[Senate Hearing 115-636]
[From the U.S. Government Publishing Office]


                                                        S. Hrg. 115-636

               THE FEDERAL RESPONSE TO THE OPIOID CRISIS

=======================================================================

                                HEARING

                                OF THE

                    COMMITTEE ON HEALTH, EDUCATION,
                          LABOR, AND PENSIONS

                          UNITED STATES SENATE

                     ONE HUNDRED FIFTEENTH CONGRESS

                             FIRST SESSION

                                   ON

          EXAMINING THE FEDERAL RESPONSE TO THE OPIOID CRISIS

                               __________

                            OCTOBER 5, 2017

                               __________

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         Committee ON HEALTH, EDUCATION, LABOR, AND PENSIONS

                  LAMAR ALEXANDER, Tennessee, Chairman
MICHAEL B. ENZI, Wyoming		PATTY MURRAY, Washington
RICHARD BURR, North Carolina		BERNARD SANDERS (I), Vermont
JOHNNY ISAKSON, Georgia			ROBERT P. CASEY, JR., Pennsylvania
RAND PAUL, Kentucky			AL FRANKEN, Minnesota
SUSAN M. COLLINS, Maine			MICHAEL F. BENNET, Colorado
BILL CASSIDY, M.D., Louisiana		SHELDON WHITEHOUSE, Rhode Island
TODD YOUNG, Indiana			TAMMY BALDWIN, Wisconsin
ORRIN G. HATCH, Utah			CHRISTOPHER S. MURPHY, Connecticut
PAT ROBERTS, Kansas			ELIZABETH WARREN, Massachusetts
LISA MURKOWSKI, Alaska			TIM KAINE, Virginia	
TIM SCOTT, South Carolina		MAGGIE WOOD HASSAN, New Hampshire                                  
                                     
               David P. Cleary, Republican Staff Director
         Lindsey Ward Seidman, Republican Deputy Staff Director
                 Evan Schatz, Democratic Staff Director
             John Righter, Democratic Deputy Staff Director
                            
                            
                            
                            C O N T E N T S

                              ----------                              

                               STATEMENTS

                       THURSDAY, OCTOBER 5, 2017

                                                                   Page

                           Committee Members

Alexander, Hon. Lamar, Chairman, Committee on Health, Education, 
  Labor, and Pensions, opening statement.........................     1
Murray, Hon. Patty, a U.S. Senator from the State of Washington..     3
Murkowski, Hon. Lisa, a U.S. Senator from the State of Alaska....    12
Hassan, Hon. Margaret Wood, a U.S. Senator from the State of New 
  Hampshire......................................................    14
Young, Hon. Todd, a U.S. Senator from the State of Indiana.......    16
Bennet, Hon. Michael F., a U.S. Senator from the State of 
  Colorado.......................................................    18
Collins, Hon. Susan M., a U.S. Senator from the State of Maine...    19
Cassidy, Hon. Bill, a U.S. Senator from the State of Louisiana...    24
Murphy, Hon. Christopher S., a U.S. Senator from the State of 
  Connecticut....................................................    26
Kaine, Hon. Tim, a U.S. Senator from the State of Virginia.......    28
Whitehouse, Hon. Sheldon, a U.S. Senator from the State of Rhode 
  Island.........................................................    29
Franken, Hon. Al, a U.S. Senator from the State of Minnesota.....    31
Baldwin, Hon. Tammy, a U.S. Senator from the State of Wisconsin..    33
Warren, Hon. Elizabeth, a U.S. Senator from the State of 
  Massachusetts..................................................    35

                               Witnesses

Statement of Elinore F. McCance-Katz, M.D., Ph.D., Assistant 
  Secretary for Mental Health and Substance Use, Substance Abuse 
  and Mental Health Services Administration, Rockville, MD.......     5
Statement of Debra Houry, M.D., MPH, Director, National Center 
  for Injury Prevention and Control, Centers for Disease Control 
  and Prevention, Atlanta, GA....................................     7
Statement of Francis Collins, M.D., Ph.D., Director, National 
  Institutes of Health, Bethesda, MD.............................     8
Statement of Scott Gottlieb, M.D., Commissioner, Food and Drug 
  Administration, Silver Spring, MD..............................    10
                          ADDITIONAL MATERIAL

Statements, articles, publications, letters, etc.:
    Written Testimony on behalf of the Witnesses from the 
      Department of Health and Human Services (HHS)..............    44
    Response by Scott Gottlieb to questions of:
        Senator Alexander........................................    53
        Senator Murray...........................................    56
        Senator Burr.............................................    59
        Senator Collins..........................................    61
        Senator Franken..........................................    61
        Senator Hassan...........................................    62
        Senator Hatch............................................    63
        Senator Roberts..........................................    63
        Senator Warren...........................................    63
        Senator Whitehouse.......................................    66
        Senator Young............................................    66
    Response by Francis Collins to questions of:
        Senator Alexander........................................    67
        Senator Murray...........................................    67
        Senator Collins..........................................    71
        Senator Franken..........................................    72
        Senator Hassan...........................................    73
        Senator Roberts..........................................    75
        Senator Warren...........................................    75
        Senator Whitehouse.......................................    81
        Senator Young............................................    81
    Response by Elinore McCance-Katz to questions of:
        Senator Alexander........................................    83
        Senator Murray...........................................    84
        Senator Burr.............................................    86
        Senator Casey............................................    86
        Senator Cassidy..........................................    87
        Senator Collins..........................................    90
        Senator Franken..........................................    90
        Senator Hassan...........................................    91
        Senator Warren...........................................    93
        Senator Whitehouse.......................................    95
        Senator Young............................................    98

