we did analysis to such attack, and we found our infrastructure was extremely vulnerable. we started a process, at least in my own conversion, started my own education coming to the conclusion how important energy is in terms of our national,

international leadership, and the future -- i came to the cop collusion, the future of the united states was not only bright, but incredibly bright, and that it would be highly advantageous for the united states to set the example to develop our energy future responsibly in a way that sets the example for the rest of the world. we know that in different parts of the world, energy is, in some cases, started conflicts, and in other cases, with people who have an abundance of energy prevented them. how you use an asset is important here. to me, energy is a national security issue that deserves its rightful place along the cyber security, along with the conventional dangers and threats that we face in the united

states, and where europe is concerned, this could be -- this could serve as revie call -- revitalization of the transatlantic dialogue, with the oldest partners, could be of assistance of them in making them less dependent on mr. putin's energy exports, and that will have a behavior change, in my view, on russia's tendency to be aggressive towards its neighbors. the -- russian economy is roughly a fourth of the united states' economy, maybe not even that, but it centrally has two components. it has nuclear weapons and energy. thankfully, we held a nuclear weapons in check, but now we have to, i think, do what we can to also come to the aide of not only the four countries that requested it, but to help our

european allies become less dependent. there's many ways to do that. we are a globally influential nation, and i presume most americans, that by the year 2050, would like us to remain that way. there's other ways to do that. using energy, champion a pipeline, transmission lines to the -- to turkey, through the port, and the mediterranean. there's other ways in which you can use energy in coalition with the arab friends. many of our arab friends have concluded that because of our own energy future, we're now less interested in the persian gulf and in their problems, in the middle east peace process, in syria and so on and so forth. my personal view? nothing could be further from the truth. this is the most dangerous place on the planet. energy plays a key role for super power and nation of influence to not only use its own influences, but to show the world how the flow of energy can

help the developing world and prevent future conflicts. thank you. >> thank you, general. let me thank you, all. let my make a comment for the record. i heard several colleagues suggest that the administration refused to testify. we inquired about an administration witness, and they thought it inappropriate to testify about a tending matter they have yet to make a time decision on. after listening to that, i did not consider it a refusal, and, clearly, when the administration makes a decision, that can be the subject of a hearing at which time we expect the administration to tiff, but since it is pending, there are many times in which we have matters that have the state department pending in review, that we don't have witnesses from the administration on, and that is true both past and present. i appreciate the testimony from all of you and the dialogue that's been had.

i think we've gotten flushed out a lot of the issues that are per innocent to -- pert innocent to the specific issues of the pipeline, and in some cases, beyond, and the record will remain open to the close of business tomorrow, and with the gratitude of the committee, this hearing is adjourned. [inaudible conversations] 20 mi.

the presiding officer: without objection, so ordered. mr. wyden: mr. president, i'm rising this afternoon to talk about the medicare program. which, of course, is a lifeline, a guarantee for 50 million older americans. and in particular, what the senate wants to do is make sure that those older people have access to primary care doctors,

nurse practitioners, specialists and other providers in their local communities because they provide critically needed care to our seniors day in and day out. now, mr. president and colleagues, many of those seniors have no idea that by march 31, just a few weeks from now, the congress has to act on their behalf to preserve access to the care the seniors depend on, and suffice it to say those providers would much rather be delivering the care than waiting for this congress to act. now, fortunately, mr. president, there is a road map for getting this done, and getting good care to seniors not just for a short period of time, but colleagues once and for all, and i want

this afternoon to urge my colleagues to seize this opportunity. and in beginning my remarks, mr. president, i want to be clear that i can take little credit for the opportunity that is before us. the path that got us here, that got us started in the effort to make the needed reforms to protect our seniors is a correct result of the leadership of my friend and colleague, senator orrin hatch. just as senator hatch has done so many times over the course of an illustrious career, senator hatch was key to forging a bipartisan solution to a challenging, long-standing problem. so what i'd like to do, mr. president, in beginning is recognize that effort by senators hatch, my predecessor as chairman of the finance

committee, senator baucus, house ways and means chair dave camp, house ways and means ranking member senator levin, house energy and commerce chair fred upton and house energy and commerce ranking member henry waxman. the work that they have been doing over the last few months in my view is exceptional and in effect they have given us the opportunity to take this flawed system of setting a kind of medicare budget known as s.g.r., sustainable growth rate. they have given us the opportunity to repeal and replace this flawed system with one that i think is going to make a huge difference in the days ahead by pushing the goal of good-quality, affordable care up and doing it in a bipartisan way, and i hope that these

colleagues will take it as a compliment that the s.g.r. bill now before the senate incorporates all of that good bipartisan work that they have been doing, along with the work that was done on the senate finance committee. i see our colleague from north carolina here who has contributed mightily to that effort. of course, the president of the senate, senator brown who has been such an eloquent spokesperson, particularly for those without political power and political clout, and i thank both of them for their efforts. to be specific, the legislation i introduced last night incorporates what those six members agreed to, the six members that i just named, three democrats and the three republicans came together with s. 2000 and in effect that legislation, along with the health extenders passed by the

senate finance committee in s. 1871 is essentially what we have the opportunity to move in the days ahead. every single thing in this bill has had strong bipartisan support, and i hope that we can all come together and with resounding bipartisan support get this bill passed before march 31. now, there are a variety of reasons why democrats and republicans, in my view, can band together and repeal and replace what again i have characterized as a flawed, really dysfunctional system that we have today known as the s.g.r. but before i go through the list of reasons, i want to make clear to my colleagues, and colleagues have known me, i'm interested in sound, sensible policy, that we move in a bipartisan way. not politics, not message but

sound policy, and that's why i'm here on the floor today. i have always tried to make it possible for both sides to secure their principles, principles that are important to them and still allow us to go forward in a bipartisan and innovative fashion to get things done. and i will say to my colleagues it is not possible any longer to just put one patch or another up and say we're going to fix the medicare challenge. it's just not going to work. now, for the last ten years, congress has always blocked these cuts. well, i would say i think it's time to stop pretending that these upcutting cuts fittingly scheduled for april fools' day are any more real than the 16 other times that the congress has intervened. what we ought to do, colleagues, is stop playing medicare make

believe. it's time to set aside a flawed formula that prevents the congress from really moving ahead constructively on medicare and to start with a clean slate. i thought "the wall street journal" editors really summed it up very well on february 19. what they said in talking about the bipartisan bill that i laud tonight, the editors of "the wall street journal" said, and i quote, simply pass the bill as is and forgo the pretense of fake paying for it. colleagues, think about those words. the editors of the "wall street journal" basically said that this is all a bunch of fakery because the cuts aren't going to be made, the savings aren't going to be realized because we have tried that route, and "the wall street journal" said pass

this good bipartisan bill. now, if the congress fails to fully repeal the flood medicare payment formula now, i believe there will be cuts to other providers, hospitals, home health care providers, drug companies, skilled nursing facilities. make no mistake about it, those providers are going to be the ones who pay for yet another patch. so a lot of this budget fakery isn't real, but the people who are going to pay for the patch, they are going to face very real cuts. now, in total, the 16 band-aid patches have already cost $115 billion. colleagues, this is the same cost as fully repealing and replacing the flawed s.g.r. plus taking care of the health extenders, and those cuts, as i have indicated, have largely been paid for in the past by cuts to other providers.

