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]

>> what are unique challenges in defining, you know, war in cyberspace, what war is, what hostiles are is, what military action is? >> from a policy perspective, we are still trying to work our ways through the issues. whatever we do within the cyber arein ya, international law will pertain, that if we find ourselves getting to a point where we believe that cyber is

taking us down armed conflict scenario, that the rules and the law of armed conflict will pertain, every much in this domain as it does in any other. i don't think cyber is inherently different in that regard. i think those sets of procedures, those sets of policies and law as a nation stood us in goodstead, represent a good point of departure. >> this weekend on c-span, senate arms services takes on military nomination saturday morning at ten eastern, and on booktv, amy and john allen look at hillary clinton's political career since the 2008 primary defeat. saturday night at 8:15 on c-span2, and on c-span3, american history tv, from march 196 # 4, poet and novelist robert penn warren interviewed martin luther king, jr., saturday night at 11.

>> jennifer is health care reporterrer with "politico". first of all, how does the payment system work, and what's been the challenge to getting a permanent solution done on it? >> caller: congress agreed there's been an agreement that the old formula should be replaced and medicare's positions should be paid for quality rather than quantity. be paid not for the number of x-rays they prescribe to

patients, but how they treat them and whether parties are healthier after their treatment. this new payment formula awards physicians who bet -- get better quality outcomes for treating their patients. there's how to pay for this. you mentioned the doc fish comes around very often. this would eliminate the need for a doc fix rather than the new way to pay providers. >> your article in "politico" points out the republican plan pays for it by suspending the individual mandate for five years, how are democrats reagenting to the proposal? >> democrats do not like it. you know, there's been several votes this year to eliminate pieces of the affordable care act, and because of that, they are posing this. democrats are in support of the underlying policy. change, but they don't want to pay for it by eliminating a part of the affordable care act.

>> republican texas congressman, also a doctor, tweeted about this yesterday. will the president veto the delay commenting on the news wednesday that the white house issued a statement against the so-called doc fix. why is the administration, in particular, opposed to it just pause of that five-year delay? >> absolutely. the president said that he doesn't want to eliminate the individual plan date and he's not going to do it, have even it means doing something that has bipartisan support like the structure for medicare. those -- similar bill in the senate proposed by senator wyden, the new chairman of the senate finance committee. it has the same replacement of the book fix, but it's not paid for at all. >> senator wyden tweeted about that yesterday introducing the bill to the senate floor. say the bill passes in the house and assuming the senate, what's the timetable in getting it

worked out between the two bodies? what's the deadline for getting this involved? >> well, the doc fix expires march 31st, driving the action here. if congressments to permanently eliminate the need for a doc fix, they do that by march 3 # 1*s, but they have to bridge a gap between the senate there's no pay-for, and in the house, it's paid for, and by two individual man at a time, and it's unlikely to drudge the divide by mar 3 isst, meaning they need a new dog patch to indicate certainly types of providers that would start on april 1st. if they can't come up with with a permanent doc fix by then, they probably would have a nine month patch, kicking the next time it comes about for the lame duck session at the end of this year. >> going baa to friday for just a second, democrats, are they likely to propose any sort of

countermeasures, some motion to recommand, or a last chance to resolve the issue? did they want, for example, to provide pay-fors in their measure? >> yes. democrats have proposed a bill that was overseen, and that way the legislation will be paid for, and republicans, some have said that they would consider using that, and others call it funny money saying it's not real money, and shouldn't be used for anything else, and we see a handful of republicans appear to vote for the measure, but i would not expect it to get enough support to stop this here. >> jennifer, "politico" health care reporter, you can follow her reporting on pilitico.com, and @jenhab on twitter.

>> thank you for having me. >> 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. in particular, what the senate wants to do is make sure 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 the seniors day in and day out. now, mr. president, colleagues, many of those seniors have no idea that by march 31st, just a

few weeks from now, the congress has to act on their behalf to preserve access to the cares that seniors depend on, and sufficive to say, those providers would much rather be delivering the care than waiting for this congress to act. there's 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. in beginning, remarks, mr. president, i want to be clear that i can take little credit about the opportunity that is before us. the path that got us here, that got us started in the efforts to

