he learned that the cost to combat his son's addiction could be can limitless. as health care carriers are unwilling to fund addiction health care beyond the point of immediate physicalological afety. his son celebrated four months of good health before relapsing again. clearly there has to be a paradigm shift here. i know there are some important bills here. i like mr. guthrie's bill with others on the recovery centers work force is a significant issue. ms. clark of massachusetts has a bill. what do we have to do? it has to be something much more extensive than we're even thinking about now. if you could redesign a system now and really we're spending so much on lost productivity and health care dollars that don't really get to the heart of the problem, how would you design this system now? what do we need to do for this paradigm shift? >> thank you for the question.

i think that you raise a number of really important issues. i think they are the exact conversations that we're having and thinking about how are we being good stewards of the dollars congress has given us as we're investing $1 billion over the last two years, president's budget up to $1 billion for s.t.r. funds. mr. jones: how are we building that system. too many times individuals are paying a lot of money for neffective care. as i mentioned earlier, thinking about centers ofence lens or hub and spoke models or nurse care manager models, those are things that have been studied in different states that have shown increased retention, improved outcomes. that's how we're trying to frame our dollars and how we're requiring those dollars to be spent by states. ms. castor: is that just building on the current system or something you need almost like a v.a.-type of system for

this? mr. jones: it's enhancing the system that does exist so that the services are co-located. and that the evidence-based treatments, i.e. medications, are being provided. moving away from a fragmented system where it may be an abstinence base approach, to a system where medications are a component. it's also taking advantage of treatment on demand. when somebody comes in, so that's again sort of the connection of the emergency department. there's somebody experiences an overdose or somebody has an infectious disease complication, using that touch point in the health system to connect that individual into treatment. that's the system we're trying to build. i usuryry as an example. they had a study that came out recently where they expanded medication assisted treatment within their incarcerated populations in rhode island. their department of corrections. they offered all three medications. they were able to do that within their regulatory scheme.

they found 60% decline in overdose deaths in the first six months of 2017 compared to the first six months of 202016. rhode island a state that's been hard hit. and they are seeing that progress because they built the system. as people are coming out of incarceration, they are connected into these centers of excellence so they can continue to get those supportive ervices. while we put a lot of money towards treatment, i tonight think i can underscore enough the importance of recovery support services. while we put a lot we want patients to get on medications, do well, we also need them to be successful in the long run and providing those supports whether they be pier supports, employment housing, legal services, those tinings are critical pieces to having that individual successful in the long run. there is a loft structure that needs to be provided and supports that need to be provided. we're building the system but we have to make surety resources are there to amply-make sure the resources are there to amplify the

system. >> the chair recognizes the gentleman from illinois, mr. shimkus. mr. shimkus: i'll try to ask quick questions get quick responses and help my colleagues and you survive this long period of question and answers. dr. gottlieb, in your testimony you talk about the difference between addiction and physical dependence, part of that is how long can a physical dependence develop? in your medical -- dr. gottlieb: i would refer to dr. jones. it could develop quickly. nyone who is prescribed opioid s for a sustained period of time will become dependent. addiction is a state where you have a more than just a physical dependence on a drug, you have a psychological dependence and engaging in behavior that's not constructive to your life to et access to the drug.

mr. chim cuss: -- mr. shimkus: in my experience they tell me the brain has been changed. the discussion with this individual was that he just said his brain, in essence, used the term pickled in that he not overwhelm has this physical dependence, but -- can someone comment about that and w quickly that can individuals are different so they'll respond -- individuals are different. so they respond in different ways. mr. jones: we do have a robust of research studies that do look at changes that happen in the brain. for some individuals that change may occur quickly. others it may take longer for changes in the brain to occur. if you look at functional m.r.i. studies, it shows brains of people who are currently addicted right up in different ways than people not exposed.

even those effects carry on many years after they have -- mr. shimkus: stop people from being hooked and deal with with those who are addicted. that's why there is a multitude of bills being presented to try to address of lot of these ifferent concerns. i also believe there is a practice, a pharmacy a practice of medicine, you-all would agree with that. i'm also concerned in a rush to judgment on some of the proposed positions. i really want to ensure that those who i'm also concerned in a rush to judgment on some of the proposed positions. i really want to ensure that those who have chronic pain can -- do not get thrown kind of -- thrown under the bus or collateral damage. in response to prescription. i'm also concerned in a rush to judgment on some those who with pain, their lives will be significantly changed if they can't have access or a long set through a prescription through a doctor. some of these short-term get a

new prescription after three days, i'm concerned about that. from the patient aspect of -- i just want to throw that on the table. dr. ms. schuchat on the prescription drug monitoring debate, in illinois. three different states, some have it, some don't. how do we fix this whole system so that we know? there can be identification? dr. schuchat: we need interstate interoperability so a clinician can automatically look -- have the information about any place that a person has been received a rescription. c.d.c. has been funding 45 states to strengthen -- mr. shimkus: you have done this

der the meth debate and it's successful when the states get their act together and we do to be able to identify this stuff. dr. schuchat: most states are doing data sharing. we basically need to speed it up and make it easy. mr. shimkus: you need to help us figure successful when the states get their act together and we do to be able to out how to do that. dr. schuchat: additional resource that is are proposed tremendously. mr. tremendously. mr. shimkus: sorry to be so short. fred upton went down this rabbit hole on the long-term aspects of different drugs that are addictive. how about the -- i'm going to did to dr. gottlieb. we talked about this about the c.m.s. funding dilemma as far as how to you get that on the actuary so these things get paid. anyone want to mention that? mr. jones: i can't speak specifically to the policies at

c.m.s. there are a multitude of products available that treat pain. do you want to see the alternatives available as well. mr. shimkus: and paid for. not an actuary. dr. gottlieb: the i.r. formulations of the opioids are cheap. shimkus: queeled back. mr. burgess: the chair recognizes the gentleman from massachusetts, mr. kennedy, for five minutes for your questions. mr. kennedy: thank you, mr. chairman. i thank you and the ranking member green and witnesses for being here convening an important hearing shimkus: duri another historic snowstorm in washington. took me 30 seconds to wipe off my car. government is shut down. great you are here. thank you. the wind. the heart of today's hearing is a sim question i believe is facing our government. are we doing enough to combat an opioid epidemic turning families apart every day.

despite the best efforts of many across government, legislative branch and others, the answer is an emphatic no. it end up being across the headlines of our local papers far too often. just recently a headline in my a city rict read that received 200 opioid. son, daughter r, who will never laugh or cry with a loved one they couldn't reach or get the help they needed in son, daughter who will never laugh or cry with a loved one they couldn't reach or get the help they needed in time. an answer written by police officers and firefighters whose resumes include a line about being addiction counselors and lifesavers in their own communities. many of us are painfully and personally aware because we have watched friends and families struggle to overcome this disease. and we know that we have not done enough. it isn't enough to offer local governments one-time funding boost on one hand and turn around and cut medicaid, the single largest payer in the

country by $800 billion with the other. it isn't enough to provide law enforcement with more narcan only to erode essential health benefits that would guarantee treatment after a life has been saved. it isn't enough to call for more treatment beds only to pose medicaid lifetime caps and work requirements that will create barriers beetling substance abuse disorder. hearings like this are positive forward, but we know they are not enough and we know there are conflicting messages come youing out of this administration. -- coming out of this administration. until our forward, but we know assault on medicaid, assault on those that are seeking to make themselves and their families heal and better, and again the largest payer of behavior health services in this contry, the answer to that question is not going to change. with that as a umbrella, i want to follow up a little bit on what our colleague, chairman burgess, commented about

earlier in his comments about neonatal syndrome, which many of us have been focused on. and my colleague from massachusetts has made it a priority of her work in congress. i believe ou mentioned it a little bit about the influence and importance of parity when it comes to some of these issues. neonatal syndrome it's an issue that affects -- impact on newborns because of addictions with pregnant women. we have a bill that is bipartisan. that is bicameral. and believe it or not has a c.b.o. score of zero. that seeks to ensure that pregnant women are able to get get ewborns, able to access to the mental baby health services they need, including addiction services. i was wondering if you could expand a little bit, in your eyes, the importance of get access access to their services. dr. jones: parity is a critical

component to addressing the issue, but more broadly mental health and substance abuse issues. through the requirements set forth in the 21st century cures act, h.h.s., seeks to be a part of that and departments of labor and treasury have been working through issuing different pieces of information that can provide facts around parity violations, tools for health plans and others to see if they are in compliance. we have been trying to put the tools in place to address parity more broadly. mr. kennedy: do you believe there is sufficient enforcement violations? would defer that to colleagues who are charged with the enforcement side. we have been trying to put out information on what would defer to colleagues who are charged with the enforcement side. we have been trying to put out information on what are the expectations through frequently asked questions around treatment limitations. other types of payment and reimbursement strategies and providing examples of what are violations. as far as the enforcement actions i defer to those

charged with that. mr. kennedy: additional witnesses want to come on the enforcement side? doctor. dr. schuchat: to say that taking a holistic approach as you mention is critical. the public health, public safety working together is critical. but the same issue in terms of making sure the care is there for those who need t we know wrap around services work better than fragmented ones. mr. kennedy: cutting medicaid by $800 billion strike the nerve or behind irthose services? dr. schuchat: wouldn't be the best to comment on that. mr. kennedy: mr. gottlieb. dr. gottlieb: i used to work in medicare 10, 15 years ago. i'm not up to speed. can't comment. mr. kennedy: $800 billion less in medicaid, you were there a little while ago, $800 billion cut strengthen or hinder the program? dr. gottlieb: can you do more with more in any program. no question. if we're properly using our resources we can do more with more. mr. kennedy: thank you.