in the last two years alone, the hospitals have been forced to produce nearly $30 billion to pay for the taxpayer patches. under the status quo, s.g.r. will always call for cuts that are too steep for providers to bear and congress will step in with yet another watch paid for by still more cuts to other providers. how can you make a case for more of the same, especially when you have an opportunity to not only repeal the flood formula but also to enact reforms that finally move medicare away from the flood fee-for-service approach that rewards quantity instead of quality and value. second, i offer the medicare s.g.r. and beneficiary act assess improvement act of 2015 in order to eliminate the ongoing threat to our seniors and the providers who serve

them. under this legislation which reflects the bipartisan, bicameral legislation that senator catch and senator baucus offered last month, physicians would receive annual payment increases of .5% for five years. the following five years, physicians would not receive automatic increases but rather would be eligible for payment increases based on performance. medicare would transition to a new focus on greater quality, value and accountability. this legislation would strengthen medicare physician payments in a number of ways. it would reward the quality of care. it would improve payment accuracy, expand the coordination of care for patients with chronic care needs and encourage participation in alternative models of payment. and the bill addresses other critical medicare and medicaid

issues. they are known as health care extenders. and with these extenders, it would be possible for the congress on a bipartisan basis to ensure that low-income seniors can have affordable medicare premiums and guarantees, that beneficiaries will have access to the therapies they need. under the bill, rural beneficiaries will have the security of knowing the hospitals and physicians will be there when they need them, and i know that rural health care for my friend from north carolina, for my friend from iowa, for the senator from ohio, it's a priority for them. you pass this bill which was put together by a bipartisan group in the house and the senate and you give a big, big boost, colleagues, for rural health care and the services that seniors depend on on their medicare. and finally, something i'm especially proud of because senator grassley was good enough to work with me for a number of years on it is this would

significantly expand medicare transparency. this legislation would open up medicare's treasure-trove of payment data and patients would have the information they needed to make informed choices about their care, and researchers and professionals will have the data needed to develop evidence-based methods. so this afternoon, in addition to thanking colleagues that i have already mentioned, i want to thank senator grassley for all those years in working with me and senator harkin knows senator grassley has been a strong, strong advocate for transparency in health care and other vital services, and you see his good work in this bill. now, this bill is bipartisan, mr. president. it doesn't cut providers, increase cost sharing for the seniors, and i defer to my colleagues to decide if it's better to offset cost s.g.r.

repeal by reducing future spending or unpaid for, but the bottom line is the same. we ought to act now, act now and put the flawed formula known as the s.g.r. which had produced medicare migraines for frustrated providers and seniors alike, let's put this behind us. every single thing in the bill that i offered today has had strong bipartisan support, and it represents a compromise. now, i know that this isn't an easy vote for colleagues on either side of the aisle, but i submit it sure means that we'll be able to accomplish what we were sent here to do, to find a way to do what's best for seniors and the doctors who care for them, and with that clean slate -- and i have enjoyed talking to the president of the senate about this because i think what this bill is all

about is doing what's right for seniors, doing what's right for the doctors, setting in place a plan for the future that ensures seniors are going to get better care, that in many instances will cost less, and that's what i hope senators will take home after we break tomorrow for the work period, that this is a chance to do what's best for seniors, what's best for doctors and what's going to pay off for taxpayers in the long run. nobody wins with medicare make believe, and after these 16 patches when you have "wall street journal" editors joining with seniors and providers and you have a bill that has strong bipartisan support, i think this is the kind of measure that

senators ought to flock to. and i will just close by saying we all know that the public is frustrated with a fair amount of what happens here in the congress, and there is a fair level of disappointment. the senator from north carolina and i were talking about a variety of issues on this point this morning. but i look around this chamber and i see senators who have spent a significant amount of time in public life, and a number of colleagues are on the floor. i am old enough to remember joining them in the other body before we came here. and we're here for a purpose. we're here to get things done. and on this medicare issue which suffice it to say, mr. president, has been one of the most polarizing in the

american public debate -- in fact, i'd venture to say on the domestic side of the budget there are few issues that have been as divisive and as polarizing as medicare. this is an opportunity, colleagues, to check the partisanship at the door, come together and set in place a new system of paying providers under medicare that is going to produce better quality at lower cost. we ought to support it in a bipartisan manner. bipartisan manner.

>> the head of the food and drug administration talked to margaret hamberg testifies next about the fda's priorities and asked about a new pain drug and allegations that doctors are overprescribing antibiotics. senator tom harkin shares the health, education, labor, and pensions committee. [inaudible conversations] >> good morning, the hearing on

health, labor, education, and pensions comes to order. we examined the initiatives undertaken by the agency like several significant reforms passed over the committee over the last few years. our nation faces a variety of public health chmgs in the early part of the 21st century, rapid changes on where products are made, how they are made, and where our food comes from. there's major innovation with treatments that save lives, more diversified foot supply, and these dynamics prented prisks and greater challenges for regulatory oversight. the health committee addressed many of the challenges in recent years, and approving the things that can still get done in washington. i want to thank ranking member al exander for being a great partner and all members on this committee and staffs. we worked together in a collaborative and bipartisan matter to address the public health issues heads on. i want to summarize a few that we have.

last fall, after a year after the meningitis outbreak from compound sterile drugs that killed 64 people and sickened 751 patients across 20 states, that we passed the drug quality and security act which clarifies and strengthens oversight of compounded drugs. in 2012, we passed the food and drug administration safety and innovation act, with along with authorizing several user-fee programs sped up patient's access to drugs, and the ability to regulate the global drug supply chain, established tools to mitigate shortages of prescription drugs, and implemented reforms to bring critical drugs and medical deviolations to market faster. in 2011, enacted the food, safety, and mods earnization act, a landmarked law that brings american's food safety system into the 21st century to better protect americans from contaminated food and food born illnesses.

