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tv   FDA Administrator Testifies on FY 2018 Budget  CSPAN  June 21, 2017 7:14pm-8:01pm EDT

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his books include "the kingdom and the power" "honor thy father" and "unto the sons." >> i wanted to write about unknown people. the little woman who fed pigeons in the park or the little woman from the ukrainian who cleaned the offices of the chrysler building at 4:00 a.m. or some doorman outside the plaza hotel and what he saw and what he didn't see. i wanted to write about sometimes what it was like to be a bus driver in manhattan or clean the subways at 4:00 a.m. those obscure characters, but people to not, ordinary people do not recognize. i wanted to be a chronicler of those unrecognized, those untitled. >> for more of this weekend's schedule go, to next, another hearing on the president's 2018 budget request. this one is with dr. scott gottlieb, who heads the food and drug administration. he testified yesterday before a
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senate appropriations subcommittee. this is 40 minutes. hearing will come to order. i would like to thank the members for being here. ranking member merkley and certainly want to welcome fda administrator gottlieb. thank you for being here this morning, we appreciate it. today's hearing will focus on the food and drug administration's fiscal year 2018 budget request. thank you again for being here, dr. gottlieb and obviously this is a good opportunity to talk about fda's priorities for the upcoming year. congratulations on your confirmation. we certainly want to welcome you in your first appearance before the subcommittee and we look forward to working with you.
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the agency you head has authority over approximately 20 cents of every dollar spent in america. americans expect that the food they eat and the drugs they take will be safe and effective. fda's reach is vast. the agency has authority over more than 300,000 foreign establishments, and 185,000 domestic establishments ranging from food processing plants, to facilities that manufacture life-saving medications. in addition to facilities themselves, the fda is tasked with the regulatory responsibility of individual products. and delivering these regulatory responsibilities your private-sector partners expect transparency and certainty from the fda. when i speak to small businesses, and ag producers in north dakota, their overwhelming concerns is that often overly burdensome regulations coming out of washington, d.c. can stifle innovation, and hinder their ability to create jobs. while we all support the fda's mission, we must also be mindful
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of these concerns. i believe the fda must avoid the trappings of one size fits all solutions and i urge you and your staff to take a common-sense approach in regard to the budget request itself. i'm concerned that this request relies on a significant increase in user fees. that is not feasible, and unlikely to gain congressional approval. i'm concerned that the proposed cuts to budget authority may negatively impact food safety programs and slow the agency's important work on drugs and medical devices. that being said, dr. gottlieb, i also recognize that these decisions were made before you were confirmed, so i hope you will pledge to work with congress to insure that fda has the resources necessary to meet its critical mission. we have many other issues to cover. so at this point i will turn to senator merkley for his opening comments. >> thank you, i'm going to keep this very brief. because we're hoping to hear your testimony and have a round of questions before we go to the
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vote at 11:00. the department you head covers products that constitute 20% of what consumers spend. both in food and drugs, it makes that work very important. and this budget before us very important on everything from scientific research, support for state and local health organizations, blood safety work. medical device, post-market surveillance, medical product exams and so much more. so i look forward to hearing your thoughts on the budget. and getting to our inquiries. thank you and congratulations. >> i would suggest at this point we go right to dr. gottlieb's statement so we can come right back for questions and then any opening statements as well. other members may have. dr. gottlieb? >> thank you, mr. chairman and mr. ranking member and members of the subcommittee. i appreciate the opportunity to testify today regarding the president's budget. i've talked to you in the past about the steps that fda is taking on the generic drug side to try to bring more low-cost opportunities to patients when it comes to new drugs and
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improve access. i want to briefly touch on some things we're going to be doing on the new drug side. the most tangible way we're going to reduce health care costs is by finding better treatments for a lot of costly diseases. and towards these ends, we'll be announcing soon a medical innovation development plan that will include a broad range of steps to make sure that our own regulatory tools and policies are designed to facilitate the development of potentially breakthrough new treatments. one area of focus of this plan is is going to be on targeted drugs, especially those that affect rare diseases or diseases for which there is no effective therapy. among other things, fda will be updating various guidance documents on the kinds of drug development techniques that facilitate the development of drug therapies, guidance on clinical trial strategies to improve efficiency and adaptive trial designs to evaluate safety and effectiveness, we'll be taking a fresh look at policies that support innovation to allow drugs to be targeted only to