yield my 30 seconds back. mr. burgess: the gentleman's time has expired. the chair recognizes the gentlelady from tennessee, five minutes for your questions, please. mrs. blackburn: thank you, mr. chairman. dr. gottlieb i want to come to you. the hearing we had back in october i went right down the dais with you-all, n.i.h., c.d.c., samhsa, d.e.a. and said is there any federal statute that prohibits you from doing your job? and you spoke up and talked with the international mail facilities and i thank you for that. and i thank you for the subsequent work you have done with my team as we have worked to to the discussion draft to address the issues with the international mail facilities. i want to talk with you for just a minute about section 2-a of that draft which looks at the unlabeled or minimally labeled products that come

through these facilities and include those active ingredients that are in some f.d.a.-approved drugs and biologics. let's talk about what authorities you currently have when you encounter these products in the i.m.f. and how this bill will change this authority. dr. gottlieb: thanks for your support of our work on this. we're happy to work with your office and provide technical assistance you work through these issues. right now, we have to, if we see a drug that we believe is violating the i.m.f., we open a package or package is pulled by cpb, it comes to us for physical inspection we open it and find drugs in it we believe are counterfeit or illicit drugs, we have to establish intended use. we have to establish that it's a drug based on its labeling. what we're seeing more and more are minimally labeled drugs. sometimes we're seeing whole

boxes of just pills with no labeling whatsoever associated with them. and in that setting if we can't establish that is a drug based on its intended use from its labeling, effectively we have to return it. we typically will return it to the sender based on an appearance standard, a lower bar. if we wanted to destroy that product or enter into some other kind of proceeding against it, we would have to establish that it's a drug based on the labeling. what we have talked about is being able to establish that it's a drug based on chemical composition. and being able to go from there to establishing that it's vieo according to some lapse on the labeling requirements of 505 section of the statute. which would be a more efficient hreshold to meach in the i.m.f. the challenge also is the label something online so what we have is our investigators in these facilities going online and doing a lot of research around these products to try to

find some link between the product and its shipper that can establish the labeling. that's why we're only able to physically inspect small number of packages per investigators. this could make us more efficient. mrs. blackburn: let's talk a little bit about the bulk shipments because the bill will and the needed authority there. when you've got that adulterated and mislabeled, misbranded drugs that and the n authority are identified in this bulk shipment. you have mention add couple of times some of the problems that exists there. as we change that authority, how will that speed up, provide those efficiencies? you talked a little about about inat the time -- a little bit about intel. when we change this, what would the agency gain through the new authority? dr. gottlieb: the agency would

gain the ability to bundle like packages so that we're not overwhelmed by the same shipper or shipping a lot of small package west can bundle the packages from the same ship earn take one action against them. we'd also gain the ability to tea stroy more of the packages as opposed to just returning them to sender. if we know something is clearly violative, we can destroy it. which we think would be a stronger deterrent than returning it back to the concerned only to seat same ckage come in again in another i.m.f., another port of entry, or sometimes the same facility. this is about gaining efficiencies in the i.m.f.'s and trying to another use our limited footprint. nonetheless a footprint that to look at to grow many more package as day. we can can get to what we believe is a representative sample of what's coming in. we're never to look at going to inspect any significant percentage of all the drug packages coming in. i think the key is to make sure we're targeting resources effectively. that requires intelligence, but it also requires the ability to

work efficiently so that we can use the resources we have in a bert way. mrs. blackburn: thank you. i yield back. mr. burgess: the gentlelady yields back. the chair recognizes the gentlelady from colorado, ms. degette, five minutes. ms. degette: i want to comment on this questioning and other questioning. dr. gottlieb, i'm happy we're talking about improving our assessments of what's coming in in the mail. this committee had a hearing many years ago which was one of those totally regulatory hearings about the import--- i am portation of drugs. can i can only imagine the situation has greatly worsened with the opioid crisis. we have somewhere in the archives of this committee some pictures of what it looks like at these mail facilities with the overwhelming amount of drugs we have coming in and the tiny number of people we have for enforcement. i'm happy we're working on this. i'll work with the majority on

making sure this bill works. i did want to ask you, dr. schuchat, but the prescription drug monitoring programs. because those are really a valuable tool to prevent the misuse and abuse of prescription opioids. it's administered by the states. he problem is that these systems can have systems can have a lag of a few hours to almost a week before the prescription drug data is available. i'm wondering what the c.d.c. is doing to help encourage real time opportunities for detection in the pdmp's. dr. schuchat: the real time nature is critical so you get the information current today, not a week older or month old. the funding we're providing to 45 states right now helps them get there, but most aren't there yet. ms. degette: what can we do to improve it? dr. schuchat: the information technology is there. it's getting the upgrades to the systems that they have. ms. degette: if we can work

with you on that, let us know. the other thing s. some of the states like my state in colorado, they are putting together regional pdmp's, that would seem to be something you could encourage. dr. schuchat: we think the states have a good platform, but having a national platform they can plug into will help with the interstate interoperability and getting really the upgrades to everyone. ms. degette: dr. jones, dr. burgess asked you about the recent press reports about the samhsa funding of $500 million from congressman upton's and my 21st century cures bill that this whole committee worked so hard on. we were really proud that we got $1 billion to help expand states' treatment programs. 15.7 million in

colorado. it's already helped 22,000 people in colorado. you said the states are having trouble getting that money out. what can we do to help encourage the states to be more efficient and get that money out? do we really need to give them more money if 15.7 million in colorado. it's already we can't get the money we have already given to the treatment and prevention? dr. jones: some of this is working through the procurement process of the state. there are wide variations in what that looks like at each individual state. ms. degette: i understand you said what the problem was. what can we do to help? can ones: one thing that be done is share information om where you are hearing there are bottle nks in the system. ms. degette: with you? dr. jones: yes. as we implement the technical assistance, that's another place to engage and provide information to samhsa. ms. degette: do you think we need more money right now? or do we need to get this money out? dr. jones: there are bottle nks in the system. ms. degette: with you? dr. jones: yes. as we when you look at the magnitude of the problem, while there have been challenges getting the money out, the scale of the epidemic is large

and growing. ms. degette: you think it's worse? dr. jones: it's important. and the 2019 budget supports increases. ms. degette: one of the bills we're considering would direct the f.d.a. to issue guidance outlining how and when the f.d.a. would provide accelerated approval of break through therapy education to treat pain or addiction. that's another bill that i worked on and it's really worked. sometimes -- we know that it can benefit patients, but we need to make sure that it's not unduly taking a toll on the f.d.a.'s resources. in 21st century cures we also paired new pathways with new funds. what has the experience with the agency been with the resources required for accelerated approval pathways? do we have appropriate resources? dr. gottlieb: pain is an immediate and subjective end point. we can establish it fairly quickly with a limited data set

using scales, analog scales we have like meshry of pain from one to six or smiley face. with respect to accelerated approval, we don't have a good prototype for an objective bioparker in this context. the issue with respect to the approval of new pain drugs and drugs that might not have all the abuse associated with it is not demonstrating he cancy. we could demonstrate that efficiently if a very -- shot mall but reasonably sized clinical trial. dozens of patients not thousands. the issue is more on the safety side. we have not seen a drug in any pain drug for chronic administration that hasn't had some liabilities associated with it. some safety issues associated with it. this has been -- when you are administering one of these drugs over a prolonged period of time. whether the nsaid class or others, we have seen side effects associated with just about every drug. that's where we usually require