 
               THE FEDERAL RESPONSE TO THE OPIOID CRISIS

                              ----------                              


                       Thursday, October 5, 2017

                                U.S. Senate
        Committee on Health, Education, Labor, and Pensions
                                                    Washington, DC.
    The Committee met, pursuant to notice, at 10:03 a.m., in 
room 430, Dirksen Senate Office Building, Hon. Lamar Alexander, 
Chairman of the Committee, presiding.
    Present: Senators Alexander [presiding], Murray, Collins, 
Cassidy, Young, Murkowski, Scott, Casey, Franken, Bennet, 
Whitehouse, Baldwin, Murphy, Warren, Kaine, and Hassan.

                 Opening Statement of Senator Alexander

    The Chairman. The Senate Committee on Health, Education, 
Labor, and Pensions will please come to order.
    Today's hearing is about the opioid crisis we're facing and 
what the Federal Government is doing about it. Senator Murray 
and I will each have an opening statement, and then we'll 
introduce the witnesses. After the witnesses' testimony, 
Senators will each have 5 minutes of questions.
    The Senate has inefficiently scheduled three votes, 
starting now, and all of us would like to hear the witnesses' 
testimony, so we'll figure out what to do about that. The best 
thing to do is to go ahead and get started with our opening 
statements.
    The opioid crisis is tearing our communities apart, tearing 
families apart, and posing an enormous challenge to health care 
providers and law enforcement officials.
    The amount of opioids prescribed in the United States in 
2015 was enough for every American to be medicated around the 
clock for 3 weeks, according to the Centers for Disease Control 
and Prevention.
    In 2016, there were over 7.6 million opioid prescriptions 
for pain in Tennessee, according to the Tennessee Department of 
Health. That means there were 1,148 opioid prescriptions for 
every 1,000 persons.
    In March, researchers published a study that found nearly 
one in five patients who were prescribed an initial 10-day 
supply of opioids were found to still be using opioids a year 
later.
    Last year, 1,631 Tennesseans died of a drug overdose, 12 
percent more than the year before, mostly due to an increase in 
overdoses of synthetic opioids, including fentanyl, a pain 
medication that is 50 to 100 times stronger than morphine and 
can kill with just a small dose.
    In Blount County, where I live in Tennessee, there were 21 
people who died from an opioid overdose in 2016 alone.
    Last year was the highest rate of drug overdose deaths in 
recorded history in our State. Nearly 3 out of 4 of the drug 
overdoses in Tennessee are related to opioids.
    Last year, over 1,000 babies born in Tennessee were born 
addicted to opioids.
    The rate of Tennesseans being prescribed opioids is one of 
the highest in the country.
    This is a crisis, not just in Tennessee, but across the 
country.
    Since 1999, the rate of overdose deaths involving opioids, 
including prescription drugs and heroin, has nearly quadrupled 
in our Nation. Ninety-one Americans die every day from an 
opioid overdose.
    I hope today's distinguished panel of witnesses can give 
this Committee an update on the Federal response to the crisis, 
what's working, and what needs work.
    This Committee has worked together to pass laws that help 
prevent addiction, encourage appropriate prescribing, and 
improve treatment.
    In July 2016, the Comprehensive Addiction and Recovery 
Act--we call it CARA--was signed into law. This legislation 
established new programs and authorities, reauthorized existing 
ones, and encouraged law enforcement, public health 
departments, and health care providers to work together to 
combat substance abuse.
    A few weeks ago, the Administration announced that, under 
CARA, $144 million in grants will be awarded to 58 recipients, 
including states, cities, health care providers, and community 
organizations.
    Tennessee will receive $6 million of that money.
    Then in December 2016, as part of the 21st Century Cures 
Act, we worked together to update drug abuse programs out of 
the Substance Abuse and Mental Health Services Administration 
and provide $1 billion to states for prevention and treatment 
efforts.
    This past spring, the Administration began issuing grants 
funded by Cures, totaling $485 million to all 50 states.
    Tennessee received nearly $14 million of that.
    The most ambitious goal of 21st Century Cures was to drive 
the research discoveries predicted over the next decade by one 
of our witnesses today, Dr. Francis Collins, the Director of 
the National Institutes of Health, which he calls the National 
Institutes of Hope. He has predicted the development of an 
artificial pancreas, organs built from patients' own stem 
cells, an HIV/AIDS vaccine, a Zika vaccine, and non-addictive 
painkillers. Non-addictive ways to treat pain could be medical 
devices or drugs.
    While there is an urgent need for this, it is not at all a 
new idea. In 1928, what became known as the ``Committee on the 
Problems of Drug Dependence'' formed to organize research in 
pursuit of a non-addictive painkiller. We all know the 
importance of finding a way to deal with pain. We were having a 
conversation just before the hearing. One report, according to 
the New York Times, is about a third of Americans have 
intermittent pain. Dr. Collins says that 25 million Americans 
live with pain every day. This is not to minimize the number of 
Americans who need some form of help relieving pain.
    I want to hear today about the public-private partnership 
that the National Institutes of Health is leading, and about 
what policies FDA has put in place to make sure that the opioid 
alternatives submitted to FDA are prioritized appropriately and 
get the attention they ought to. I have heard from numerous 
companies that have either submitted to the FDA or have 
products for pain in development, and I want to make sure they 
have clear guidance on what is necessary for FDA to review them 
in a timely way. If traditional fast track, priority, or 
breakthrough pathways do not fit these products, I would like 
to hear how we could provide the help FDA may need.
    Prescription drug monitoring programs, which are state-run 
electronic data bases that can track controlled substances 
prescribed by doctors and dispensed by pharmacists, are an 
important and innovative tool. I look forward to hearing today 
how we can help states better integrate prescription drug 
monitoring programs with electronic health records to help 
inform physicians' practices while protecting patient privacy.
    Congress has accomplished a lot in a bipartisan way to 
provide funding and update programs to assist states and help 
combat this public health crisis. I look forward to hearing how 
the Administration is moving forward in this important work.
    Senator Murray.