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those patients who most likely to benefit from the medicine and take a broad range of new steps. among these new actions, we'll be issuing a new document within the next section months on the clinical evaluation of targeted therapies for rare disease subsets. this policy will address targeted drugs and how we can simplify the development of drugs where diseases all have a similar genetic fingerprint. even if they have a slightly different clinical expression. one example is the cancer where a drug target as particular molecular subsit of cancer, regardless of where the tumor arises, we'll clarify where we can give a broad approval to a drug in similar kinds of cancers which are not particular to the tumor being in one specific tissue or organ. in other cases rare subsets may be grouped by lab testing to be studied in a single clinical trial this medicine is more common as we understand the genetic basis of disease. our new policy will describe when we will approach drug review, less by how a disease is
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expressed and more by how it is expressed by a commonly set of driven factors, rare and orphan diseases, right now we have a backlog of 200 orphan drug designation requests where we haven't responded to sponsors and whether the drug will receive an orphan drug designation from the fda. we're committing that 90 days we'll eliminate this backlog of requests and provide an answer back to the sponsors. to help eliminate the backlog we've created a special orphan designation s.w.a.t. team and we'll never again develop a backlog. going forward we're committing that every orphan drug application will receive a response from the fda within 90 days, to enable more efficient reviews and timely responses to sponsors who are also implementing a new streamlined orphan designation review template. these are some things we're working on. i look forward to discussing with you how fda's budget and this committees can support all agencies key priorities, including food safety and enable consumers to improve their lives, thanks a lot.
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>> thank you. and we'll start with the questioning. i have concerns about the administration's proposal to essentially double user fees. and it doesn't appear that the health committee will move forward with that proposal and instead congress will likely pass the previously negotiated user fee so my question is, based on the fy 17 appropriation, are you confident that you're going to be able to meet the program needs? based on your current appropriate yated level? >> fy 17. >> senator, thanks for your question. the bottom line is we can always do more with more. when it comes to the resources that the agency has. i'm confident that we have been able to be efficient in everything we do. i think there's still places that we can look within the agency to try to improve our operational efficiency. we recently made an announcement with respect to a realignment when it comes to the field activities, i think we're going
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to continue to look for places to improve our operational efficiency. we appreciate very much the resources that we've gotten from this committee. in particular, the resources on the food safety side and the resources we've gotten under that. i think it's dramatically improved the stature and the base of resources for food safety. it's a very different agency today than the one that i left ten years ago in that regard. >> you have about 1,000 vacancies, hiring freeze has been lifted for your agency. are you moving forward and where are you in that process of filling positions? >> thanks for the question. that's right. we negotiated the lifting of the hiring freeze about two weeks ago i believe. and we're starting to move forward with filling those vacancies. i put out a notification recently to the office of the commissioner as well as the different senators in terms of process for moving forward. there's already activity with filling some of those existing open slots. >> what is the fda's role in addressing the opioid crisis? and what are you doing? >> well it's multifaceted.
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this is in my view the biggest challenge facing the agency. i think one of the biggest public health crises facing this country. there's a lot of different components where the fda is going to play a role. you look at medically assisted therapy where the agency plays an important role trying to address the current addiction problem. trying to get better opioids on the market, that are more tamper-resistant. we can play a particularly important role is on the new addiction aspects of this crisis. we know that most people who are going to become addicted to opioids are first ex-pokesed to opioid drugs in the clinical setting through legitimate prescription. certain pesage of patients who are exposed to opioids in the clinical setting will go on to develop an addiction. i think it's incumbent upon all of us to make sure that only properly indicated patients are being prescribed opioids and when they are prescribed them, they're prescribed them for a duration comports with the clinical circumstance for which the prescription was writ
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innocent first place there are things that the fda can do to try to address these aspects of the problem. that's going to be a particular area of focus of ours. s we recently developed a steering committee made up of all the center leadership and senior clinicians within the agency to look at trying to see how we can think differently about this problem. the other place where i've tried to focus some policy-making attention is looking at the risk in the illicit setting we traditionally have looked at the risk of illicit use as a component of how we evaluate the risk and benefit of opioids overall. but i twoont make sure we have a proper framework in place for doing this. and we're looking not just at the risks associated with these drugs in their labeled indication, but also the risks associated with how they might be abused and misused and diverted and used illicitly. we've recently taken an action, that baked into it, a consideration of how the drug was being used in the illicit setting. >> what about approval of drugs that actually help wean people
