding officer: the senator from iowa. mr. harkin: i just wanted to know where the time is coming from for the senator from tennessee. the presiding officer: the senator said that he was speaking on the bill. mr. harkin: madam president, how much time is left on the bill?

the presiding officer: the senator from iowa controls 15 minutes, and the senator from wyoming controls 22 minutes. mr. harkin: how much time does the senator from tennessee seek? mr. corker: three minutes. mr. harkin: i didn't know how long you wanted to talk. that's fine. madam president -- the presiding officer: the senator from wyoming. mr. enzi: i'll yield the senator three minutes. mr. harkin: i'll yield him three minutes, too, if he needs it. mr. corker: i'm rising to thank the majority and minority leader on this bill for their efforts and i'm pleased to talk about a growing, unpublic threat in tennessee and across the nation. several months ago senator blumenthal and i introduced the gain pactd, this bipartisan provision provides meaningful

market incentives and reduces regulatory burdens to encourage the development of new antibiotics that will help save lives and reduce health care costs. drug-resistant bacteria or super bugs as we call them, are becoming harder and harder to treat because we lack new antibiotics capable of combating these infections. not only do these infections take a toll on patients and their families, but they also run up health care spending to the tune of $35 billion to $45 billion annually. it's crucial that these new antibiotics are discovered in order to stay ahead of this growing trend of drug resistance drug discoveries do not happen overnight as we all know so we must act to make sure we have lifesaving medications when we need them. the gain act is a commonsense bill that provides market incentives to encourage innovation without putting federal dollars at stake and is

included in the f.d.a. reauthorization. antibiotic resistance is a growing issue that we must address now to properly prepare for the future. doctor william evans, director and c.e.o. of st. jude's hospital in tennessee recently wrote a letter supporting this bill. this his is his quote. don't want want to find ourselves in a situation in which we've been able to save a child's life after cancer diagnosis only to lose them to an untreatable multidrug resistant infection. i'd like to thank my colleague, senator blumenthal from connecticut for his leadership on this bill, and i especially want to thank senators harkin and enzi for working with us the way they have to include this provision in the f.d.a. safety and innovation act. madam president, i think i've stayed within my limit. i yield the floor and thank you for the time. the presiding officer: who yields time?

the senator from wyoming. mr. enzi: i'd yield five minutes from my time on the bill to the senator from ohio. mr. portman: i thank the ranking member, and i congratulate him -- the presiding officer: the senator from ohio. mr. portman: thank you, madam president. i want to congratulate the ranking member and the chair for their good work on this legislation. there are a couple of amendments that i'd like to speak briefly about. the first has to do with prescription drug abuse, a problem we all face as representatives of our states, and i want to particularly thank senator whitehouse for his partnership on this important bill. in the past decade, unfortunately, prescription drug abuse has reached epidemic proportions in states like ohio and in so many other states around the country. in doing so, it's devastated the lives of so many individuals, but also the well-being of our communities and of course

affected their families, affected our economy. it's caused a big spike in crimes, including theft, as addicts look for ways to support their addictions. and the crime, of course, has doubly strained law enforcement which has already had to contend in the increase in drug trafficking with constrained budgets. it's also served, usm, aes a gateway to other drug use, including heroin use, which tends to be less expensive and has caused additional public health challenges. amazingly, since 2007, drug overdoses have now moved ahead of car accidents as the leading cause of accidental death in my home state of ohio, and again we've seen this unfortunately too often around the country. we've had record levels of help hepatitis c infection from needle-sharing. in one ohio county, 10% of the babies born in 2010 had drugs in their system. the good news is progress is being made in places like soda

county, and thanks to law enforcement, families, schools, and churches and others. but they need some help. one tool the they are looking fs a better way to upon tear prescription drug use -- to monitor prescription drug use. there are databases around the country called prescription drug monitoring programs. they allow states to track the prescriptions of drugs to be able to identify abuse and stop abuse. so people getting prescriptions for these drugs in various different doctors' offices and what have been called pill mills. preliminary research has shown that monitoring programs are highly effective in stemming the tide of abuse. that's why 41 straigh states ane territory have them. different states can't communicate with each other,

though. this is especially true in places like soda county, very close to west virginia. we want these states tock able to -- to be able to work together. that's why senator whitehouse and i have offered this amendment of it is a federal solution to offer sharing of information. the amendment also supports collaborating between in order to further research a ssess challenges that have an impact on state interoppose rafnlt some have called for a national monitoring program, one federal program. i don't think that's necessary. i don't think it'll work as well. a lost states have programs that are working extremely well. they have put a the although of money into it and it is based on different health information standards state by state. our amendment gets these disparate programs to work together securely, reliably and efficiently without undermining or jeopardizing the state you a

tongue me. states should remain free to establish laws that determine user eligibility and reporting requirements you for instance. so this legislation, is smart legislation to help give communities the tools they need to fight this prescription drug abuse. finally, i would say our amendment has no effect on drug -- on direct spending or revenues. the other amendment i want to mention is about the dangers of what we unfortunately all here in this chamber heard about, which is synthetic drug abuse, including k-2 spice, bass bath salts, herbal. let's prohibit these drugs from getting into the hands of our children, our servicemen and women, and others. this amendment addresses the growing use and misuse of synthetic drugs by placing 15 synthetic drugs, two stimulants, nine hal hallucinogens to expose those who distribute and export

synthetic drugs. with full penalties and sanctions and regulatory controls. i'd like to give special thanks to the people who have led this effort here over the years in this chamber, senator grassley, senator schumer, senator klobuchar. they've workeddard on this issue and we're all pleased that this is part of the underlying legislation. senator grassley as well as folks from the antidrug coalition originally introduced knee this rising ref len risingf designing drugs. i was told stories about 0 those who have as you understand and the deaths that have occurred around the country. the amendment would have no significant effects on direct spending and revenues over the ten-year period and again is a good commonsense approach to trying to get our hands around this issue, help the constituents we represent, help our communities to fight, to stem this substance abuse that's affect us all. madam chairwoman. i yield the floor.

madam president, i yield back the remainder of my time, yield the floor, and note the absence of a quorum. the presiding officer: would the senator withhold his request? the senator from north carolina. nor senator madam president, you rise today to speak in support of the food and drug administration safety and innovation act. mr. enzi: could i inquire of the senator how much time the senator would like? a senator: i would request six minutes. mr. harkin: we yield six minutes off the bill. the presiding officer: the senator from recognize. mrs. hagan: thank you. first i do want to applaud the hard work of the chairman, senator harkin, and the ranking member, senator mike enzi. this bill is truly one of the most bipartisan efforts i have had the opportunity to be a part of in the three years i have served in the u.s. senate. it ought to be a reminder that, yes, when we work together across the aisle, the senate can get things done. i'm particularly proud to support this bill because of what it will mean for patients who are suffering with diseases,

who do not have access to adequate treatments or who do not have access to any treatment at all. this bill we are voting on includes key provisions of the treat act. the treat act is the transforming the regulatory environment to accelerate access to treatments act, which i introduced in february. these important provisions will expedite the review of treatments for serious or life-threatening diseases without compromising the f.d.a.'s already high standards for safety and effectiveness. i introduced the treat act after meeting with a family whose child suffered from spinal muscular atrophy or s.m.a. it is an incurable neuromuscular disease, the leading genetic cause of infant deaths. this family was not alone. there are 30 million americans suffering from rare diseases. i have had the honor to meet a number of them. their stories are both heartbreaking and inspiring. when i visited the north

carolina children's hospital last month, i met with megan and jared hindrun. whose 13-year-old twins suffer from a disease, a metabolic disorder for which currently there is no cure. i also met with an 8-year-old ashley burnett from raleigh who is resilient and wise suffering from neuroblass stome ma. for patients like these suffering from these rare diseases for which there are no apriewstled proved medications, medical advances for these patients and their families cannot come fast enough. there are so many rare diseases but fewer than 250 have f.d.a.-approved therapies. the provisions of the treat act that have been included in this bill take great steps toward resolving the problem. there is currently a pathway at the f.d.a. that expedites the review of drugs for illnesses

that are serious or life-threatening and for which there is no adequate treatment. this is called the accelerated approval pathway. since the early 1990's it has been successfully used to advance treatments for patients with h.i.v. and cancer by leaps and bounds. however, it has not been applied regularly or consistently to the review of drugs to treat other diseases. and this is inconsistent and this inconsistency is why i introduced the treat afnlgt my bill will broadening the application of the accelerated approval pathway beyond hiv-aids and cancer to a wider range of diseases, with a particularly focus on rare diseases. that's why my proposal enjoys broad support from patient voashts, including the national -- advocates including the national organization of rare diseases, the huntington's disease soviet america and many more.

by providing for consistent application, we will help the f.d.a. implement these provisions, assist drug sporks navigate the approval process and hopefully bring safe and effective treatments more rapidly to the patients that need them. i'm also prowrd to have played -- i'm also proud to have played a critical role that led to the negotiations of the first biosimilars user fees agreement which is also in the bill before us. last congress we passed the bite yow logics -- the biologics act for low-cost alternatives to biologic drugs, while ensuring continued research and development into innovative biologics which could save or improve the lives of millions of americans. the user fees negotiated by the industry and the f.d.a. will provide the necessary funding for the review of these critical therapies. the biosimilars industry is in the earliest stages of development, and the biosimilars

user fee agreement will help facilitate this industry's growth. in addition, the f.d.a. safety and innovation act provides the necessary regulatory updates to keep pace with the rapid innovations of the biopharmaceutical industry. this is imperative for creating jobs in states like mine in north carolina and maintaining america's competitive edge in the global economy. companies with footprints in north carolina are partnering with our world-class universities to improve the health of people all across the globe every day by researching, discovering, and developing lifesaving treatments for those cuffing from these devastating diseases. the passage of the f.d.a. safety and innovation act for states like north carolina and for our nation to remain global leaders is important and especially to help attract the jobs of the future. the american public also expects the f.d.a. to be the world's gold standard when it comes to

ensuring the supply, the safety, and the integrity of our drug supply. by sending the f.d.a. safety and innovation act to the president's deck, we will establish a clear and effective pathway for turning ideas into cures and cures into treatments and will have shoant foresight and -- shown the foresight required to maintain our country's position at the top. thank you, mr. chairman tsh madam president. urge my colleagues to join in supporting the f.d.a. safety innovation act. madam president, i yield the floor.

