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. The agency you had 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. Fdas 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 lifesaving medications. In addition to facilities themselves fda is tasked with the regulatory responsibility of individual products. In 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 concern is overburdensome regulations coming to washington, d. C. Can stifle innovation and hinder their ability to create jobs. While we all support the fdas mission we must also be mindful of these concerns. Fda must avoid the trappings of one size fits all solutions and a junior staff to take a common sense approach. In regard to the budget request itself im concerned that this request relies on a significant increase in user fees that is not feasible and unlikely to gain congressional approval. Im concerned that the proposed cuts to Budget Authority may negatively impact food safety impacts and slow the agencys 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 ensure that fda has the resources necessary to meet its critical mission. We have many other issues to cover, so this morning, so at this point i will turn to senator merkley for his opening comments. Thank you. Im going to keep this very brief because were hoping to hear your testimony and have a round of questions before we go to the 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. And 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. Gottliebs statement so that we can come right back for questions and then any Opening Statements as well that other members may have. All right. Dr. Gottlieb. Thank you. Mr. Chairman, mr. Ranking member and members of the subcommittee, i appreciate the opportunity to testify today regarding the president s budget. Ive 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 improve access. I want to just wreefl touch on some of the things were going to be doing on the new drug side. The most tangible way were going to reduce healthcare costs is by finding better treatments for a lot of costly diseases. Towards these ends we will be announcing soon a medical Innovation Development plan that will include a broad range of steps we will take to make sure that our own regulatory tools and policies are modern and risk based and designed to facilitate the development of potentially break through new treatments. One area of focus of this new plan 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 help facilitate the discovery and development of targeted their piece. This includes guidance on Clinical Trial enrichment strategies to improve efficient sis and trial designs that we can modernize the tools we use to evaluate safety and effectiveness. We will be taking a fresh look at policies to allow drugs to be targeted only to patients most likely to benefit from medicine is. We will be taking a broad range of new steps. Among these new actions will be issuing a new guidance document within the next six months on the clinical evaluation of targeted their piece for rare disease subsets. This new policy will address targeted drugs and how we can simplify the development of drugs targeted to Rare Disorders that are driven by genetic variation and where diseases all have a similar genetic fingerprint even if they have a slightly different clinical eggs pregs. One example is a cancer, regardless of where the tumor arises. We will clarify when we can give a broad approval to a drug in mole he can lateral similar cancers. In other cases rare subsets may be grouped by lab testing so they can be studied in a single Clinical Trial. This sort of genetically driven medicine is more common as we understand the genetic basis of disease. Now our new policy will describe when we will approach drug review less by how a disease is expressed and more by how it is driven by genetically driven factors. Many of drugs are aimed at orphan diseases. We have a backlog on whether the drugs will receive an orphan Drug Designation from fda. As part of our new plan were committing today that 90 days we will completely eliminate this backlog of requests and provide an answer back to the sponsors to help eliminate the backlog weve created a special orphan designation s. W. A. T. Team. More over. We will never again develop a backlog. Were committing today every orphan drug application will receive a response from fda within 90 days of the request. To enable timely responses to sponsors we are also implementing a streamlined orphan designation review template. These are some of the things were working on. I look forward to discussing with you how fdas budget and this committees can support all of the agencys key priorities including food safety and enable consumers to improve their lives. Thanks a lot. Thank you, doctor. And we will start with questioning. As i noted in my opening comments i have concerns about the with the administrations proposal to essentially double user fees. It doesnt appear that the help committee will forward 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 youre going to be able to meet the Program Needs based on your current appropriated 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 Agency has. Im confident that we have been able to be efficient in everything we do. There are still places we can look within the agency to improve our operational efficiency. We recently made an announcement with respect to a rea loonment when it comes to the field activities. Were going to continue to look for places with to improve our operational efficiency. With he appreciate very much the resources that weve gotten from this committee, in collateral the resources on the food safety side and the reforces under fisma. That has dramatically improved the stature and base of resources for food safety. Its a very Different Agency today than the one that i left ten years ago in that regard. You have about 1,000 vacancies, the 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. Thats right. We negotiated the lifting of the hiring freeze about two weeks ago, i believe, and were 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 Centers in terms of the process for moving forward, but there is already activity with filling some of those existing open slots. What is the fdas role in addressing the open joyed crisis and what are you doing . Well, its multifacetted. This is in my view the biggest challenge facing the agency and one the of the biggest Public Health crease ease facing this country. There are a lot of different components where the fda will 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 open oids on the market that are more tamper resistant. We can play a particularly Important Role, however, on the new addiction aspects of this crisis. We know that most people who are going to become addicted to opioids are first exposed to opioid drugs in the clinical setting through legitimate prescription. A certain percentage of patients who are exposed to opioids will go on to develop an addiction. Its incumbent upon all of us to make sure only properly indicated patients are being prescribed opioids and when they are prescribed opioids they are prescribed opioids for a duration that comports with the clinical circumstance for which the prescription was written in the first place. There are things that fda can do to try to address these aspects of the problem and so thats going to be a particular area of focus of ours. 