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off some of the opioids? i know there's development in this area. >> right. this is the medically assisted therapy. we need to continue to develop good drugs in this area. one of the challenges, though, has been reimbursement. while it's outside of my mandate, getting these drugs to patients is an important step as well. so we're looking at things we can do to help facilitate the development of clinical trials that move these drugs into different clinical settings to see how we might better study them in real-world settings and hopefully we'll have more to say on that soon. >> last week the fda announced a delay for compliance to the nutrition facts panel regulations and i know you're limited on what can you say until it's published in the federal register. but given my comment regarding one size fits all solutions, will fda use a common-sense approach towards those nutrition regulations? >> thanks a lot. i am confident we will, senator. we announced the delay in part
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to provide additional guidance to sponsors on how to interpret aspects of the new nutrition facts label. this is a time-limited delay. this is not a suspension of the regulation and we're not reopening the regulation. we are just using this time to develop additional guidance documents that will be issuing to help inform how people can comply with the new, with the new labelling. >> senator merkley? >> thank you, mr. chairman. and welcome, dr. gottlieb. and the question first question i have for you is, is a number of news reports have discussed the administration's directive to federal agencies, not to respond to requests from minority members of the senate. that is completely contrary to the very long and positive bipartisan history, both on this subcommittee and in our dealings with the fda under both republicans and democrats. i think dialogue with the
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executive branch for all members results in stronger bills, more likely to have support. and clearly benefits the fda and the american public to have that dialogue. can we count on you to be engaged in that dialogue and respond to inquiries and requests for the majority and minority? >> absolutely, senator, i responded to all the requests for new information that i got during my confirmation process from the minority. i am prioritizing timely responses equally from both the majority and the minority. we have reached out to many offices, including your own. i had the pleasure to meet with you twice. and so we will not pick sides in how we, how we provide information to congress. i respect congress and we're going to make sure we, we're providing you the information you need. >> thank you very much. and your outreach has been appreciated and i appreciate your commitment to continuing on that course. during your confirmation process, you described the
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staggering human consequences of opioid addiction and characterized that epidemic as the biggest crisis facing the agency. now we have prediction that the trump, the cdc engaged in various other experts, that the trump care bill coming out of the house, we don't know what version we'll see in the senate yet, would cut billions of dollars from treatment for mental health and substance abuse disorders. and also the millions of people would lose their insurance which makes very likely that they would be seeking medical care in the first place. we're concerned that this, this budget would damage the ability to take on opioid addiction with its enormous daily toll in lives. as someone who is leading the charge on this epidemic, who has presented it as a top priority, do you have concerns about the
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loss of access to health care by millions of americans, if this bill is enacted? >> senator, i'm very focused on what we're doing at fda right now. to address this crisis. as i know you can, you appreciate. and you're going to continue to see a series of activity out of the agency to address this crisis in you know, different ways that hopefully start moving us to a posture where we're getting ahead of the problem instead of always being one step behind. i have not focused a lot of attention on the various legislation moving through respect to the affordable care act. i'm focused on what i'm doing at the fda which is more than a full-time job. which i know can you appreciate and we'll continue to talk to you about those priorities. >> there are 13 senator who is are holding a series of closed meetings to work to prepare a version of the bill that would come before the senate probably next week. have those individuals or as a
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group, brought you into get your consultation and insights on the opioid epidemic? >> i've had, i don't know what group you're talking about. but i have had conversations with individual members about the opioid epidemic. i met with probably 60 members in the run-up to my confirmation process. and i would say that this issue came up in most of those meetings. and since i've been in this position, we've taken a lot of additional meetings with both democratic and republican members in the house and the senate and this issue comes up a lot. so i have consulted widely on this issue. including with you, senator. and appreciate all the dialogue i've had with congress. >> the group i'm referring to are the 13 republican senators who have been delegated the authority to prepare a bill to move out to the floor, one that will have no public input. that's the group. has that group asked you to come and share your expertise on this issue? >> i've had no dialogue with any group working on legislation as
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a group, no. >> well i imagine just knowing your background that you probably share my concerns, that such issues get the insight from experts and also that the public has a chance to weigh in so that we get in this we the people, republic, a full opportunity to make sure we get kind of policy right, if you will. that hassan impact on so many people. >> thank you. senator. >> thank you. >> senator collins. >> thank you, mr. chairman. mr. chairman, i have an opening statement that i would request be submitted for the record. >> without objection. >> thank you. doctor, we have previously discussed the need for improved health care provider education with regard to the prescribing of opioids.