                  Opening Statement of Senator Murray

    Senator Murray. Well, thank you very much, Chairman 
Alexander. Thank you to all of our colleagues for coming 
together for this truly urgent discussion.
    Every day, from every corner of the country, we hear more 
about the damage being caused by the opioid crisis: lives being 
taken off track; mothers and dads who worry about the late-
night calls they might get, or what it means if no call comes 
through; children who have lost their parents; and communities, 
hospitals, and emergency services overwhelmed. It is hard to 
grasp the full scope and scale of this crisis, even as we learn 
more.
    I was recently in Longview, Washington, a small town in my 
state, visited a local hospital, and I was told by the staff 
that nearly 50 percent of all babies born there last year have 
mothers who struggle with substance use. That was just 
overwhelming and heartbreaking. It speaks to what I've heard 
all over my state, in every community, from the big 
communities, Seattle and Everett, to smaller Bellingham, 
Spokane, the Tri-Cities, Vancouver, everywhere I go. In 
meetings I hear the same thing, with families and providers and 
patients and law enforcement professionals.
    This is not somebody else's problem. It's all of ours. 
Again, that's why I am very glad that we have this opportunity 
today to discuss this and hear from leaders who are closest to 
these issues about what they are seeing and learning in each of 
their roles.
    Thank you all for joining us today. I am very glad that you 
could all be here with us today, though I have to say I am very 
concerned that Dr. Fitzgerald has not sufficiently divested to 
be able to testify on such an important issue. We'll be 
following up on that because we do need CDC to be at full 
strength and not subject to the distractions that have been 
plaguing this Administration.
    Your agencies all play a critical role, and I know we are 
all looking forward to hearing how this administration is 
stepping up and where it is falling behind, and that includes 
on implementation of the Comprehensive Addiction and Recovery 
Act and the 21st Century Cures Act.
    I will have specific questions for all of you, including 
how SAMHSA is making sure Federal funds to address this crisis 
are being used to help people in all our communities; what 
steps CDC can take to prevent opioid misuse in the first place; 
how NIH is working to support biomedical research that helps us 
better understand chronic pain; and how FDA is working to 
include public health considerations when it approves new pain 
products and assuring that non-addictive pain products are 
being handled with clarity, consistency, and an all-hands-on-
deck approach.
    I do want to make a couple of points from the outset. First 
of all is that today's hearing is only possible because the 
latest Trumpcare Bill met a dead end, because it's a no-brainer 
that undercutting the entirety of the country's health care 
system would set us back in addressing this crisis. What we've 
seen from every repeal bill is drastic cuts to funding for 
treatment and addiction services, hits to Medicaid and critical 
patient protections that are today provided under current law.
    I hope that we can finally turn the page on those fights 
and focus on moving forward. On that I am, Mr. Chairman, very 
appreciative of the bipartisanship that many on this Committee 
have shown in our ongoing work on market stabilization.
    Another step is making sure we are doing everything we can 
right now to fight this crisis head on, and I do have several 
concerns. The Administration has delayed critical steps that 
could help provide immediate relief to families suffering 
today, proposing budget cuts for prevention efforts around 
substance use disorder and mental health programs under SAMHSA; 
undermining the value of medication-assisted treatment in 
effectively managing opioid use disorders; and pushing the 
Department of Justice to treat addiction as a criminal justice 
issue.
    Fortunately, we've made some progress in this Committee. 
Like everyone here, I am very proud to have worked on the 21st 
Century Cures Act, which authorized nearly $1 billion for 
states to address the opioid crisis through prevention, 
treatment, and recovery efforts; and the CARA Act, which 
supports outreach for veterans and pregnant and postpartum 
women, expands access to medication-assisted treatments, and 
more.
    I can't say clearly enough that our work is not over, and 
we must do more. As we work to buildupon our work in CARA and 
Cures, it's absolutely critical that we put investments into 
making sure these policies have the impact that families and 
communities need.
    We should be doing everything we can to tackle this crisis 
and push for actual results. Critical to that is that the 
Administration is a partner and not a hindrance to our efforts.
    We have a lot to cover today, and I am very much looking 
forward to our conversation. I know, Mr. Chairman, a lot of our 
senators are juggling a lot of commitments today, including 
votes which have just started, and a budget day-long hearing, 
and many other hearings. I just want to make sure we include a 
statement for the record right now from Senator Sanders and 
anybody else before we move to questions.
    The Chairman. We will be glad to do that.
    I'm going to offer brief introductions of our witnesses and 
hope that we can hear all four of them before I have to leave 
to go vote, and then we'll see how to handle the three votes.
    First, Dr. McCance-Katz is the Assistant Secretary for 
Mental Health and Substance Use, the lead agency. SAMHSA is the 
lead agency within the Department of Health and Human Services 
related to substance abuse and mental health.
    Dr. Debra Houry, Director of the National Center for Injury 
and Prevention Control, the Centers for Disease Control and 
Prevention.
    Dr. Francis Collins, who has been Director of the National 
Institutes of Health since 2009.
    Dr. Scott Gottlieb, who is Commissioner of the Food and 
Drug Administration, who was confirmed in May of this year.
    Dr. McCance-Katz, why don't we begin with you? I will ask 
each of you to please summarize your comments in about 5 
minutes.