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 ive 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 want to make sure we have a proper framework in place for doing this. We are 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. Weve recently taking an action that baked into it is consideration of how the drug was being used in the illicit setting. What about approval of drugs that actually help wean people off some of the opioids. I know theres do. 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 its outside of my mandate, getting these drugs to patients is an important step as well. So were 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 will have more to say on that soon. Last week fda announced a delay for compliance to the Nutrition Facts Panel regulations. I know you are limited on what you can say until its published in the federal register. Given my comment regarding one size fits all solutions, will fda use a common sense approach towards those nutrition regulations . Thanks a lot. Im confident we will, senator. We announced a delay in part 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 are not reopening the regulation. We are just using this time to develop Additional Guidance documents that will we will be issuing to help inform how people comply with the new labeling. Senator merkley. Thank you, mr. Chairman. And welcome dr. Gottlieb. The question first question i have for you is a number of news reports have discussed administrations 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 our dealings with the fda under both republicans and democrats. I think a dialogue with the executive branch for all members results in stronger bills, more likely to have support and it 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 from the majority and the 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 of the minority. We have reached out to many offices including your own. I had the measure 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 were going to make sure were providing you the information you need. Thank you very much. Your outreach has been appreciated and i appreciate your commitment to continuing on that course. During your confirmation process you described the staggering human consequences of opioid addiction and characterized that epidemic as the biggest crisis facing the agency. Now, we have a prediction that the trump the cdc engaged in various other experts that the trump care bill coming out of the house, i dont know what version we will see in the senate yet, would cut billions of dollars from treatment from Mental Health and Substance Abuse disorders and also that millions of people would lose their insurance which makes it very likely that she will be seeking medical care in the first place. Were concerned that this budget would damage the ability to take on opioid addiction with its enormous daily toll and 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 loss of access to healthcare by millions of americans if this bill is enacted . Senator, im very focused on what were doing at fda right now to address this crisis. As i know you appreciate, and youre 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 were 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 with respect to the Affordable Care act. Im very focused on what im doing at fda right now, which is more than a fulltime job as i know you can appreciate and we will continue to talk to you about those priorities. There are 13 senators who are holding a series of closed meetings to work to prepare a version of the bill that will come before the senate probably next week. Have those to prepare have those individuals or as a Group Brought you in to get your consultations and insights on the Opioid Epidemic. Ive had i dont know what group youre talking about, but i have had conversations with individual members about the Opioid Epidemic. I met with probably 60 members in the runup to my confirmation process and i would say that this issue came up in most of those meetings. And since ive been in this position weve 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 ive had with congress. The group im referring to are the 13 republican senators who have been delegated the authority to prepare a bill to be out to the floor, one that will have no public input. Thats the group. Has that group asked you to come and share your expertise on this . Ive had no dialogue with any group working on legislation as 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 weighin so we get in this we the people republic a full opportunity to make sure we get kind of policy right if you will has impact on so many people. Thank you, senator. Thank you. Senator collins. Thank you, mr. Chairman. Mr. Chairman, i have an Opening Statement 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. Medicaid beneficiaries are prescribed 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 do in conjunction with our partners at the justice department. As part of the committee weve set up were currently having discussions about what steps we can take to improve provider education and maybe take a look at packaging as well as a way to help make sure prescriptions are more appropriately matched to clinical circumstances for which theyre being written. I dont want to get too far ahead of that process other than to say this is something thats at the top of the list of things that were looking at right now what additional steps we can do under our current authorities both through the Risk Management plans that we currently promulgate in conjunction with opioids, the approval of opioids and other narcotics or scheduled drugs as well as in partnership with the dea which obviously has authority to potentially look at certain requirements as part of the process for giving a d. A. 