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medicaid beneficiaries are described pain relievers at a higher rate than those with other sources of insurance and they also not surprisingly, given the higher rate, have a higher risk of overdose from prescription opioids, heroin, and fentanyl. what opportunities do you see for greater collaboration among the fda, cms, state medicaid directors, medical societies, and other parties in order to address this problem of appropriate prescribing of opioids? >> right. i appreciate the question, senator, i would also add dea to that, because there might be things we can could had in conjunction with our partners at the justice department. as part of the steering committee, we're currently having discussions about what steps we can take to improve
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provider education and maybe take a look at packaging as well as a way to help make sure prescriptions are more, more appropriately match the clinical circumstances for which they're being written. i don't want to get too far ahead of that process. other than to say that this is something that's at the top of the list of things that we're looking at right now. what additional steps we can do under our current authorities, both through the risk management plans that we currently promle gait in conjunction with opioids, the approval of opioids and other schedule drugs, as well as in partnership potentially with the dea, which obviously has authority to potentially look at certain requirements as part of the, the process for giving a dea license to individual practitioners. >> thank you. as you know from our numerous discussions, the senate aging committee last year undertook a major investigation, examining the explosion in prices of
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off-patent prescription drugs for which there is no generic equivalent. and one case, a drug was purchased by a company that played absolutely no role in developing the medicine and then raised its price. by 5,000% overnight. and one of the problems that we found is that these companies warded off competition from generic companies, by putting their drugs in closed distribution systems, or in specialty pharmacies. and the intent in doing so, was to delay access or even block access to a sufficient quantity of the brand-name drug to do the b bioequivalency studies that the fda requires. and these abuses are serious and contribute to the cost increases
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in a we're seeing by one estimate in 2014, such abuses resulted in increased costs to consumers of $5.4 billion per year. i've had extensive conversations and hearings privately with dr. janet woodcock about this problem and she has testified that fda has done 150 referrals to the ftc, to take a look at this anti-competitive process without any success. and she suggested that there needs to be a law change in order for the r.e.m. system not to be abused. i know that you've testified before the house appropriations subcommittee and noted your concern about this type of anti-competitive behavior.
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should congress revise the rems law as suggested by dr. woodcock, since there's only so much that fda can do now about the problem? >> i know there's legislation that congress is currently contemplating in this regard and we'd be happy to provide technical assistance. think we already have. i think there are things we can do within the scope of our current authorities through administrative action to address this challenge. two different challenges here. one is the rems, which is sometimes misused as a way to block the ability of generic companies to get access to the samples they need in order to develop a generic drug, it takes between 1500 and 3,000 actual doses to in order to develop a generic equivalent. the other issue is things embedded in the contracts with sometimes the distributors or special pharma companies that make it hard for the distributors or special pharma companies, to sell the drugs to the generic companies when they try to purchase them at fair market value in the marketplace so there are two different
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issues. some we can solve i think or address within the scope of fda and some might require us if we want to try to address it administratively, to partner with medicare. there might be opportunities to do that. we can identify to your point the situations, the circumstances where we believe generic companies aren't able to get the access to the doses and make referrals. we can't fully address some of the commercial restrictions that prevent them from getting access to those doses, but we could in partnership with other agencies. >> thank you. >> senator tester, i understand that you're deferring to senator leahy, is that correct? >> i wasn't going to, but go ahead. >> there's going to be some advantage of being vice chairman of this committee. >> senator leahy? >> thank you. i'll be brief. i'll put my full statement in the record. i do state in there, commissioner, i'm glad you're here today and i appreciate you being here. i was disappointed to see the
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woefully inadequate budget submission from the fda. when you exclude user fee proposals, mandatory funding to the 21st century cures act, that's about a 34% cut. $119 million cut from monitoring food safety. $55 million reduction medical product safety. i've been here for over 40 years, i've heard repeatedly the fda needs more money. not less. first time i've seen such a huge cut. especially with the price of prescription drugs on the rise and opioid and so forth. so i think the budget, that the president has submitted is abysmal. it assumes deep cuts of the medicaid program it assumes
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repeal from the affordable care act. it's kind of saying the check's in the mail. but i would really like to have a budget that puts americans first, not political slogans first. i want to follow up on something senator colins was saying about drug prices and it creates act. we are all of us, i don't care whether you're republican or democrat from our state, about the high cost of prescription drugs. and i know that some of the pharmaceutical companies have used inappropriate delay tactics to limit the ability of generic competitors, to enter the market. some won't give the generics the samples needed for testing. i propose a bill joined by republicans and democrats, both
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here and the senate and the house the creates act. which would deter pharmaceutical companies from blocking cheaper generic alternatives. so can you explain again the role, access to these samples, please? for market competition. >> well the, thanks for the question. the bottom line is that there's no question, there are places where companies do take advantage of rules meant for one purpose as a way to gain commercial advantage. and what i want to do is make sure we have a framework in place that makes it hard to do that. i think when we put in place rules for in this case, a risk management plan trying to address drug safety questions, we don't want to see those rules misused as a way to try to forestall access to generic competition, that congress intended under the laws that exist right now. so i don't want to be playing whack-a-mole with companies, either.