mr. harkin: madam president? the presiding officer: the senator from iowa. mr. harkin: i ask that furlt proceedings under the quorum call be dispensed with. the presiding officer: without objection. mr. harkin: i ask that the -- i suggest the absence of a quorum and i ask that the time

be taken off of the burr amendment. on both sides, equally on both sides off the burr amendment. the presiding officer: without objection, so ordered. the clerk will call the roll. quorum call: quorum call:

a senator: madam president? the presiding officer: the senator from delaware. mr. carper: i ask unanimous consent the quorum call be vitiated. the presiding officer: without objection. mr. carper: i ask unanimous consent to be recognized for ten minutes and the time taken from the burr amendment, equally divided from both sides. the presiding officer: without objection. mr. carp jerks thanks madam chair. we have three counties in delaware, the southernmost is sussex county. i spoke as a lay speaker at a church there to encourage people to become mentors. the minister was reverend reynolds, now deceased. a great old guy.

he said these words and i've never forgotten them. he said the main thing is to keep the main thing the minimum -- the main thing. the main thing is to keep the main thing the main thing. and at first i wasn't sure what he was talking about but the more i thought about it, i thought this guy's smart and if i'm smart, i will keep the main thing the main thing. and i think for us here in the senate and in congress one of the things -- the main thing for the voters of this country is they want to us work together. maybe there are two main things. they want us to work together, they want democrats and republicans to work together, they want to us get things done. and one of the things that they want us to get done is to create what i call nurturing environment for job creation, job preservation. they want to us do things that are going to encourage the creation of jobs. and the preservation of jobs. little known to loot of folks across this country, we've been doing some of that in the senate for much of this year.

and we've worked productively across party lines to pass a series of bills that i think do help create a more nurturing environment for job preservation and job creation. a couple of examples if i could, madam president. one the reauthorization of the federal aviation administration. a new source of redicial revenues to modernize and updates airports across the country to bring the air traffic control system of our country into the 21st century. really kind of an analog system and bring it into the digital age. patent reform is another significant step forward earlier this year where we say enough of this patent, people who come in after someone swurp springfield filed a patent, that was my idea and botch things up and drog drag things out in the court. under our patent reform legislation, you're first to file, you're first to file. that's your patent. and to provide in the same legislation the resources needed in feant office to expeditiously, more expeditiously patent process

applicants. free trade agreements, one of our roles as a government is to try to make sure that we have access to foreign markets, and if you're gods and -- goods and services are being closed out in foreign markets to open them up and we agreed to by a broad bipartisan proposal this year, three of them actually, three, one with south korea, one with colombia and one with panama, negotiated originally by the george w. bush administration and signed by the obama administration, that is the law of the land if you will. to make sure when businesses have the opportunity to export and the barriers that are knocked down or eliminated to make sure if they -- american businesses need financing and help they have that help through the export-import bank which we have reauthorized and extended into the future. we -- another one we've worked on together, bipartisan bill supported by the president was something called the jobs act and what it really is all about

is trying to make sure companies have better access to capital when they happen to be like a privately held company that wants to go public to make sure they can do it through something called an i.p.o. onramp as opposed to jump trying to jump into it and get it done all at once or companies that want to stay privately held and to be capped at a 165 level, 500 shareholders, no, up to a thousand, 2,000 shareholders, to continue to grow and to create jobs. other examples of bipartisan legislation which we've worked on in one case the transportation bill, the land transportation, roads, highways, bridges and transit. we passed a good bill in the senate, paid for to help at least the next couple years to meet our transportation needs and make sure the three million people working on transportation and transit projects across the country don't basically get laid off in a month or two we passed a good bill. i give a lot of credit to

senators boxer and inhofe for leading the bipartisan approach. and also seven or eight million jobs depend on the postal service. the postal service is in tough straits, running out of money and losing 25 million bucks a day, we're hoping the house of representatives will pass a bill. they need to. so we can go to conference and help fix that problem. good bipartisan legislation here to affect positively seven or eight million jobs that depend on the postal service. all that stuff in terms of the american people wanting us to work together, we have been. those are just a couple of examples. in terms of actually doing things that help create jobs and preserve jobs, every one of the items i just mentioned does create a more nurturing environment for job creation and job preservation. in the coming weeks we also want to look on an agricultural legislation, bipartisan bill again out of the ag committee. it will save billions of dollars, deficit, on the deficit side, also help to strengthen our agricultural economy. we have -- need to get to work

on a national flood insurance update and that legislation helps to bolster the home building industry in this country which is struggling as we know. and we have the opportunity for those things that are on the to-do list to get them done. but today the senate is considering another important bipartisan piece of legislation. as we know, the food and drug administration safety and innovation act, affectionally known by its acronym, i love this, pdufa. the f.d.a. and how do we make sure the f.d.a. has the resources they need to do their jobs. and like the other bills passed by the senate that i just talked about, this bill helps to create a more nurturing environment for businesses to thrive. those businesses include pharmaceutical business, it includes businesses that make and sell medical devices. but just as important, this bill helps ensure that americans get access to lifesaving medications and medical devices that are developed in this country as soon an and as safely

as possible. this bill reflects a strong bipartisan, bicameral effort for which chairman harkin and ranking member mike enzi deserve enormous praise. i praise them even though they're not in the chamber, they've done great work and i thank them and their staffs for bringing us to this point today. but the legislation builds upon the successful current user fee programs that for a number of years that companies have paid a user fee if they want the f.d.a. to approve a drug or medical qies dwies and we're making -- device and we're making progress to have more resources to do this, but they need additional help. and this legislation would do that, paid for by the industries that are seeking the -- the consideration of the new pharmaceuticals and the new medical devices. the legislation also adds important new user fees for generic and biological drugs. those user fees are paid by bye the prescription drug and

medical device industries to help cover the f.d.a.'s cost for reviewing new drugs and medical devices. what this means, safer drugs and a speedier process to bring new and less expensive drugs and medical devices to markets for consumers and i think it's a win-win for just about everybody. as a result of this legislation, the f.d.a. legislation, affectionately known as pdufa, the f.d.a.'s drug review times have already been cut in half, that's good. if these user fees, user programs are not reauthorized the f.d.a. would have to lay off i'm told about 2,000 employees which would put them back in the soup, back had in the ditch if you will and begin delaying the approval of new drugs. we don't want to see that happen. that would threaten patent patient access to new therapies as well as pharmaceutical and medical devices for industry, for jobs and america's global leadership in biomedical innovation. the bill also makes medicines safer for millions of children,

improves the f.d.a.'s tools to police the global drug supply chain and reduces the risk of drug shortages. now, there are a number of amendments that are being offered to the bill, we voted on a couple of those. one of the amendments that we'll be voting on i believe a little bit later this afternoon is legislation that would in my view weaken or contaminate our country's supply of prescription drugs. put our patients and our health care system at risk. some of my colleagues have proposed to include a measure in this bill that ostensibly would lower prescription drug prices. this amendment in my view, however, is not without unintended consequences and we always have to be careful of those. the presiding officer: the senator's time has expired. mr. carper: could i ask unanimous consent for three more minutes, madam president. equally divided. the presiding officer: without objection. mr. carper: it would increase the number of con contaminated drugs. 39 it it would allow drugs to be

imported wholesale, often from illegal internet pharmacy. and though the measure is supposed to be about impoarpting drugs from canada, in truth it would allow drugs to come from countries that don't have the policing of prescription drugs we have here in the united states. instead of going down that road, we should work to increase the f.d.a.'s ability to protect and regulate our drug supply and while doing so, we should reject any proposal to import drugs, i think, from canada that undermine our ability to ensure that prescription drugs are safe and effective. one last thing i want to mention is an amendment that is going to be offered tba today, maybe already has been, i'm going to mention it anyway. it has to, it deals with generic drugs and concern about the ability for larger pharmaceutical companies to work with and really pay off, buy out the generic drug companies so they don't object to a --

the end of -- the generic drug company doesn't bring a generic version of a name brand drug to market. i just want to say, we need to be careful what we're doing here. i came out of the navy, came to this congress in 1983, a freshman congressman, in 1982, 20%, 20% of the prescriptions filled in this country were generic drugs. 20%. this year, 80% of the medicines that are being -- prescriptions that are filled, 80% of generic. and one of the well-intentioned amendments offered today is one that says, well, we're not making enough progress toward allowing the generics to grow. say that again. we've gone from 20% generic penetration in 1982 to today, 80%.