              STATEMENT OF ELINORE F. MCCANCE-KATZ

    Dr. McCance-Katz. Thank you, Senator Alexander. Chairman 
Alexander, Ranking Member Murray, and Members of the Senate 
Health, Education, Labor, and Pensions Committee, thank you for 
inviting me to testify at this important hearing. I'm honored 
to testify today along with my colleagues from the Department 
of Health and Human Services on the Federal response to the 
opioid crisis.
    Over the past 15 years, communities across our Nation have 
been devastated by increasing prescription and illicit opioid 
abuse, addiction, and overdose. In 2016, over 11 million 
Americans misused prescription opioids, nearly 1 million used 
heroin, and 2.1 million had an opioid use disorder due to 
prescription opioids or heroin.
    Most alarming are the continued increases in overdose 
deaths, especially the rapid increase in deaths involving 
illicitly made fentanyl and other highly potent synthetic 
opioids since 2013. The Trump Administration is committed to 
bringing everything the Federal Government has to bear on this 
health crisis.
    The Department of Health and Human Services has identified 
five specific strategies that are guiding the response. This 
comprehensive, evidence-based opioid strategy aims to improve 
access to treatment and recovery services to prevent the 
health, social, and economic consequences associated with 
opioid addiction and to enable individuals to achieve long-term 
recovery; to target the availability and distribution of 
overdose-reversing drugs to ensure the broad provision of these 
drugs to people likely to experience an overdose; to strengthen 
public health data reporting and collection to improve the 
timeliness and specificity of data and to inform a real-time 
public health response as the epidemic evolves; to support 
cutting-edge research that advances our understanding of pain 
and addiction, leads to the development of new treatments, and 
identifies effective public health interventions to reduce 
opioid-related health harms; and to advance the practice of 
pain management to enable access to high-quality, evidence-
based pain care that reduces the burden of pain for 
individuals, families, and society while also reducing the 
inappropriate use of opioids and opioid-related harms.
    HHS appreciates Congress' dedication to this issue as 
evidenced by passage of the 21st Century Cures Act and the 
Comprehensive Addiction and Recovery Act.
    In my role as Assistant Secretary for Mental Health and 
Substance Use at HHS, I lead the Substance Abuse and Mental 
Health Services Administration. I appreciate the opportunity to 
share with you a portion of SAMHSA's portfolio of activities in 
alignment with HHS' five strategies and how SAMHSA is 
implementing the 21st Century Cures Act and CARA.
    SAMHSA is administering the Opioid State Targeted Response 
grants program created by the 21st Century Cures Act. By 
providing $485 million to states in Fiscal Year 2017, this 
program is increasing access to treatment, reducing unmet 
treatment need, and reducing opioid overdose-related deaths 
through the provision of prevention, treatment, and recovery 
services.
    Further, HHS is working to ensure that the funding 
allocations and policies are as clinically sound, evidence-
based, effective and efficient as they can be. SAMHSA has 
several initiatives aimed at advancing the utilization of 
medication-assisted treatment for opioid use disorder. For 
example, in the past 4 years more than 62,000 medical 
professionals have participated in online or in-person SAMHSA-
funded trainings on medication-assisted treatment for opioid 
use disorders. SAMHSA regulates opioid treatment programs and 
provides waivers to providers that prescribe buprenorphine for 
the treatment of opioid addiction.
    Last year, SAMHSA published a final rule allowing certain 
physicians who have had a waiver to prescribe buprenorphine for 
up to 100 patients to obtain a waiver to treat up to 275 
patients. As of September 19th, 3,573 physicians have done so.
    SAMHSA has also implemented the CARA provision that allows 
nurse practitioners and physician assistants to prescribe 
buprenorphine. As of September 19th, 2,756 nurse practitioners 
and 773 physician assistants have received a waiver from 
SAMHSA.
    SAMHSA also promotes recovery from opioid and other 
substance use disorders through targeted grants such as last 
month's award of $4.6 million over 3 years in the Building 
Communities of Recovery grant program created by CARA.
    SAMHSA has been a leader in efforts to reduce overdose 
deaths by increasing the availability and use of naloxone to 
reverse overdose. SAMHSA is currently providing grants to 
prevent opioid overdose-related deaths, which are being used to 
train first responders as well as to purchase and distribute 
naloxone. Last month SAMHSA awarded additional grants 
authorized by CARA, including almost $46 million over 5 years 
to grantees in 22 states to provide resources to first 
responders as well as substance use disorder treatment 
providers who work directly with populations at highest risk 
for overdose. states can also use opioid STR funds to purchase 
and distribute naloxone, and some states are using a portion of 
their block grants for this purpose.
    SAMHSA's National Survey on Drug Use and Health provides 
key national and State-level data on a variety of substance use 
and mental health topics, including opioid misuse. NSDUH is a 
vital part of the surveillance effort related to opioids, and 
the data from NSDUH has been used to track historical and 
emerging trends in opioid misuse, including geographic and 
demographic variability.
    SAMHSA also works collaboratively with other agencies to 
better understand the epidemic through sharing of data and 
assessing the implications of that data.
    Thank you again for the opportunity to share with you our 
work to combat the opioid epidemic, and I look forward to 
answering your questions.
    The Chairman. Thank you, Dr. McCance-Katz.
    For the information of senators, I'm going to stay through 
the four witnesses statements and then go vote. If you want to 
stay through that, we won't miss the vote, maybe leave when I 
leave, or you can fire me if I'm wrong.
    [Laughter.]
    Dr. Houry.