the tobacco control act in 2009, which which committee spearheaded, became law, giving the fda authority to regulate the manufacture and distribution of tobacco products to protect public health. this committee, i believe, has been very active in addressing the health and safety needs of americans. i want to take this opportunity to thank you, administrator hamberg, and for the recently recent proposal, and we see this in packaged food, and latest update to the latest in 2006, reduce transfact, and new proposal will further support americans in efforts to make healthy decisions for themselves and their families. this hearing will focus on fda's implementation reforms as well as other key public health initiatives that are now confronting us, undertaken by the agency and other members of the committee. we're pleased to have the

commissioner of the fda here to talk to us about efforts and answer our questions and alternative senator for his opening remarks. >> thank you, mr. chairman, thank you for having this very timely hearing, and, doctor, thank you for being here today, we look forward to visiting with you. i'll devote attention to the drug security law last fall to clarify fda authority over compounding pharmacies. that's very important to many states, but especially to tennessee. the men ji tis outbreak in 2012 was a nightmare for us. 137 in tennessee were sick, 16 others died from the outbreak caused by contaminated steroid injections districted by a poorly regulated compounding facility in massachusetts. while the final legislation, the law, was not as strong as the bill that passed this committee, the law does make it clear

either the fda or the state is overseeing each compounding facility. just to review, the law says large facilities, compounding sterile drugs without prescriptions now have the ability to voluntarily register with the fda as outsourcing facilities, committed to higher standards for sterile compounded drugs to report adverse events, mutt the labels and list the products made with the fda. the legislation, the new law, kept state oversight of traditional pharmacies, the corner drugstore, and oversight over drug manufacturers. the fda gets criticism from time to time, but i want to give credit where credit is due on this one. you responded to a crisis, although it were as if it were a crisis. you're off to a fast start in implementing this important legislation, and i appropriate that. on december 4th, just one week after the legislation was signed into law, fda published three

guidance documents. it's been just a little over a hundred days since the president signed the law, and in that sometime, 30 filletses registered as outsources facilities nationwide, doing it voluntarily, and 30 facilities have doing this without receiving guidance on requirements they have to meet for the sterile drugs they meet. that's a good sign. wonings we have more clarity, the facilities go up significantly. now that the law's established, who is on the flag pole? fda and states take action necessary to make sure compounded drugs are safer in the future. you've continued inspections and enforcement actions, sent newspaper resource warning letters to state boards and examining observations from many pharmacies. i hope to learn what policies you are developing and where do we see the guidance on the quality standards outsourcing filleteds must comply with? number duo, what are your

enforcement priorities, follow up on the warning letters, the pharmacy received a warning letter, and i want to ensure there's appropriate follow-up this time, and, third, now that we established who is on the pole, how are you coordinated with states on what they are doing? thank you for quick work in making this law, and i look forward to hearing about future plans on some other areas the fda's pace seems to be moving rather slowly, and i hope the way you worked op compounding pharmacies sets an example how to move ahead, example, on center for tobacco products. you got 1.7 billion in user fees to date, for tobacco, and over 4,000 applications filed. you've acted on 34. congress also instructed fda to set up a regulatory pathway for similars, march 2010, and established a bicenter user fee,

and two years later, almost four years later, we were not approved for a similar prilgt in the united states, and many questions languager. the last example is the em prelimmation of the food safety modernization act. the fda will repropose the part of the proposed regulations due to stake hodder concern about cost and complexity of the the regulations after emphasizing the need for science and risk-based flexible approach. i urge the fda to improve responsiveness to congressional inquiries. there a letter i sent in july, to which i have not yet received a response. in that light, i will submit writing to a question that senator fisher of nebraska has shements answered. i will not deal with that orally, but providing that to you separately. all in all, fissioner, thank you for the fda's fast start on implementing the pharmacy legislation, and we welcome you to the hearing.

>> thank you, very much, senator, on behalf of the committee, i want to welcome our witness today, dr. march great hamberg, 21st century of the u.s. and food and drug administration since 2009. she's the top official of the fda, emission to protect and promote the publish health. she received the mb from harvard, completed residency in new york presbyterian hospital and cornell medical center. a tremendous background as a doctor, scientist, cig post -- public health and mental hygiene, and health and human services, and, doctor, we thank you for sharing your exper seize with the committee and being here today. you're statement which is an extepeesive statement, which i got through yesterday, last night, it will be mealed a part of the record in its entirety. i'd like to ask maybe -- give

you up to ten minutes to did through that, if you'd like, rather than just five, but maybe if gsh however close you keep it, but below ten minutes. request the letter remain open for senator smith's statement or other questions for the for the record. a couple thingses, 10:30, i have to leave. >> you probably do too. >> both of us have to leave. >> [inaudible] >> okay, good. i think -- we have -- senator franken will take over at that time if we're still on then, beyond that time, but we're managing a bill on the floor we have to leave for at 10:30. begin, doctor, welcome, and please proceed. >> well, thank you, very much, and i know that you with pressed for time, so i wanted to keep the oral statement relatively short. you know, really, thank you, mr chairman, and members of the committee.

for the opportunity to be here to discuss important initiatives fda's been working op with regard to the implementation of several new laws recently passed with this committee's leadership. the food safety modernization act, the food and drug and safety administration act, and drug quality security act. i also realliment to express gratitude to you and members of the committee for championing the passage of the land mark laws. they really all represent remarkable accomplishments done, as you noted, in a bipart san way, and they are spornt -- important to public health that cannot be overstated. we welcome the opportunity to return to the committee to provide a more detailed review of the implementation of the 2009 family smoking prevention tobacco control act as requested, which really lays a strong foundation for protecting the public health on harms of tobacco products. first, food safety. reducing food-born illness in

the united states is one of the fda's most important responsibilities. the toll that it takes on public health is profound. an estimated 48 million illnesses, 128,000 hospitalizations, and 3,000 deaths, and moreover, the overall economic impact of food-born illness in the united states including cost to farmers, food processers, and consumers are as high as 77 billion a year. thanks to you and your colleagues, who enact the the food safety modernization act, we have tools to significantly lessen these impacts. central frame work, as you know, is aimed at building preventionive measures across the food system from farms to table including produce safety, modern preventative controls, guarding against intentional contamination, modernizing oversight of imported foods, and ensuring safety transport, and over the past year, fda put