80%. and i would just suggest that we should declare victory and as time goes by that 80% will become 85% or 90%. we've gone a long ways and as a result of that people need to buy medicines, you can find a generic version of almost any medicine sold in this country. and i think the system is working just fine and we ought to allow it to continue to work. in closing, madam president, the main thing is the main thing, the main thing is to keep the main thing the main thing. and for us the main thing is to work together. we are in a whole host of ways including the leadership of senator harkin and senator enzi working to make sure our pharmaceutical industry is vibrant and strong, medical device vital and strong, but that patients are not disadvantaged, they're advantaged by all of that. responding to folks in delaware and iowa and across the country, missouri, we're working together, and not just working 0 together on a couple of things, a whole host of

things, a whole litany of provisions, laws and proposals that do what, help us to create a more nurturing environment for job creation and job preservation. that's a good things. that's a very good thing. with that having been said i want to thank senator harkin for giving me a chance to say a few words today, for a great work you and senator enzi have done and happy to follow your leadership here today. thank you. mr. harkin: madam president? the presiding officer: the senator from iowa. mr. harkin: i appreciate the remarks made by my good friend from delaware and i ask him and his staff for their inputs on this bill. again, this bill is the work of a lot of different people. i want to thank the senator from delaware for helping us get to pint the point where good consensus bill. thank him very much for his input on it. does the senator from new jersey -- i'm sorry.

i didn't know who was here first. the senator from west virginia seek time? mr. marriage: yes, sir. the presiding officer: mr. harkin: how much time would the senator like? mr. manchin: about seven. mr. harkin: i think the senator from new jersey was here first. how much time? mr. a lautenberg: about six or seven minutes at most. mr. harkin: is there any time remaining on the burr amendment? the presiding officer: no. there is no time remaining on the burr amendment. mr. harkin: i yield six minutes off the bill to the senator from new jersey. madam president, let me revise that. take six minutes off of the mccain amendment on our side for the senator from new jersey. the presiding officer: without objection.

mr. lautenberg: i thank the senator from iowa. and, madam president, i rise to speak against the amendment, 2107, the one that talks about pharmaceutical product, medicines. we -- we know how important the prescription medicines are and improving health in this country and the need to make sure that those drugs are safe and affordable. prescription drugs have brought great advances in health outcomes. just look at how much longer people are living. over the past century, life expectancy increased from 49 years to 77 years and that's over -- since the past century,

great improvements made. we know that beneficial drugs need to be more affordable, more readily available, but allowing drugs to enter into the united states from other countries is not the answer. the department of health and human services found that importing prescription drugs might save 1% to 2% on their prescription drugs, and i'm not describing that as insignificant. but these are modest savings compared to what the outcome might be. importing risky prescription drugs from other countries could cause more health problems, more suffering and in the final analysis, more expensive treatments. americans buy medicine to lower their cholesterol, fight cancer, prevent heart disease, and some of these have had remarkable, remarkable effects.

heart disease is much less threatening. still a dangerous disease but much less than it was some years ago. imagine what would happen to a mother or a child if they were relying on imported drugs only to find out that the drugs were unsafe. we need to be absolutely certain that we are not putting americans' lives at risk. and that's why i'm opposing amendment 2107, the mccain amendment, which would allow potentially unsafe prescription drugs to be shipped across our border and directly into the medicine cabinets of homes throughout america. instead of safeguarding american patients, this amendment would bring -- could bring potentially dangerous and ineffective drugs

from canada. and i say that, because though they may seem safe, canadian drugs, but we already know that drugs that claim to be from canada are not always reliable, that they're not worth a risk. an f.d.a. investigation found out -- found that 85% of drugs imported from canada -- canadian internet pharmacies were actually from 27 other countries, and many of these were pure counterfeit. the senate already recognized the danger that imported drugs pose to americans. on five previous occasions, this chamber has asked the department of health and human services to certify that importation will not put people at risk. and the secretary still has not been able to confirm that imported drugs would be safe.

so, madam president, i want to make another observation. i find it kind of amusing to watch republican colleagues talk about how wonderful the canadian health system is. last i checked, canadians' health care system is socialized medicine. and during the health care reform debate, these same colleagues were decrying the canadian system as a horrible socialist experiment. and so my colleagues need to make up their minds. do they prefer socialized medicine? if so, it comes with some risks, and i'm proud that many of our country's drugs originate in the state of new jersey, commonly known as the medicine chest state. in fact, there are over 46,000

highly-skilled people in my home state working to produce lifesaving drugs, and it would be wrong to undercut the hard work of these trained new jerseyans only to put americans in danger. right now the drugs in our country are safe, effective -- as we've seen by the results -- and thanks to senator harkin and senator enzi, this bill will make -- even make our drugs more safe. americans deserve real peace of mind when they open the pill bottle, swallow their medicine, they have to know that this -- the product is safe and effective. and i urge my colleagues to support keeping medicine in our country safe and affordable and i urge the drug companies, the medicine companies to do whatever they can to make drugs drugs -- medicines more

available at cheap -- cheaper prices. and i urge my colleagues, vote against amendment 2107. with that, i yield the floor. mr. harkin: madam president, i would yield six minutes to the senator from west virginia, again, off of the opposition to the mccain amendment time. the presiding officer: without objection. the senator from west virginia is recognized. mr. manchin: madam president and thank you, mr. chairman, i appreciate so much your hard work on this bill, a very important piece of legislation. before i speak to the bill, i want to commemorate the life of a dear friend and a true west virginia, coach bill stewart. bill was taken from us two days ago at the age of 59. he was a proud west virginian in every sense of the word and he was the best cheerleader it state ever had. whether it was playing ball at fairmont state, where i first met him, or coaching west virginia university to a fiesta bowl win, where he took an

underdog team to a thrilling victory, you never had to worry about bill's enthusiasm. he had enough for all of us. in fact, you were either a friend of bill stewart's or he hadn't met you yet, because when he did, you were his friend for life. bill was raised in new martinsville, west virginia, and was a west virginian through and through. countless young men thrived under his coaching, but he was also a truly dedicated family man. to his wife, karen and his son, blain, i hope karen and blain, both of them know just how much bill meant to all of the people of our state, how much we loved him and how much we're all going to miss him. my wife, gayle and i, will keep bill's entire family in our thoughts and prayers. thank you, madam president. and now i would like to turn to another issue, one that touches all of us, democrats and republicans, riches and poor, young and old, west virginians and new yorkers alike. madam president, as you know, the prescription drug epidemic is destroying communities across this nation. it's wreaking havoc on our

educational system. it's devastating our work force and our economy and tearing our families apart. prescription drug abuse is the fastest-growing drug problem in the united states and it is claiming the lives of thousands of americans every year. according to a report issued by the center of disease control in november, the death toll from overdoses of prescription painkillers has more than tripled in the past decade. more than 40 people die every day -- every single day -- from overdoses involving narcotic pain relievers. these prescription painkillers kill more americans than heroin and cocaine combined. it's especially tough in my home state of west virginia which has the highest rate of drug overdose deaths in the country. nearly 90% of those deaths are linked to prescription drugs abuse. for months now, i've been going out and listening to the stories of so many people in my state: law enforcement, business owners, schoolteachers, pastors, and especially the children, who

ask for help to get their parents off this stuff. so i worked with all of them to offer an amendment to this bill that would make it harder for anyone to abuse prescription drugs. that bipartisan amendment was submitted on behalf of the countless west virginians and americans whose lives have been cut short by drug abuse and the families who are picking up the pieces. and it is on their behalf that i thank my colleagues in the senate for passing it last night unanimously. madam president, i was so moved and encouraged to see the members of the u.s. senate come together across party lines and unanimously approve this measure to take a serious step to fight this prescription drug epidemic. i strongly urge our friends in the house to do the same and the president to sign this important bill. this measure is not the work of just one person. however, i'd like to thank the cosponsors of this bill, who all believe so strongly in it. senator mark kirk, my dear friend from illinois; senator

kristin gillibrand of new york, and senator chuck schumer of new york, and, of course, my senior senator from west virginia, senator jay rockefeller. i also want to thank governor tomlin and congressman nick rahall for their tireless work on this issue, aas long as with congressman vern buchanan of florida, who's doing excellent work to end the pill mills. as we all know, last night's vote gives this amendment a solid step forward, but there is much work remaining to give our communities the right tools to fight this epidemic. that's because all too often, we all hear stories like this one, in which the ohio county substance abuse prevention coalition in my state shared with me. a young boy was injured and was prescribed prescription painkillers containing hydrocodon't. after the injury, he began using the opiates with the other teens in his school. they began by taking pills and event way by -- eventually by graduation, snorting the pills

on a daily basis. one day he was convinced by a friend to try i.v. use. he was married, he was able to hold down a job until he began using it through i.v. his wife was addicted to painkillers and their child was born addicted to drugs. he wanted more than anything to be a hardworking father and husband. he wanted to live -- to amend his past behaviors. he completed treatment but eventually began using painkillers again. this man in his mid-20's overdosed and died. think about it. this young man was snorting pills by high school graduation and dead in his mid-20's. unfortunately, that story is more common than we would all like to believe. a 2012 study by the national institute on drug abuse found that 8% of high school seniors had admitted to abusing vike din in the past year. -- vicodin in the past year. the centers for disease control has town that about 12 million americans have reported nonmedical use of prescription painkillers in the last year.

unlike many illegal drugs, prescription drugs aren't produced in basement labs or smuggled across the border. they are found in our own medicine cabinets and are often prescribed for medically necessary reasons. and that makes it much easier for people to become addicted or abuse these medications. in 2010 alone, pharmacies dispensed the equivalent of 42 tons of pure hydrocodone. that is enough to give every man, woman and child in america 24vicodin pills. the fact is the number is just too high, people are getting these pills because it's just too easy. the presiding officer: time has expired. mr. manchin: that is why this amendment would make it harder to get addicted to prescription drugs by moving them to a more restrictive category in our drug category classification system. in practicality, this means that patients would need an original prescription for refills and pildz and would have to be -- pills and would have to be stored more personally. the presiding officer: the senator's time has expired.

