Resume the testimony beginning with dr. Gotly. We wanted to hear dr. Gotly and then we will proceed to questions. Theres one more vote and senator kz leave and come back. So welcome. Thank you, chairman alexa alexander, Ranking Member murray, thank you for the opportunity to testify before the committee on issues related to the opioid addiction devastating American Families and our culture. This crisis has gotten so large and pervasive that it was beyond the scope to make a meaningful impact. Its only in partnership that were going to slowly reverse the trend and help move more people towards a life of sobriety. It has now spread so wide and so deep that we need acknowledge its not going to be reversed fda has engaged in efforts across multiple fruntsz to do its part to more forcefully confront the crisis. And were looking for ways to work with public and private partners. When it came to our role in combatting addiction, i inherited policies already in process. But weve set out in new directions in recent months and i want to briefly frame for you how were going to approach this challenge going forward. Im focussed on three domains of activity. First, how do we reduce the rate of addiction by reducing overall exposu exposure. We know most people will be medically addicted. Their first exposure will be through a legitimate prescription. For many that will be for an Immediate Release formulation of these drugs. And when they receive a prescription, arts for a duration of use to address their condition. To address these goals weve taken a number of recent steps and pursuing additional actions in coming months. Were providing Immediate Release opioid drugs and provide all providers. And were actively providing new step steps and limit dispensing. Last week our formed committee. The second domain of activity that were focussed on relates to new Product Innovation that can render current products less prone to abuse or see them replaced entirely by nonaddictive pain treatments. Among the steps woo s weve tak towards the second set of goals, they support a transition dominated by conventional opioids. Where they have meaningful deterrent properties. Theyre harder to manipulate in ways that make them attractive for abusz. Separately also working to and will soon issue final guidance on these drugs. At the same time were working on improving the path and nontreatment alternatives. To more efficiently advance these drugs, theyve been using break through therapy designations to facilitate products intended to treat serious unmet medical needs. The work also includes consideration of nondrug alternatives for pain such as medical devices. We plan to have more to say on this in a little bit. To address these issues related to approval, theyre participating in Public Private partnership. When it comes to the development of better medical therapy, were currently developing a policy that we believe will promote the development for opioid addiction and exploring ideas to help their broader adoption. For the treatment of addiction is a top priority. These are just some of the domains in which were actively addressing the crisis. Its clear no loan agency, no single set of policies and certainly no single action is going to meaningfully change our bleak trajectory. The scope of the crisis is just too large. And why im grateful to this committee for convening the discussion today. Thanks a lot. Thanck you, dr. Gotly. Well now begin five minute rounds of questions. Thank you, mr. Chairman. Very important hearing. I do apologize i wasnt hear to hear the testimony from the first group here. But thank you for the contributions in this area. As my colleagues know, alaskas pretty rural, in fact so rural its bush. 80 of our communities are not accessible by roads. So much comes in by mail. When we think about the drugs that impact our communities and i want to ask about drugs that come in over the internet. But the first question was raised in a meeting i was just in this week and it was as it related to the medical assisted treatment and how these are administered, whether its subox own or others. Its our understanding the prescribing provider is required to be physically in a room with a patient. In far too many of our rural communities, we dont have that provider. We do so much of the care by distance delivery. Youve got a health aid that is administering but the it question that was raised with me is whether or not there is any kind of an exemption, option or waver option under the ryan, hate act that would allow providers to prescribe subox own to telemedicine. In highly rural communities, bush communities. Is there a way we can use these technologies to help in the event of an emergency. Do you have anything you can offer me . Heres what i would say about that. While i dont have the ryan hate act at my finger tips, i believe that what it requires is a valid physicianpatient relationship and thats generally charactered by at least one visit. Face to face where there is an examination thats done, a diagnoses that is made and a treatment plan that is then follows. But afterwards telemedicine will be used. Whether we can have in a telehealth kind of setting, a provider who has done those things and can work with a waver and provider who might be in a distant place. So those are the kinds of details that, to my knowledge, have not yet been worked out. But theres already precedent for telehealth where a provider is distant and can work with another practitioner who is actually seeing the patient in a community. So that model exists. What doesnt exist can and isnt well defined yet is the issue of controlled substance prescribing. So we can work with dea on that. Well, it is something id like to explore with whom ever is willing to work with us. Because i look at this as an issue. We do some pretty extraordinary things with telehealth and how we dispense the controlled substances in a tightly regulated controlled way. And we think that weve got the tools in place but we do need to have some level of exemption or waver option out there. So id really like to work with you. Dr. Collins. If i may i think