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 off patent Prescription Drugs for which there is no generic or equivalent. In one case a drug was purchased by a company that played absolutely no role in developing the medicine and then raised its price by five thousand percent overnight. And one of the problems that we found is that these companies were at 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 bioequivalency studies that the fda requires. And these abuses are serious and contribute to the Cost Increases that were seeing. By one estimate in 2014 such abuses resulted in increase cost to consumers of 5. 4 billion per year. Ive had extensive conversations in hearings and 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 anticompetitive process without any success. And she suggested that there needs to be a law change in order for the rem system not to be abused. I know that youve testified before the House Appropriations subcommittee and noted your concern about this type of anticompetitive behavior. Should congress revise the law as suggested by dr. Woodcock, since theres only so much that fda can do now about the problem . Well, i appreciate the question, senator. I know theres some legislation that congress is currently contemplating in this regard, and wed be happy to provide Technical Assistance on that, i think we already have. I think there are things we can do within the scope of our current to face the challenges, theres two different challenges. Sometimes theyre misused by the way of companies to get access to samples they need to develop a generic drug. It takes about 13,000 doses to develop a generic. Other things embedded within contracts of specialty or far ma companies that make it hard for the 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 issues, some we can solve i think or address within the scope of fda and some might require us if we want to address it administratively to partner with medicare where there might be opportunities to do that. We can identify to your point the situations, the circumstances we believe Generic Companies arent able to get the access to the doses and make referrals. We cant fully address some of the commercial restrictions that prevent them from getting access to those doses. But we couldnt partnership with other agencies. Thank you. Senator, i understand youre testifying for senator leahy, is that correct . I wasnt going to, but okay. Theres got to be some advantage being vice chairman of this committee. Senator leahy. Thank you, ill be brief. Ill put my full statement in the record. I appreciate you being here. I was disappointed to see the woefully inadequate budgets admission from the fda when you exclude user fee proposal and mandatory funding to the 21st century cures act, thats about 34 cut. 119 million cut from monitoring food safety. 55 million reduction in medical product safety. Ive been here for over 40 years, ive heard repeatedly the fda needs more money, not less. First time ive seen such a huge cut, especially with the price of Prescription Drugs on the rise and crippling opioid and so forth. So i think the budget that the president has submitted is abysmal. It assumes deep cuts to the medicaid program. It assumes repeal from the Affordable Care act. Its kind of saying the checks in the mail. But id like a budget that puts americans first, not political slogans first. But i want to follow up on something senator collins was saying about drug prices and creates act. All of us, i dont care republican or democrats from our state about the high cost of Prescription Drugs, i know some of the pharmaceutical companies have used inappropriate delay tactics to limit the ability to generic competitors to enter the market. Some wont give the generics the samples needed for testing. I propose a bill joined by republicans and democrats both here and the senate and the house, the creates act, which deter pharmaceutical companies from blocking cheaper generic alternatives. Can you explain access to these samples, please, through Market Competition . Well, the thanks for the question. The bottom line is that theres 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 that when we put in place rules for in this case a Risk Management plan trying to address drug safety questions, we dont 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 dont want to be playing whackamole with companies either. I want to have in place a consistent framework and consistent set of rules that prevent these kinds of abuses. I think we can achieve that. Id be happy to work with congress on the legislation that youre contemplating, but i also think there are things we can do administratively through our current authorities. And thats where im going to be focusing my attention. Now, the rems isnt the only place where this kind of anti potentially anticompetitive behavior goes on. Were going to be looking across all those places. Were going to have having a Public Meeting that were going to be announcing very 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. But this is an important focus of mine im sorry. No, no, you commented recently the fdas evaluate whether to waive the laws existing preference for brands and generics to four rems and Janet Woodcock weve mentioned already testified a statutory change might be needed. Which is better for you, statutory, or can you do it from regulatory . Well, ive spent a lot of my time and been on the job for about six weeks now and i spent a lot of time looking at what i can do. And starting to put those actions in motion. So ive spent farless ti less t looking at potential statutory solutions. I think you referred to the single rems where companies are obligated to try to locate a single rems to try to produce 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 were going to allow the generics to move forward with their own rems program. Thats a decision we can make. We have to develop the administrative record to do that. Thats something where we through our current policy can help address a potential stall tactic. And i think if we put in place a policy signifying that we were willing to step in and say, you know what, these negotiations have gone on long enough, were going