                    STATEMENT OF DEBRA HOURY

    Dr. Houry. Good morning, Chairman Alexander, Ranking Member 
Murray, and Members of the Committee. I am Dr. Deb Houry, 
Director of the National Center for Injury Prevention and 
Control at the CDC.
    As an emergency physician, I was honored to join CDC 3 
years ago to save even more lives in this role. I am pleased to 
have the opportunity to testify before you today.
    CDC's expertise as the Nation's public health and 
prevention agency is essential in reversing the opioid 
epidemic. CDC is focused on preventing people from getting 
addicted in the first place. CDC has the unique role of leading 
prevention by addressing opioid prescribing, tracking trends, 
and driving community-based prevention activities.
    America's opioid epidemic affects people from every 
community, and it is one of the few public health problems that 
is getting worse instead of better. Drug overdoses have 
dramatically increased, nearly tripling over the last two 
decades. Further, the opioid overdose crisis has led to a 
number of other problems, including increases in babies born 
withdrawing from narcotics and a drop in life expectancy for 
the first time since the AIDS epidemic in 1993.
    Today's overdose fatalities are just the tip of the 
iceberg. For every one person who dies of an opioid overdose, 
over 60 more are already addicted to prescription opioids, 
almost 400 misuse them, and nearly 3,000 have taken one. Using 
a comprehensive approach as outlined in the HHS Priorities, we 
will work together to stop this epidemic.
    CDC has been on the front lines since the beginning. Over a 
decade ago, after hearing alarming news from medical examiners 
about increases in overdose deaths, and after an outbreak 
investigation in North Carolina, CDC scientists made the 
connection to prescription opioids.
    Today we are working closely with state health departments 
and providing guidance on best practices so states can rapidly 
adapt and we can use what we learned what works best in this 
evolving epidemic. CDC now funds 45 states and Washington, DC 
to advance prevention in key areas at the community level, 
including improving prescription drug monitoring programs, or 
PDMPs, improving prescribing practices, and evaluating 
policies.
    In Georgia, where I have worked in the ER, these 
investments help make it easier for me to check the 
prescription history of my patients. In Kentucky, prompts were 
added to the PDMP to alert to high doses, which resulted in a 
25 percent reduction in opioid prescribing to youth. These 
investments can literally save lives.
    CDC is also leading improvements to the public health data 
we all rely on to understand the crisis. We are now releasing 
preliminary overdose data and have improved reporting 
significantly from a lag of 2 years down to 7 months.
    As part of CDC's funding to states, we're ramping up our 
efforts to get more reliable and timely data from emergency 
rooms and medical examiners and coroners to enhance 
surveillance programs. For the first time, this program tracks 
non-fatal opioid overdoses so that we have a better 
understanding of the changing epidemic so that states can 
respond accordingly. This is the value of informed and nimble 
public health.
    States call on CDC to provide on-the-ground assistance when 
they experience an opioid-related crisis. We helped 
Massachusetts identify that a surge in opioid deaths was caused 
by fentanyl, and we assisted Indiana to identify and contain an 
HIV and hepatitis C outbreak related to injections of 
prescription opioids. We truly appreciate the support we 
receive from this Committee for our Guideline for Prescribing 
Opioids for Chronic Pain, which we released last year. Now we 
are focused on making the guideline easy for clinicians to 
implement through interactive trainings and a mobile app.
    We are also focusing on patients and families. Just last 
week, CDC released the Rx Awareness Communications Campaign to 
raise awareness about the risks of prescription opioids. That 
campaign features real-life accounts of individuals living in 
recovery and those who have lost someone to an overdose.
    CDC's unique approach to surveillance and prevention are 
key in reversing the opioid epidemic. CDC continues to be 
committed to the comprehensive priorities outlined in the HHS 
Strategy and to saving the lives of those touched by this 
epidemic.
    Thank you for your time, and I'm happy to answer any 
questions you might have.
    The Chairman. Thank you, Dr. Houry.
    Dr. Collins.