forth seven proposed rules on topics for public comment, but new rules alone will not get us to the goal. fda must have resources to implement them to provide the technical assistance to small food processers, for example, to build the capacity of our states as partners in the important effort, and, also, vrt importantly, begin the long delayed process of better oversight of imported foods which are increasingly important in our food sploi. simply put, without a significant increase in resources, we will not achieve the vision of a modern food safety system and safer food sly. with respect, building on a successful model, the food and drug administration casted and innovation act reauthorized music fee programs for innovator drugs and medical devices and established two new important user fee programs for by yo similars and generic drugs. in a time of budget restraints,

this steady source of funding is essential in speeding new products to patients and providing predictability and consistency for industry. the law gave fda new authority to better protect the drug supply chain in an increasingly global marketplace. in addition, he provided agency with new authorities to combat drug shortages and stimlite drug development, enhanced development of medicines and encourage drug and device product innovation. i want to highlight just a few of the successes we've already seen as part of the dwoashted agreement within industry, fda committed to meeting much enhanced performance goal for review, and since fiscal year 2010, we achieved a 23727% increase in the backlogs of lower device applications and 10% decrease in average total

review time. for higher risk devices, there's a 43% increase in the backlog and a 3 # #% decrease in average total review time. recognizing the need to stimulate investment in anti-bacterial drugs, there's incentives for the development, and since the passage, fda grarnted 41 qualified disease programs. a promising start. i'm pleased after a series of interventions, new use providedded, the number of new drug shortages declined very significantly from 251 to 117 between 20 # 1 is and 2012 and fell further to 44 in 2012. however, there do continue to be shortages that persist for longer periods and work aggressively with all the tools at the dispoe stall to any grate them. with respect to the drug

security and security act, the last time, as was noted, that i appeared before the committee, in the midst of a nationwide outbreak cause the by compounded medications. thanks, truly, to the committee's leadership, we have the drug quality and curet act that contains important fro visions reeledded to oversight and outlines steps to a system to identify and trace certain prescription drugs. as was noted, within a week of passage at bqsa, fda took action to implement imp policemennation like draft gypses, three notices soliciting nominations for drugs that can and cannot be compounded, and eight stake holder gofer reach undertaken. as of this week, 35 firms have, in fact, registered with the fda as outsourcing facilities. when you continue inspections of pharmacies and take enforcement actions as appropriate to protect pairkts.

so without a doubt, fda's responsibilities had huge frank formations through the important new laws, and our commitment to implementing the responsibility entrusted to the education by congress to improve lives of the american public to protect their health, safety, and welfare is unwaiverring. we're committed to working closely with you on these important now laws as well as so many other issues, and we really believe that our work is vital and partnership with you is vital, and we are making a difference in the lives of americans. thank you. >> thank you very much, doctor hamberg, and we'll start a round of five minute questions here. >> i have two tracks to go on. i don't know if i can get them in under five misseens, but i'll try. that is that have you addressed, if you can't here, perhaps i'll

submit the question, but addressing coyed yum consumption and reduction of the sodium in our foods, but i really want to focus my question on yoids. in 2002, doctors many america wrote 144 million prescriptions for opioids. ten years later, 241 million prescriptions. 4030 # people died from overdose in 1999. 16 # 651 died in 2010. more than heroin, opium, everything else combined. that's percocet, vicodin, owl of those, and on october 25th, 2013, fda approved a new hide --

hydrocodeine, and here's a statement made, quote, in the midst of a severe drug addiction epidemic fueled by over prescribing of opeiods, the last thing the country needs is a new high dose, end quote. president of the physicians for responsible prescribing said, quote, it's a whopping dose of hydrocodeine packed into an easy to crush capsule. it will kill people as soon as it's released, end quote. then i found there was in the newspaper this morning, "the washington post" where i get some of the information, and i don't know that it's right, but i'm just reporting what they said, the advisory panel, your advisory panel voted 11-2 against approving, and, yet, they approved it. now, again, what i find

startling is in the united states, we have 5% of the world's pop pew lyings, but we have 99% of the world's consumption of hydrocodeine. these are the most prescribed pharmacy drugs in the u.s.. i said 131 million, but 241 million for hydrocodeine, 131 million for prescriptions in 2011. i didn't know we were so painful in the country. what's happened? we had a hearing on pain here last year. i may have to have another one. pain clinics, all this stuff, all these -- go to a doctor, and they prescribe painkillers, open yoids, people get them refilled, and you got a pain? go to the dro. they prescribe it. what's happening to the doctors in the country? when we had a panel here last year, they said a lot is not fizz logically caused, may have a manifestation, but it's not

miss logically caused, and the fda comes along and approves what i understand to be something that is ten-20 times more powerful than oxy con tin. when your advisory panel voted 11-2. a story in the post this morning and another story in the post. could you address yourself to that, please? >> it's a serious health problem, a serious health threat, and we are working really hard to address what fda can do to make sure that patients with pain needs get what they need, but also recognize addiction of the drugs and do what we can to work broadly with the components as you note, prescribe or practice as an important component of the overall problem. with respect to the question, i have to address it best i can.

this hydrocodeine is a very important treatment of legitimate pain, and, you know, we do have many medical needs for both acute and chronic pain management. hydrocodeine, up until the approval, was only available in a product that also included acetaminophen, and for some patients, as you know, some patients respond to different drugs differently, and some can tolerate hydrocodeine much better than other drugs, but at lower doses available in the combination product, serious risks, if you upped the dose of the hydrocodeine of liver toxicity and serious life-threatening complications from the acetaminophen. this product is unique in terms of its availability as a sing the hydrocodeine product without

that associated liver toxicity risk. it is -- it was approved. the advisory committee met actually before we put in place more stringent labeling requirements around use of this -- of this class of drugs, that we think are important for assuring appropriate use for patients with legitimate pain. it is scheduled as a schedule 2 drug means there are additional restrictions on prescribing. physicians have to have a special license. there's limits on prescriptions. no refills. they are special security precautions, and requirements that have to be undertaken with respect to the storage of the drug and reporting requirements so that's it's a schedule two drug with additional requirementings to limit its use and hopefully to make sure that it is prescribed in used

appropriately for pain where it is required. in addition, there is rems for this drug product that places further restrictions on the use, and also requires company to make available physicians' training for its appropriate use, so we recognize that this is a powerful drug, but we also believe that appropriately used, is serves an important and unique niche with respect too pain medication, and it meets the standards for safety and ethics recognizing its addiction potential and understanding, of course, the broader context of the serious problem of medication abuse and misuse in

the country. we weigh carefully risks and benefits, and we hope that as a nation we can make progress in addressing all of these issue that cricket to this ongoing serious misuse and abuse epidemic, and, you know, we'll continue to push hard, and we're trying to ensure that work goes forward with respect to the science and technology so that hopefully we move in that direction going forward. >> thanks. i have follow-up questions, and my time is out. i'll submit in writing. thank you, plmp. ..

