Transcripts For CSPAN3 Senate Health Panel On Opioid Crisis Part 2 20171006

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 Behavioral Health 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 within hhss, we will do whatever congress and the president agree upon. Is there anybody in this panel that thinks a jail cell is a preferred place for treatment for opioid addiction . It absolutely is not the place to do treatment for opioid addiction. I certainly agree addiction is not a crime. It would be worth mentioning we have an opportunity with those who ended up in these difficult circumstances that once they have become opioid free during the course of their time in jail theres an opportunity to help them maintain that state by injectable drug which currently lasts about a month. We have done studies to look and see what the success rate is in terms of keeping people from slipping back into addiction and its substantially better than other alternatives. One of the things were working on as a partner is an injectable that lasts up to six months and keep them going in terms of somebody reentering the workplace and finding themselves in a better path. A month is good and six months is better. I understand. I thank you for that. Thank you. Senator. Madam chairman, you like hearing those words, right, again . [ laughter ] this morning headlined in the largest newspaper in the state of maine says this. Portland officials deliver leaked reports on Opioid Crisis. Its getting worse. And this headline disturbed me greatly because i feel theres been so much focus on the opioid problem, the epidemic that is tearing apart our communities and costing the lives of so many. We had legislation, weve increased funding, we recognize that you have to focus on education and prevention, Law Enforcement, treatment and recovery, and yet we seem not to be making the kind of progress that we need to make. Already, for the First Six Months in the state of maine, 185 people died from overdose. That means that that number remains stable, were going to have a very similar death rate, 376 deaths, that we did last year. The cdc has put out my favorite chart, which shows that forevery one overdosed death we have an enormous problem underneath. So my question to each of you is what more do we need to do . Why are the efforts that everybody is making and working so hard not working . Ill briefly comment, senator, i appreciate the question. One of the places where fda can have an outside impact and we all have different roles to play, trying to reduce the rate of new addiction by trying to decrease the overall exposure to opioids. It comes down to math. A certain percentage of patients exposed to opioids will become addicted and the key is to reduce exposure. We will do that by changing prescribing among physicians. Most people become addicted become medically addicted and a drug like percocet and then low cost alternatives, which is street drugs. We have taken steps in recent months to increase provider interjection. Weve been looking at dispensing and were asking what we can do with respect to mandatory education. The key for us is to try to reduce overall exposure. I think youre absolutely right that we have to put more effort at the front end of this problem, and reduce access by changing prescribing habits, particularly by allowing partial cells, by allowing physicians, by training physicians, that they should only give 10 pills, not 50, that sort of thing. Dr. Collins, do you have anything to add . Totally agree with what my colleague, scott, just said. I also want to say we really need to push them into the space of having alternatives to opioids of those people with chronic pain. We cant leave them hanging with nothing to help them. What may have right now is where opioids are not the right treatment. Putting our foot on the accelerator and working with the industry in an unprecedented way to try to cut in half the time it takes to prevent the next generation of highly addictive is something that needs to be happen. We are spending 100,000 a year on abuse and we think it needs to be greatly increased and we can then speed up this process looking for better alternatives. I would add washington is one of the states that really integrated their modeling programs with their er records. Theyve seen a lot of proactive reporting. Were preventing those people on that pyramid from getting addicted. Its identified, people are taking high dose morphine doses and sending alerts to physicians to intervene and tapering that patient off. We just started in maine, Surveillance Drones that we use in bioterrorism and we look at new trends and that is how many of those on this panel did to prevent community outbreaks. We picked up five in georgia for the fake percocet pills and now we know where to intervene more quickly. Dr. Mccancekatz. I agree with everything my colleagues said. We still do not have access to evidencebased treatment for people who need it. As long as that situation occurs, we will continue to have the terrible kinds of tragedies that are the opiate epidemic. We need more speciality care an integration of treatment into primary care and need to use our Certified Community Behavior Health programs for treatment. We need to educate practitioners starting at the understand graduate level. Everybody, my view, should come out, being eligible, having gotten the education to get that data waiver. They need more than classroom experience. They need practical experience in the states i come from, rhode island, we had started a program where clinicians could come to our centers of excellence to get that practical experience to give them the confidence to provide that care in their communities. We need to be doing all these things. Thank you. Thank you, senator collins. Senator murray. Thank you. We know that 2 Million People or over suffer from addictions. There are safer opioid subscribing practices and assisted treatment. I hear so often and its really important to make sure everyone has access to appropriate healthcare to prevent and treat substance disorders. On that Medicaid Expansion has really been life saving for a lot of people who suffer from opioid use disorder. In my home state of washington we have 30,000 newly enrollees new accessing it because of Medicaid Expansion. Thats why its so troubling i see so often going after medicaid, i want to ask you, dr. Mccancekatz, do you think coverage for Treatment Services for Substance Use disorders including medicaid is important to combat the Opioid Crisis . Yeah. I do. I think thats really important. A short statement and really important. I hear it from everyone. Thank you. The president s proposal to cut samhsas budget, im sure you know that. How would those cuts affect your ability for this crisis . We would have to when ever we get the appropriation we would have to look at it and determine what programs would no longer be able to be implemented as a result. We look to congress and the president to come to an agreement that will allow us to continue our programs. I think this is important and ive been working to increase it and hope we get support for that. I want to ask all of you. You know we worked hard to provide the 21st century cures act providing a billion dollars for states to respond to this crisis. I was really pleased my state, Washington State, has used their part of this funding to partner with Washington State university to analyze evidencebased practices to use misuse and abuse of Prescription Drugs. Can each one of you speak about how your agencies are currently using evidencebased practices for prevention and treatment and importance of the federal government in evidencebased policies . Samhsa has a number of programs that address prevention and treatment. Our block grants include a 20 set aside for prevention. We work with experts in the field and the states to provide them information and dissemination of best practices as well as evidencebased treatment of Substance Use disorders. I