moreau bust data premarket to try to discharge any safety concern. ms. degette: the opposite of what often happens. thanks. mr. burgess: the chair recognizes the gentleman from mr. latta, for five minutes. mr. latta: thank you very much, mr. chairman. thank you very much to our panel for being here today, as you-all know about every member in this committee represents a district that's having a real epidemic on their own. unfortunately in ohio we all know what's happening there. we're behind florida and pennsylvania. we saw in 2015, 3,050 pass away. n 2016, that number went up to 4,050. in the 4,050. in the fiscal year ending june 30 of last year, it was 5,232 people. it's affecting lives across this country. it's destroying too many families. so many babies are being born with complication was addiction issues that -- they are losing

their parents. it's truly a epidemic in this country. with my legislation that i have introduced it's important, my belief, one of the things that i have run across my district and talked with professionals out there, law enforcement, it's very difficult for individuals out there to find, especially from smaller areas like -- that i represent, that they don't have those riders out there to get help. at we want to do is have a dashboard out there for dashboard out there for these individuals to go to and not only find help but also find what it really takes is the money. dr. schuchat, if i could start with my questions of you. in your testimony you stated the data are crucial in driving public health action. timely high quality data can can help public health -- public health, public safety, and mental health experts focus resourceser with they are needed most and evaluate the success or prevention of response efforts. i couldn't agree more.

making that data public-l available is a large component of my bill, the info act, because i believe this crisis will get worse. we need to fight it. would you speak in depth to how the data derived public health ? tion results dr. schuchat: this has been a fast moving epidemic. we have seen changes in the principal factors driving it. so the more timely our data r. the more rapidly we can target interveppingses. in some states having timely complete data heaps them identify hot spots with increased drug supply or increased overdose occurrences. and helps target the resource that is can be built there. whether it's the wrap around services or strengthsening the narcan distribution so we can resuscitate people. at the clinical level, it can be very important to know what happened to your patient. so one of the innovative approaches being used right now in some states is after there is a fatal overdose, alerting

anybody who gave the -- a prescription to the individual who overdosed in the period before the fatality. so that the clinician actually gets that reinforcing behavior that sometimes prescriptions can be contributing to unintended consequences. we know we know from medical practice that feedback on how you're doing helps you improve. and most of us think we're doing better than we're. getting needback into your prescribing and your -- the outcomes for your patients. the other point is know what works and how we can can scale that up. with all of the expansion we hope of the medically assisted treatment, we really need to understand more -- in a more timely way which approach works of for which kinds patients. we're working with samhsa right now to evaluate different courses of medically assisted outcomes. nd the mr. latta: dr. jones, you

mentioned strengthening public health data and reporting. do you anything to add? dr. jones: i think it's important more timely data we have the better we help states that are thinking about how are they spending down dollars? where are the needs? rural versus urban, different populations. the more granular we can get and timely, we can be more efficient and targeted with our resources. mr. latta: the common thing as i mentioned i hear in my district, grant opportunities or other funding streams which is difficult. that's why we introduced my legislation with this dashboard. how is samhsa currently putting out information on their targeted grant programs to support prevention, treatment, and recovery? dr. jones: we use a variety of different means to get information out about grants. we have a specific grant webpage on the website right at the top where can you find information, what are the application processes. we also post on grants.gova more centralized hub for

funding. then put out press releases or different announcements to stakeholders who wouldlike be the potential grantees so they know today samhsa announced x amount of funding for this and articulate who is eligible for that. after we make announcements of funding opportunities, we often hold webinars or calls with potential grantees to walkthrough what's the intent. what are the deadlines, what do you need to put in your application and answer questions. it's helped people be successful in their grant applications. mr. latta: thank you very much. i yield back. mr. burgess: the chair recognizes the gentleman from new mexico, five minutes for your questions. >> i have some questions for our panel, mr. chairman, but quickly. it's my understanding that you had a very hearing yesterday in o.n.i. specific to west virginia, mr. chairman, and i want to thank you for holding that important hearing. i think it would be bruteful to find out what's happening in other states as well.

in new mexico our attorney general has also -- mr. burgess: if gentleman -- that was oversight situation. that was the gentleman from mississippi. mr. lujan: i ale pol guise. mr. chairman i know that you share the goals of what was conducted in o.n.i. as well. all of these states are trying data, his level of including new mexico and our attorney general. the automation of reports and consolidated order system, the data is invaluable. i think all members and states would benefit from seeing this data. i think that it's important that the committee work together data, to make sure we' able to access that information. dr. schuchat, now the opioid crisis a major issue your agency has been dealing with over the past decade or more, correct? yes? i see a nod yes. i also know that c.d.c. has been concerned about the opioid prescribing rates for quite some time as well, is that correct? dr. schuchat: increased concern

since 2010. mr. lujan: increased concern since 2010. 2010?nce before dr. schuchat: there's been concern, with you i would say there has been accelerated concern as we saw some of the data. mr. lujan: isn't it true that you issued prescribing gines to providers because of the concern that an oversupply of these drugs has contributed to the opioid epidemic? dr. schuchat: in 2016 we issued guidelines for chronic pain. mr. lujan: this committee has been trying to investigate the distribution trends regarding opioids in certain communities. we have tried to understand where increases occurred and whether they represent overdistribution. i'd like to share with you a chart showing some of the opioid trends in my district. i think that there should be a hard copy in front of you as well. this chart is based on d.e.a.'s data. t showed the total amount of hydrocould he donne it and objectiony could he donne that distributors sent to my district from 20000 to 2016. you can can see the amount increased dramatically by over

400% between 2000 and 2012. c.d.c., the question i have actually in my district, population actually fell during this time period. what i'm interested in understanding is which of these numbers reflects the true medical need of opioids in my district? dr. schuchat: there is excess opioid prescribing throughout the country. what we have right now is a sixfold variation from the counties to ribing the lower. we think we can decrease opioid prescribing substantially with best practices about treatment, other r chronic pain and counto conditions, because too many people get started on opioids who don't need them. and some people are continued the the time where they are necessary. our prescribing guidelines from 2016 began a process to improve prescriber practices. the upgrades to the prescription drug monitoring programs, and the consumers facing awareness campaign we're

running should reinforce improving practices. we have done this before with prescribing for antibiotics in pediatrics where we saw decreases. we think we can do this again. i would not say one of these numbers is the right one. currently in the united states we have threefold the prescribing of opioid that they have in europe. e do not have three fold the pain. mr. lujan: you may not able to identify now or suggest any of these numbers was correct. would you agree trend is alarming? dr. schuchat: it's terrible. mr. lujan: does c.d.c. use this information to identify these so they can es alert us when there is a problem? dr. schuchat: that's right. and we issued a report last summer of the county level opioid prescribing. and shared the data -- the more granular data with the counties and states so that they could take action that their hotter spot localities. we also think working with the

health care professional companies, licensing grournings education of our trainees will help us get prescribing into better order o. mr. lujan: as we can see these trends in new mexico, there is another slide we have, not up for the big screen today, it's consistent with the national trends. across the country, what's concerning what's concerning to me is it's only because of the attention that's been brought by one of our colleagues on the committee from west virginia, about a small community, what is happening with distributors out there, that now we have staff majority and minority that are looking into this issue. aren't these federal agencies supposed to be doing this work? that's my concern. i'm not sure they're doing it because these problems are continuing to grow. get out of control. and so we'll continue to submit questions to take a deeper dive here. i just want to thank the majority and minority staff for the work that they're doing. these oversight hearings are critically important and us making sure we're doing everything that we can to get to the bottom of this. mr. chairman, thank you for the indulgence and to the staff, i

appreciate their work on this issue. mr. burgess: the chair thanks the gentleman. the chair likewise appreciates the staff on this. i recognize mr. lance of new jersey. five minutes for questions, please. mr. lance: thank you very much, mr. chairman. before i ask questions, i'd like to submit for the record letters from various groups in support of legislation which i'm working , eliminating opiate-related infect shuzz diseases. a -- infectious diseases. a letter from the city and county health officials, a letter from the national alines of state and territorial aids directors, a letter from the national viral hepatitis round table, a letter from the american liver foundation, and a letter from the aids institute. mr. burgess: without objection, so ordered. mr. lance: thank you very much, mr. chairman.