mr. manchin: okay. i just want to say this to the chairman, to both of our chairmen on both sides of the aisle, thank you so much for a piece of legislation that's much needed. thank you for an amendment that was agreed upon, voted upon unanimously and accepted last night. it's going to go a long way to fight the drug abuse in america and save countless children's lives. thank you. thank you so much. i yield the floor.

mr. harkin: madam president? the presiding officer: the senator from iowa. mr. harkin: madam president, i yield myself -- how much more time is left on the mccain opposition? the presiding officer: 3 minutes. mr. harkin: i yield myself that time and a couple of minutes off of the bill. madam president, again, for senators to note that we're going to start voting here in about nine or ten minutes. and these will be ten-minute votes. the first vote will be on the amendment offered by the senator from kentucky, senator paul. and then the next amendment would be senator mccain's amendment, and then senator sanders' amendment, senator durbin's amendment and then final passage. by consent earlier, all of those votes will be ten-minute votes. so i just wanted to make sure that people knew just what the

lay of the land was here. madam president, i might just say is that we're rapidly approaching the final passage of this bill. we've had great cooperation from all senators on both sides in moving this legislation forward here on the floor. we've had good debates. they haven't been drawn out endlessly, but we've had good debates and i think a good airing of the amendments and the bill. so i want to thank all senators for that, and hopefully that we can move rapidly to wrap up this bill and move it on. this bill, as i said many times, is the product of about 18 months of very hard work by senator enzi and all of the senators on our committee on both sides of the aisle. it is a true compromise bill, a bipartisan bill. it has, as i mentioned earlier, the support of a broad spectrum of stakeholders from the

pharmaceutical companies to pharmacists to consumer organizations, across a broad spectrum supports this bill. and it's necessary that we get it done, and that's why we have urged everyone to expeditiously get this done before the break period coming up for memorial day, because we have to get this done so that the food and drug administration won't have to start sending pink slips out to people this summer, that there won't be any disruptions and that they can get on with the business of making sure that we get drugs and devices to patients expeditiously, but safely, making sure that our tkregz and our -- our drugs and our devices are safe. it's a good bill and the result of a lot of hard work by a lot of people. and so i hope that we can move these amendments rapidly and move to final passage this

afternoon. mr. enzi: madam president? the presiding officer: the senator from wyoming. mr. enzi: i just ask unanimous consent that when we begin the next vote, senator paul has 7 minutes left on his time, that he be given 2 minutes as the explanation for his bill in exchange for those 7 minutes. the presiding officer: is there objection? without objection. mr. harkin: madam president? the presiding officer: the senator from iowa. mr. harkin: again, i yield myself such time as i may consume off of the bill. the presiding officer: without objection. mr. harkin: madam president, we're rapidly opposing a vote on the paul amendment. i know the senator wants to have a couple of minutes to speak on that. so i rise in opposition to the

paul amendment. i oppose it for several reasons. perhaps the most important reason is that this is a drug bill. this bill deals with drugs and devices. it does not deal with food. we dealt with dietary supplements and vitamins and things like that in the food safety bill that we passed here two years ago, and that bill, again, was a consensus bill. it's been through the committee structure. we brought it on the floor, had a lot of debate on it. we made modifications at that time to the whole area of supplements, vitamins, minerals and supplements. and that's the proper place to address it, not on a bill like this. this bill is a bill on drugs. not on supplements and food. so that's the most important reason. i'll make that same argument on

the durbin amendment, that it shouldn't be here because this is a drug bill. on substance, i would say this bill really turns kind of food law on its head. it would allow supplements to be sold with claims to cure any disease such as aids or cancer, without any kind of f.d.a. review whatsoever. i take a back seat to no one in terms of my support for the vitamin, mineral and supplement industry or their products. senator hatch and i were the two people that put through the desha bill, the dietary supplement and education act in 1994. we have sort of been protectors in working to make sure it's implemented correctly since that time. but the paul amendment would just go way too far, way too far. it is not consensus policy. in fact, it's strongly opposed by even the dietary supplement

industry. i would note that the natural products association, the united natural products association, the council on responsible nutrition, all three big umbrella groups, are all opposed to the paul amendment. so, again, this would just open up this industry to just snake oil salesmen. those of us who want to make sure that people have access, unfettered access to safe products and to good nutritious vitamins, minerals and supplements, the last thing you want to see is people in their garages mixing things up and selling them as snake oil. this is not, this is not good for america. it's not good for people who want to take vitamins and supplements and minerals for their own health.

it would just throw this thing open and turn the clock back 50 years or more to where anybody can make any claim they want and the f.d.a. would have no way of reviewing it whatsoever. so, i will move to table the amendment at the appropriate time, but i urge all senators to oppose the paul amendment. madam president, i yield the floor. the presiding officer: who yields time? who yields time? mr. enzi: madam president, i yield -- i'd yield the senator from kentucky the time that he's already entitled to. mr. paul: madam president? the presiding officer: the senator from -- the senator from

kentucky is recognized for 2 minutes under the previous order. mr. paul: my amendment is to rein in the f.d.a. i believe they have gotten overzealous in their duties. they do have important duties, but i think they've gotten overblown. my amendment has three parts. first, it attempts to stop the f.d.a.'s overzealous regulation of vitamins, foods and supplements by codifying the first amendment, the first amendment prohibition on prior restraint. what this means is the first amendment says that you can't restrain speech before it happens. this amendment also helps to make explicit that commercial speech is speech and should be protected. under current rules, the f.d.a. prevents even the manufacture of prune juice from saying that prune juice relieves constipation. i think that's an f.d.a. that's gotten a little bit out of hand,

and i think vitamin supplement manufacturers and distributors should be allowed to give you information and that the buyers should be allowed to review that information in making decisions about the product, and that the speech should not be restricted. second, my amendment says the f.d.a. doesn't need to be carrying weapons. i don't need to see bureaucrats carrying automatic weapons. i would rather, if there are police officers necessary in the operation of their duties, that they have the f.b.i. the f.d.a. does not need to be sending armed agents to the amish farms to arrest a farmer for selling milk from the cow. third, my amendment fixes what needs to be fixed in a lot of regulatory crimes. we need to add in the component of men's rea. -- mens rea. when they put you in jail, you have to have proof that you had a guilty mind and had intent to

commit a crime. we have two words. if they're going to accuse you of a crime, you have to be -- it has to be knowing and willful. these are very simple words but changes the burden of government if the government is going to accuse you of the crime, they need to know this. if congress is going to criminalize conduct at a federal level as it does in the f.d.a. act, then the least we can do is add in -- the presiding officer: the senator's time has expired. mr. paul: thank you. i urge support for my amendment. mr. harkin: madam president? the presiding officer: the senator from iowa. mr. harkin: madam president, i move to table the amendment by the senator from kentucky and ask for the yeas and nays. the presiding officer: is there a sufficient second? there appears to be a sufficient second. the clerk will call the roll. vote:

vote: test

vote:

the presiding officer: is there any senator who has not yet voted or wishes to change his or her vote? if not, on this amendment the yeas are 78. the nays are 15. the amendment carries. the motion to table is agreed to. under the previous order, there will be two minutes of debate equally divided prior to a vote in relation to amendment 2107 offered by the senator from arizona, mr. mccain. mr. harkin: mr. president, can we first have order, please? the presiding officer: the senate will be in order.

the senator from arizona. who wishes the floor? the senator from arizona. mr. mccain: mr. president, this amendment is a simple one. it creates a safe individual drug importation program only from approved canadian pharmacies overseen by the secretary of health and human services. in a normal world, this would probably require a voice vote, but what we're about to see is the incredible influence of the special interests of particularly pharmahere in washington that keeps people who cannot afford, that have to make a choice between eating and medicine, they will not be allowed to purchase medication at less than half the price than many times they will in american pharmacies in canada.

what you're about to see is the reason for the cynicism that the american people have about the way we do business here in washington. pharma, one of the most powerful lobbies in washington, will exert its influence again at the expense of average low-income americans who again will have to choose between medication and eating. mr. mr. menendez: mr. president? the presiding officer: the senator from new jersey. mr. menendez: it is not the special interests that has caused the senate countless times to reject this policy. it is an amendment that puts americans at risk, undermines the f.d.a.'s authority, has a devastating ripple effect throughout the country's drug supply by allowing foreign pharmaceuticals into the country. it is not simply about canada. the canadians themselves have said they cannot be expected to monitor all the drugs coming through canada and into our

country. and all of the web-based opportunities allow untraceable drugs to come through canada into the united states. this is about the health and security of the american people. that's why time after time the united states senate has rejected, it's why it should be rejected once again. mr. reid: mr. president? the presiding officer: the majority leader. mr. reid: i've had during this short time four different senators come to me and say please hold the votes to ten minutes with a five-minute penalty. we're going to do that. a number of senators already missed votes today. we're going to cut those votes off. if you're not here, there is no excuse. these votes have been scheduled since yesterday. we're going to turn these votes in exactly at 15 minutes. if you're late, you're late. the presiding officer: under the previous order, this amendment is subject to a 60-vote threshold. the yeas and nays have been

ordered. the clerk will call the roll. vote:

vote:

the presiding officer: are there any senators in the chamber wishing to vote or change their vote? if not, on this vote, the yeas are 43, the nays are 54. under the previous order requiring 60 votes for the adoption of this amendment, the amendment is not agreed to. under the previous order, there will now be two minutes of debate equally divided -- mr. harkin: mr. president, could we please have order, so we can ... the presiding officer: the senate will come to order. under the previous order, there will now be two minutes of debate equally divided prior to a vote in relation to amendment 210 ofdz by the senator from vermont, mr. sanders. mr. sanders: mr. president?