                  STATEMENT OF FRANCIS COLLINS

    Dr. Collins. Thank you. Good morning, Mr. Chairman, Ranking 
Member Murray, and distinguished Members of this Committee. My 
colleagues have given you a vivid picture of the vast scope of 
the opioid epidemic. I'd like to take a moment to put a 
personal face on this crisis, a crisis that has devastated the 
lives of so many Americans, Americans like a young man I'll 
call Jeff.
    When this 29-year-old Alaskan Native returned from serving 
in the war in Afghanistan, he experienced a series of personal 
crises and sought relief in the wrong places. He got hooked on 
cheap heroin, and eventually he ended up homeless on the 
streets of Seattle.
    Desperate to escape this downward spiral, Jeff sought help. 
He turned to NIH-funded researchers at the VA in Seattle, and 
they enrolled him in a new protocol for medication-assisted 
treatment, MAT. Unlike traditional treatment programs that have 
long waiting lists, Jeff was started on oral buprenorphine 
immediately. The results? Jeff stopped using heroin right away 
but still sometimes experienced strong cravings for opioids.
    Researchers adjusted his treatment, giving him an 
additional evidence-based medicine to bring those cravings 
under control. I'm glad to tell you today that Jeff has not 
used heroin for several months, he's no longer homeless, and 
he's holding down a regular job.
    I don't want to give the impression that Jeff's story is 
easy or typical. People who fall into opioid addiction, many 
starting with prescription drugs, have different stories, and 
they need different interventions. Jeff's story does show how 
research can provide a broader array of options for treating 
opioid use disorders.
    Addiction is a powerful force, driven by the powerful ways 
in which opioids literally can rewire the brain. When people 
suffering from addiction seek help, we owe it to them to 
provide treatments that will work for them. Research can help 
us get there.
    Currently, we have three FDA-approved medications for 
opioid use disorder--buprenorphine, methadone, and naltrexone. 
Relapse rates are way too high, and more options are needed to 
end this epidemic. We need to understand which individuals 
succeed on which medicine, in what doses, over what time 
period, combined with what kind of psycho-social support.
    NIH has a successful record of partnering with industry to 
develop some of these new treatments and interventions. For 
example, many communities have invested in naloxone injection 
kits to enable their first responders to reverse opioid 
overdoses. Unfortunately, the kits are expensive and not 
everyone is comfortable administering an injection. In 
partnership with industry, NIH developed this naloxone nasal 
spray.
    That was, by the way, just distilled water, in case anybody 
is worried about my using an inappropriate substance in the 
hearing room.
    [Laughter.]
    Dr. Collins. This can be far more easily administered by 
anyone and is now the most widely used antidote for overdose, 
saving many lives.
    We're not stopping. Just last week, following a series of 
no less than seven action-oriented meetings since April, NIH, 
the FDA, and our industry partners invited more than 50 
companies to explore a research partnership that would include 
two important research goals: first, to expand medication 
options to treat addiction, as well as to reverse overdose in 
the face of even more deadly opioids like fentanyl or 
carfentanil. The second goal, and critical for the long term, 
is to develop potent non-addictive medications for pain. We 
must find better ways to help those 25 million Americans who 
suffer from pain on a daily basis.
    The developing partnership will build on basic science 
insights that are opening new avenues for development of non-
addictive drugs. For example, we once thought that the brain's 
pain and reward systems were inextricably intertwined, but 
we've recently learned that when drug molecules bind to an 
opioid receptor, they can activate two different pathways, pain 
relief and reward. New technology is now being applied to 
design drugs that provide the pain relief without activating 
the reward system that leads to addiction.
    Other potential targets for non-addictive pain medications 
have been identified through studies of neuroscience. One 
promising drug target has been identified by studying rare 
individuals who are born with genetic complete insensitivity to 
pain. Building on our evolving understanding of inflammation's 
role in chronic pain, the partnership will also seek to 
determine whether agents that reduce inflammation can provide 
potent pain relief.
    That's not all. We're working with industry to explore ways 
to develop biomarkers that can distinguish different types of 
pain and predict likely responses to intervention. We will 
strive to develop objective measures of pain that can be used 
to compare experimental therapies with greater precision, and 
we'll explore the creation of a new clinical trial network to 
enable the rapid testing of promising new therapies and 
facilitate the sharing of such data.
    There's a great deal to be done. For this effort to 
succeed, we do need all hands on deck, my Federal colleagues 
here, academic researchers, private sector partners, advocates 
for pain research, and last but certainly not least we need 
you, Members of Congress. Your support is essential to help end 
this terrible epidemic that is costing so many American lives.
    Thank you for holding this hearing today.
    The Chairman. Thank you, Dr. Collins.
    Well, we are 75 percent complete.
    Dr. Gottlieb, I'm going to recess the hearing for about 20 
minutes so that--the floor has asked us to come vote because of 
the Budget Committee's meetings, et cetera. We'd like to hear 
your testimony, so we're going to recess for 20 minutes, vote 
twice--that's what I'm going to do--and then come back, and 
we'll hear you and then begin questions.
    The hearing is recessed for 20 minutes.
    [Recess.]
    The Chairman. The Committee will come to order.
    We'll resume the testimony, beginning with Dr. Gottlieb. 
Excuse us for having interrupted it, but we wanted to hear Dr. 
Gottlieb, and then we will proceed to questions.
    There's one more vote, but we'll continue the hearing 
during the vote and Senators can leave and come back as they 
wish.
    Dr. Gottlieb, welcome.