make the needed reforms to protect our seniors is a direct result of the leadership of our friends and colleagues, orrin hatch just as senator hatch has done so many times over the course of an e lust yows career, senator hatch was key to forging a bipartisan solution to a challenging long standing problem. what i'd like to do, mr. president, in beginning, is recognize that effort by senators hatch, my preed predec, chairman of the finance committee, senator baucus, house ways and means ranking member, senator levin, chair production, and health editor 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've given us the opportunity to take this flawed system of setting a kind of medicare budget, known as sgr, sustainable growth rate. they've given us the opportunity to repeal and replace this slug system with one that i think 1 going to make a huge difference in the days ahead by pushing the goal of good quality affordable care up and doing did in a bipartisan way. i hope that these colleagues will take it as a compliment that the fgr bill now before the senate incorporates all of that good bipartisan work they've been doing along with the work that was done on the senate finance complete. i see our league from north

carolina here, who contributed mightily to the effort, and, of course, the president, senate, senator brown, an eloquent spokesperson, particularly for those with political power and clout, i'd like to thank both of them for their efforts. now, to be specific, the legislation introduced last night incorporates what those six members agreed to, the six members i named the three democrats and the flee republicans, came together with f-2,000, and in effect, that legislation along with the help extenders passed by the senate finance committee in f1871 is essentially what we have the opportunity to move in the dayings ahead. every single thing in the bill has strong by partisan support, and we hope we can all come together, and with resounding

bipartisan support, get the bill passed before march 31st. now there's a variety of reasons why democrats and republicans, in my view, can ban together and repeal and replace what, again, i have characterized as a flawed, really dysfunctional system that we have today known as the sgr. before i go flu the list of reasons, i want to make clear to my colleagues and colleagues who have known me, i'm interested in sound, sensible policy that we move in a bipartisan way, not politics or methods, but sound policy, and that's why i'm here on the floor today. i've 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 put one patch or another up and say we're going to fix the medicare challenge. it's just not going to work. for the last ten years, congress always blocked these cuts. i would say i think it's time to stop pretending these upcutting cuttings fittingly scheduled for april fool's day are any more reel 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 moving ahead constructively with health care and start with a clean slate. i thought the "wall street journal" editors really summed it up very well on february

19th. what they said in talking about the bipartisan bill and i learned tonight the editors of the "wall street journal" said, and i quod, simply pass the be as is and forego 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 around going to be realized because we've tried that route, and the "wall street journal" said pass this good bipartisan bill. now, if the congress fails to fully repeal the act now, there's cuts to hospitals, providers, home health care providers, drug companies, skilled nursing filletses. make no mistake about it. those providers will be the ones

that pay for yet another patch. a lot of this budget fakery is real. the people who are going to pay for the patch, they are going to face very real cuts. the patches cost 150 billion. colleagues, that is the same cost as fully repealing and replacing the flawedded sgr plus taking care of the health extenders. those cuts, as i've indicated, have largely been paid for in the past by cuts to other providers, and in the last two years alone, the hospitals have been forced to produce nearly 30 billion dollars to pay for the temporary ri passes. under the status quo, it calls for cuts too steep for providers to bear, and congress will step in with yet another patch paid

for by more cuts to other providers. how can you make a case for more of the saim? especially when you have an opportunity to not only repeal the flawed formula, but to enagent reforms that finally move medicare away for the service approach that awards quantity rather than quality and values. second, i offered refeel and beneficiary act improvement act of 2014 in order to eliminate the ongoing threat to our seniors and providers that serve them. under this legislation, which reflects the bipartisan, bicamera legislation that senator hatch and senator baucus offered last month, physicians receive annual payment increases of .5% for five years. the following five years, physicians would not receive automatic increases, but eligible for payment increases

based on perform. medicare would transition to a new focus on greater quality, value, and accountability. this legislation would strengthen medicare position 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 payments. the bill addresses other critical medicare issues, and it's known as health care extenders, and with that, it's possible for the congress on a bipartisan basis to ensure low income seniors can have affordable medicare premiums and guarantees that beneficiaries will have access to therapies they need. under the bill, rural beneficiaries have the security of knowing hospitals and

physicians will be there when they need them. i know that rural health care for my friends from north carolina, for my friend from ohio, the senator in iowa, it's a priority for them. you pass this bill, put together by a bipartisan group in the house and senate, and you give a big, big boost, colleagues r for rural health care and what seniors depend on under 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 was this expands medicare transparency. this legislation would open up medicare's treasure-trove of payment data and patients would have insertion they needed to make informed choices about their care. researchers and professionals will have data needed to develop