the presiding officer: the senator from vermont is recognized. mr. sanders: this amendment is supported by u.s. pirg, public citizen, and the national women's health networks. mr. president, in the united states we pay, by far, the highest prices in the world for prescription drugs, much higher than canada, much higher than europe. there are a number of reasons for that. one of the reasons is the widespread fraud, systemic fraud being perpetrated on the american people by virtually every major drug company in this country. in the last few years, companies like abbott, pfizer, johnson & johnson, merck, glaxosmithkline and many others combined have paid billions of dollars in fines because they're ripping off medicare, they're ripping off medicaid, and they're ripping off the american

consumer. it is high time that we said that fraud cannot be perpetrated as a business model by some of the major corporations in this country. i ask for a "yes" vote. mr. harkin: mr. president? the presiding officer: the senator from wyoming. mr. enzi: mr. president, i would oppose this amendment. we do need to combat health care fraud. this amendment goes too far in several aspects. first and most important, it would discourage any settlement agreements. people would fight it to the death if they're going to lose their exclusivity. second, as drafted, the amendment would require companies to forfeit exclusivity any time there is a civil or criminal liability and it's disproportionate. this could be triggered by a misdemeanor. such liability may not reflect fraud. the amendment would discourage the development of new cures for patients. if developers know they would use exclusivity for even miner infractions, they will not invest the dollars necessary for

new lifesaving treatments. i ask that you oppose the amendment and yield the floor. the presiding officer: all time, having been expired, under this previous order, this amendment is subject to a 60-vote threshold for adoption. is there a sufficient second? there appears to be. the clerk will now call the roll. vote:

vote:

the presiding officer: is there any senator who wishes to change his or her vote or has not yet voted? if not, on this vote the yeas are nine, the yeas are 88. under the previous order requiring 60 votes for the adoption of this amendment, the amendment is not agreed to. a senator: mr. president? the presiding officer: the senator from north carolina. mr. burr: mr. president, i rise to ask unanimous consent to withdraw the burr amendment, 2130. the presiding officer: is there objection? without objection. under the previous order, there will now be two minutes of debate equally divided prior to a vote in relation to amendment 2127 offered by the senator from illinois, mr. durbin.

the senator from illinois. the senator from illinois. mr. durbin: this is a very simple amendment. if you go into the drugstore and take a look at the prescription drugs, every single one of them has been registered with f.d.a. if you look at the over-the-counter drugs they've all been registered with the f.d.a. but when you go to the dietary supplement section, no requirement under the law for the companies selling those products to register the name of the products, the ingredients or a copy of the label. they had a g.a.o. study in 2009 and the f.d.a. said we need this information to protect american consumers. from what? one is an example right here. this is a chinese product which was imported into the united states, put up for sale and then we discovered one of the ingredients was life threatening. it never was registered with the f.d.a. there was never a disclosure of ingredients. if you want to sell on the

shelves and counters of america, shouldn't you be required about whether you're from china, india, mexico or anywhere in the united states to register your products, tell us the ingredients, give us a copy of the label? the f.d.a. says they need this information to keep americans safe. i hope you'll support this amendment. the presiding officer: the time has expired. the senator from iowa. mr. harkin: first of all this is a drug and device bill. not a food bill. we addressed food issues in the food safety bill two years ago. this does not solve the problem that senator durbin has talked about. this bill is a delicate balance. we've worked on this bill for 18 months. stakeholders all over the country, consumers, pharmaceutical industry, pharmacists, all supporting this bill. this would upset that delicate balance. i would say that senator durbin, every -- every supplement has a label, has the ingredients and the potency by law on every single item that is sold as a supplement. this is not a food bill.

it's a drug bill. i would yield to my friend, senator hatch. mr. hatch: i strongly oppose this amendment. i'll be voting to table it and i hope everybody else will. it will impose a layer of regulation on an industry that has a regulatory framework. it's unnecessary, only going to increase costs for those who use dietary supplements. a few points, h.h.s. has pose an immediate ban on any dietary supplement that poses imminent hazard to public health. second, four former commissioners and a former deputy commission agree that dshea -- the presiding officer: all time has expired. mr. hatch: i ask for 15 additional seconds. the presiding officer: without objection. mr. hatch: this amendment would strap the f.d.a. with a huge burden they can't afford to do now. they're already struggling to perform its current core responsibilities. third, it expands reg strairgs requirements. one other thing --. the presiding officer: the senator's time has expired. the senator from illinois.

mr. durbin: i just ask consent to have the same amount of time given on the other side. the presiding officer: without objection. mr. durbin: mr. president, the f.d.a. asked for this knowledge and information. what am i asking them to disclose? the name of the product, the ingredients and a copy of the label. if a chinese manufacturerrer wants to sell a dietary supplement in des moines, iowa, shouldn't they have to at least report to the f.d.a. the name of the product and the ingredients? it is not required by law now. please give the f.d.a. this extra information to keep americans safe. the presiding officer: time has expired. mr. harkin: i move to table the durbin amendment and ask for the yeas and nays. the presiding officer: is there a sufficient second? there appears to be. the clerk will call the roll. vote: jurvetionz

vote:

a vote:

he. the presiding officer: are there necessity senators wishing to vote or to change their vote? if not, on this motion to table, the ayes are 77, the nays are 20. the motion is agreed to. mr. harkin: move to lay it on the table. the presiding officer: without objection. the clerk will read the bill for a third time. the clerk: calendar number 400, s. 3187, a bill to amend the food -- 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: order. there will now be two minutes of debatey equally divided provided to a vote on passage of the bill, as amended. mr. harkin: madam president? the presiding officer: the senator from iowa. mr. hark iin: mald

madam president, can we we haven order the chamber. the presiding officer: the senate will be in order. mr. harkin: we have all put in a lot of work and we have been blessed with the constructive ideas of all the members of this body. i want to sincerely thank all of my colleagues, especial senator enzi, for their hard work on this must-pass legislation. this excellent bill is a shining example of what we can achieve when we all work together. now we must keep our promise to patients and the biomedical industry and pass this critical bill. today, with one vote, we can railroad authorize the essential f.d.a. user fee agreements, systematically modernize f.d.a.'s medical product authority, and help to boost american innovation and ensure that patients have access to the therapies they need. so i urge my colleagues to join in this bipartisan spirit of cooperation, pass this important legislation, the f.d.a. safety and innovation act. mr. enzi: madam president? the presiding officer: the senator from wyoming. mr. enzi: the chairman has said it well.

we appreciate the bipartisan spirit in which people have participated, especially in committee for a year and a half working out amendments, working out ideas, coming up with a bill that had a good consensus. and i appreciate the action here on the floor, the people that were willing to do time limits on their amendments and how wickly we've gotten through the votes -- quickly we've gotten through the votes. i particularly want to thank the chairman for the way he's handled this in the committee and in the process since then. we had a couple of issues that were outstanding. those got worked out. i want to thank the staffs on both sides. their dedication for a year and a half is what made this happen. we have outstanding staff on both sides. every member of the committee and every committee member staff helped on this one, and that makes a difference. i ask everyone to support the bill. i yield the floor. the presiding officer: the question is on passage of the bill as amended. is there a sufficient second?

there appears to be. the clerk will call the roll. vote:

vote:

the presiding officer: are there any senators in the chamber wishing to vote or change their vote? seeing none, on s. 3187, as amended, the yeas are 96, the nays are one. the bill, as amended, has passed. mr. reid: move to reconsider and lay that on the table. the presiding officer: without objection. the majority leader. mr. reid: could we have order? the presiding officer: may we have order, senators. please take your conversations -- mr. reid: i know people are interested in moving on, and i am, too, but i have to say just a word.

i've said in my own caucus how much i appreciate the cooperation of senator enzi. he is a fine senator. he and senator harkin a have worked so well on this. it is exemplary for what the rest of us should do. i repeat, it is how we should get other work done. this is an important piece of legislation, and we made a look simple. it wasn't, but because of these two fine senators, we were able to get this done in a very short period of time and do good things for the american people. the presiding officer: under the previous order, the senate will proceed to s. 2343, which the clerk will report. the clerk: calendar number 365, s. 2343, a bill to amend the higher education act of 1965 and so forth and for other purposes. the presiding officer: under the previous order, there will be ten minutes of debate equally divided and controlled between the two leaders or their designees. mr. mcconnell: madam president? the presiding officer: the republican leader.