                  STATEMENT OF SCOTT GOTTLIEB

    Dr. Gottlieb. Thank you, Chairman Alexander, Ranking Member 
Murray, and Members of the Committee. Thank you for the 
opportunity to testify today before the Committee on issues 
related to the epidemic of opioid addiction that is devastating 
American families and our culture.
    This crisis has gotten so large and pervasive that it's 
simply beyond the scope of any one of our agencies to make a 
meaningful impact. It's only by working together and in 
partnership with State and private entities that we're going to 
slowly begin to reverse the trend of new addiction and help 
move more people toward a life of sobriety.
    An epidemic that might have been more fully within our 
grasp just a decade ago has now spread so wide and so deep that 
we need to acknowledge that it's not going to be reversed with 
any one collection of measures, and certainly not by any one 
single agency. FDA has engaged in efforts across multiple 
fronts in trying to do its part to more forcefully confront 
this crisis, and we're looking for ways to work more creatively 
with public and private partners.
    There's a lot of good work that has already been done by my 
agency before I arrived to address these challenges and rethink 
some old dogma when it came to combatting addiction. I 
inherited a lot of creative ideas and new policies that were 
already in process. We've also set out some new directions in 
recent months, and I want to briefly frame for you how we're 
going to approach this challenge going forward.
    I'm especially focused on three domains of activity. First, 
how do we reduce the rate of new addiction by also reducing 
overall exposure of American patients to opioid drugs? We know 
that most people addicted to opioids will be medically 
addicted. Their first exposure to opioids will be through a 
legitimate prescription. For many of these patients, that first 
prescription will be for an immediate-release formulation of 
these drugs.
    The key is to reduce the rate of overall exposure to help 
make sure that only properly indicated patients are being 
prescribed opioids, and when they receive a prescription it's 
for a duration of use that is the shortest necessary to address 
their condition.
    To address these goals, we've taken a number of recent 
steps, and we're pursuing some additional actions in the coming 
months. Among some of the steps we've already taken, for the 
first time we're extending our risk management programs to 
include our provider education requirements to immediate-
release opioid drugs. We're also expanding this to cover all 
providers who come into contact with patients, including nurses 
and pharmacists.
    We're also actively considering new steps to make that 
education mandatory, and also use our authorities to limit 
dispensing based on the indication for which an opioid is being 
prescribed. Last week our newly formed Opioid Steering 
Committee opened the public docket to solicit input on each of 
these specific questions.
    The second domain of activity that we're focused on relates 
to new product innovation that can either render current opioid 
products less prone to abuse or, alternatively, see these 
products replaced entirely by non-addictive pain treatments 
and/or medical devices. Among the steps we've taken toward this 
second set of goals, FDA strongly supports a transition from 
the current market dominated by conventional opioids to one 
where the majority of opioids have meaningful abuse-deterrent 
properties. While these products can still lead to addiction, 
they are harder to manipulate in ways that make them attractive 
for abuse by routes such as inhalation and injection.
    In support of this transition, FDA is focusing its effort 
on determining how effective the current abuse-deterrent 
products are in the real world. Separately, FDA is also working 
to support the development of generic forms of abuse-deterrent 
opioids and will soon issue final guidance on the development 
of generic versions of these drugs.
    At the same time, we're also working on improving the path 
for the development of non-opioid and non-addictive treatment 
alternatives. To more efficiently advance these drugs with 
these characteristics, FDA is using programs such as fast track 
and breakthrough therapy designations to facilitate the 
development of products that, for example, are intended to 
treat serious unmet medical needs. FDA's work also includes a 
more careful consideration of non-drug alternatives for pain 
such as medical devices that can deliver more localized 
analgesic. We plan to have more to say on this very soon.
    To address these issues related to trials needed for 
approval, FDA is participating in public-private partnership 
with the Analgesic Clinical Trial Translation Innovations 
Opportunities Networks, or ACTTION.
    The third domain on which we're taking new actions to 
address the opioid addiction crisis is when it comes to the 
development of better medical therapy to help those addicted 
transition to lives of sobriety. We're currently developing a 
policy that we believe will promote the development of 
additional therapies for the treatment of opioid addiction. 
We're also exploring ideas to help promote their broader 
adoption. Ensuring patients have access to effective medically 
assisted therapy for the treatment of addiction is a top 
priority.
    These are just some of the domains on which we're actively 
addressing this crisis. It's clear that no lone agency, no 
single set of policies, and certainly no single action is going 
to meaningfully change our bleak trajectory. The scope of this 
crisis is just too large. That's why I'm especially grateful to 
be joined by my HHS colleagues here and why I'm grateful to 
this Committee for convening this discussion here today. We 
need to work together to have any chance of making real 
progress.
    Thanks a lot.
    The Chairman. Thank you, Dr. Gottlieb. Thanks to all the 
witnesses.
    We'll now begin 5-minute rounds of questions.
    Senator Murkowski.