>> the requirements for oversight this is a very important step forward with that effort and to defining a new role for the fda i do

have concerns that you are aware the fda and legislation that even with clarifying so we do know that it applies nationwide it is still possible a, counting pharmacy could be in compliance with some aspect of specific 503a but out of compliance with other components such as compounding and fda approved drugs and there's still is an opportunity for some confusion there isn't with respect to 503b it is voluntary to register.

some may not and if they hide out under 503a we may not even know. >> we only have five minutes. but i a understand that the senate bill wants to go further than it did not go that far but fundamentally the facilities have already agreed to be regulated bayou. at the same time you are able, you are issuing letters to others so a couple of questions but some states are indicating i have heard they may have the outsourcing facility regulated by the fda and the state as a pharmacy. that was not the intent of the legislation but to permit a facility to choose

one or the other. >> i have not heard that a specific concern. states vary considerably with their lives and resources at what i have heard from states from these large facilities they often don't feel equipped to provide that a regulatory oversight. they hope they will register >> that the defectors defectors, outsourcing facilities, the rest are the state's. when will you be issuing a more draft quality standards

so the other, pounding pharmacies know what is expected of them if they choose to be via outsourcing facility? >> we are working through the good manufacturing practices guidelines for those facilities and we will get that out as quickly as we can. the clients of facilities with good sterility practices that this is very high priority for us. >> do you have any estimate how many of these facilities that compound sterile drugs exist eligible to be outsourcing facilities? >> we really don't know what that number is and we hope as we implement this law and begin the process we will get a much better sense and

of course, we're increasing our partnership with the state to have us second, 50 state meeting to communicate the understanding what the new law means for all of us to make sure we have the right to communication in doing not reach with health care providers hoping they will see this the mechanism as what is best for their patience with regulatory oversight to become the standard of care so more companies will declare themselves. >> that is my hope and i will be anxious as this moves along. >> i have in order here.

>> thank you. good to see you here today. is such a estimate more than 2 million people develop antibiotic resistant infections every year in and increasing scientific evidence the overuse of antibiotics with animal agriculture is contributing to the rise of antibiotic resistance. the more use them the less effective if it becomes progressively continue to use 30 million pounds as antibiotics in the food animals every year which is four times as much as we use in people, we're likely to have more resistant infections and fewer antibiotics to work when we need them. so the most recent guidance on this subject concluded the use of antibiotics in animal agriculture to

pro-growth "may contribute to its antibiotic resistance '' but the fda says that antibiotic use for disease prevention is all right into half-assed pharmaceutical companies to sell antibiotics voluntarily we have heard preliminary reports that all 27 companies that manufacture in of antibiotics agreed to comply with the supplemental new drug application to revise labels. surely the removal of production and use is a good first step and i am hopeful this will lead to the increasing use of antibiotics. but fda guidance does not guarantee of prudent use of the antibiotics with disease

prevention. even with every animal drug company agreeing to comply with the most recent guidance there could still we a lot of use in animals that is for disease prevention but still far more than necessary and will continue increasing resistance. how will this guidance and the review in sure we are reducing use in agriculture and decreasing the risk of perpetuating resistance? fennecs such an important topic on a personal level i have been working on most of my career. i really am encouraged by some of the steps we are taking now and i think they will begin entering difference. s united we put for the

guidance asking for companies manufacturers in generics to show us how over a period of a tough time they will remove the products for growth promotion purpose which is what we call upon judicious use and there was a 90 day period to report to us their plans how they would voluntarily comply that just closed we have preliminary indication of participation to review that we are comfortable and will work with them but with respect to your question how do we insure these antibiotics don't continue to be used inappropriately although not

targeted for the growth prevention purposes, we will also be moving the oversight of the use of these products to the supervision of a veterinarian. it will be much more like what you are familiar with as a prescription and the release of a drug with oversight of the use of these products. there will always be a need for antibiotics for important illnesses they may have been there is a role for prevention but to make sure it is appropriate and adequately supervised and especially when they are of importance for human medical needs as well. >> i am running out of time. i will make notes sold

better in areas have to prescribe. it is a good first step but they can prescribe anything for label use. as long as they are permitted to use it for preventative disease, that means there is a possibility to continue to keep these drugs out there all the time even with the approval of a veterinarian. i am concerned and i will address my question is for the record including how he will do that. >> i am happy to. we will work in oversight of the prescribing practices. >> i appreciate that. think you very much. >> had dr. hamburg thank you

for being here. so what is reaching epidemic proportions one person got melanoma and not to mention in squamous cell m basil's guilt -- so skin cancer 1990 was the last time the fda applied one dash approved for the enhanced ingredient for sunscreen capability and some applications have been pending more than a decade. can you are familiar with those initials and trying to make more transparent and determination with skin-care ingredients we don't want to legislate what the fda should approve but a more transparent and effective system to evaluate these ingredients for this cancer. would you agree to work with our office to get a more

rapid response? >> absolutely. it has been taking too long. we are eager to work with you on the decision we are moving forward with our evaluation of sunscreen additives getting back to sponsors on our assessment and we're looking if we can modernize the overall framework how these over-the-counter products submit applications to streamline and make it more responsive to the modern world. >> we will work with your office to be a positive influence. we don't want to make the decision by get them to be made. second, of president in my state i will not get into a specific question of their product but the bank of time it takes for fda to respond to an appeal for the

decision. one particular case brought to my attention a decision was made by fda the company government appealed based on scientific facts and it has been two years if we still have not gotten an answer and last july when they called for an update they said the decision was pending and that has been nine months. what can people expect for repeal for a reasonable time to get an answer? >> it depends on the product or the regulatory pathway that is undertaken. so i cannot give you one size fits all but i would say i recognize how important it is to make sure this process works well clearly understood by the company's.