mr. mcconnell: madam president, could we have order in the senate. the presiding officer: the republican leader. mr. mcconnell: madam president, there's still are a lot of murmuring going on. the presiding officer: senators, please take your conversations off the floor of the senate. the republican leader. mr. mcconnell: madam president, we're in a ratherry duck urather --we're in a rathes process waiting for our friends to pass a process that will actually pass, when we've got one if front of us. we've wasted nearly two weeks on this student loan issue for no good reason. neither i nor the ranking member have heard a word from the democrats on how they propose to resolve the issue and actually prevent the interest rate from rising. as we learned earlier this weerk the president doesn't seem to even talk to his committee chairmen anymore. all of this suggests that the white house dispwhite house doet

to solve this problem, that it would rather allow these rates to rise so we can run around all summer pointing our finger at those republicans in the snavment i'd like to believe that's not the case. we had chance to talk to the president about this and other issues last week at white house. i'm convince that he'd like to get a solution. whyet the fact of the matter is, all he'd have to do is just simply pick up the phone and tell the democratic leadership here that he'd like to get this done, and i'm pretty confident that we could work it out. unfortunately, we can't just wait around hoping the president is going to pick up the phone. college students can't wait either. they want us to resolve the issue now, and i know we can. so to move the ball forward, i would say to my colleague, the majority leader, if he agrees with me that senator harkin and senator enzi just did a good job of coming up with a bipartisan

solution to this f.d.a. bill, i'm confident that they could do the same thing on the student loan issue. they are the chairman and the ranking member of the committee that over sees student yellowstone legislation. i have a lot of confidence in their ability to do it. so i'm going to proffer a consent agreement that i think would allow us to go forward. my colleague from tennessee will take the balance of our time after i've concluded. i would ask consent that following the completion of the two scheduled votes on the student loan bill, the next order of business be a harkin-enzi bill dealing with the issue of the current student loan rate, provided further that no motions to proceed to other items be in order, unless agreed to by both leaders. now, the purpose of this consent agreement that i've just proffered is to allow senator harkin and senator enzi to negotiate on this important issue, the increase in the

student loan rates, and to keep the senate focused on how to resolve this issue in a timely way before the rate goes up. the bill they would negotiate would be the next order of business, but it would also provide that both leaders could agree to allow the senate to worg on other measure -- to work on other measures, if necessary, if those -- as those student loan discussions continue. the presiding officer: is there objection? mr. reid: mr. president, we've all heard of a reverse engineering. what we've just heard is reverse reasoning. this is one of the most interesting things i have heard that makes no sense. we've been trying to get on this bill for weeks. the republicans -- the republicans have refused to allow us to get on the bill.

mr. president, student loan issue is important. we should be -- we should already have completed this and h. had we been allowed to get on the bill. but we weren't allowed to get on the bill. we were faced with one of our many fables, scores of them -- with one of our many filibusters, scores of them. not one, two, three, or four -- scores of them. this is another example of them stopping us from legislating on a bill. in our to come here and say, we could have been doing something ... you my friend knows the rules of this senate as well as i do. and he knows this suggestion is absurd. i object. the presiding officer: objection is heard. mr. mcconnell: mr. president, on behalf of senator alexander, i call up amendment 2153. the presiding officer: the clerk will report the amendment. the clerk: mr. mcconnell for mr. alexander and others proposes amendment numbered 2153. mr. alexander: mr. president? the presiding officer: the snoer from tennessee. mr. alexander: on july 1 for 7 million students students gettiw

loans to go to college, the rate for interest will go from 3.4% to 6.8%. this is an amendment to get a result. this is the house-passed bill. president obama says he wants to freeze the rate for a year. governor romney says he wants to freeze the rate for a year. the house of representatives has voted to freeze the rate for a year. a vote "yes" on the house-passed bill will permit us to send it to the president and he signs it and we solve the problem. the presiding officer: the senator from iowa. mr. harkin: mr. president, while appreciate the compliments he and the minority leader has in senator enzi's and my ability to get things done, what they are sproapg that we totally end, totally eliminate all the of the prevention and wellness money that we have out there in the

wellness fund. what would this do? we got vaccinations for children, i am munizations, smoking cessation programs, colorectal screening, diabetes prevention, breast cancer screening, all funded by this prevention and wellness fund. none one of them would be funded from that fund if that amendment passed. so the choice is very clear on the two amendments that we have coming up. we can either vote to close a tax loophole that allows wealthy tax dodgers not to pay their fair share of taxes -- we can close that loophole and keep the interest rate rates 3.4%. or, as the republicans want to do, totally eliminate the wellness and prevention fund, and he the money that we're putting into diabetes prevention, breast cancer, colorectal screening, all the things i mentioned. i don't think the choice could be more clear to the american

people. -- about the direction we ought to go. close the tax loophole. keep the prevention fund in there. keep our people healthy. mr. alexander: mr. president, we have two minutes left. i'll wiewns of them. -- i'll use one of thevment our friends on the other side have their usual solution to any problem -- let's put some more taxes on the small business men and women. we have a better way to pay for this bill. we'll take some of the savings that the congressional budget office said that our friends found when they took over the student health program in the health care bill, instead of giving the students the benefit of those savings, they spen spet on government. they spent $8.3 billion on the health care bill. so we'll give back to the students enough known pay thor this freezing of the -- for this freezing of the rate. we won't tax the small business people. we'll have a little left overed and reduce the debt. then we can send our bill to the house, they'll pass it like that, send it to the president and the problem is solved.

a senator: mr. president? mr. president? the presiding officer: the senator from rhode island. mr. reed: mr. president, as senator harkin pointed out, the republicans proposal goes right to the heart of health prevention. it will deny us the chance to ban the proverbial health care cost curve. if we do not control those costs, we will be in a fiscal disaster. that measure they're proposing does not make sense. we have proposed to close a tax loophole that has been described by the inspector general for the tax administration as a multibillion-dollar employment tax shelter. we have restricted it to the people who are receiving over $200,000 a year. this is not small business men and women. this is not the corner hardware store. these are lobbyists, these are lawyers who have craftily used subchapter "s" corporations to

avoid paying payroll taxes. this liam has been criticized on the editorial pages of the "wall street journal." this is no "just raise taxes." this is trying to find a loophole which has been criticized by the right as well as the left to pay for and ensure that we do not double the interest rates on students. i can't think of a clearer choice. reject the republican proposal, accept our proposal. do not allow student interest rates to rise on july 1, as they're scheduled to do. nor senator plop? the presiding officer: the senate will be in order. mr. alexander: how much time remains? the presiding officer: one minute and 20 seconds. mr. alexander: it is assuring to me that my friend is reading the editorial page of the "wall street journal." i'm sure that will have some benefit over the next several months. a vote "yes" means a result --

the presiding officer: the senate will be in order. mr. alexander: this is the same as the house-passed bill which freezes interest at 3.4% for a year. send it to the house, down to the president, he signs it, the problem is sovmentd instead of raising taxes on small business people, we give back to students the money that they should have had the benefit of when the other side took over the entire health care -- whole student loan program before. if you want a result, please vote "yes." if you want more debate and delay, vote "no." mr. harkin: mr. president? the presiding officer: the senator from iowa. mr. harkin: the president has already said that if the republican measure were to pass and be sent to him, he would veto it. that's a nonstarter. surely my friend from tennessee does not want to cut out all of this funding that we do for hepatitis screening, colorectal screening, diabetes prevention, vaccinations for our kids that are all funded -- all that have would be ended -- ended -- by

their amendment of i don't know what my friend is talking about in terms of student money and this and that. their provision takes all of this money out of the prevention and wellness fund. that is not what we want. we don't want to keep our kids from getting vaccinations or hepatitis screening or diabetes prevention in order to keep the interest rates low. let's close the tax loophole that's been talked about that senator reid, both senator reid and reed talked about. send it to the president, he'll sign it. that's that way we'll keep the interest rates down at 3.4% and not allow them to double on july 1. the presiding officer: the senate will be in order. who seeks recognition? mr. reid: has all time expired? the presiding officer: the minority has 35 seconds. and the majority 38. mr. alexander: the case is so compelling we'll give back the rest of our time.

mr. reid: mr. president, time has been yielded back. we think there will be two more votes. i can't say there will be no more votes. we have a few things to work out like flood insurance. i think we're there but i can't give everyone that assurance at this time. the presiding officer: the question is on the amendment offered by the senator from kentucky. is there a sufficient second? there is. the clerk will call the roll. vote:

the presiding officer: are there any senators who wish to change their vote? seeing none, the yeas are 6, 4 the nays are 62, one announced presented. under the previous order requiring 60 votes for the adoption of this amendment, the amendment is not agreed to.

mr. reid: mr. president? the presiding officer: the majority leader. the senate will be in order. mr. reid: mr. president? the presiding officer: please take your conversations outside. the majority leader is recognized. mr. reid: as we've noted on the floor many times the last few days, the flood insurance program covers almost 6 million people. it was set to expire next week. if it were to expire, new housing construction would stall in fact, in many places, just come to a halt, real estate transactions would come to a screaming halt, taxpayers would be on the hook for future disasters. this is something we have no choice, we have to get it done. i appreciate very much the work of chairman johnson, ranking member shelby, the chairman of the subcommittees -- subcommittee, senator testing, the ranking member, senator vitter. i also appreciate the work put into this by senator coburn. he worked closely with senator schumer. and we were able to get this done. i'm grateful to have one's help.

it was a team -- teamwork that got us where we are. i now there -- i now ask unanimous consent that the senate proceed to calendar number 407, flood insurance extension, that a johnson substitute amendment which is at the desk be agreed to, the bill as amended be read a third time, passed, the motions to reconsider be laid on the table, there be no intervening action or debate. if anything has anything to say about this, you can put it in the record. the presiding officer: is there objection? without objection, so ordered. mr. reid: this will be the last vote coming up. no speeches, we're going to start voting. the presiding officer: the clerk will read the bill for the third time. the clerk: daler -- calendar you are in 365, a bill to amend the highered indication act of 1965 and so forth and -- higher education act of 1965 and so forth and other purposes. the presiding officer: the

question is on the bill. yeas and nays have been asked for. is there a sufficient second? there is a sufficient second. the clerk will call the roll. vote:

vote:

the presiding officer: on this vote the yeas are 51. the nays are 43. one senator responded "present." under the previous order requiring 60 votes for passage of the bill, the bill does not pass. mr. reid: move to reconsider, lay that on the table. the presiding officer: without objection. mr. reid: mr. president, i move to proceed to calendar number 410, s. 3220. the presiding officer: the clerk will report the motion. the clerk: motion to proceed to calendar number 410, s. 3220, a bill to amend the fair labor standards act 1938 to provide more effective remedies to victims of discrimination in the payment of wages on the basis of sex and for other purposes. mr. reid: mr. president, i have a cloture petition at the