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i want to have in place a consistent framework and consistent set of rules to prevent these kinds of abuses. think we can achieve that i would be happy to work with congress on legislation that you're contemplating. think there are things we can do administratively through our current authorities and that's where i'm going to be focusing my attention. now the rems isn't the only place with this kind of anti- potentially anti-competitive behavior goes on. we're going to be looking across all of those places, we're going to have having a public meeting we're going to be announcing soon to solicit input from the public on where other people believe there are practices that could be forestalling access to generic competition. where branded companies might be taking advantage of certain rules that we could potentially address through our existing authorities. >> thank you. >> i'm sorry? >> you commented recently the fda's evaluate whether to waive the laws existing preference for brands of generics to programs
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and janet woodcock who you mentioned already, testified to a statutory change might be needed. which is better for you? statutory or can you do it from regularry? >> well i spent a let of my time and have been on the job for six weeks now, i've spent a lot of time looking at what i can do and starting to put those actions in motion. i think you just referred to the single-shared rems, where branded companies and generic companies are obligated to try to negotiate a single rems to try to reduce burdens on providers. and the question there becomes at what point do we step in and say you know what, the negotiations have gone on for long enough. and we're going to allow the generics to move forward with their own rems program. that's a decision we could make we have to develop the administrative record to do that. that's something where we through our current policy, can help address a potential stall tactic. i think if we put in place a
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policy, signifying that we were willing to step in and say you know what, these negotiations have gone on long enough, we going to allow the generic company to move on their own, i think maybe companies might reach agreement quicker than they are today. >> well thank you, and thank you, mr. chairman. i think you're going to find republicans and democrats going to be interested in working with you to do that. because these prices are getting out of control. >> senator rubio? >> thank you, thank you, dr. gottlieb for being here. as you know we've discussed before your confirmation a number of small businesses in florida that have been making premium hand-rolled cigars for generations. the industry is at stake last year under the previous administration, they finalized a rule that would require premium cigars, not the stuff you get from behind a counter, but the premium ones, to regulate the manufacture, import, packaging, labelling, advertising, promotion, sale and distribution at the premium cigar level. so it's already illegal to sell tobacco products to anyone under the age of 18. which i think addresses the
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underage smoking issue. plus a premium cigar market really is not marketed towards that. it's a different market altogether. are there any plans to re-evaluate the inclusion of premium hand-rolled cigars from this rule as was proposed under the preliminary rule? >> thanks for the question. we're currently looking at aspects of the rule as you know, there was a three-month delay in implementation of certain compliance states and that was before i arrived at the fda and we're coming up on the end of that delay. whatever we do in this regard is going to need to be science-based of course. but where cognizant of the challenges faced by small businesses. i also understand that there are a number of legislative measures to exempt premium cigars. if congress were to act, we'd be happy to work with legislators to omit any unintended congresss. >> i don't want to comment too specifically given that there's pending litigation around this issue. i understand the concerns you and i have had an opportunity to talk about them on a few occasions and i do understand
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the concerns of the small businesses that make premium cigars, senator. >> yes. and just for those who might be watching, or we're talking about the premium cigars, or what the name implies, a premium cigar, an expensive product marketed towards a very specific audience. and it's science-based, i think it will show as we've seen repeatedly, that's really not a product that is marketed at people under age or the like. real quick, i really appreciate the assistance the fda has provided to me and to senator bennett on our legislation, race for children to close the gap on cancer treatments that exist between adults and children. i was wondering if you could provide some background as to why the fda initially requested legislation to close this loophole after years of trying to encourage development of pediatric cancer treatments only through the best pharmaceutical practices for children's act? >> well i, i know the legislation, senator. and i assure you we want to do
