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 discuss