i note that in your testimony you mentioned oipt-related harms of infectious disease and how surveillance for viral hepatitis is limited. i commend you for. that because my questions are on this topic. why seasoning the scope of infectious disease important with regard to the opiate federal response and how does the work of the c.d.c. dovetail into the broader strategy? dr. schuchat: many of the infectious disease complications of opioid use or injecting drug use can have life-long consequences, not just for the individual but also for those they are in contact with. clearly hepatitis c can lead to long-term complications, including liver failure and cancer. and hepatitis b can be passed from mother to baby and lead to chronic infection in the child as well. of course h.i.v. is treatable, but a terrible consequence of injecting drug use.

while we've seen decreases in h.i.v. in infecting drug use, we're starting to see that pattern change right now. with our recent opioid problem. so improving surveillance for the infectious disease complications of opioid use is very important in order to better target resources and get screening and care to those who need it. mr. lance: thank you. i hope you'll review legislation i just introduced with my colleague, congressman kennedy, on the other side of the aisle on this kevment completely bipartisan in nature -- committee. completely bipartisan in nature. my understand something that currently c.d.c. is running a hepatitis c surveillance program in 14 states, including the state ofry -- the state i represent, new jersey, at a cost of $3.2 million. the current program is passive surveillance, but i've been told by c.d.c. that with additional resources, the agency could plus up to active surveillance. could you please speak to the types of tools and resources that the c.d.c. could activate with additional funding? dr. schuchat: yes. the hepatitis c surveillance

isn't wide enough spread. in fact, broader surveillance for viral hepatitis, the other types as well, could help. because we're seeing consequences of hepatitis a outbreaks in addition to the hepatitis c and b problem. the problem with hepatitis c is that a single lab test doesn't necessarily tell you if it's a new inferks or an old infection -- infection or an old infection. the active surveillance approach, collecting more data, could be helpful. mr. lance: thank you. congressman lujan mentioned the incidence of opiate abuse across the country and i believe you indicated in your response that it may vary. i guess this would be county by county. up to a six fold. is that right? dr. schuchat: it's the prescribing that varies six fold but the overdose rates vary substantially as well. mr. lance: are those figures readily available county by county? dr. schuchat: yes. we posted the figure last july and it's available from our website. for the county level data.

mr. lance: thank you. i'd be interested. i would be interested to know where the counties i represent might stand in that. thank you for that information. dr. gottlieb, you've spoken extensively to the challenges the agency is facing when it comes to intercepting illegal drugs at international mail acilities. can you give us an idea of the volume of drugs coming into this country? dr. gottlieb: i brought some pictures from our visit to the i.m.f. at j.f.k. if we can walk through them. thls the j.f.k. international mail facility. shows you the package volume coming into the facility. we can go to the next slide. these are parcels that were refused and subject to destruction under 708. this is 318 parcels shown in the background of this photo. mr. lance: this was taken recently? dr. gottlieb: this is from the visit that chairman burgess and i did to this facility.

these are about a million counterfeit and misbranded drugs as scheduled to be destroyed early this spring. next slide. these are packing ans that were flagged for refusal -- packages that were flagged for refusal. we were going to send them back. next slide. i mentioned that we see packages with unmarked tablets. this is one such box that we saw that day, of a box of purple pills. not sure what they are. wouldn't suggest trying one. mr. lance: i will not. [laughter] dr. gottlieb: next slide. this is another shipment of unknown green pills that came in from hong kong. this is shipped as cosmetics. these haven't been tested. we're not sure what they are. next slide. this is another box containing loose blister pax with no labeling. so it's unable to determine what they are based on labeling. next slide. this particular photo was taken out of a mail facility. we have another i.m.f. there. lance lanls to the nation, -- mr. lance: to the nation, that's in new jersey.

and the kennedy airport is owned by the port authority of new york and new jersey, a bistate facility. dr. gottlieb: i grew up nearby. this is unmarked pills. so this is typically what we see, talking about the difficulty in establishing labeling. next slide. when i talked about multiple shipments of boxes, small boxes this gives you a good indication. these are 10,000 separate boxes from one shipper. next slide. just some more photos of those individual small boxes, from one shipper. this came in through the miami i.m.f. actually. next slide. this shows you what we're increasingly seeing which is small packages with a lot of different drug contents in them. since we take a risk-based approach in the i.m.f., typically we might not be opening for inspection the very small packages where it looks like it might be for personal use. next slide. this again shows you an individual package, again with a

popery of different drugs in it, including opioids. the drugs on the far ride, with the green labeling, are actually narcotics. next slide. these are two individuals watching -- mr. lance: who is the person on the left there? dr. gottlieb: we were bravely watching this package being opened while the official was masked. we braved it. but they do -- it is a fair point that the officers, and our own, but particularly the first line of defense looking at the narcotics do gown up and mask themselves because they don't know what they're going to be cutting into. this was a big box of different drugs that we opened right off the line. so it had been x-rayed right when we were standing there and we opened it up. and found a lot of different kind of drugs. including o.t.c. products which is unusual to find and raises some suspicions. next slide. this is a teddy bear. we didn't set out to seize the teddy bear but next slide -- this is what we found inside the teddy bear. again, unlabeled drug products.

this is actually counterfeit viagra. final slide, if we can go to it, this is our laboratory facility in the i.m.f. so when we talk about trying to increase our footprint and improve the physical resources that we have there, this would be something that we would be looking to augment. we've put some additional resources into this recently but this is the lab we use to do the testing. mr. lance: thank you. my time is elapsed but i point out how dramatic this is and on a bipartisan basis, this committee intends to get to the bottom of it and to rectify the situation. thank you, mr. chairman. mr. burgess: the chair thanks the gentleman. the chair recognizes the gentlelady from illinois. ms. schakowsky: where were those packages going? there were addresses on there. dr. gottlieb: you know, i don't have the signees off hand. all different places in the united states. i would just make one more observation, that these are volumes that are clearly intended for secondary distribution. we're not typically seizing --

unless a package comes in and we have some targeted information around it that would lead to us believe that it's a volatile package. it might contain illicit substances, we wouldn't be looking at the small volumes. we're typically opening up the big packages or the packages that come from known locales or shippers we know to be shipping dangerous products into the u.s. ms. schakowsky: they're going to pharmacies? dr. gottlieb: pharmacies -- overseas pharmacies? ms. schakowsky:. no directed to pharmacies? dr. gottlieb: all different -- it wouldn't be commercial pharmacies. these are typically going to illegal roots of distribution in the u.s. we're looking at volumes that are intended for secondary distribution, that big box of purple pills isn't going to an individual. ms. schakowsky: is there follow-up with the -- to the receiver of these pills? dr. gottlieb: depending on what we find, sometimes -- we refer hundreds of cases for investigation and sometimes criminal investigation,

depending on what we find. and sometimes we will, when we hold up a package, we will then give a notification that it's oming through and maybe do a dummy drop to find who will pick it up. a lot of time these are going to drop shipment points, they're not going to an individual's home or business. so we will do investigations off what have we're finding in the i.m.f. depending on what it is. and what our level of concern. is but we refer hundreds of cases away from thiels. ms. schakowsky: thank you. on the opioid issue, advocate hospital system in the chicago area, i went to visit the advocate opioid unit. actually the substance abuse unit. and they provide detox in their ed mically managed withdrawal unit. it's an in-patient process. they only have 12 beds. it's four to seven days.

and many of the patients have mental health issues as well as substance abuse. including depression, anxiety, and undiagnosed mental health problems. but when the detox is over, there are not enough programs available to provide essential ongoing follow-up treatment. so we talked about that. dr. jones, i wanted to ask you, there's only a certain number of substance abuse beds available in facilities and there's a really long wait. mental health resources for people have been steadily declining in illinois and around the country. they were telling me that sometimes it takes six to nine months to place somebody. so they did the detox, they say, this is not treatment. this is just getting them stable. and then i said, and then what? in some cases if a person is homeless, they're just out on the street again.