this is another wonderful example of how our efforts to help those seeking treatment for addiction need have broader range of options than what currently is possible. But we need to make sure theyre evidence based. What ultimately one would like to have is a sort of Precision Medicine approach to helping people addicted so you find the right treatment at the right situation with the right kind of psycho social support and the right mat that works for that person and obviously the answer to that is going to be very different for somebody in the bush in alaska verses somebody in an urban center. Theyre very much interested in trying to contribute to those other aupgds options and i thie raised an important issue we should look at closely. I do have a question about drugs over the internet but ill wait for the second round. Thank you. Well, thank you, mr. Chairman. I want to thank you and Ranking Member murray for holding this hearing. I want to thank all the witnesses hear today because i know how hard youre working on this issue. The Opioid Epidemic is absolutely devastating my state of new hampshire. And its not something were going to fix overnight. We didnt get here overnight. One of the things we have to continue to focus on is that addiction is a chronic disease and we need to realize the longterm nature of it because the reality is that part of this disease is relapse. The disease is multifaceted and its often made worse by the underlying trauma and Mental Health disorders and on top of that is complicated medical diseases, like ones spread by injection drug use. I was on the phone with a friend of mine who lost her 34yearold son about a week ago. Were not sure yet whether it was an over dose or a heart event, a cardiac event related to Substance Use disorder, but this is the type of ongoing issue, along with longterm societal issues. We have grandparents who are raising their grandchildren. We are in this for the long haul. And one of the things i want to emphasize is while i appreciate greatly what the four of you are doing, the trump administrations interest in repealing Medicaid Expansion which has been the critical number one tool in my state for getting treatment to people and its proposed budget really would undermine our efforts to combat this epidemic in our states. So i hope that kwhiwhile youre doing this work, we hope the budget and interest in repealing Medicaid Expansion really poses difficulties for those people on the ground trying to get treatment to people who are suffering with this do d zeez. I appreciate very much the work yourv rr been doing. When you were last here before this committee you agreed there was an outstanding and whether its conveying the right message to providers and patients and i was glad to hear you speak about it just now. Senator young and i sponsored the opioid addiction Transparency Act recently signed into law and intended to make sure that health care doctors, and intern patients are provided with information about the limitations in patient care implications. So now that the legislations been signed into law and has given you the authorization, what steps has the fda taken to use the authority provided by the opioid addiction Transparency Act . Thank you for the question, senator. We set out, probably about three weeks ago four weeks ago to undertake a formal study of the nomenclature that we use and the lexicon we use and you and i have had had the opportunity to talk about this. To make sure were not conveying to providers and patients that a drug that has abuse deterrent features is less prone to addiction. The abuse deterrent make them less prone to manipulation. But they still can cause addiction. And so were looking at this scientifically and we should have that information back in a reasonable time frame and id be happy to come in i would just urge you. We are now giving you all tools to get information out there and these drugs were approved without a full understanding of this potential impact and i think the more quickly you can move, the better off we will be, even as youre gathering data. I firmly agree but we will move quickly. Thank you. And dr. Mccannkatz. I will say like my colleague whos not in this committee but leading the charge on this, idea ive got real concerns about the formula for 2017 because it didnt provide adequate resources to new hampshire, a state with one of the highest per capita death rates in the nation but only eligible for 3 million of the 5 million available in the formula used. In addition, addiction is chronic addiction. So we need long term invests to address the crasis. But aside from the cures money there are other federal resources we need to strengthen and was described in your testimony, the Substance Abuse prevention block grant is fundamental but it hasnt kept up with inflation in terms of dollars. So because i see that im running out of time, ill just ask you if you can briefly speak to what theyre rir briefly spe theyre trying to do in the need of such services. Thank you, senator. It allows flexibility to the states to use the block ground for Substance Abuse prevention and treatment. They present us plans. Provides us Technical Assistance and allow them to implement as they wish to do in their communities. Every state is different. S samsa also works with the states in terms of pretty extensive ways of helping them to look at how they can best provide care, these funds in block grants are funds of last resort for those in medicaid. Stick with the five minutes. Ill wait until the second round and followup. Thank you, senator hassan. I believe senator young is next. I will go vote. I have a lot to cover and i will go quickly. I will begin with dr. Mccancekatz. A small number of people were catapulted into the spotlight two years ago. We had many diagnosed with hepatitis c primarily due to drug use. What role do you think the federal government should play for people with opioid abuse disorders linked to screening and treatment of hepc and hiv . And more narrowly, what do you think they should do to keep people who inject drugs from landing in jails and further add