think your point is a very important one about use. We learned from our National Survey on drug use this year that theyre struggling with Substance Abuse, including alcohol, by the way, very troubling, also with increases in depression and suicidality. One of the things i have done since starting at samsung, we have put together a project that will bring experts together to better inform how to address Mental Health issues and substance issues in transitional use. Thank you. One of the things were doing working through the heroin response strategy. On the ground with a lot of high intensity Drug Trafficking areas, on the ground with Public Safety helping them develop Public Health intervention, things like academic detailing to where if theres a high prescribing area, you send somebody to counsel the prescriptions and if theres an overdose the person is linked to services looking for ways to integrate primary care practices and prevention efforts along with Public Safety. The second thing, using the best evidence, like our chronic pain guideline and making sure the family can translate it into tools for providers like we have a mobile app now downloaded 17,000 times that providers can use the best Available Research to integrate into their practice. Dr. Collins. Very quickly. Nih is in the business of generating the evidence. Theres a lot we still need to know. Very critical. We do not know the appropriation accreditation to allow people to remain free of opioids, a lot longer than the programs currently offered. We need to know more about drug approaches to treating pain needed. We started an 81 Million Program with the v. A. And department of defense to look at this in terms of returning veterans and figure out what other kinds of things, such as a transcranial magnetic stimulation, acupuncture and so on, might turn out to be quite effective in this space and keep people from getting into this terrible downward spiral. Negative 15 seconds, i will mention three things were looking at. Evaluating the prescribing guidelines, treatments and medically assisted therapy and guidelines among other things that might need to be done in perpetuity. Changing the duration of use, were currently reevaluating the guidance we give to Drug Developers around the development of mat we will be issuing soon sometime i wont say soon within the next year updated guidance in the development of mat. Were also looking at steps we can take and taking active steps to bring it over the counter and also what information we can prescribe around the coadministration of that with opioids. Thank you all very much. Thank you, senator murray. Senator cassie. I thank you all. First, i want to address a couple comments senator murray made, addressing the effort to do something about obamacare as cut resources for nonexpansion states, billions more. Senator in wisconsin will have billions if not more for those who would otherwise not have and you can say that for every single expansion state and those held harmless and given the ability to move resources where they can be used. Folks who shake their head no havent read the bill. I say that not to be rude but to point it out. Panel, thank you for your work. Dr. Katz, i understand when i speak topraktioners of treatment programs there is great variability in outcomes. Some do it very well, some do it not so well. A cynic would say some do it for profit but not for the patients benefit. You nod your head gently yes. Thats what i get when ever i speak. Is there a way to monitor the Outcomes Data associated with these different treatment programs to see which are doing it well and which not . I understand samhsa has client data. Can this be put into treatment assessment and if not, why not . The Treatment Episode data seth is a data seset are the facilities they enter their data and states can get information on those facilities. That is possible to do. If there is any confusion about it, we are ready and able to help with doing that. You say states could do that. Im told some of the Insurance Companies, some mentioned united. I dont know if it is united, does a very good job finding out, based on Outcomes Data which are doing well and which is not. Were spending lots of money on this. As a guy who wants to see these patients treated, i know without Outcomes Data we may not be doing what we should be doing with scarce federal taxpayer resources. Why isnt it automatic, if a state is applying for a grant, you have to show you are monitoring Outcomes Data for treatment programs and those doing well expanded, those not so well corrected . Im asking that. What i would say is that with the 21st century cares act, we are starting to work with the states on exactly those kinds of issues and we will be asking them to look at those kinds of data. They should be able to do it with things like teds. As far as the Insurance Data goes, this is something i could look at with my staff to find out whether theres a way we can access that data through agreement. After hurricane katrina, the people that were aggregating all this script data, suddenly the doctor in oklahoma could access the records of the people in louisiana. It was opened up. Now, i guess what im asking, maybe dr. Howery for you, is there any kind of does dea or you have access to prescription data clearinghouses . Its my experience there are certain physicians high intensity prescribers. Dr. Gottlieb mentioned its just math. If somebody is writing higher scripts there will be more people addicted. Seem likes you can figure out whether its a pain doctor or fp moving through states with a pill mill. Do we have access to that and if not what do we need to give you access to that . Each state owns their own Prescription Drug monitoring program. One of the things weve been doing is working with states to allow them to identify prescribers and working with medical boards. Its drif ant the state. I thought this was dea function . It can be owned by a board of health, board of pharmacy and Law Enforcement. It varies who its owned by. They issued letters of the top 5 of prescribers under medicare. Different ways to do it under the federal level and usually at the state level. When i write about controlled substances and you had my dea number and you knew it was me and knew my practices looking in the phonebook. I talk to drug detail folks, they say, you know who the pill mill is. You go in and somebody writing a 500 check for a five minute visit and walking out with a big prescription pad opposed to a pain doctor who really does it right and you have a waiting room full of patients waiting to be seen. The drug detail person knows it. How come were having such a hard time figuring it out . Dea monitors it for elicit use. On our website we list by county prescribing rate, anybody can go in and see where are the highest prescribing counties and state Health Department can see where we have the highest prescriber. Im over, negative 15. We have this data. We should be having those pill mill docs. I think it varies on the state. Rhode island was one of the ones doing academic detailing and new york state as well identifying the high prescribers and sending them letters on going over evidencebased practices. Senator murphy. Thank you very much. Thank you for being here. Let me note that dr. Mccancekatz is our First Assistant secretary for Mental Health and Substance Abuse. This committee in a bipartisan way passed the reforms act and created the position and were all very excited to support dr. Mccancekatz for that position. Its kind of wild we did not have someone at hhss who was at the top level focuses on this abuse. Shes from rhode island. Shes from rhode island. Thank you all for being here. Let me maybe pose this question to dr. Gottlieb and dr. Houry. What the data tells us with regard to prescription patterns. For years, pain medication description were going up and up and up and from what ive seen over the last few years we finally bent the curve downwards. Samhsa has a document out