so i'm just concerned about, you know, we've heard the president talk a lot about mental health and we all talk a lot about mental health, behavioral health. so, how do we really address this problem once we find people in need and get them sober? john: i think it's a really important -- dr. jones: i think it's a really important point that we move away from the idea that we need more beds. the vast majority of people who have an opiate use disorder can be treated very effectively in the outpatient setting. whether that be in the outpatient treatment in combination with medications or an office-based setting, or methadone in an opioid treatment program. so we certainly want to make sure that beds are available for those people who have, say, opioid use disorder with a co-occurring serious mental illness and they need that accuse kate to -- acute care to stabilize. ms. schakowsky: i think it's real obvious what we need to do,

but my real question is what are h.h.s. agencies actually doing to address this problem. it's not really mysterious, we need more beds for detox, we need more behavioral health outpatient. dr. jones: so the opioid-specific dollars that have gone out to states are trying to build the capacity to provide that treatment on-demand. and moving away, again, from an in-patient treatment perspective to the outpatient setting. i think it's also important to clarify that detox is not treatment and if someone is detoxed they absolutely should be connected to ongoing care. in particular, you can take advantage of the fact that they've been detocksd to induct them into extend release because people need to be detoxed before they can be on that. so we're putting dollars into states to build this system of care that can provide care for people with opioid use disorders. we're also making investments in work force. we can have all the money in the world for capacity but if we

don't have the people who can provide the care, we're not going to move the needle. part of the work on the work force side is through our technical assistance that we're providing to the states. money within that t.a. program can actually be used to create teams that can train people to get a waiver to prescribe things that can address other work orce-related issues. we often hear from primary care doctors that they're he's tapt to engage with patients who have -- hesitant to engage with parent -- patients who have opioid use disorder because they don't feel supportive. we have a mentoring program. and we're also looking at things like project echo, centers of excellence, hub and spoke models that can handle the acute phase, get somebody stabilized and pass them off to a primary care doctor who can manage them moving forward. those are the things we're using our dollars to invest in with the states and through the t.a. we're trying to support the rapid scale-up of those

innovations because people are at such high-risk of dying if they're coming out of detox and they're not connected to treatment or if they're on a waiting list. the human life is too great to lose and we should be building those systems that when somebody's ready, they can get the treatment that they need. ms. schakowsky: thank you so much. mr. burgess: the chair recognizes the gentleman from virginia, five minutes for questions, please. >> thank you very much, mr. chairman. you are not the only ones looking at some of these things? am i correct in that? you said several times, y'all don't look at when the international mail facilities and so forth, i'm just trying to figure it out. mr. griffith: we recently had one of those drop sting operations in my district but it was for a small. a fentanyl. to whats would a eye -- a small amount of fentanyl that appears to be of personal use. they said in the newspaper article that was customs. would that have been you all as well? dr. gottlieb: customs has primary responsibility and the i.m.f. for things identified as controlled substances.

we will often times work with them. we have criminal investigates that are will sometimes work with them. we provide certain expertise. mr. griffith: but you focus on the big shipments, is that correct? dr. gottlieb: customs will x-ray all the packages and they'll do some detection, including with dogs to try to pull out the ones that they believe have controlled substances. they will pull a certain number of packages that they identify with pills that they believe are for secondary distribution. based on either volume or where it's coming from. they'll pull them for physical inspection for f.d.a. in those facilities. they'll only pull a number of packages that they think we can physically inspect inside each facility. mr. griffith: let's talk about that. the blackburn bill is very interesting. we heard comments from mr. lance and you showed us the slides. what i'm asking is, should we put into the blackburn bill authority four to say a shipment has to have this specific labeling and give you the authority if that labeling does not exist? for all of those pictures we saw of the boxes and boxes of drugs

unlabeled, you automatically get to destroy those. wouldn't that be helpful if we added that in? yes or no? i'm running out of time. dr. gottlieb: it would make us more efficient. the blackburn bill does provide for that because it allows us to make a determination. and then we go to the secondary question of whether or not it's labeled appropriately and most of these products wouldn't be. they'd be misbranded. mr. griffith: if it's not labeled at all, before you even get to the testing it, if it comes in and it's not labeled -- destroy. it dr. gottlieb: you're speaking about the information we have about the package or the labeling on it. mr. griffith: you showed us pictures of these unlabeled items coming in, you didn't know what they were. the purple pills, you weren't sure what they were. we know what they're supposed to be and so forth. wouldn't you all like the authority to say, if it's not labled in accordance with what you've set forth, it's coming from a foreign country, let's just destroy, it wouldn't that free up time for going after the folks who might be shipping

something that that is labeled but labeled improperly? dr. gottlieb: or not establish that it's a drug at all. mr. griffith: not labeled, destroy it. get back to me. i appreciate that. we've got a discussion drafting considered to help c.d.c. and in turn the states build upon and improve state tdmp's to achieve maximum effectiveness. how would that discussion draft help c.d.c.? dr. schuchat: we think that having improving the states' specific pdmp's and access to a national platform, that would help them share data across states and have everybody benefit from the upgrades that individual states have done, would be helpful. we need to make sure that when we reflect the state-specific laws and policies, and that they need access to their data to be able to use it and improve it, and we don't really want the

lowest common denominator state to be what a new interoperable system would be. but greater attention to the prescription drug monitoring programs and the flexibility to improve them rapidly is important. mr. griffith: i know this is going to get controversial but you said something earlier that triggered my brain to work on something. you said that some of these programs will alert the health care provider if they're overprescribing an opioid. is that correct? dr. schuchat: about high dose. if you have many different types of opioids, you can't in your head calculate what's the more even if milligram equivalent. in our guideline we alert people that over a certain level, special attention is needed because the border between safely taking those medicines and unintentionally overdosing is small. so we want clinicians to recognize when the cumulative opioid level is very high. so that they can look into it and assess whether it's needed

or not. mr. griffith: yes we were talking with d.e.a. and all the problems we're having there with pharmacist and some doctors -- pharmacies and some doctors. would it be helpful or would it create problems if we shared that information when a doctor consistently or a health care provider consistly is giving too high doses out, would it be helpful to share that information with the d.e.a.? so that we can maybe identify quicker where we might have a problem? try to educate first, if it's not criminal. but then look at if it is. dr. schuchat: in most states the medical boards would be looking at these highland level prescribing. i think we think sharing information across systems is very helpful to alert for whatever the issue is. in terms of what the prescription drug monitoring programs are doing is they're looking at prescribing to the patient, not the pharmacy level data.

and dr. jones might have something to add there. mr. griffith: want to add to that? dr. jones: the states are -- because they fall under the rubric of practice of medicine, they have different variations in their state statutes but many have proactive reporting so it's looking at outliar prescribers and either sending that in some cases to the medical board and in some cases to law enforcement. mr. griffith: one of the issues yesterday was getting the information to show that a health care provider, whether it be a pharmacist or a doctor, was not following standard medical procedures in order to get a show cause order. i was more concerned with the i.s.o.'s because i think they're not using those effectively and should be more aggressive on that. but in the show cause, this is information that could be very helpful and i would hope we could figure it out. i know it's a little dicey and appreciate your time and i yield back. mr. burgess: the gentleman yields back the balance of his time. the chair thanks the gentleman. the chair recognizes the gentleman from north carolina, mr. butterfield, five minutes for questioning. mr. butterfield: thank you, mr. chairman. i too would like to thank you, dr. jones, for your testimony

today. and all of you as that goes. dr. jones, i appreciate the many care programs you highlighted in your testimony earlier. this committee worked diligently on a bipartisan basis on 21st century cures and on care. one of those programs, the minority fellowship program, is not mentioned at all in your testimony. i believe it to be appropriate to fully fund this bipartisan effort that we passed in the it.t iteration of through research has h.h.s. come to the conclusion that there's significant behavioral health disparities in diverse communities across the country? dr. jones: we certainly know that health disparities in social determine nance of help play an important role in the overall health, as well as behavioral health for individuals. creating culturally appropriate interventions that are evidence-based are really important. again, as i mentioned, we have the state t.a. program for

s.t.r. dollars, focusing on opioids, because we recognize that there are state-specific contexts in which interventions are going to be implemented. so i think that's certainly an important area and it's part of our overall rubric for how we think about dissemination and adotchings evidence-based practices. mr. butterfield: so this research is ongoing and continues to be on your radar? dr. jones: absolutely. we continue to put our data and analyses around different disparities that exist around behavioral health issues, among different racial ethnic groups, among different age groups, among people with lower socioeconomic status to get a more comprehensive and holistic picture of how different individuals in our countries are being impacted by these issues. mr. butterfield: this committee unanimously approved the re-authorization of the minority fellowship program and an increase in its authorization. there is no other program that will focus on preparing behavioral health practitioners to more effectively treat and