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everything we can to try to make products available to pediatric patients, particularly pediatric patients who have rare diseases. where current available therapy might not fully address their clinical needs. i know that we've provided technical assistance, with respect to this legislation. and have worked with your office and will continue to do that. >> and just again as an aside, while senator bennett and i are aiming at is it's an incentive system, trying to incentivize companies, in every trial that has a pediatric component, unfortunately it's not working, they're not doing that enough. because sometimes the target audience is not big enough for them or the target potential patient mix is not large enough for them to be encouraged to do that. so our hope is to be able to drive more of that and i think everyone has been impacted in their own families by pediatric cancer and it's critically important that we develop new treatment options at that level. because when it strikes a family, it's devastating. we thank you for your cooperation and we look forward
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to continuing to interact with you. >> thank you. >> senator test centre. >> thank you, mr. chairman. and i'm glad i stuck around for marco's questions, i would tell you on the other side there are companies that are marketing their tobacco products to kids and hopefully can you do something about that, too, because that's, it's ridiculous, it smells bad, you don't need to comment on that. i just hope would you pursue that. would you agree that expediting the review of high needs generic drugs should be a priority for the fda? >> we currently do expedite various categories of what i think you and i might agree are high-need generic drugs, including drugs that we just announced we're going to be prioritizing the review of drugs that don't face any competition. there's about 180 generic drugs right now, or drugs that are off-patent. >> so in the chairman talked about 1,000 vacancies, cbo has estimated if we're going to do this, it could be as many as 500
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additional employees over the next five years. but $60,000 a year a pop. that's a fair amount of money. i think it's the right thing to, do i think it's an important thing to do. how under this budget are you going to be able to accomplish that? >> well look, as the chairman noted, i wasn't involved in the formulation of the budget. i'm -- >> i got it. >> i would have to -- obviously make it work. if the budget would pass as it was proposed. these are challenging budgetary times and we're going to have to it figure out ways to do more with less. we tried to target the cuts that this budget does distribute this budget is an overall increase. but there will be certain cuts distributed under the budget because of the way the money is allocated with the emphasis towards the user fees. we'll have to try to and we have tried to allocate the reductions to places of lower priority. but in an agency where there's an important mission and a lot of what we do is important, sometimes it's challenging to
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find those areas. we've tried to dot best we can to identify them. >> i think it's, this is really important. i think as many of the people on this committee talked about prescription drugs is a huge driver prescription drugs being a huge driver in health care costs. we have to make sure they're safe. the backlog with generics oregon fan drugs is critically important. i love to do more with less. but we got to do a lot more with a third less. i don't see how that works. you don't have to justify. this i saw the more with less on a lot of different folks. the truth is in the end, if we're going thoeo hold you accountable and say i didn't have the manpower to do it, that's our job here to make sure you have the man power to do it and your recommendations are really important when it comes to manpower. i get it. there is fat in every agency. there is priorities in every agency. so i would hope that you would be honest with us and say, you know what? this is a big issue.
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i think generic drug sthing a huge issue. and to get these high need generics out i think is something we should all try to achieve. but you also need to be realistic on a manpower and budget that takes. it's important. can you rest assured i'd be happy to work with you. >> and not only me, but this entire subcommittee on your budget. i would love to get your recommendations. like i said, i think this is an incredible driver in health care and figure out ways to reduce costs. generics are a bright light over the last 15, 20 years. and so we see hedge fund folks buying the prescription drugs that senator collins talked about, we have to block that whether it's your agency or some other agency. >> right. we're going contemplate this very issue in the authorization that's before congress right now. >> all right. thank you. now i want to talk about importation of prescription drugs. there's been all sorts of
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efforts over the last 20 years that i know of from montana hauling bus loads of folks into canada to buy prescription drugs. there are bills put forth here for reimportation. some, good some not so good. do you think americans should be able toim po import drugs from countries? >> this question has been put forward to both republican and democratic organizations. a certification -- it's current currently legal to have drug reimportation as long as they can certify the drugs coming in. that legislation existed tloe through both republican and democratic administrations. i have not taken a fresh look at this question. i haven't been asked. i'm happy to look at it. i would remind the committee that fda commissioners dating back to when i was last at the agency 15 years ago haven't been able to make that certificate.