that suggesting the actual number of pills being prescribed may not be heading in the right direction as fast. Overall, number of prescriptions going down. As you all noted, the epidemic continues to get worse. I think a lot of us have hung our hat on this idea that if you get ahold of the overprescription, that you will make a big impact ultimately on the number of overdoses and addictions. That doesnt seem to be the case. A, what does the data tell us about how were doing on the overprescription of medications and why is this heading in the wrong direction if were finally getting a handle on pain meds . What i would say is we are starting to go in the right direction. The amounts of opioids prescribed has gone down 10, 15 . You look where we are compared to 1999, we are still three times what we were. The slope is going down but still tremendous progress that needs to be made. The second thing is i have a paper coming out next week that looks at how theres not a huge increase in the number of people injecting drugs. Were seeing the fentanyl on the streets is very potent and thats driving a lot of these fatalities is the potency of the drugs and people are continuing to get addicted to opioid is in the first place and moving on to fentanyl and heroin and moving to something deadlier. I would agree with everything i said. The scripts are a lagging indicator of the impact because people have become addicted and now moving on to a low cost alternative, the street drugs increasingly laced with fentanyl and other things that can cause great harm. Im reluctant, quite frankly, senator, to draw firm conclusions from the data points we have. Its encouraging scripts are declining. We need sustained data points to conclude we started impact prescribing patterns. Dr. Collins, what are the additional avenues for research on Pain Management . Drugs are not the only way to manage pain yet Insurance Companies seem to drive payment towards prescriptions rather than other methods that maybe in the short term more expensive but in the long term may keep you off these dangerous drugs. What are the additional avenues we need to do to help give doctors and potentially Insurance Companies different ways to manage pain other than the drug. Thats a great question. I think the pain clinics we used to have 20 years ago were multimo dahlty efforts to try to provide opportunities for people with chronic significant pain ways to manage their pain gave much better opportunity than something other than opioid prescription. Those are harder to find now and because they werent particularly well compensated for doctors trying to figure out the optimum approach and spend ac lot of time with the patients. There are alternatives. Cognitive behavioral therapy. I chiropractors do in fact provide benefit to people with low back pain. Weve seen that. The opportunity to use such things as acupuncture. Certainly, transcranial magnetic stimulation, the ability to do various local kinds of nerve blocks for somebody who has a very localized form of pain. All of those do in fact have evidence behind them. There are relatively few practitioners who have that full array of options available to them. All too often it is write the opioid prescription and send patients out again. I would note that is in part because of the problem you identified, insurance reimbursement and insurers are not willing to reimburse for the scope of services or bring providers in. It speaks to the way that risk allocation simply does not work for this population because if you dont keep someone off of this pathway to addiction, you may not as the insurer bear the responsibility because the cost to the individual is so catastrophic, they are likely to come off your Insurance Plan because they end up in jail or homeless or end up out of work. We have to have a conversation about how you structure risk allocation here to promote insurers to pay for the stuff that actually keeps you off that pain medication pathway. Thank you. Senator murphy and senator kaine. Thanks and thanks to the witnesses in virginia in 2016s. 1460 people died of overdoses, a 38 increase over the Previous Year even while everybody was paying attention to it we had a governors Emergency Task force paying attention to it. 80 of the deaths were opioids and a significant reason for the increases, the increased presence of fentanyl, more potent opioids killing people. Youre our pros. I want to ask you a big picture question. When john f. Kennedy was president , he said we will put a man on the moon by the end of the decade. That was a bold audacious, a lot of people thought it wasnt possible but we organized an awful lot of efforts around it and we not only put a man on the moon, what we did to organize efforts produced other kinds of great scientists and mathematicians, even tang orange drink, which i still enjoy. I was with a group of Technology Leaders recently and in asked them, what should we be saying we want to do by 2030. You might imagine technologists said low carbon energy, cure for cancer and somebody said we should set the goal for being addictionfree by 2030. Thats not what i expected a technologist to tell me. I was interested and struck by that. I want to ask you first, you should set a bold and audacious goal at the very edge of human ability to reach but reachable, not one that is laughable. Would setting such a goal, addictionfree by 2030 be doable but incredibly difficult or is it beyond our capacity not doable and hence not worth making. I will start. Dr. Collins, i knew you would start. I love bold and audacious ideas. That served us well not just going to the moon, the genome project and cancer moon shot and other things. I think represented by the folks at this table and many others is just what is needed. Lets be bold about it. Certainly from nihs perspective, there are things we are thinking about although they are hard to imagine without a lot of resources. To come up in short time better alternatives to medication assisted treatment, better antidotes for those who have fentanyl in their system where the narcan does not have the potency needed. But to develop the new generation of highly potent pain medicines we have good drug targets lined up but years away from bringing those to the clinic, even with lots of help from the fda and spreading that regulatory process. We need to put the foot on the accelerator and hundreds of millions of dollars of whats going into it. It would be great if we could set up right now a few demonstration projects, two or three states put forward to see could we actually, if we had all hands on deck, both in terms of treatment and research, put the whole enterprise together in one coordinated way and see what we could achieve in terms of really changing the landscape how we prevent and treat this. Senator, you talked about an addictionfree society. I fear people always find things to abuse. I think we can solve this problem. Its going to take a lot. I think first and foremost and dr. Collins talked about finding nonaddictive alternatives for the treatment of pain. I think we also have to sharply change prescribing patterns so a whole generation of prescriptions, my generation taught to treat pain very differently than the generation before me and the generation in school right now and will take a while to reeducate us. The final thing i say, we havent focused today, we need to do much more to enforce at the border and look inside the International Mail facilities how were pulling packages and examining them to keep dangerous drugs in this country. I visited imf in new york and the thin blue line is very tenuous, the facilities work very hard but this is simply a matter of resources. I think we need to take a look at that. Senator, what i want to say is i dont know we can eliminate addiction by 2030 but i do think we can remove the stigma and make it just like any other disorder or disease so people can get the care that they need. We need to do that very quickly. We can term do it by 