serve people of different cultural and economic backgrounds. we have heard that the -- at the center for mental health services, national advisory council meeting recently, the newly appointed assistant secretary for mental health and substance abuse expressed her support for this program. why did h.h.s. propose elimination of this program in the 2019 budget? dr. jones: i'll just say, you know, some of the specifics of our budget are still working through and we have a budget and brief that's out but the other specifics are still in process. we are committed to work force development, that is a priority for the assistant secretary. and making sure that work force development incorporates different racial ethnic groups who may have different impacts and differential impacts of substance use and mental health. mr. butterfield: considering the strong congressional and bipartisan support for this program, i would ask that you really a serious look at

re-authorizing and funding this program. chairman bureau jerks i would like to submit for -- burgess, i would like to submit for the record a bipartisan letter to appropriators in support of full funding for the minority fellowship program, if i can find it. here it is. may i include it in the record? mr. burgess: without objection, so ordered. mr. butterfield: thank you. a number your colleagues have highlighted the tragedy of neonatal abstinence syndrome that occurs when a mother takes prescription or illicit opiates during her pregnancy and her baby is born with physicallogical dependence to that drug. far too many babies are born into a life that began with opiate dependency because their mothers used or at least abused these drugs while she was pregnant. would you agree or disagree that there should be special treatment for these newborns? dr. gottlieb: i would welcome the opportunity to try to help any sponsor that's trying to develop treatments that could specifically address this tragic

condition. mr. butterfield: well, it is my understanding that there are few options for treating opiate withdrawals in infants. if that is not correct, i'd like to know. it but it's my understanding that there are few options for treating opiate withdrawal in infants and existing options for these babies in the first month of life are not streamlined or standardized and none of the currently used therapeutics are f.d.a.-approved for the population. would you be willing to work with companies, you said you'd work with us, of course, but would you be willing to work with companies and other stakeholders to help identify incentives to accelerate research into this area? dr. gottlieb: we'd be delighted to work with sponsors in this regard, congress mfpblet i'd be delighted to work with congress to see what additional incentives we can try to craft to incentivize development for what is a very small population. but a critical medical need. mr. butterfield: let me now address -- oh, my time is up.

let me address in closing the testimony about the types of packaging and exs opiate disposal. mr. hudson and i are working on legislation to help assist with the f.d.a.'s efforts. can you describe whether additional authority could be helpful in those efforts to limit the number of opiates dispensed to patients and to make it easier for patients to dispose of leftover opiates? dr. gottlieb: we're actively contemplating what we can do under our existing authorities to try to create pathways to blister pack some of the immediate relief formulations of drugs. we have a working group that we stood up in the agency looking at this question. this might be something that's hard to reach under our current authorities. to either mandate that or to require it to be offered as an option in the health care system, could try to incentivize use of. we do believe at a policy level that if the i.r. drugs were in blister pack formulation tharps -- the number of pills that were

appropriate for three days, five days, seven day, i think you would see more default prescribing for those shorter duration uses. more physicians would opt for. that we see in other areas of clinical medicine where there's convenience packaging, physicians will opt for that. this is an opportunity i think for congress to address this. congress could conceivably direct it, direct it to be done, particularly for the i.r. drugs. but we will continue to work within the scope of our authority to see whether this makes sense from a public health stand point -- standpoint. if it does, how we reach tund our current authorities. wrapt to disposal we think there are a lot of opportunity -- with respect to disposal we think there are a lot of opportunities to dispose of these drugs for consumers and that would presumably very clearly take more pills out of circulation that didn't go on to be diverted because we have data, we've developed data that shows a lot of pills are left over on an average prescription. mr. butterfield: thank you. i yield back. mr. burgess: the chair thanks

the gentleman. the gentleman yields back. the gentleman from texas. mr. green: mr. chairman, i ask unanimous consent to place into the record a letter and also a statement by congressman jeffries on h.r. 449. mr. burgess: without objection, so ordered. the chair recognizes the gentleman from florida. mr. bilirakis: thank you, mr. chairman. i appreciate it. doctor, the c.d.c. released new prescribing guidelines for opioids back in march, 2016. it recently released a report by the agency indicates that despite this change, e.r. admissions due to opioid overdoses has since increased by 30%. nationwide. the midwest by 70%. and by 54% in large cities in 16 states. what is c.d.c. durntly doing to address this issue -- currently doing to address this issue? dr. schuchat: we're funding 45 states and the district of columbia to strengthen their community-based prevention work.

we're particularly focused on the prescription drug monitoring program so that we can improve prescribing and not have people start down the path toward addiction to begin with. but we're also doing work in part of the heroin response strategy on community-level projects that explore innovative approaches like having recovery coaches in the emergency room, to help people navigate into care from the emergency room. so this is a big problem that's getting worse, but we're supporting states, working with the medical community, trying to have system changes. and also doing consumer outreach as well. mr. bilirakis: why did we not see any type of an improvement with these new prescribing guidelines? dr. schuchat: we've started to see a decline in prescriptions of opioids. the recent increase in emergency department visits is likely related to the illegally manufactured fept nell that we've been hearing about -- fentanyl that we've been hearing about through the international mail facilities. while the prescribing is starting to come down, it's actually still too high. so there's a lot more room for

improvement and we're trying to scale up the uptake of our guidelines through medical care, through technology improvements, through academic detailing. mr. bilirakis: what do you suggest we do as legislators? dr. schuchat: i think the focus on this is critical and the resources that have been coming and are being proposed are also very important. there are some authorities that could help speed things up. you know, as you hear about the work force gaps and the medication assisted treatment world, there's similar work force gaps in public health, information specialists and so forth. so there's things like direct hiring authority or loan repayment for certain kinds of these special needs that really need to increase for to us turn the epidemic around. mr. bilirakis: thank you. i appreciate you holding this hearing, mr. chairman. dr. gottlieb, in your testimony you mentioned that the -- that f.d.a.'s regulatory oversight over lawfully prescribed drugs gives your agency some important

opportunities to impact prescribing in ways that can reduce the rate of new addiction, while making sure patients with medical needs have access to appropriate therapy. that's all very important, we need a balance there. would you discuss these opportunities? dr. gottlieb: thank you. i just want to echo your closing statement about patients who have medical need. we have to remember that there are a lot of parents -- patients with chronic pain conditions, including patients with cancer pain who require long-term use of opioids. in some cases opioids are the only drug that's going to work for certain patients, itly patients with cancer pain. so we need to remember that in terms what have we do and we don't lock those patients out of critical drugs. but we have taken steps with respect to the use of our authorities, particularly under the risk management plans that we promulgate in conjunction with the prescribing the drugs to try to put in place certain measures that will try

rationalize prescribing and steer the pro prier to towards ore appropriate prescribing. we know that most of the prescribing and most of the new addiction is through immediate release formulations of drugs. that would be the first medication that patients use. we also expand that to include not just physician prescribers but anyone who comes into contact with the patient. so nurses and pharmacists. so we updated the education and we also expanded it to include education around alternatives. instead of just educating providers around the abuse liability associated with opioids and the proper prescribing, we are now requiring education to include alternative treatments for pain. so that they have a full picture of what the scope of prescribing could be. we're looking at other ways to try to steer prescribing in a better direction. packaging i've talked about.

making the education mandatory or make it mandatory if you want to prescribe higher volume, longer duration drugs. we're talking about maybe requiring sponsors to impose requirements where physicians have to document if they're prescribing certain patterns of use that we know comport with a higher rate of addiction from the use of prescription products. so there's a range of things dwoke. i will say in response to the question you asked earlier, what can we do to get at this problem, it's very clear there's not a magic bullet here. there's no one solution. it's going to be a compliment of many stheaps we all take working together to try to affect a rye sis of this magnitude. mr. bilirakis: thank you very much. my time has expired so i yield back. mr. burgess: correct. the chair recognizes the gentleman from new york, mr. engel, five minutes. mr. engel: thank you, mr. chairman. i'm pleased to be the democratic lead on two of the bipartisan

bills we're considering during this hearing. the poison center network enhancement act and the results act. and during this panel i'd like to focus on the results act which is a bill i've introduced with congressman stivers. in a bipartisan way. the goal of the results act is to ensure that federal grants intended to treat mental health and substance abuse disorders, fund activities that are backed by sound evidence so it will help build the evidence-based inowevative interventions. -- innovative interventions. while the concept is straightforward, i want to be sures that executed carefully as we work to end the opioid crisis. we need to ensure that results drive decision making and that we always keep the door open to new and innovative approaches that could be game changers. i hope that this discussion will help us strike the right balance. one of the objectives of the results act is to ensure that there are tools available for stakeholders looking to emulate