to allow the Generic Company move on their own, i think maybe Companies MightReach Agreement quicker than they are today. Well, thank you. And thank you, mr. Chairman. I think youre going to find both 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, weve discussed before your confirmation there are a number of Small Businesses in florida that have been making premium hand rolled cigars for generations. The industry is at stake because last year under the Previous Administration they finalized the rule that would require premium cigars, not the stuff you get from behind the counter, but the premium ones, the regulate the manufacturer import, packaging, labeling, advertising, promotion, sale and distribution at the premium cigar level. So its already illegal to sell Tobacco Products to anyone under the age of 18, which i think addresses the underage smoking issue plus a premium cigar market really is not marketed towards that. Its a different market altogether. Are there any plans to reevaluate the inclusion premium hand rolled cigars from this rules as was proposed under the preliminary rule . Thanks for the question. Were currently looking at aspects of the rule. As you know there was a threemonth delay in implementation of certain compliance that was before i arrived at fda and were coming up on the end of that delay. Whatever we do in this regard is going to need to be sciencebased of course, but were 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, wed be happy to work with legislators to mitigate any unintended consequences of these measures. I dont want to comment too specifically given that theres pending litigation right now around this issue, other than to say that i understand the concerns you and i have had the opportunity to talk about them on a few occasions now. And i do understand the concerns of the Small Businesses that make premium cigars, senator. Yes. And just for those who might be watching or were talking about the premium cigars, what the name implies, a premium cigar. Its an expensive product marketed towards a very specific audience. And if its sciencebased, i think it will show as we have seen repeatedly thats really not a product that is marketed at people underage or the like. Real quick, i really appreciate the assistance the fdas provided to me and 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 background as to why the fda initially requested to close this loophole after years of trying to encourage development of pediatric cancer treatments only through the best pharmaceutical practices for childrens act . Well, i know the legislation, senator. And i assure you we want to do everything we can to try to make products available to pediatric patients, particularly pediatric patients who have Rare Diseases where current and available therapy might not fully address their clinical needs. I know that weve provided Technical Assistance, well continue to work with your office. What were aiming at is basically on an incentive system where were trying to incentivize companies in every one of their trials to have a pediatric component. Unfortunately its not working. Theyre not doing that enough because the audience 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. And so our hope is to be able to drive more of that. Right. And i think everyones been impacted in their own families by pediatric cancer and its critically important we develop new Treatment Options at that level because when it strikes a family, its devastating. Again, we thank you for your cooperation and look forward to continuing to interact with you. Thank you, mr. Chairman. Senator tester. Thank you, mr. Chairman. Im glad i stuck around for marcos questions because the fact is i think hes absolutely right on the premium cigars. I would tell you on the other side there are companies that are marketing their Tobacco Products to kids and hopefully you can do something about that too because its ridiculous. It smells bad. You dont need to comment on that. I just hope you would pursue that. Would you agree that expediting the review of high need 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 we Just Announced were going to be prioritizing the review of drugs that dont face any competition. Theres about 180 generic drugs right now or drugs that are off patent. The chairman talked about a thousand vacancies. Cbo has estimated if were going to do this it could be as many as 500 additional employees over the next five years. I think its the right thing to do, i think its an important thing to do. But how under this budget are you going to be able to accomplish that . Well, look, as the chairman noted, i wasnt involved in the formulation of the budget. No. Right. I got it. I would have to obviously make it work if the budget were passed as it was proposed. These are challenging budgetary times and were going to have to figure out ways to do more with less. Weve tried to target the cuts that this budget does distribute. This budgets an overall increase, but there will be certain cuts distributed under the budget because of the way the moneys allocated with the emphasis towards the user fees. Well have to try and were trying to allocate reductions to places of lower priority, but in an agency where theres an Important Mission and a lot of what we do is important, sometimes its challenging to find those areas. Weve tried to do the best we can to identify them. I think this is really important. I think as many of the people on this committee talked about Prescription Drugs is a huge driver in health care costs. Theyre huge. We need to make sure theyre safe. But the backlog whether its with generics or orphan drugs as you talked about in your Opening Statement is critically important. And i love to do more with less, but we got to do a lot more with a third less. And i just dont see how that works. You dont have to justify this because ive heard the more with less on a lot of different from a lot of different folks. But the truth is in the end if were going to be able to hold you accountable and you come back in and you say i didnt have the manpower to do it, thats our job to make sure you have the manpower you do it and your recommendations are really important when it comes to manpower. And i get it theres priorities in every agency so i would hope you would be honest with us and say, you know what, this is a big issue. Because i think the generic drug thing is a huge issue. And to get these high need generics out, i think, is something we