2030. I agree. We need a balance, treatment with prevention. Absolutely, what we need to do is treat the millions addicted. You look at the pipeline, 92 million u. S. Adults that took a prescription for opioids in the last year, im worried about that 3 that will go on to get addicted. How do i prevent them . Two months ago when i was in the er, i saw a woman who overdosed and passed away. I looked through her record and saw she had so many visits in the emergency room and years prior. If we could have prevented it along the way we would have prevented that addiction and ultimately prevented her demise. Thats the value of prevention by 2030 is preventing people from getting addicted in the first place. Thank you, senator kaine. Id like to ask the panels help with a couple of things as we go forward. Weve talked about Prescription Drug monitoring programs. The pdmps. The program that has long existed with them has been a lack of integration between states, a mishmash of different reporting requirements and a poor or fraught relationship with Law Enforcement. We got some additional money for grants to support improvements in the pdmps. Doj will uprate that but i do think they will be looking for interagency support on all of that. I hope you will support pdmp grants that do a better job of crossing state lines. It is rules for somebody to go from win socket to adeleboro and not have it picked up. We just went at the state legislative level with Law Enforcement. There had been such weak policy work at the federal level to sort out what makes sense for Law Enforcement to have and what maybe doesnt make sense for Law Enforcement to have. I hope those two areas will be a focus for you as you are consulted and deal with pdmps. The second has to do with the next half billion in cures act money. I hope that all of your agencies will vigorously support making sure that gets into the december funding bill. We shouldnt have to wait around for that. I hope you will also support efforts here to in the terms and conditions for the grants, that the 500 million will flow out into, try to encourage alignment with the goals of cara, set a big bipartisan signal with that. Doesnt have to be a hard stop but it ought to be part of the by which grant applications are measured. Another one would be a higher focus on the extent to which particular states have been impacted by the problem. Were going to try to make sure that that gets into the funding measure. But i really think those are important considerations. I hope well have your support on those as we lobby for them towards the december spending. The last thing, this will be more in the nature of a question, you can have all kinds of medically assisted treatment, you can have all kinds of experts properly trained. But if people dont have access to the treatment it really doesnt matter. You have to catch them. The two places we have the greatest frustrations are emergency rooms. We just did a good program in rhode island. They actually do connect and you dont leave an emergency room if you come in for an overdose without a treatment coach, without a recovery coach. The second is people who volunteer, come in and say, im desperate, i finally need treatment. You cant tell somebody like that, sure, come back tuesday two weeks from now and well be able to see you. You might as well tell them to do i wont use the term i hope we can think of ways to catch people when theyre most amenable, either because they just had a horrible experience with an overdose and maybe had their lives saved in the er. Part of that is recovery coach and part of that is also breaking through hipaa. It is bonkers that a mom and a dad may nat know that a 22yearold or 24yearold child has been in and out of the emergency room for overdose. That is not what hipaa was intended to do. If you could give us some advice on ways we should be fixing that. I know my time is running short. Its a long thing. Feel free to make this a response for the record. We need to fix this. We cannot have people turned away at their time of openness to this who are sent back out into the street after they turned out into the er. Dr. Katz, you have rhode island experience to answer. We do have place in rhode island that put people with recovery coaches who overdose. Heres another thing we have done in rhode island we will talk to the other states about. Heres what we have learned because i worked in Rhode Island Hospital ed. When they come in and their overdose is reversed, one of the things we need to be aware of, thats often not the time theyre interested in treatment because theyre going through withdrawal and they really want to get out of the e. D. What theyre doing in rhode island is sign a consent form so our recovery coaches can contact them a few days later. We think that is going to make a big difference getting people to the care they need. Im familiar with that. I just want to see it more of a national model. Thats where samhsa comes in and we will be disseminating those models, absolutely. Thank you senator whitehouse. Senator franken. I will go to a different line of questioning. To the last question about being able to get people in the recovery when theyre at that moment. There arent the beds. We have to make sure there are. Thats another piece of this. I want to talk about my experience in my state with the nativeamerican community. The neonatal abstinence has doubled in the past four years and the nativeamerican community has been disproportionately affected and related to Substance Use during pregnancy characterized by feeding difficulties, hyper irritability, seizures, you had this in your testimony, doctor. All of these difficulties. Last year, nativeamerican babies within minnesotas program were ten times likely to be born with this syndrome than white children. For several years now we have heard a growing and urgent cry for help from clinicians and tribal leaders about the epidemic and in particular its impact on Indian Country. Thats why i asked the indian acting director how the administration could address this issue and the Opioid Epidemic in the Indian Country more broadly. He had two recommendations. First, bring tribes to the table, and second, consider community and culturally specific drug abuse prevention and treatment programs. Yesterday, i sent a letter to governor christie, chair of the president s commission on combatting this, and asking him to consider these recommendations and to specifically address how to combat this crisis in Indian Country in the final report for the president. The final report for all of you, id like to begin with dr. Katz, can you speak to what your offices are doing to address Substance Abuse disorders particularly in Indian Country. Can you describe how youre engaging with tribal communities in working to develop and implement culturally specific programs . Samhsa has a branch dedicated to issues in tribal communities. Were very well aware of the issues around the need to be culturally sensitive to nativeamerican groups and to support their ability to deliver those services that are specific to their people. Samhsa just yesterday posted a funding announcement to fund an Addiction Technology transfer center that is specific for nativeamerican people, and we will be awarding that very soon. In addition, in addition, we also have had the Behavioral Health coordinating committee for hhs has worked on a plan to identify what the needs are for mothers and infants opioid exposed and the recommendations have come forward and we are in the process now of putting together a plan to address whats in that report. That should be coming in the next few months. Some of the things we have done is worked first with the Indian Health service to have them adopt the cdc guidelines and all the the nhs clinics and have the same treatment. I went to the reservations last month and spent time with the tribes to see how best we can provide Technical Assistance to your point that is using their practices. We have a workgroup