to the hepc crisis in those facilities. We do focus on integrated care, both bringing primary care into our Community BehavioralHealth Treatment programs and healthcare into primary care. So we know advise people should be screened and supported a program called screening, brief intervention and referral to treatment for years now. Weve done a pretty good job getting that established nationwide. Bringing those resources together we can identify early on their needs for care and get them to the appropriation intervention. Your thoughts about local jails at the federal level. I understand there may be jurisdictional issues i would characterize as a crisis. Addiction is not a crime and we have programs across the nation to work towards drug courts to work to divert people from the jail system we treat and we continue to support those and congress has been very helpful to us allowing us to do that. Thank you. I will address all these questions to each of you and give you an opportunity to respond. Dr. Gotley, id like to move to you. To encourage the treatment option nonopioid alternatives, you committed to using all the agencys authorities including fast track. During your confirmation hearings you and i discussed the imbalance of those programs across the various review divisions of the fda. What sort of progress in your short term have you been able to make sure the fda is using all the tools available to them . Thank you for your question with respect to the work janet wilcox is doing with respect to the office of new drugs and structural changes shes implementing i think we have brought more uniform policies to expedite programs across different therapeutic areas and moving in directions you and i discussed. With respect to this drug equally there have been drugs that have been granted fast track status and no publicly admitted drugs that have break through status of drugs. I will ask this question and ask one of you to pipe up if you feel impelled to do so. If not, ill call on one of you. Relates to translating medical research to medical practice. I found out years ago it takes an average of 17 years to reach clinical practice. Hoosiers dont have 17 years to wait for best practices to be implemented fighting implementing of addiction. How are you working together . Working with medical associations . Maybe you could speak to that to make sure the best practices are translated into clinical practice and what can be done if anything by your agencies or congress to speed up this research to practice pipeline ill call it. We do work collaboratively with nih. One of the real advantages to having an assistant secretary as the head of samsa is we are already talking about the kind of collaborations to help assem min nate the best practices and i think Something Else needs to be done, that is you have to bring the right people together that have the right kind of skills. By that i mean you have to bring People Experts in various treatment of disorders, addiction and opioid use disorder and our state officials, because those are the people making decisions about how practice is done in the various states and jurisdictions. When we bring these folks together we should be better able to disseminate practices. Thank you. I know im over time. As i travel around my state its pretty clear to me know one is certain what treatments and strategies have been rigorously tested and evaluated and which ones are best. I want to thank you and the ones voting for holding this important hearing on a set of issues that touch every corner of communities. Last year, there were 442 deaths in colorado related to opioid overdoses. That includes overdoses from prescription opioid and heroin and synthetic fentanyl more than quadruple in 1999. Were trying to bring the clock back in prevention and we have a lot more to do. Dr. Gottlieb, thank you for coming to colorado. Youre able to see some emergency work when you visited in august. Im grateful you came to colorado and i want to thank all the witnesses here today for your work. I also want to talk about jails throughout colorado have been overwhelmed by the influx of people suffering with opioid addiction. Recently in fremont county, colorado, a rural part of our state, 100 out of 115 inmates were dependent on prescription opioids or heroin. I was in another jail in colorado the sheriff took me to the cells and said, i want you to see this. I went and he opened up the door. I said, what do you want me to see . I have women in my jail. I have never had women in my jail before, two cells of people addicted to opioids. Because these folks immediately lose medicaid coverage. Counties are struggling to find Addiction Treatment and the ability to manage their care. We heard from county administrators especially Rural Counties how difficult it can be to provide this care when medicaid is immediately terminated and they have to stretch their budget somehow to meet this need. Dr. Mccancekatz, i wonder if you oversee the administration to close the gaps in care, not specifically for these settings, jails, i wonder what we can do to help states manage this population of patients simply locked out of access and treatment . So, absolutely. Its a huge issue that people lose their medicaid as soon as they go into any kind of incarceration. We do have programs at samsa, where we divert people through drug courts into treatment rather than jail. We also have offender reentry programs. We dont have a lot of funding for that right now. We do have those programs going on in various parts of the country and try too promulgate best practices from those programs. There also is a large movement within the correctional system, where people are being opioid addicted and started on treatments and hooked up to treatment as theyre leaving the jail or prison. That is a program i hope to see going forward. Do you think it makes any sense to cut off medicaid when you have so many people addicted to opioid . Does that make sense to cut off their access to treatment and funds . Senator, i would say that is a decision that needs to be made at the level of congress and the president and