desk. the presiding officer: the clerk will report the motion. the clerk: we the undersigned senators in accordance with the provisions of rule 22 of the standing rules of the senate hereby move to bring to a close the debate on the motion to proceed to calendar number 410, s. 3220, a bill to amend the fair labor standards act of 1938, and so forth and for other purposes, signed by 18 senators as follows: mikulski, reid of nevada, cantwell, murray, lautenberg, bingaman, whitehouse, shaheen, udall of new mexico, klobuchar, levin, warner, pryor, reed of rhode island, and gillibrand. mr. reid: mr. president, i ask unanimous consent the mandatory quorum under rule 22 be waived and the vote on the motion to invoke cloture on the motion to proceed to s. 3220 occur at 2:15 p.m. on tuesday, june 5. the presiding officer: without objection. mr. reid: mr. president, we're going to arrange a vote monday night on one of the members who

is trying to become a judge. one of the nominees, i should say. i note -- a senator: mr. president? the presiding officer: the senator from rhode island. mr. whitehouse: thank you, mr. president. i want to take a few moments this afternoon to do something that has become a bit of a ritual with me, and that is to try to take some time each week to speak about the damage that we are doing to our atmosphere, to our oceans and to our climate with the relentless carbon pollution that we are discharging. as each week goes by, the information continues to pile up

about the harms that we're causing. a recent story says that rising temperatures could eliminate two-thirds of california's snow pack by the end of this century. the snow pack that helps provide water for california's cities and farms could shrink by two-thirds because of the climate change according to new research submitted to the state's energy commission. higher temperatures appear likely to wipe out a third of the golden state's snow pack by 2050 and two-thirds by the end of the century. the scripps institution of oceanography found. "science daily" reports that black carbon aerosols and tropospheric ozone emitted predominantly in the low to midlatitudes, basically us, are

most likely pushing the boundary of the tropics farther pole ward north and south, new research by a team of scientist shows. the lead climatologist says if the tropics are moving pole ward, the subtropics will become dryer. if a displacement occurs, this will shift midlatitude precipation pole wardaticking the economy and society. the american people have not been taken in by the campaign of propaganda that primarily the polluting industries have put out. there have been significant reports in the past on exxonmobil's funding of essentially phony research agencies so that they can offer their opinions on this issue without having it be exxonmobil's opinion. they either create or take over

or subsidize organizations that then put out the message and they sound legit, heartland institute, annapolis council. but the american people are not fooled, it turns out. 71% of visitors who come to the nation's wildlife refuges say that they are personally concerned about climate change's effects on fish, wildlife, and habitats. 74% said that working to limit climate change's effects on fish, wildlife, and habitats would benefit future generations and 69% said doing so would improve the quality of life today. one of the original researchers on climate change -- i quoted an article earlier describing how

over time the facts have proven his initial predictions accurate -- is james hansen. he wrote an article just a few weeks ago in the "new york times" headlined "game over for the climate." it begins with these two sentences: "global warming is a prediction. it is happening." and clearly we see that in measurements and observations around the planet but what happens if it keeps goingnes gos he's talking about the tar sand up in canada, and he says this: "if we were to fully exploit this new oil source and continue to burn our conventional oil, gas, and coal supplies, concentrations of carbon dioxide in the atmosphere eventually

would reach levels higher than in the pliocene era when sea level was at least 50 feet higher than it is now. that level of heat-trapping gases would assure that the disintegration of the ice sheets would accelerate out of control. sea levels would rise and destroy coastal cities, global temperatures would become intolerable, 20% to 50% of the planet's species would be driven to extinction, civilization would be at risk." now, that's clearly, as he admits, a long-term outlook. but it's an outlook that deserves our attention. when he's given us long-term outlooks in the past, as time has marched forward, they've been proven over and over again to be true. it's convenient around here to pretend that none of this is

happening, and it would be nice if we could wait until the disaster, the wolf was really at the door and then do something about it. but there's a strong likelied this that by the time we take action, it will be too late. in september of 1940, there was an american living in the philippines with his wife and son. he looked at what was happening over in europe. he looked at the threat to britain, and he cabled back to the united states his recommendation. he said, "the history of failure in war can almost be summed up in two words: too late.

too late in comprehending the deadly purpose of a potential enemy, too late in realizing the mortal danger, too late in preparedness, too late in uniting all possible forces for resistance, too late in standing by one's friends." the author of that cable was general george macarthur. he continued later on in the cable, "the greatest strategic mistake in all history will be made if america fails to recognize the vital moment; if they permits again the writing of that fatal epitaph, "too late." of course general macarthur was talking about what was becoming world war i i. he was not talking about climate change. yet his warning rings very true

against this threat as well. too late will be the epitaph if we do not prepare now, and i very much regret that we are in a situation in which we don't seem able as a body to take this threat seriously. the house shows no indication whatsoever of taking this threat seriously. even the white house has dialed back its expressions of interest and concern on this issue, probably for the practical reason that the republican-controlled house doesn't want to deal with this issue at all, period, end of story. but it's happening out there. it's happening out there. people see the dying forests of the west, as the pine bark beetle works its way more and

more north because winters are no longer cold enough to kill off the lei already a vai. people say -- to kill off the already a vai. people see the places where they used to be able to go fish with their grandchildren no longer available. farmers see changes, gardeners see changes, plants that could no longer grow in certain zones now can. tropical plants can grow in northern areas because of changes. in rhode island, we have had winter blooms of some of our fruit trees because it has gotten so warm. my wife did her dissertation on a species called the winter flounder. it was a very significant cash crop for the rhode island fishing industry. it was not very long ago.

and she wrote her dissertation about it because it was such an important part of the rhode island fishing industry and because it had an interesting connection with a shrimp in which one fed on the other until it got big enough and then the predatory cycle reversed itself, and the winter flounder began to eat the thrirch instea shrimp ie versa. well, landings of winter flounder in rhode island have crashed catastrophicically. the reason: at temperature of narragansett say about up. fishermen now catch scup instead, which is a far less remune aive crop and frankly, not as good a fish to eat. in my opinion, anyway. so these changes are really

happening, and it is regrettable that we are unable to address them. the science has been discredited by propaganda campaigns that are deliberately and strategically designed to create doubt in the minds of the public where no doubt should exist. the fact of the matter is that this science is rock-solid. the notion that when you put lots of carbon disci oxid discip into the atmosphere it warns the atheatmosphere has been around r years. john tyndall first reported this feng nominee none in 1 1853. we can measure the gigatons of gar bonn that we're discharging into the atmosphere. of course it will are make a difference. the negs it doesn't has been a -- the notion that it doesn't has been a public relations

campaign by well-heeled public reels because it makes money for the companies. but the damage it does to or future, it is hard to hoafntsly look my children in the eye and say that i'm doing my job for them here in washington while we do nothing on carbon pollution. in fact we continue to subsidize the biggest polluters. exxonmobil makes more money than any corporation has in the history of the world, and they still claim a subsidy from the american taxpayer. it is a ridiculous subsidy, and yet we subsidize them. so i see that the very distinguished chairman of the health, education, labor, and pensions committee is here on the floor, and i want to conclude my remarks and thank him for the amazing work that he and the ranking member, michael enzi, did on the f.d.a. bill that we just passed with a strong vote, virtually unanimous

vote, and a lot of very, very good work that was done there. so that proves that there are areas where we can do good work. irhope that the day comes -- i hope that the day comes when we can begin to do good work on the damage that we're doing to our atmosphere and to our oceans, with our relentless discharge of does on dioxide into the -- of carbon dioxide into the atmosphere. one day we will be called into account for our inaction, and we will have earned the condemnation of history. i yield the floor. mr. harkin: mr. president? the presiding officer: the senator from iowa. mr. harkin: i want to thank my friend from rhode island for, i think, a very eloquent speech -- elegant speech, too -- eloquent and elegant in portraying what is so frustrating, and that is science knows what's happening. the scientists know what's

happening. we have good datapoints about what's happening to our clierntle our atmosphere, our -- our climate, our at most spheerk-- ouratmosphere, our oc. and yet we can't seem do anything about it. i was reading recently the "american sign be tsk" magazine that i love to read every month in that terms of this whole global climate change, what's happening is that by the time we really recognize it happening -- that broadly, not just the scientists and others who really do know what's happening -- by the time it is broadly accepted, it'll be too late. that we will have reached that tipping point. the evidence is there for all really to see. it is a shame that we can't do something about it. you mentioned the fish catch in rhode island. i think -- and also in the recent issue of "scientific

american" was a story about the fisheries and oceans at large, and there were three pictures. one was a picture taken toon a peer in key west in the 1950's showing the size of the fish that were caught -- big. i think the average weight was like 30-some pounds. and then there was a picture taken in the 1970's, early80's. now it is dune to maybe 15 pound. so i am picture -- same pier, same dock and everything and now the catch is down to little teeny little fish. somsame place, same ocean, same waters. the article went ton point out how if you look at the first picture, people are very happy. they're happy with this big catch. then the second page, people are happy with what they've got.