at cdc focused at American Indian tribal population so we can of much more culturally aware treatments. The other thing i would say is we participate in the outbreak association in minnesota to look at Substance Abuse issue some pregnant women were having native populations, then, we also have a program at cdc called Indian Health and wellness that has a very holistic approach using culturally informed practices. Certainly, the National Institute on drug abuse directed by nora willcof has tried to explain the differences in similarities how the opioid process has affected them with full engagement of tribal members where we learn we need to do a lot of listening and not so much talking and different ways to achieve better prevention strategies. I believe maybe as soon as next week the doctor is meeting with the chief medical officer of the Indian Health service to get engaged trying to help out with this very serious problem. Were taking steps to broaden inclusion under the mandate including culturebased criteria. We have certainly and will continue to take steps to encourage the study of treatment in the prenatal setting and particularly treatment for addiction. I will quickly point you to the solicitation put out in july or august recently for a very large study that would look at a prenatal setting and that would be an opportunity to address some issues. I wont ask another question, just bring up the connection between trauma, in the Indian Country, theres all kinds of trauma, theres historical trauma people talk about all the time which is very real but theres also the trauma of having a parent who had addiction, you know, domestic violence, just poverty. Being exposed to because of housing in Indian Country, exposed to other familys traumas, behavior that is traumatic. It will be for the record, im done, just dr. Collins, id love to see the research between not just trauma in Indian Country and addiction but trauma and addiction, because i think that sometimes in treating addiction, and this is about keeping people treating people and recovery, is addressing trauma. Thank you. Thank you, senator franken. Saturday baldwin. Thank you. I really want to thank the witnesses for all your work on this epidemic. I am concerned that as our federal response to this epidemic has evolved, so has the epidemic. Youve been testifying to that this morning, especially now with the rise of fentanyl and other synthetic highly potent opioids. In milwaukee, wisconsin, which is close to chicago, a major port of entry, they have seen 101 fentanyl related deaths this year and thats already exceeded the total number for last year. Its clear, more action is needed. Dr. Gottlieb, i wanted to start with you because fda plays an Important Role with customs and Border Protection in stopping Illegal Drugs at our border. Serious gaps remain, as more and more fentanyl is smuggled in from places like china. You recently shared that the fda will be increasing efforts to stop the elicit entry of fentanyl at International Mail facilities and we had a chance to talk about this earlier this week. Can you describe for the committee the fdas plan and tell us what additional authorities or tools you need from congress to modernize our Global Supply Chain Security to protect against this evolving threat . Thank you for the question, senator. I appreciate the opportunity to discuss this briefly with you earlier this week. We recently committed to triple the number of fda officials that we have in the ims, in the International Mail facilities, imf, in tripling it we only brought it from 8 to 22. We still have a very small footprint and have a mandate to inspect packages and do testing which were very good at to look for opioid analogs to increase our ability to come in. That will increase it four fold but still inspecting a small amount of packages carrying drugs. The system is overwhelmed with packages coming in with illegal narcotics. Were looking to what additional steps we can take in this regard to try to step up our footprint in the imf and doing our work. I recently met with the commissioner and we committed to Work Together to try to look at these issues. Theyve been very good partners to us. With respect to your question about authorities, we do have specific ideas around certain seizure authorities that could help us. Happy to talk to congress about that. A lot of our seizure authorities are based on old maritime law and sometimes hard to implement against a modern threat. Id be happy to work with you and talk about how we may improve our footprint there. Thank you. Dr. Houry, as we work to stem the tide of illegal open joyeds like heroin and fentanyl, obviously, so many of my colleagues focused on our efforts to our needs to continue to prevent. As noted it often begins with a prescription from a doctor from a broken bone to address chronic pain. And its why i strongly support the cdcs work in prescribing the safe opioid prescribing guidelines to make sure they have the most opioid tools to best care for their patients. The issues, and im reminded of the 2012 article comparing driving changes at the Cheesecake Factory to changes in recipes, et cetera, to the slow pace of making changes in medicine. He famously said in med kn good ideas take an appallingly long time to triple down. And compared the example of the Cheesecake Factory driving changes in seven weeks, whereas guidelines to reduce migraines in patients that were issued 13 years prior had only been implemented in about one third of the cases. I think a lot of people remembered that. So can you please provide me with an update on cdcs work supporting and educationing providers in implementing these guidelines . Whats working well . And what are the cdcs plan to provide new tools to educate the public about safe use . Absolutely. And we actually use the tool to develop the checklist. We have a checklist with his consultation on the guideline. And thats been downloaded i think over 10, 20,000 times at this point. But were doing a lot more than that. We also work with more than 60,000 medical schools to get the guide integrated so first and second year medical schools now understand the payment used by our guideline. Also has things like brief motivational how do you have those Difficult Conversations with patients . Weve developed six online trainings at this point for that. And then were working with different pharmacy and Insurance Companies as well. Sigma adopted a guideline a year ago, 12 reduction in usability. And cvs is implementing our guideline for their facilities. For things like acute pain were also creating some additional materials. And weve also been talking to Emergency Physicians as well around that acute pain aspect. I did not want all that work around the guideline to be a document that went nowhere. Weve worked with medical facilities, doctors, nurses, et cetera to make sure this is used. Senator warren. Thank you. About five people die every day in massachusetts from Opioid Epidemic. Now, we think were seeing the number of opioid deaths decline slightly. But we are seeing more and more Overdose Deaths that involve fentanyl. As you know its an incredibly potent synthetic opioid. Its about 100 times stronger than meth amphetamine. This Study Released last year found that epiioid related fatalities in the state of which it was impossible to conduct a toxicology screen, 70 of individuals tested positive for fentanyl. Now, it means we can now do a better job of responding to the epidemic. For example, when someone responds to an overdose involving fentanyl, it often requires multiple doses of medications in order to revive them. When we know that three out of every four Overdose Deaths in massachusetts involve fentanyl, we are better prepared when someone presents unconscious. So the question i want to ask the doctor is how does the cdc track the use of opioids so that states and communities at a local level can know more about this epidemic . So were doing it in a few ways. The first is