activities and intervention that have shown results and may work in their communities. it's my understanding that samhsa intends to use the national mental health and substance use policy laboratory or policy lab created by the 21st century curious act -- cures act, which we're all proud about here, to make information about evidence-based mental health and substance use disorder interventions available to the public. in light of this suspension of the national registry of evidence-based programs, and practices, i'm anxious to learn more about what the plans are for the policy labs. so, dr. jones, would you explain exactly what types of tools and information will be made available to the public through the policy lab and when would you expect that policy lab to be fully operational? dr. jones: thank you for the question. i think it is really important that we are good stewards of our federal dollars and that we're helping support, where it be ommunity programs or

practitioners' implement evidence-based practices. that's the frame we're using as we're setting up a new resource .ertainty within samhsa so what we're doing now is we're actually going through resources that already exist at samhsa that are broader than just sort of a program by program listing. which is largely what enrap was. that can actually help facilitate communities and practitioners to understand what the context in which they want to implement an intervention, based on that information, a needs assessment, what are the right interventions that fit our needs and hen how to do we actually implement that? so samhsa has spent time and resource in creating different types of evidence-based tool kits around community treatment or other mental health treatment approaches or medication assisted treatment or community-based substance use prevention. where those resources are somewhat buried on the website at samhsa. and we want to bring those to

the forefront because they do provide the road map for how a community or a practitioner would implement evidence-based practices. so we've been culling through that information. we've reached out to our colleagues across h.h.s. who also have that type of information that could be useful and we're synthesizing that and creating a website that we believe is quite useful across the spectrum. so people from the public who are interested in these issues, who are not expert in different topics, would be able to kind of point and click into the specific area. so if they want to learn about substance use prevention, they would be able to quickly identify what are the fact sheets that might exist for that, versus a community implementation guide. which might not be the most appropriate thing for them. similarly we're doing that for clinicians. there are a number of clinical guidance documents that samhsa has put out. tip 63 around medications. we have the c.d.c. opioid prescribing guideline. and putting that into a one-stop-shop where individuals can get to that. we're absolutely committed to

advancing the adotchings evidence-based practices. that's what's been asked of us by congress for the policy lab and the assistant secretary as well is committed to that. mr. engel: i'm glad to hear. it how will the policy lab help access to evidence-based treatment and promote results-driven activities? and how can we in congress help samhsa achieve those goals? dr. jones: certainly the charge that was given to the policy lab is a tremendous step forward in helping us to do that. to identify what's working and to help disseminate that information. so one thing that we're doing specific to medication is with our s.t.r. opioid dollars, there are quite a lot of natural experiments that are happening in the state. sort of a natural laboratory of people looking at how do we initiate themental department nd connect people to care -- initiate the emergency department and connect people to care. what we're doing now sent gauging with states to evaluate

those innovations and interventions and the plan would be to very quickly, once we identify what's working, to then desimilar nate that information out -- disseminate that information out, but also fuse it into our funding announcements so we're helping to drive evidence into practice through our funding streams and not continuing to support nonevidence-based practices. mr. engel: that i very much. mr. burgess: the gentleman's time has expired. the chair recognizes the gentleman from missouri. mr. long: thank you, mr. chairman. thank you for having the hearing and thank you to the witnesses for being here today. in missouri from 2012 to 2016, we received a 78% increase in opioid overdose deaths. i experienced three of those myself. people, friends of mine lost children in their 20's in those same years. 2012-2016. they were children from columbia, missouri, university of missouri, springfield,

missouri, 160,000 population. kansas city mureks. so these were not rural areas -- kansas city, missouri. so these were not rural areas. however, in the study that the missouri hospital association did, that showed the 78% increase from 2012 to 2016, the biggest spike was in the rural areas. i do a farm tour every year, an agricultural tour. we tour through our district. i have a lot of rural areas in my district. we were driving along on the bus one day, riding along on the bus and looking out. it was just picturesque. it was gorgeous. it looked like could you have a farmland ad on their in tv with green fields and everything. and the fellow lead the tour said their number one problem in the area was heroin addiction. of the high school kids. nd so my question is this. with that sharp increase in the rural areas, how do we ensure that rural areas are getting the resources they need to combat opioid abuse and what else do you think need to be done to

make sure rural areas can adequately address abuse? dr. schuchat: thank you for that question. it's a terrible problem in some of the rural areas. one of the things we've been doing is working with samhsa on evaluating the distribution of naloxone to help wake people up who have overdosed and there are some gaps in rural areas in a lot of states. so trying to make sure there's the naloxone distribution, but also ability to link to care and the recognition that perhaps telemedicine may be helpful for some of the treatments where there are low access areas. i think it's a big problem that's going to take a lot of time. but the way that c.d.c. shepping is by providing resources to the state health departments and letting them improve their data so they know where the hot spots are so they can improve prevention, treatment and recovery in the hot spot areas which in many places are rural. dr. jones: i would just add that

we've worked collaboratively with c.d.c. we did a paper last year looking specifically at drug overdose and drug use disorders in rural areas to highlight this important issue. with our s.t.r. dollars, i think looking at the systems innovations is a way to help address some of the capacity issues in rural areas. i'll use project echo as an example. which started in new mexico, which has had very high rates of opioid addiction and overdose in very rural communities that have very little infrastructure for health care. project echo is at the university of new mexico and they actually worked with the rural providers to train them, to provide them with resources that really help supported them to provide addiction care in the community. so the individual from the rural area didn't have to travel to the academic medical center two hours away in order to get care. so with our opioid state target of response grants, a number of states are looking at that project echo mold, looking at other models that you can build

that capacity in those areas to address those issues. i think underscoring the importance of the data to understand where do we need to be targeting those resources is really critical and working with the states to analyze that data, to say, you know, you thought you had a problem in city x but it's actually city y and we need to make sure that we're deploying resources to that area. mr. long: there's a fellow that sits behind you all occasionally in here, comes in here quite a few times. he has a son i think when he was 19 or 20 years old a few years ago got out of rehab for his hired time, they had i believe -- third time, they had i believe christmas, they found their son on the floor in the bathroom and -- they thought he was dead. they got him to the hospital. the e.m.t.'s revived him and he looked at his dad the next day in the hospital and said, i knew when i got out of rehab that i couldn't do the same amount of heroin that i used to do but i just did a -- i could hardly get

it to melt on the spoon and it about killed him. they got him on whatever drug it is, the high-priced injection thing. i say high-priced, $1,000 a month, but he's done really, really well since then. is it money, if you had all the money in the world, can we attack this problem or not? you just siter, if there and write checks all day, is there anything we can do that -- what would be the most effective thing we could do if you had an unlimited budget for this problem? dr. gottlieb: certainly resources are helpful but work force is equally as important. we have a lack of sufficient work force to address the addiction and mental health problems that face our country. dr. jones: i think -- mr. long: if you had the money could you hire the help? dr. jones: we have to think about how resources are used. part of that is to build at that thank capacity which is what

we're doing with the funding benefit fow -- we have now. so it's building the work force and systems and frals. many of the issues that we're talking about today -- the infrastructure. many of the issues that we're talking about today are the things we need to be doing to advance. that how do we more quickly scale those things up? resources are deleerl a -- resources are clearly a part of that. mr. long: i thank you. >> i thank the gentleman for yielding back and the chair recognizes dr. bucshon from indiana for five minutes for questions. mr. buchanan: -- mr. bucshon: thank you, mr. chairman. i was a physician before i was in congress. web of seen this coming for quite a while. and i'm really pleased that now there's a national attention on this issue. i'm interested in finding solutions to the opioid epidemic partially by focusing on addressing the underlying causes of the opioid use disorder and specifically looking at innovative solutions to address acute and chronic pain. does the c.d.c. collect statistics information about how many americans suffer from

chronic pain? or information related to access to treatment? dr. schuchat: that's not a core part of our surveillance systems right now. we don't think that pain itself has increased over the past few decades. but we have changed how we were prescribing for pain, with the availability of the longer acting opioids. mr. bucshon: is there a need for more information in that space? the speaker pro tempore: she's -- dul dr. schuchat: i think better understanding of pain and the different factors contributing to it will be important, as well as access to alternative approaches for pain management, which are safer and perhaps more effective. mr. bucshon: feign he is -- pain's very subjective and it's sometimes difficult to put your finger on. i can tell you just doing the surgery that i did the variance in the amount of postoperative discomfort that people would claim to have, that did have the severity of that is very across an entire spectrum.