now, you have this little teeny fish and people are still heaping happy because we tend to accept what it is right now and be happy with what we've got without realizing what we've lost in the fast. -- in the past. so again i thank the senator for his speech. we need to do more of that around here. we need -- we really need to focus on this, and we just seem to be drifting. and you're right, our grandkids are going to wonder why we didn't do something. i thank the senator. mr. whitehouse: i would suggest that it's more than just that we are drifting. i would suggest that we are being drifted by politics and by the money in politics, particularly the big money, the big polluters -- that big polluters can throw into politics, not only directly by giving campaign contributions to people, but by flooding money

into phony so-called scientific organizations that then parrot their message but without people being able to say, wait a minute; this is exxonmobil telling me. maybe i should be a little more guarded about it. so they launder it through a legitimate sounding organization, not one -- dozens -- and we get bombarded with false propaganda. scientists aren't good at propaganda. it's not why they went to graduate school. it's not what they do when they're in the field taking measurements. so you put them up against a company like exxonmobil with all of its money and with its propaganda skills, and it's not an even contest. by the time, as you point out, chairman, by the time we are looking around and see, oh, my gosh, what have we allowed to happen, now we're awake, we reject the plop ganda, we have to do something about this, it will probably be as general macarthur said, too late. that's the great danger and i

thank the gentleman the chairman for his recognition and i again yield the floor. mr. harkin: thank you, senator. mr. president -- the presiding officer: the senator from iowa. mr. harkin: i ask my following statement and the insertion i ask to put in the record appear in the record just prior to the final vote on the passage of the f.d.a. safety and innovation act. the presiding officer: without objection. mr. harkin: madam president, today with passage. f.d.a. safety and innovation act and reauthorization of the user fee agreements we have helped both the f.d.a. and the biomedical industry assure they cannot can get needed medical products to patients quickly and safely. this legislation will ensure that the f.d.a. can swiftly approve drugs and medical devices, save biomedical industry jobs, protect patient access to new therapies, and preserve america's global leadership in a biomedical innovation. it will keep patients safer by

modernizing the f.d.a.'s inspection process for foreign manufacturing facilities. while also improving access to new and innovative medicines and devices. it will reduce drug costs for consumers by speeding the approval of lower cost generic drugs and it will also help prevent and address drug shortages. finally, by improving the way f.d.a. does business, increasing accountability and transparency, u.s. companies will be better able to innovate and compete in the global marketplace. mr. president, by passing the f.d.a. safety and innovation act we have taken an important -- we are taking an important step to improving america's families' access to lifesaving drugs and medical devices. as i have said throughout this debate, the bipartisan process that produced this excellent bill has been quite remarkable. i have worked closely with my colleagues on both sides of the aisle as well as industry stakeholders, patient groups, and consumer groups, to solicit

ideas and improvements on the critical provisions in this bill. we have a better product thanks to everyone's input. i would like to extend a spent thank you to my colleague, ranking member enzi. i have been working with senator enzi for over a year on this bill, and it has been a wonderful and cooperative partnership and trusting friendship. i can honestly say we would not have gotten this done without his excellent leadership and wise counsel and i want to thank senator enzi for that. i also want to thank all of the help committee members as well as members off the committee who were thoroughly engaged with this process from the beginning as part of the bipartisan working groups that we established. each of you has contributed significantly to this legislation, and i am sincerely grateful for all your contributions. mr. president, i request to submit for the record a list of all the staff members who were part of our bipartisan working

groups throughout the past year. we all know we could not achieve this without the tireless and diligent work of our loyal staffs. i want to extend my deep appreciation for their hard work and extraordinary efforts. and i ask that that list be included in the record. the presiding officer: without objection. mr. harkin: on that note i want to specifically thank the staff of ranking member enzi's office, i want to thank frank makrola, keith flanigan, melissa faff, katie spanningler and riley swanghart. i'm sincerely grateful for their dedicated efforts. i want to thank my own staff on the help committee who have spent many a night, long days and weekends with senator enzi's staff and other member offices working to come to consensus on the critical policy issues in this legislation. as especially want to thank our staff director, dan smith, his

assistant, our assistant staff director, pam smith who, by the way, will be very shortly taking over as our new staff director. dan smith is leaving our staff and going into the private sector, and pam smith will be taking over as our new staff director. i also want to thank janelle cristabudi for all the tireless work she has put in on this. i can't thank her enough for all of her hard work. elizabeth youngman, kathleen laird, kathleen wise, justine sessions, elizabeth donovan and edwin griffith. i thank you from the bottom of my heart for getting this legislation through. we would be repiss mist if we

did not thank the congressional budget office for their knowledgeable and capable team willing to work around the clock to estimate the budgetary effects of this legislation. finally we owe an enormous gret of -- debt of gratitude to the legislative counsel's office, they worked long hours in assisting my staff in drafting this legislation and working out the technical issues. mr. president, this bill's passage is a victory for the millions of americans who need medicines or medical devices. a victory that would not have been possible without the dedicated work of our senate family. i want to thank all of you for your extraordinary public service. mr. president, i yield the floor and note the absence of a quorum. a senator: mr. president?

the presiding officer: the senator from south dakota. mr. thune: i ask unanimous consent the quorum call be dispensed with. the presiding officer: the senate is not in a quorum call, sir. mr. thune: i ask unanimous consent to speak as if in morning business. the presiding officer: without objection. mr. thune: i rise to recognize senator jim be abdnor of south dakota. he passed away last week in the company of friends and family. we are products of the dusty short grass countries west of the missouri river on the plains of central south dakota. jim was a product of the active and civically minded political culture of lyman county and i was from next door jones county. despite these counties' sports rivalries over the year, jim took me under his wing and introduced me to the american political process. if not for jim abdnor, i would not be spanned standing here today --, standing here today. after a basketball game when i

was a freshman in high school, jim struck up a conversation with me that would dhaing change the course of my life. i went to work for jim as a legislative assistant when he was a senator and later at the small business administration. when i first ran for office, jim's guidance and support were invaluable to me. this past weekend, hundreds of south dakotans came out to honor jim be a -- jim abdnor and remember his love for his state. his funeral was held in a lutheran church in pierre, where he first served in statewide offer as lieutenant governor. he was buried outside kenne of bec near where his immigrant father homesteaded. jim leaves us with many legacies and i want to messengers a few of them here today. first and foremost, jim's was an american story. it started as the tale of an immigrant who boarded a ship for the united states not even knowing the english language but knowing he was heading for the land of opportunity. that imgrant, jim's father,

sam abdnor, wanted to escape the growing authoritarianism of his native lebanon. it's a frontier story. his father settled in south dakota. sam planted corn and wheat. he peddled his wares to the other farmers, and when kennebec was established, sam was one of the first to establish a business on main street. jim grew up learning how to balance the books in a small town store and how to work the family farm. he learned financial responsibility and hard work and how one can climb the ladder of success in america. jim's story is also a story of the land in a -- and of farming. some of us who knew jim through politics may forget before he was elected to congress, jim had owned and run the family farm for three decades. jim was very proud of the fact that he was good at representing south dakota agriculture because he was an active farmer who did

the planting and hauled his grain to the elevator in the fall. when he was in congress, south dakota was ranked as the most agricultural state in the nation and jim was the first farmer elected to congress from south dakota. jim was proud of that correlation and he never forgot his farming roots. during the 1970's when people were organizing sit-ins and teach-ins and other types of protests, jim helped organize a beef-in. he brought 100 ranchers to washington, d.c. to talk about farm issues. they set up pens of cattle on the washington mall and met with agricultural officials. jim didn't rest until these ranchers had their voices heard. jim's story is also about water. we all live comfortably now with running water and hot showers but that's not how jim grew up. he grew up on the wind, are dry-land farm in lyman county. he lived through the droughts of the 1930's.

he understood the importance of water. never stopped working on the issues of water access including being a champion of the web water project in brown county in north central south dakota that began in 1983. the question of water was never far from jim's mind and i think it had something to do with his heritage. that certainly is true of his lyman county roots which is where the humid midwest begins to turn into the arid high plains. but also of his roots in lebanon where water is also scarce. his family's home village was founded because it was a watering hole. its name means spring or well. more specifically, it means spring of the arab. when they had enough water there, they would grow wheat like the abdnors would do in lyman county, south dakota. jim's is a story about organizing. as soon as he came home from college he started organizing republicans in lyman county and became head of the lyman county

young republicans. he helped organize and founds the elks lodge in pierre in 1953. he joined every organization he could and brought as many people into community affairs and politics and civic organizations as he could as well. jim also pushed other people to organize. he liked to tell the story of the people in faith, south dakota who wanted a new grandstand for their rodeo grounds. they took one look at the federal regulations involved with some grant program and promptly did everything themselves. raising all the money that they needed from local sources and fundraisers, and did it at 10% of the cost. they put in 4,000 hours of their own time and made it happen themselves and jim appreciated that. he liked communities working together to solve their own problems. during the 1970's when tensions in the middle east worsened, jim called for his fellow arab americans to become more involved in the political process.

he opposed as what he saw as their tendency toward isolation and self-segregation. he said his ethnic cam patriot rats -- come patriots should become part of the community. jim never stopped believing in working with others to make life better. this is judge jim had so many friends. he never stopped working. to meet people and bring them together around issues. and simply to socialize. a friend of mine says he doesn't think anyone in the state of south dakota has ever attended more weddings, graduations, ceremonial dinners or basketball, basketball, and football games than jim abdnor. as someone from the wide open plains who wanted groups of people to come together to solve problems on their own, jim was always resisting federal encroachment on local control. as the son of a small businessman, jim was sensitive of federal regulations and how much this encroachment cost small businesses. for years he was especially

incensed about osha mandating rules for small stores on south dakota main streets. in the 1970's jim also had a big fight with osha because it was trying to mandate that south dakota wheat farmers maintain port-a-potties in fields. which a practicing wheat farmer from south dakota knew was the definition of absurd. as a small business man and farmer jim was worried about the bottom line and tried to apply these concerns in the area of the federal budget. jim was sounding the alarm bell in the 1970's when the federal government spent less than $400 billion a year which today seems laughably small given our current state of affairs. back then he was attacking deficits of $70 billion. he was also adamantly opposed to the federal government bailing out new york city in the 1970's because he said it would set a bad precedent. he attacked a federal