through a National Vital statistic system. And thats where were now releasing preliminary overdose data. Because of the time that it took to release certificates and collect toxicology, but were seeing how we can get more data to states and look at these quicker. Now we have enhanced surveillance program, where were using bioterrorism techniques. Lets talk about that a little bit because it is urgent that we do this. We are now seeing drugs even more potent than fentanyl emerging. So fentanyl is 100 times more potent than morphine. But cor fentanyl is 100 times more potent than fentanyl and is now starting to show up. So the increasing role of these drugs is a powerful reason that a group of democratic colleagues got together to press the leadership for additional funding to fight the Opioid Epidemic in the last budget deal. We got additional money and some of this went directly to the cdc. Dr. Howard, can i ask you just to give a brief word about how that additional funding helped the cdc support states as they fight this epidemic, including emergent problems like the problems we have fentanyl and corafentanyl. Absolutely. We were able to get that funding to 32 states. All those states now have additional funding for toxicological testing. Wow, thats a lot out of what was a pretty modest increase, but at least we got some money in there. Im really glad to hear this. I recently conducted a survey of Addiction Treatment and Recovery Service providers in massachusetts to try to better understand whats working in their fight and the challenges they face in combating this epidemic. And the results of the survey are incredibly ininformative. But they shed light on only one piece. We need the cdcs data so we can understand and respond quickly to them. I continue to look forward to work with you. Thank you, mr. Chairman. Thank you, senator warren. And once again youre below time. Thank you for that. Let me ask a couple of questions out of senator murkowskis stage. I know she wanted a second round of questions. Dr. Collins and dr. Gottieb, you both emphasized this today is that is the nonb addictive pain medications. You said 25 million americans live with some pain every day as they would in the hospital. Is that, between 0 and 10, what degree of pain do they have . Is the the minimum or is it 3, 4, or 5, 7, 8, or 9. Its sufficient to interfere with a life on a quality basis. Those are people that have daily pain that interferes with their daily experience. Well, thats 1 out of every 12 americans the. Yes, sir. And a larger number have pain. Sure. And on a more acute basis. And you said as i mentioned in my opening statement, i think we were all struck by your testimony when we were working on the cures legislation, and it had an impact about the medical miracles that are headed our way. We sufficiently fund biomedical research, and then we move treatments and cures through the investment regulatory process fast enough to get in the hands of people. So lets take nonaddictive pain medicine. Youre taking some extraordinary steps, dr. Collins, involving funding and involving organizing researchers and companies on nonaddictive pain medicine. And dr. Gottlieb, on your side of the ledger, you have several tools, priority review, break through fast track, other tools to get whatever products are produced approved more rapidly. Is there anything else you need from us in order to move these new ideas more rapidly through the regulatory process . Well, senator, i would just touch on one other area we need to make progress and new innovation. I think congress through 21st century cures gave us the tools to do this. And thats just with respect to the kinds of Development Tools that yuszed to develop these products, design clinical trials, measure the outcomes in these settings, the kind of scales we use to receive patient outcomes, reliability. Were making investments in all those areas to make new standards on which we judge new products while still applying a very our Gold Standard for insurance and safety effectiveness. In addition to everything were talking about and doing with respect to trying to develop nonopioid and nonaddictive alternatives to current drugs, i would also point to medical device alternatives that in many cases can treat pain more locally. Sometimes treating it more localized with systemic therapy isnt the way to do that. That pipeline also looks pretty rich. I can certainly say that the opportunity to move this forward with now full engagement with industry seems like something we just have to do. At the present time with no resources, we dont have resources set aside for this, and that could certainly be something that could accelerate the pros. Were sending about we also could use some help from congress in a couple of other ways. It would be great if we had a very flexible and rapidly expanding research, something were use frg the Precision Medicine initiative with great benefit and which we dont have at the present time. And working with companies we could go a lot faster if we had some relief from some of the otherwise limitations of how quickly we could fund something that needs to happen. And finally i would say if we had the opportunity for relief on the very heavy restrictions on doing research that involve drugs that are schedule one on the research track, for instance with that, that would help us as well. Finally, ill say it one more time. I mentioned earlier this dream of maybe being able to launch demonstration projects maybe in two or three states, where we really pulled everything together. All of the care delivery and the research, the emergency runs the primary care physicians, the hospital, everything to try and figure out when we were really serious about this and pulled all of the parties together that had a role in solving this particular crisis, we might learn something pretty interesting. And that we could do also although it would require financial resources. And ill ask staff to follow up with dr. Collins on all three of those suggestions particularly the first two to find out if we need legislative language and maybe opioids could be a pilot and then using in Precision Medicine, opioids we could use it in other areas. Now yv about 300 eighth graders that are waiting for me about 12 45 in tennessee, and i dont want to miss them. But i want senator murkowski and hassen to ask their questions. What ill do is first call on murkowski and then senator hassen. If im gone by the time you finish, if you could kindly wrap up the committee hearing, whichever oneof you goes last, i would appreciate it. Senator murkowski. Thank you, senator. We do not want you to miss the students out there. I came back because i wanted to ask a question about how we are dealing with the ability, the pretty easy ability of individuals to purchase online, gain drugs, illicit drugs or unfortunately in alaska, were seeing the purchasing of drugs that have not been theyve not been rescheduled. And so theyre effectively legal to purchase over the internet. And i was at the Healing Center in bethel just a few months ago and talking with folks about where are people getting their drugs here in a Community Like bethel where the only way inor out is flying in. And no question about it, they were very open in where they got their drugs, actually naming some of the websites that are out there. It is just common knowledge. And unfortunately this is this is a reality that were dealing with. And i know that dr. Gottlieb, there was a target through the fda of these rogue websites that are illegally selling opioids, other Prescription Drugs out there. And this was an effort led by interpol to, i understand, 13 letters were sent to operators of over 400 websites, seized almost 100 domain names linked to online illicit drug sales. I was looking at the article. Its not like these folks are hiding these websites. And one of the names of the web site is buy hidrocodeine online. Com. Theres no secret there. So the question that i have is whether or not