evidence-based medicine. this afternoon, in addition to thanking colleagues that i already mentioned, i thank senator grassley for all those years 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 or increase cost sharing for the seniors, and i defer to my colleagues to decide if it's belter to offset costs, fgr repeal, by reducing future work spenting or unpaid for, but the bottom line is the same. we ought to act now. act now, and put the flawed fofer mullah known as fdgr, producing 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 strong bipartisan support, and it remits the compromise. tennessee it's not an easy vote for colleagues on either side of the aisle. i submit it sure means we accomplish what we were cement 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've 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 than in many instances, will cost less and that's what i hope senators will

take home after we break tomorrow for the work period. this is a chance to do what's best for seniors, what's best for doctors, and what's beginning to pay off or taxpayers in the long run. nobody wins with medicare make believe, and after the 16 patches, when you have the "wall street journal" editors joining with seniors and providers and you have a bill has strong bipartisan support, i think this is the kind of measure that senators awghts to apply to. i'll just close by saying we all know that the public is frustrated with a fair amount of what happened here in the congress, and there's a fair level of disappointment.

the senator from north carolina and i talked about a variety of issues on this point this morning. i look around the chamber, and i see senators who have spent significant amount of time in public life, a number of colleagues around the floor, and i'm 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 sufficive to say, plt, has been one of the most polarizing in the american public debate. in fact, i venture to say on the domestic side of the budget there's few issues that's been as devicive and polar rising 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 of lower cost. we ought it support it in a bay partisan manner, and with that enthrpts i kneeled the floor. >> whatever the situation is, there's no question, i completely agree with senator feinstein that this is a matter of great seriousness, the attitude that the cia has to the rights of congress in all of this, whatever else there is to be examined in terms of what happened and when, and this may

be one of the healthiest things we can do, but i know one thing, whatever it was -- the intelligence community writes the report on it. they leave. they write a book on it. all the sudden, it's conventional, i wouldn't say "wisdom," but conventional gossip this is what happened there. we have to have the ground truth. president obama, op his first day in office stopped the controversies and interrogations that this is about. i don't know -- i mean, to tell you the truth, i have not really seep much of secretary director brennan's statements on this, what've seen are befuddling to any. i have high regard for him, proudly seep over the same patrick holiday and maybe get an attitude of, you know, where he

thinks this is going because that's usually when i see him on st. pat trig's day, mr. brennan, but it is -- it is as if i don't sit in on the the committees and get the hears, but i senator the senator. you take on the intelligence community, you're a person of courage. she does not do that lightly, not without ed, and when i say evidence, documentation of what it is that she's putting forth. >> so the administration wisely withdrew a cor they were proposed on the medicare drug plan because of significant bipartisan opposition. there is similar opposition to the looming changes of medicare advantage, and the president should act in a similar fashion. we learning? new this week. quietly, without any fanfare, there's a real question of whether the white house had just

abandoned the individual mandate. the heart of bock caver itself, the president claimed getting rid of the individual mandate is tear mount to gutting obamacare. yet, the white house quietly added a new hardship exemption for essentially everyone hoping no one will notice. this is a huge public policy discussion that could affect millions of americans. tomorrow, the house votes to delay the individual mandate tax and give everyone the same extension that the whoition is already given them. yet, the white house opposes the bill. frankly, i think the american people deserve explanation, as to what the white house really is doing. finally, i'm going to touch again on the situation in ukraine. the house is acting on a loan guarantee package with a strong bipartisan support.

the senate should pass this bill, send it to the president's desk before leaving for district work period. i also received a letter last week from many of our central european allies urging action on the issue of american energy. the fact no export ban on u.s. natural gas exports would not only help our economy, but help keep putin in check. i urge the president to heed this call from our allies and have him call the secretary of energy to begin to pass export licenses.

>> when we say "freedom of choice, let people go their own way" what we mean is they know best. the government does not know best of the the notion of autonomy, pretty elaborate word, is basically a way of a one-way way of saying people know better on what makes their lives go better. this is academic and abstract, but i think the stakes a real and con create, which is the question, really, in thinking about policies, at least a lot of the question is are people going to be sick, going to be miserable, are they going to be

dead? whether it involves savings for retirement or privacy on the internet or involves air quality, if we can think of some way that makes them less likely to be sick or miserable or dead while also letting them ultimately go their own way, if that's what they want, that's a good bargain. >> former obama administration official on his latest "why nudge" on sunday night at eight on c-span's "q&a." >> 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. . .