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>> the certification of it being safe? >> to put in the architecture that if you have reimportation of drugs to make sure that the chain of custody can be guaranteed that you're actually getting a drug that was manufactured by the legitimate -- >> that's a legitimate concern. i think there is also a legitimate concern of americans being gouged for their prescription drugs to the point that we may be subsidizing other countries for the cheaper prescription drugs. i don't know that to be a fact. the truth is when i go into montana and i think the same can be said for north dakota oregon or, we hear about this issue a lot. >> and i'm trying to take steps to address it. as you know, what we're doing to try to bring more competition on to the market. i think you're right. i don't think it is a debatable proposition. we are subsidizing drugs for other countries through the high
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prices we pay here to support the research and development. we have to address that, too. trade representative, obviously. i'm trying to do all i can with my agency. >> thank you for your answers. thank you for allowing me to go over time. >> absolutely, senator. we have votes to call. at this point we're going adjourn the hearing. i want to thank you for being the here today. i appreciate your good work. and for membersst committ of th committee, any questions you want to submit should be turned into subcommittee staff within one week which is tuesday, june 27th. and we would appreciate if we could have a response back from you, doctor, within four weeks from that point. i want to thank everyone for coming to day. we are adjourned.
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this weekend on american history tv on c-span3, saturday at 6:00 p.m. eastern on the sieve war, the disbanding of the confederate army of northern virginia is discussed by purdue university professor carolyn janie. >> remember, lee's terms, the terms had surrendered his army. they had said nothing about declaring the confederacy
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defunct. there was no peace treaty. and jefferson davis remained on the run. >> at 8:00 p.m. on lectures in history, university of notre dame history professor darren docha on the east texas oil boom of the mid 20th century and the expansion of u.s. oil businesses to saudi arabia and canada. >> a geologist frames the theory of peak oil saying that american oil reserves were going to really collapse by 1970 forcing the country into a difficult situation. and so this kind of apocalyptic fear of america lotion its oil sources is going to drive exploration abroad. >> and sunday at 4:00 p.m. eastern on reel america, the 1979 united nations film the palestinian people do have rights. >> violence breeds hatred. retaliation brings only further retaliation. an eye for an eye is often paid at high interest rates in our
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day and age. >> and at 6:30, president reagan's speechwriter peter robinson and former u.s. ambassador to germany richard bird recall reagan's 1987 troip berlin and the gate speech. >> we knew it was a great applause line. i knew it was authentic ronald reagan. but, you know, history as president obama said has an heart. we would never celebrate that famous speech if in fact the events of 1989 had not transpired the way they did. >> for our complete american history tv schedule, go to sp >> sunday on q&a. >> ways a reporter that covered politics and i got interested in political power. and i conceived of these books first moses power in cities
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urban power, linyndon johnson national power as studies in political power. but i thought when you were a reporter, i won a couple of minor journalistic awards. but when you win an award, you think you know everything. first time robert moses started talking to america i realized i didn't know anything about power at all. >> biographer robert caro talks about his audio project on power, looking at the evolution and xer siexercise of political in america. he hears prot gres on the multipart biography of linldon johnson. >> he had compassion from the beginning. i wrote in the book but the ambition was the overriding considering with him. it was only when compassion and ambition coincided when he's in the senate. he realizes if he wants to be president, he has to pass a civil rights bill. that he really turns to this.
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but then you say, so was he feeling false? not at all. because all his life he had wanted to help poor people and particularly poor people of color. >> sunday night at 8:00 eastern on c-span's q&a. >> coming up next, from earlier to dashgs the confirmation hearing for tsa administrator. that's followed by a nasa briefing on the upcoming solar eclipse in mid august that will be visible here in the u.s. and later, lawmakers and health experts discuss the opioid crisis and solutions for combatting drug addiction at a forum hosted by "the washington post." >> david picosk whoichlt has been picked to head the tsa had his confirmation theerg dhearin on capitol hill. he spent 30 years with the u.s. coast


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