that effort was successful, whether or not theres going to be on ongoing follow up of this. Its just i struggle with how i go back to people in these villages that are saying, hey, its coming in the mail. Its coming in every day, how are you going to stop it . Whats my response . What progress are we making . Well, were making progress, senator, but not enough. These rogue operators, to your point, are hiding in plain sight. Well have other operations. This is an operation we conducted recently with International Partners including interpol as you mentioned. I mention that we increased the number of ftes, a request when i came to the agency, from 8 to 22 we tripled our footprint. We physically maxed our space, thats why i couldnt put good people in there. And thats why i talked to cdc about getting more space. Having looked at the operations we have there and the hardworking people we have in these facilities, i can tell you that the people who are shipping drugs through this country arent going through a lot of efforts to cover their tracks. Because they know a small percent are getting seized. And once they notice that, theyll change. Im certainly hopeful that within fda it is its kind of a multiagency approach with how were going to deal with us, working with postal service, working with dea. But, again, as you say theyre hiding in plain sight. And it doesnt take a genius to figure out how to access this and then bring these products into the communities. I want to ask one more question here, and that is about treatment. Senator franken raised it, Treatment Facilities and our reservations in the lower 48. Weve had some conversations about how in alaska this 16bed limit on medicaid reimbursement, the imds is a real limiting factor for us. But i also appreciate as much as we need in patient, when we have outpatient treatment, a lot of the population were dealing with are individuals that are homeless. They dont have they dont have the alternate or transitional housing that they need. Theyre coming out of incarceration. So youve got the housing piece of it. But it kind of speaks to the kind of treatment, then, that goes on within the prison system itself. And its my understanding that for the treatment for those that are incarcerated, they lose any preexisting medicaid benefits when they are due to be released. And they have when they come in, and then they have to reapply at the time of the release. So youve got a situation where at a time someone might need the treatment most, they dont have that coverage. What are we doing as were dealing with the need for treatment for those that are in this situation, which is really very much influx, whether youre in prison or whether youre coming out of prison, those that are in an outpatient but really have no place how big of an issue is the housing piece in terms of how we deal with treatment . I think that the housing issue is a very significant one. And we know that a large number of homeless folks in our country have either or Substance Use disorders or mental illness. And its also true that people, once theyre incarcerated, they do lose any medicaid benefits that they might have had. And so what needs to happen is when we know when peoples sentences are going to flatten, when theyre going to be released. And we have to be working with the justice system, the department of corrections months ahead of that to make sure well, were not doing that. Were not doing it well, but there are models for it. And my state of rhode island has a very nice model for that. But sampsa also work to provide around other states as well. Its an issue that will require not only the resources that we can provide through the government but also community resources. And so we have to be working with people in the community, recovery coaches, peers and other faithbased groups and other types of supports within communities. Families and significant others that will help people with these issues. And the goal would be to bring all of them together so that that happens before somebody comes out of incarceration. And unfortunately, i think thats where weve got a real big gap right now. We do. You are right. Thank you, senator. And thank you witnesses for being here for quite a long time. We are pulling up the rear here, but we are very grateful for your fortitude not only here today but in your leadership every day of the week. So i wanted to focus on something that we are grappling with in new hampshire. And this is really a question for you about the Substance Use work force. Because when we discuss the Opioid Epidemic we talk a lot about access to treatment. But one thing i dont think we pay enough attention is the infrastructure that makes expanding treatment such a challenge. Part of that is the treatment work force. I hear a lot about the importance about treatment into primary care. And while i agree its critically important, i also think we need to recognize 90 of the Addiction Treatment work force are not physicians. All of the professionals are on the front lines of this Opioid Epidemic. Stress is high. They are too often under paid, and it also means turn over can also be im interested, doctor, in your thoughts in particular what can sampsa do to train, and retain the work force we need to treat this epidemic . So youre right. The vast majority of people that will provide services to those that have Substance Use disorders will be nonphysicians. And so sampsa has a number of Type Training programs that do not just focus on physicians but focus on nursepractitioners, physician assistants. We also encourage interactions and collaboration with our colleagues at hersa because they do have funding programs to train various types of Health Care Professionals that sampsa does not have purview over. But we do work collaboratively with them. We work with National Stakeholder groups that are involved in the credentialing of the various professions to make sure the training on treatment and Substance Use disorders gets into the curriculum. And we will continue all of those efforts. Well, thank you. Because its running late, i thought what i would do is ask you all because the record will remain open for some time, to just reflect on what it is your agency isnt doing right now that it could be doing or should be doing to help us combat this crisis. And if youd be willing to submit that in writing, i would greatly appreciate it. I would also just add one of the questions i get on the ground in new hampshire, and sadly this has been the focus of my work both as a governor and now as a senator for some time because of the nature of the epidemic and mortality rates in particular, new hampshire, is people ask me why we dont have the resources we already do, knowing how hard everybody here is working. Ask and it relates back to the stigma you talked about, that if this were a different kind of epidemic, would we have more money on the ground . Would we be having a debate at all about whether we needed more resources . And i think its a good question. The people in my state have been extraordinarily brave, starting with parents who finally started writing obituaries for their children that said their son or daughter died of a heroin overdose. I mean think about the courage that takes and the courage it takes for people to come forward to their elected officials and say im in treatment right now, or im raising myground daughter because my daughter died of an overdose last month. People have been willing to stand up and talk about this illness, but it stigma is still out there. And i hope with every piece of energy you all have the jobs you have been entrusted with, you will speak for the need for us to devoted resources to what is an epidemic, a disease that will include relapse and have cooccurring problems that will challenge us moving forward. And that its not something going away in a year or two. We will stop, we hope, the overprescribing, and well get a better handle with training with your physicians. But at the end