no doubt an area where we can often be more efficient and responsible so we are committed to try to do the best job possible but not knowing the specifics i cannot tell you win. i do believe i saw a letter from you and we are moving forward on that in a timely way but i will get back to you specifically to end more broadly i would say over the last two years we have been working hard to modernize the regulatory system to address the business process issues to recognize the importance of could clear communication with companies around these kinds of

activities. >> with breakthroughs of medical science sometimes devices we have to determine which one day are. >> with this every as in many others, avifauna authority is first established looks very different today why we have to modernize to update to the compound in pharmacy laws. wheel is need to look at whether our system matches the real world needs. >> host. >> my time is almost up but i will submit another question that fda is considering. >> there is a great deal of interest. >> we need to look at

conkers responsibilities. >>. >> think you for holding this important hearing. commissioner welcome back. i want to take a minute to thank you for the fda work over the last few years it has not ben ec -- not been easy but you came out to colorado to listen to many people all across the state communicating back and forth with the fda making a commitment to and i can tell you they have seen a positive change at home and i think a lot of that is through your of leadership. nothing is perfect and i

hear consistently how much things have improved and on behalf of my constituents, thank deal. also i was pleased to see the implementation of the bill that i worked on with senator hatch with the breakthrough therapy dissipation showing dramatic results today over 40 treatments have received this designation. if you would have said we had for the drug side would say you were delusional. and with hepatitis c and other conditions visiting colorado patients receiving break to therapies pitcher lee has made a life-saving difference that the dream is only to live a normal life. so as a result to get effort

we have seen a number of people asking for more direct dialogue and what should be considered as the breakthrough therapy. i believe there should be an avenue for patients to give the fda their opinions so in light of all the work i wonder if you can talk about the effect of this new designation for the industry and to patients and you're willing to have more of a dialogue with what they would supply with breakthrough therapy. i am excited to see something working well in the government. >> like to do an answer that would be very long but it is such an exciting new

opportunity for us included in the legislation that was much more popular and successful than we anticipated the other side is we did not get new resources to implement this program but we have been able to identify a very large number of exciting old promise to you treat serious or life-threatening illnesses and already have approved three different products for four different indications under the breakthrough therapy pathway. and i think we will continue to see it as a very important program. it underscores another set of important points with broader ramifications with the aspect of the early

engagement with the fda review team san senior level scientist to help shape what is the best strategy so we can ask and answer critical questions to address safety and efficacy to move it through the system as quickly as possible so the candidates can get to the people and in that regard the opportunity is critical and in another aspect we have been establishing a series of meetings with patients from critical diseased areas with how it manifest itself as a condition in their lives and how they think of patients reported outcomes as part of the design and to make sure

we are helping to address critical care deeds while feeding innovation and product development. >> my time is up but thank you. mr. chairman, your of leadership including this has made a material difference as we see the fda exercising its muscles as one part of the pipeline my hope is we can see it across the fda to make sure it maintains its leadership with bioscience. thank you. >> my thanks to you because she were first on this committee to spearhead that effort so i'm grateful that you took that over and run with it.

>> senator robert. i forgot. he was on that issue. >> mr. chairman that used up 10 seconds of flight time. [laughter] i would follow up what senator warren was asking about the animal antibiotics she comes from a very heavily populated state mine is very parsley -- a sparsely populated states so we do have different problems and in light of one question taking a ball five minutes i will submit that in writing. i worked on the tester amendment to provide specific accommodations for controls for small farmers and producers.

what is the status of the implementation of that? >> the tester amendment in particular? we have been doing not reach in response to developing propose rules and now as we take comments one of the things more broadly is the impact on small farmers and the fact we have a system where there are very different types of producers we need to find a way to assure greater food safety but not impose undue burden. >> will also submit that one also. >> with producers of the overly prescriptive framework when considering the preventive controls for human food but it does not

appear as the fda in here's to the requirements how it went to publicize those rules. can you provide this committee with a commitment to win here to the minister edith procedures act on future rule making? been a i have not heard that i think we have done a remarkable job with the engagement to take comments in responding to comments. i will go back and ask questions and follow of. >> we will provide more detail on that. for next question concerns about the abuse deterrent foreign relations come if the agency establishes a clear path away and standard companies will continue to invest in this research. i have been troubled to hear from the drug manufacturers who would like to adopt

these formulations they are stymied and confused of the lack of clear and consistent standards when we finalize guidance and can we expect that to have a generic versions with the fight for prescription in drug abuse to use all the available tools that is slowing down and that is unacceptable so could you finalize the guidance within the next six months? >> that is important but in all honesty the science and technology also need to be developed to incentivize companies to work hard to provide with as much clarity as possible and we need to develop abuse deterrent approaches for these powerful drugs spinet but there is no timetable?

>> i am not sure what the time frame is i know be issued the guidance of a few months ago. >> it is very complicated. i would like a fairly extensive answer. i appreciate the efforts. there is also a new pathway to kraft that bipartisan proposal bin to ratify the user fees i am very interested have both are implemented because it is consensus driven. i am looking for a commitment it will issue guidance that we understand do give the stake holders

then includes us the opportunity to engage with policy questions before final decisions are made. >> we are committed to that and have had many discussions with companies that either developing or interested in developing as part of the program. >> i have additional questions but my time is up. >> senator casey, we are grateful for your presence a and your good work. to get at least two areas one is that allows law enforcement and others to administer a drug in the case of an overdose to

reverse. in particular i want to highlight the element of legislation senator udall 1/6 57 which says increasing prescription in drug use act of 20131 provision would ask the fda to reconsider the status and i want you to speak to that i know you cannot make a determination today but speak to that issue in terms of its value of the context of law enforcement more particular as a way to deal with a crisis situation as the overdose. >> it is a very important the decision to reverse opiate overdose and certainly used on a frequent basis and effectively in a

health care setting. we have been concerned many opportunities when it could save a life have been committed because they have heard in the community but we encourage manufacturers to of this product to consider coming in with a formulation that could be provided as the auto ejector or nasal inhaler with kennedy's settings like law-enforcement or others to take a vantage of this kind of formulation that could save lives. we are encouraged by the response we had from the manufacturer and we will continue to work on this important issue. >> the chairman raised this issue with the numbers we

have seen the one number i keep coming back to those who reduce prescription drug czar 19 times more likely to reduce karoline. stunning. pennsylvania is third of third-place finish we did not want but we see it not in the stereotypical fashion not urban communities with the popular image of this abuse is in big cities but rule areas so it is very substantial that the chair ben used which is high drone -- with against the approval