should all try to achieve. But we also need to be realistic on the manpower and budget it takes because its important. Well, senator, as youre trying to think through what you think of the appropriate allocations to help support the agencys mission, you can rest assured id be happy to work with you and provide you any advice you need. Not only me but this entire subcommittee on your budget. I would love to get your recommendations because like you said i think this is an incredible driver in health care and we need to figure out ways to reduce costs. I think generics have been one of the bright lights over the last 15, 20 years, however theyve been around. And so when we see hedge fund folks buying up Prescription Drug companies, doing kind of things senator collins talked about, we got to figure out ways to block that whether its your agency or some other agency. Right. And were also going to contemplate this very issue in authorization before congress right now. Thank you. And i want to talk about importation of Prescription Drugs. You know, theres been all sorts of efforts over the last 20 years that i know of from montana hauling bus loads of folks up into canada buying Prescription Drugs, theres been bills put forth here for reimportation, some good, some not so good. Do you think americans should be allowed to import drugs from other countries . Well, this question has been put to fda commissioners across both republican and democratic administrations, and theres a certification its currently legal to have drug reimportation as long as the secretary of health and Human Services can certify the safety of the drugs that are coming in. That legislations existed through both republican and democratic administrations. I have not taken a fresh look at this question. I havent been asked to. Im happy to look at it, but i would remind the committee that fda commissioners dating back to when i was last at the agency about 15 years ago havent been able to make that certification. Yeah, havent been able to make the certification of safety, of it being a safe product reimported . Of the ability to put in place the proper regulatory architecture that if you have reimportation of drugs to make sure that the chain of custody can be guaranteed that youre actually getting a drug that was manufactured by the legitimate got ya. Thats a legitimate concern. I think theres also a legitimate concern of americans being gouged for their Prescription Drugs. Almost to the point where i think we may be subsidizing other countries for their cheaper Prescription Drugs. I dont know that to be a fact, but the truth is when i go into montana and i think the same could be said for north dakota, oregon, we hear about this issue a lot. And im trying to take steps to address it, senator. As you know, through what were doing to try to bring more competition on to the market i think youre absolutely right. I dont think its a debatable proposition. We are subsidizing drugs for other countries through the high prices we pay here to support the research and development. And we need to address that too. Okay. Im not the trade representative, obviously, but im trying to do all i can within the context of my agency. Thank you for your answers. Thank you, mr. Chairman, for allowing me to go over time. Absolutely, senator. We have votes that have been called and so at this point we are going to adjourn the hearing. I do want to thank you, dr. Gottlieb, for being here today. Appreciate not only you being here but your good work. And for members of the committee any questions you want to submit for the hearing record should be submitted to staff within one week tuesday june 27th and we would appreciate it if we could have a response back from you, doctor, within four weeks from that point. Again, i want to thank everyone for coming today, most of all the commissioner. And, again, we look forward to working with you. Thank you. We are adjourned. The National GovernorsAssociation Summer meeting starts today. And live coverage begins at 4 00 p. M. Eastern on cspan3 with governors on the front line of the Opioid Epidemic dealing with prevention, treatment and recovery, friday live at 9 45 a. M. Eastern on cspan 2 governors look at Cyber Threats facing our country with opening speaker Vice President mike pence and keynote speak erica new years day yan Prime Minister justin trudeau. And Live Saturday on cspan starting at 9 30 a. M. Eastern, governors talk about computer coding and the importance of Computer Science in schools with girls who code ceo, former microsoft ceo steve ballmer, and Tesla Ceo Elon musk who will speak at the governors closing session. Watch the National GovernorsAssociation Summer meeting live on the cspan networks, cspan. Org and listen live on the free cspan radio app. Sunday on q a. In a country with absolute monarchy, speaking up about the distribution of wealth, about the corruption could get you in jail, could get you arrested, could get you in so much trouble. Saudi arabian womens rights activist manal alsharif talks about her time in prison in her book daring to drive, a saudi womans awakening. Never see a woman driving in the street in a huge country the size of three texas, you can put three texas inside saudi arabia. And women cant drive. We want to change this by this movement. And the movement is going on, it never stopped. Were still campaigning for the right to drive. For us the right to drive is more act of civil obedience because women are not supposed to drive. We show that we are able, we are capable of driving our own life and being in the drivers seat of our own destiny by doing this act of civil disobedience. Sunday night at 8 00 eastern on cspans q a. Vice admiral thomas moore, commander of the Naval Sea Systems Command talked about the navys plans for maintenance and new Ship Construction to work toward the goal of a fleet of 355 active ships by the year 2045. He spoke at the center for strategic and international studies. His remarks are about an hour 20 minutes. All right, well, were going to get started. Good morning, everyone. Im tom carico, im a senior fellow here in the International Security system here at cis. Im delighted to kick off this mornings Maritime Security dialogue with vice admiral moore. The Maritime Security dialogue represents a cohosted series between csis and the u. S. Naval institution or usni. And it seeks to highlight both current thinking and future challenges facing the navy, the marine corps and the coast guard. Today