so that's difficult. information on people that truly have i think chronic pain syndromes that may require long-term opioid treatment would -- might be important. i think that's one of the concerns. that i think patient advocacy groups in that space are concerned about and information on the actual number and how we deal with that might be helpful. dr. schuchat: yeah. but also knowing what are the best approaches for that. recently there was a randomized control trial that compared opioids with anti-inflammatories for back pain and other things and at a year out people who were on the nonsteroids were doing better. mr. bucshon: i just read that. dr. schuchat: i think we've been taught that we were undertreating pain and people thought the way to treat pain was with the opioids and probably there are better ways to treat many kind of pain but of course not all. our guidelines were not to take in medicine away from people with certain things.

there's a lot of -- mr. bucshon: people get resistant so they need more and more. a lot of these parents -- patient, the pain initiated the therapy in the first place is not the reason why they're continuing to take the medication. successfully tackling the opioid crisis requires in part ensuring that patients have access to alternative effective treatments for chronic pain. i'd like to note the recent f.d.a. education blueprint for health care providers involved in the treatment and monitoring of patients with pain highlights the importance of provider awareness regarding the range of therapeutic options for managing pain, including nonpharmacy approaches and farmsy -- and nonopioid they are miss. include -- therapies. i know there are a number of existing medical technologies on the market today, including

spinal cord stimulation and implantable drug pumps for nonopioid medications, radio frequency, amongst a variety of other things. could you speak to your per speckive on the role of medical -- perspective on the role of medical technology in advancing the treatment of pain and alleviating partially helping with the opioid crisis? dr. gottlieb: i think it plays a crit krall role. we -- a critical role. we have over 200 approved medical devices for different pain indications, about 10 of those are very novel technologies. and i think that there's a lot of opportunity for medical devices for a lot of different pain syndromes. particularly where you have regional pain. or where you might be taking a systemic drug for what is a regional condition, a regional muscular skeletal pain in particular, where you might be able to address it with medical device that's delivering localized anesthesia. so there's a big opportunity. we're looking at what we can do through our policy tools to try to incentivize development there.

we're looking at particularly some challenge programs in trying to get out better guidance on the development of devices that could address pain. as a way to try incentivize more development those kinds of products. mr. bucshon: you think you have the tools you need to get some of these innovative products to the consumer or are there barriers that are legislative that might be necessary to help you in along in that process? dr. gottlieb: i'd be happy to give that some thought. i can't say right now that there are limitations in our review authorities where we don't have adequate flexibility to make accommodations here or think in innovative ways. we do have flexibility under the medical device statute which allows the complexity of the product and the risk inherent in the product. we do have flexibility on the medical device side of our house to address sort of unique swrations where we might want to foster -- situations where we

might want to foster innovation. we've come up with things we can do under our existing authority. mr. bucshon: the actual barrier could be over at c.m.s. at the end of the day. sometimes i think i found that to be true. since i've been in congress. so we're trying to address that side of it also. thank you. i yield back. >> i thank the gentleman for yielding back and the chair recognizes mrs. brooks from indiana. mrs. brooks: thank you, mr. chairman. some time ago in about 2015, indiana, scott county in particular, experienced a horrific hisk outbreak and i know the c.d.c., a lot of different agencies were very involved in helping us curb that outbreak. and now most recently we are eing and papers reported a massive increase in help c cases throughout our state and in some of my counties i represent specifically. and being directly connected in many ways to opioid use.

and so we know that majority of these infectious diseases are attributable injection drug use and we know public health officials are focusing hard on these problems and on solutions. but i guess i'm curious, i want to come back to the c.d.c., i believe we've talked about this in the past. having to do with the h.i.v. outbreaks. but can you talk to us about what you're doing to continue to monitor the infectious disease outbreaks, particularly as we're not turning the tide on the opioid use and what kind of levels are we seeing nationally and what tools are available to states to help them react or to try to get ahead of it maybe faster than we are right now? because i think we're losing another battle in addition to the opioid battle. but they are i think very related. dr. schuchat: the indiana outbreak in scott county was a wakeup call. we did molding to identify over

200 vulnerable counties around the country that could be just like scott county in terms of outbreaks of hisk or help c in the context -- h.i.v. or help c in the context of the opioid use. we distributed that information to the state and local health departments but much more is needed in terms of improving the vary lance for those infectious disease -- surveillance of those infectious disease complications of opioid use disorder and also the screening treatment and longer term care. the hepatitis c is increasing in many areas. but we don't have as good surveillance for it as we would like. mrs. brooks: can you talk to us about surveillance tools that either you use or do you need any additional authorities? how are you surveilling for these outbreaks? dr. schuchat: the surveillance is usually laboratory based. the labs do the testing but there's usually a need for active follow-up to determine, is it new, has it already been reported somewhere else? it's really strengthening that public health front line infrastructure in the labs and the health departments to be

able to improve the quality of surveillance and feed the information back more rapidly. mrs. brooks: and do you -- so that collaboration that you have with the state and county labs in many ways, and state health departments, is there additional funding that, as we are hopefully getting ready to in this next budget provide a lot more funding to state and locals who are on the front lines of this, is this something that we need to make sure or that samhsa and the grants they put out, that you all can make sure there is more funding for this type of surveillance? dr. schuchat: yes. this does need to be better supported. we're tracking some of the infectious complications but not all of them. and we're not doing it quickly enough. we think that better data on prescrike, better data on overdoses, and better data on the infectious complications will help us turn the epidemic

around. mrs. brooks: are there any other infectious diseases specifically that we ought to be looking for, monitoring for, and raising the level of awareness with our state and local health officials? dr. schuchat: yeah. i'd like to signal the need for nameable and flexible public health response. we wouldn't have expected hepatitis a to increase in associated with injecting drug use but it has and we've had large outbreaks in michigan, in multiple states. california, many states around the country. of hepatitis a. so we think that the broader infectious disease complications of injecting drug use or opioid epidemic would be helpful. right now we have a group a strep, the flesh-eating bacteria, outbreak that's associated with the injection of drugs. so i think -- mrs. brooks: would you repeat that? dr. schuchat: the group a strap, the flesh eating back tear yarks we're having an outbreak of that that's been -- bacteria, we're having an outbreak of that

that's traced back to injecting drugs. it can come in through the skin. so i think just as we started this wave of yore doses with -- overdoses with prescriptions, complicated later by heroin and most recently fentanyl, in terms of infect shuzz diseases we have to have -- infectious diseases we have to have our eyes wide open. i was talking about an outbreak in scotland of anthrax that was swoshede injection drugs there. so -- associated with injection drugs there. so we need to look more broadly and certainly the viral hepatitis infections are the leading ones we have to be worried about. mrs. brooks: thank you. >> the chair recognizes mr. crarter -- carter from georgia for five minutes. mr. carter: thank you, mr. chairman. around thank all of you for being here. -- and thank you all for being here. something that former chairman upton asked but, that's the abuse deterrent formulations. i know that in your 2018 action plan, that your plan states, among our science-based efforts we will assist toward wider use

of opioid drugs with improved formulations that are harder to manipulate and abuse. comment on that and what you see as the role of these particular formulations in the future. dr. gottlieb: we do think there's an opportunity for these drugs to potentially reduce the rate of overall abuse and addiction in the market. and do see a potential opportunity from converting more of the market to abuse deterrent formulations that are harder to manipulate in ways this allow -- [captioning performed by the national captioning institute, which is responsible for its caption content and accuracy. visit ncicap.org] [captions copyright national cable satellite corp. 2018] >> this hearing about to wrap up. you can see all of it online if you search opioid epidemic in the search bar. also the president's speech on the issue from monday in new hampshire. the u.s. house gaveling in momentarily and off the floor, news that an omnibus spending bill is imminent. spending deal is imminent. the headline in "the hill" saying, after meetings breaking up on capitol hill, a tweet from erric, writing for bloomberg, saying that the spending bill will address school gun violence

by bolstering federal background checks database, fixing the nics, and funding protections at schools. wider gun control is not part of the deal. the deal should be announced and released within the hour. the u.s. house many while gaveling back in momentarily and we expect them to take up a bill that they failed to pass on suspension last week. the right to try act. which would allow terminally ill patients to try medication that has yet to be approved by the f.d.a. we expect votes this afternoon sometime in the 2:00 hour. and perhaps word on the timetable for that fiscal year 2018 spending bill, the so called omnibus legislation. the senate in session this afternoon. they continue debate on a sex trafficking bill that's passed the u.s. house. you can follow the senate on c-span2 and the house gaveling in momentarily here on c-span.