of the product also apparently the product was approved without any abuse deter properties? >> that is correct. >> a related question of concern a number of us have about the implications of allowing this product on the market without the abuse teacherage properties. >> i would love if we had a deterrent foreign relations that were meaningful and effective if to detour and use in all instances. we are moving in that direction with guidance how we think about revealing and improving the abuse teacherage what they need to demonstrate because it does no good to live off

something as the abuse deterrent but technology is for. there is one formulation that is in the marketplace recently approved in terms of an immediate test crashing for use of injection or sniffing but does not prevent abuse or misuse when taken orally. frankly it is not where we'd need to be but to demonstrate utility and opportunity but we need to continue to work with companies and engineering communities to come up with better abuse deterrent formulations. also committed to working to develop non the opioid paid medication as that makes a

huge difference to to chronic pain that needs to be treated will be its are very effective for acute paid less effective for chronic pain but we don't have a lot of alternatives. that is something fda is working to try to develop non opioid paid medications to make a difference. >> i will submit more for the record. thank you. >> senator roberts. >> thank you so much for coming your time is valuable. this is the same question senator nancy asked and some did it up every like to go through it i think you're

answer under enzi was yes that is the answer i am looking for. the food industry leaders with the implementation of food safety modernization act specifically concerns related to preventive controls for the proposed rule that is still open for comments. specifically interested in the proposed rule testing in supplier verification requirements but does not provide specific requirements that this could get pretty expensive to do say the least with a whole host i will not go into but can you assure me that you will not finalize with the use more verification requirements that are so expensive to go through a

process with the revised economic analysis and assured me it is not issued as the interim a final rule? >> from the beginning we have tried to reach out to the stake holders. we have done lots of public meetings with specific groups and individuals it has been a complex to put forward with many competing interests and concerns. to carefully go through all the comments end we may well real issue with certain key

provisions i have heard the concerns of the economic impacts so yes we will work and a very deliberate and transparent way to drill down on the critical questions was what will really work. >> i appreciate that. i think it is a long yes. with the food and drug administration safety and innovation act looking at these practices to be modified in order to prevent drug shortages with the fda staff during the drafting of the legislation can you tell me where it is with the

internal review of regulations that the fda policy are or were they deem to drug shortages? >> what progress has been made our team that has been expanded to address a minute potential shortages in this country obviously industry plays a critical role they generally occurred because or importantly quality concerns of the manufacturing but with the improvement of the number of shortages to help strengthen

the progress made to enable us to institutionalize ways to do interact with the fda so we're moving forward to have real progress with systems that are working to and we need them to be strengthened. >> i only have 11 seconds but where is your internal review? where are we? >> i am not quite sure with respect to regulations we had some delays to get the report. >> it is an ongoing process? >> we are getting their.

i really do think it is a system that is working. >> i appreciate that. >> first i want to thank senator robbers for your work on the code pending bill -- compound a bill. >> thank you, mr. chairman chairman. i will be happy to compound with you anytime. [laughter] we go to senator baldwin. [laughter] >> also with chairman harkin and the ranking member to convened the hearing to give us the opportunity to ask questions wisconsin is home to a vibrant community of innovative medical device companies and there is

always interesting things going:to make contributions said chest it of the art:cancer in and day sepsis detection in device. with the last several years has taken on encouraging steps to spur product innovation we are very excited about some of those with a fda pilot program that allows the fda and cm us to simultaneous leave approve approval and coverage determination to help streamline the process for those patients better served by those innovations. so commissioner the fda's

center for devices is indicated the agency plans on establishing a new pathway to the accelerate the approval of certain devices with those of unmet medical needs. some of the data typically collected in the device studies could be submitted once it has been approved for use this proposal has the potential to improve treatment options but to empower smaller companies to bring new and cutting edge technology to target resources most efficiently and effectively through the approval process. so i hope you could elaborate on the development of this new pathway and specifically how the fda

will ensure predictability for a device companies and how well the agency make sure the needed evidence is collected post market setting to guarantee patient safety? >> important question so much excitement in the medical device every man and the center is working hard to harness those opportunities with the innovation and pathway hands looking at how we can learn with the drug center to build into mechanisms the understanding safety and effectiveness of say a product has to be a life cycle approach.

as we look at the pre-approval with post marketing surveillance and collection of data that our continued in the continuing now with the center for devices strategic plan going forward this approach of integrating post market studies for the understanding we will be eager to work with industry with other stakeholders as it moves forward.

>> we look forward to that with interest. thank you for the opportunity. >> senator murkowski. >> dr. hamburg thank you for what you do. there have been question is asked about drug shortages and issues that i have concerns with but in fairness to your time a couple that have not been brought up one was the shellfish banned chinese the post -- imposed on parts of alaska and the west coast. it may be very narrow in its scope impacting some family

alone to businesses taking a real hit right now. we sent a letter on march march 6th to the anchorage there is a delegation to go tear china to discuss this issue to see if we cannot get faster resolution. i am understand that this meeting is scheduled on march 21st with the usda foreign agriculture service. but the question to you this morning can you give me assurances we are fast tracking a the resolution and if you will be sending that delegation and if not, why not? >> it is something where the

department of commerce has a lead so as well as information so we are not formally part of the delegation so we do have an office in china. to provide additional support. we do have been flushed but we are not in the lead. >> i appreciate that but my concern issues that arise that speak to the specific jurisdiction. >> we will be available to them 24 hours a day.

>> i would like to return to a subject i brought up before the committee and a new offense to the chairman to refer to this fish as the franken fish. >> but the offense is taken. [laughter] >>. >> that is worse. [laughter] i don't want to consume by a time talking about how bad the name is but a genetically engineered fish and specifically salmon. i have very strong concerns and reservations. i don't need to show you pictures of beautiful wildlife salmon but i will show you a picture of the

eel the dna is taken from this fish injected into a chinook salmon to cause them to grow quicker to get to market more readily i strongly oppose, strongly opposed but fda to approve a genetically engineered cnn. think they have studied the environmental effects or economic impact but the seafood markets with the impact so given the concerns that i have come mccann you a share made that fda is prepared to deny approval of the sale of genetically engineered salmon if you determined it cannot guarantee it is safe to eat?