of the day, this is an illness. There will be other substances that may trigger an addiction and other kinds of addiction going forward. And i just thank you for the work youre already doing. But i hope i can ask you to be even greater champions for the notion this an illness and people need care. With that, im going to turn over the gavel to senator warren, who will ask her second rounds and then closeout the hearing. Thank you so much. Thank you, senator hassen. And thank you all for staying here until the end of the day. Were fighting back every way we can. Were picking up every possible tool and trying to figure out how we can reduce the number of people who are addicted and how to deal with those who have addictions. So one of the things weve been focused on is how to limit the number of pills left sitting in patients medicine cabinets from 2000 to 2015, the number of opio opioid prescriptions in massachusetts increased by over 175 . It is a particular problem because as you know of the people who abuse prescriptions of opioids, almost 80 of them started with pills that were prescribed legally to someone, themselves, friends relative. So reduce the number of pills in circulation senator capano and i introduced a bill introducing unused medications act, which allows the partial filling of opioid prescriptions. That means patients are able to have a pharmacist fill only a few days of their opioid prescription. And then they can return for more if they still feel the need. If they dont, those pills never make it into anyones medicine cabinet. Now that bill was signed into law in 2016. Dr. Gottlieb, when you formed your committee at the fda, i cept you a letter that we managed to get passed last year. And i want to thank you for your response on that. Let me ask you so we can get it on the record, do you think partial fill of opioid prescriptions is one way to cut down on the opioids in circulation . I do. Ive been on the record supporting various measures that we can try to rationalize dispensing. And so anything that we can do in that regard, that makes sense, that can be implemented without untowards side effects, unintended consequences, i would support. Good, good. And now that we have this new tool available to us to help tackle the Opioid Epidemic, we realize for it to work a lot of people need to know about it. And that means doctors need to know about it, pharmacists, a lot of patients need to know about it. So i wanted to ask you, doctor, you are the person in charge of sampsa. And i want to ask whether sampsa has a role to play in engaging everyone on this issue so that patients can do fills and not end up with opioids they do not need. Absolutely sampsa does have a role to play. We do out reach and training and work with both providers and with communities. So in terms of i would see this as something that would fall under the purview of some of our prevention activities. And this is definitely something sampsa could play a role in. Good. Also we will continue to work with cdc because they have a large role to play in this as well. We worked on this legislation so that patients would have the power to reduce the number of pills they take home. And we just keep looking for places where we can reduce the number of opioids in circulation. Recently senator capano and i sent letters to governors across the country and to National Medical associations to try to continue this conversation around the implementation of the partial fill bill and their efforts to try to reduce the number of pills in circulation. Were making progress, but not enough has been done yet. And so i look forward to working with all of you on this as we go forward. Again, thanks from everyone on this committee. Thanks for the people across america for your coming today and bringing us uptodate on your efforts, for the work you already have done and for the work you will do in the future. We really need you out there fighting. And with that, todays hearing is the first in a series of hearings this committee intends to hold on the Opioid Crisis. We plan to hold a second one next month. We will hear state and local perspectives on the challenges they face and the successes theyve had in combating this crisis. The hearing record will remain ohm for ten days. Members may submit Additional Information for the record within that time if they would like. The help committee will meet again on october 17th to continue our hearing on the costs of Prescription Drugs. So thank you all for coming here today. The jury stands adjourned. No one gave me a gavel. There we go. Next on cspan 3, a Panel Discussion on biological weapons and bio technology. Then government officials discuss data analysis, Artificial Intelligence and threat forecasting. Then later, facebooks plan to tackle hate speech and the future of u. S. Counterterrorism. Congresswoman Linda Sanchez is this weeks guest on our news makers program. Shes the House Democratic caucus vice chair. On the program she called for a shakeup in her partys leadership. I personally think that, you know, our leadership does a tremendous job. But i do think we have this real breadth and depth of talent within our caucus. And i think its time to pass the torch to our generational leaders. I want to pass the torch and see that happen. I think we have two really great members here that dont always get the opportunities they should. And i would like to see that change. Would nancy pelosi win a caucus leadership fight right now if she were challenged . I dont know. I mean, i dont know. There are a lot of members in our caucus, and again, everybody has their opinion. I dont know what the answer to that is. By saying its time for a generational change, what youre suggesting is win or lose next year its time for her to go . I dont want to single her out i think its time to pass the torch to a new generation. Theyre all of the same generation. And again theyre contributions to the caucus is substantial. But i think there comes a time when you need to pass that torch, and i think its time. You can watch representative sanchezs full interview on news makers this sunday on cspan at 10 00 a. M. And 6 00 p. M. Eastern. Cspans cities tour takes book tv and American History tv to pierre, south dakota. Saturday at noon eastern on book tv, we talk about it was essential along with mining and the expansion of the railroad into the growth of our state in the early 20th century. The director of the pioneer project explores the memory and inspiration of laura ingles wilder. The pioneer project is a research and Publishing Program of the south Dakota Historical society that is designed to study and publish a comprehensive edition of laura engles wilders pioneer girl, which is her autobiography. At 2 00 p. M. Eastern on American History tv, well tour the south dakota state capitol. If you look up, there are also four corner areas with flags. Obviously the south dakota flag. There is a flag from the dakota territory, flag fla flags from the united states, and also flags from spain and france because they controlled this territory at different timemis. And then each corner one has a white flag, one black, one red and one yellow. And hear about lewis and clarks encounters with members of the lucoata sioux along the river. Watch saturday at noon eastern and sunday at 2 00 p. M. On American History tv on cspan 3. Working with our cable affiliates and visiting cities across the country. Next on cspan 3, the cia and George Washington university cohost an intelligence and National Security conference. This portion featured a Panel Discussion about threats posed by biological weapons and biotechnology. Well, our second panel of the day will tackle the dangers of bio tech, biological warfare agents and bioinnovation. Addressing these issues requires focus not only from the intelligence can community but also development of national and international strategies, consensus on laws, standards, and authorities. Weve got an Awesome Group to shed some light on these