>> if we could guarantee it is not safe to eat then it would not pass approval. >> wayne wanta this assurance. pre-don't know if it is safe to eat we don't know what has been determined this genetically engineered salmon is safe to eat also we cannot determine whether or not it would impact negatively or jeopardize the wild alaskan salmon so i would ask again to look very critical at this. the threat i believe not only to humans with the bizarre fish but if in fact, fda should finance to a sale to consumers and has been demanding the agency provide

very clear labeling them is in fact, what they're purchasing for consumption. with the level of assurance but there should be clearer labeling allowed. >> i can assure you that we have been taking a very systematic approach that does represent the first in its class cemetery important wip pathway for the pathway of the environmental assessment. to address your concerns the wild salmon population.

the preliminary findings was 33 or 35,000 comments so we have been taking these very seriously and moving forward in the delivery of science drifted way reflecting the employment including the perspective that you brought forward today and earlier as we consider the product application. >> chairman my time is expired but dr. hamburg we could have a opportunity to discuss middle the genetically is engineered salmon but i have other questions i will submit and please pay particular attention to the level of inquiry how we're doing with

als research in the meetings with us stakeholders and acura for als. >> okay. >> senator any questions for the record referred to franken fish? [laughter] >> senator hatch may be coming but i will take a round of questioning first. i want to start by thanking chairman harkin and their ranking member for calling this important hearing for their leadership they have both shown regarding policy issues it has been a pleasure to work with both of them with a number of an

fda policies and i applied to thank you dr. hamburg for working closely with us. in your testimony you noted the implementation to register as the outsourcing facilities it is a critical component of the bell how does this option improve public health to prevent new outbreaks? >> it is targeted on high-risk products that we know can be contaminated to have very serious consequences. this will enable for those countries -- companies to

have good manufacturing practice with adherents with the kind of procedures that need to be undertaken to make these safe. is hugely important. we hope companies will choose to go this pathway into port in the the marketplace will view this as the appropriate standard of care with the health and safety and protection to seek out those that have not just registered but submitted applications to become outsourcing facilities with ongoing oversight which will include regular inspections to

ensure compliance with the manufacturing procedures and safety protection. >> thank you for that answer. dr. hamburg i tried to represent minnesota where we have the medical device industry and i spent a lot of time with startup device companies that serve as a major source of innovation with that industry and to innovation for the next life-saving therapies. these entrepreneurs and investors are pretty tenacious spend years to bring our anti-before they see a profit before having a therapy to approve a vice. i am doing my part to fight for the device industry in minnesota and around the

country that is why i thought the device tax and working now to find a bipartisan solution to repeal that tax once and for all the to do everything i can to help make sure the company's that face international competition can compete so this is another area of where the process or review is streamlined. with fda and the industry have different cultures. i have often seen the fda talk past each other and in minnesota we did something that is remarkable the fda

and the unknown my science trade association to form a partnership called the of medical device innovation consortium. this public-private partnership is the first of its kind to create the efficiency and quality and its coal talks about regulatory science. can you tell me what progress is made to indians to benefit patients because of the creation of this organization? >> 84 the question i felt badly i forgot to mention it to earlier what exciting things are happening with

medical device innovation. it is public-private partnership off to a good start. it was announced not too long ago and has doubled in size with the consumer groups and research organizations. . .

and also one of the things that excites me is developing computer simulations and models so that you can actually study some of these devices in that context instead of in animal models or people in the early stages so that you can really number one manipulate things and play with it more but also reduce costs and potential risks to patients but still really get import information to again moved things that have promise into the marketplace and making a difference in peoples lives. so i think it's a wonderful public credit partnership. thank you for your leadership in helping to make it possible and we are very committed to working with it read we are seeing the

benefits already and we see more importantly a foundation for lots more progress. >> well thank you for your role in that and for your excitement about it. senator enzi. >> thank you mr. chairman. i would like to revisit the goals you immediately identified when he took the helm at the fda modernizing how the agency considers new therapies and closing a regulatory science gap. those goals are ones we obviously all share. that said there's a continued level of frustration on patients and manufactures that the fda lags behind other countries in timeliness and up-to-date understanding of critical responsibilities including clinical trial design, ballot in points for assessing the value of new therapies and how the risk evaluation and mitigating strategies are tools to protect haitians and allow risk products

were patients are desperate for treatments. senator harkin's opening statement and questions he mentioned a case where the committee voted against it and it was overridden by the fda. i will talk about a little different situation and that's dealing with multiple sclerosis. the fda recently made a decision to break with an overwhelming advisory committee vote to support the safety and effectiveness of the novel therapy for multiple sclerosis and the agency chose not to approve the drug despite his having been approved in 30 jurisdictions based on the same dataset. can explain the logic behind the agency's decisions? what did the fda seed that the advisory committee could not? >> well first let me address your broader question about in terms of we are i think the cutting-edge in terms of review and approval of new products if you look at drugs approved in recent years. i think about three-quarters of

them approved in the united states first and on devices apart from the highest devices we are at par with comparable other countries in terms of review times etc.. we do ask for more clinical data often on the higher risks of devices so i think you know there is some urban mythology about where we stand in comparison to review times and leadership there. i would have to say the user fee programs for devices and drugs have made a real difference in our ability to be as competitive as possible. with respect to the role advisory committees in the decision-making within the fda, the advisory committees are very a very important component of the review process but they are not determined as you well know and we seek expert advice in many ways including advisory

committees. advisory committees are not used with every raw text that is reviewed of course but it's sometimes frustrating for me i have to say when people ask questions about a specific ruddock and why we didn't up prove it. that information is confidential information that we are not allowed to share with the company. but i can assure you that the fda teams take their jobs seriously going through a systematic way the data that's available to them, assessing safety and efficacy in overall risk benefit and the benefit to patients. there are often are things that are not obvious but that make a real difference in terms of a decision that is made. >> and the advisory committee? >> the advisory committee is a very important part of our implant on a decision. i would say the majority of

times our decision alliance but not always. >> that you are saying they're lacking information that the people at the fda would have so they are not getting the full story? >> you know i think there are many components to the review and the advisory committee is an important piece of it. but the advisory committee is not spending time with a the patient level data that the routine are and aspects of the review the advisory committee is not always engaged in. but we value and take their input seriously and we try to engage subject matter experts to the greatest degree that we can. >> the only reason that i've noticed this one it had been approved and 30 other jurisdictions already by the same dataset so those other jurisdictions are considered

wrong too. that is the decision i guess that the fda can make and we do want you to keep us safe. my time has run out. >> would you care to ask another question? >> well it would be your turn. >> i know but go ahead. [laughter] >> i know that the fda is underway in its implementation of the generic drug user fee act and it's my understanding that not all first generic applications have been approved on the same day as the patent expiration. is there a reason for that? >> well this is a program as i think you know we have had backlogs, serious backlogs in. that was a big part of why the user fee program was begun with the passage. we are moving forward in