                     Statement of Senator Murkowski

    Senator Murkowski. Thank you, Mr. Chairman, for this very 
important hearing. I do apologize. I wasn't here to hear the 
testimony from the first group here, but thank you each for 
your contributions in this area.
    As my colleagues know, Alaska is pretty rural. In fact, 
Alaska is so rural it's bush. Eighty percent of our communities 
are not accessible by road. 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.
    The first question was raised in a meeting that I was in 
just this week with providers that serve our rural areas, and 
it was as it related to the medically assisted treatment and 
how these are administered, whether it's suboxone or others. 
It's our understanding that the prescribing provider is 
required to be physically in the room with the patient.
    Well, in far too many of our rural communities, we don't 
have that provider. We do so much of the care by distance 
delivery. You've got a health aide that is administering. The 
question that was raised with me is whether or not there is any 
kind of an exemption option or a waiver option under the Ryan 
Haight Act that would allow providers to prescribe suboxone 
through telemedicine to these individuals that are in highly 
rural communities, bush communities. Is there a way that we can 
use these technologies to help in the event of an emergency? Do 
you have anything that you can offer me?
    Dr. McCance.
    Dr. McCance-Katz. Yes. Thank you, Senator Murkowski. Here's 
what I would say about that. While I don't have the Ryan Haight 
Act at my fingertips, I believe that what it requires is a 
valid physician-patient relationship, and that is generally 
characterized by at least one visit face-to-face where there is 
an examination that's done, a diagnosis that is made, and a 
treatment plan that then follows. Afterwards I think 
telemedicine can be used, and it may be possible that we can 
work with DEA around the issues of whether we can have in a 
telehealth kind of setting a provider who has done those things 
and can work with a waiver, a provider who might be in a 
distant place.
    Those are the kinds of details that, to my knowledge, have 
not yet been worked out, but there is already precedent for 
telehealth where a provider is distant and can work with 
another practitioner who is actually seeing the patient in a 
community. That model exists. What doesn't exist and isn't well 
defined yet is the issue of controlled substance prescribing, 
so we can work with DEA on that.
    Senator Murkowski. Well, it is something that I'd like to 
explore with whomever 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 we've got the tools in place, but we do need to have some 
level of exemption or waiver option out there, so I'd really 
like to work with you.
    Dr. McCance-Katz. Sure.
    Senator Murkowski.
    Dr. Collins.
    Dr. Collins. If I may, I think this is another wonderful 
example of how our efforts to help those who are seeking 
treatment for addiction need to have a broader range of options 
than what currently is possible, but we need to be sure those 
options are evidence-based.
    Ultimately, what one would like to have is a sort of 
precision medicine approach to helping people who are addicted 
so that you find the right treatment in the right situation at 
the right dose with the right kind of psycho-social support in 
the right MAT that works for that person. Obviously, the answer 
to that is going to be very different for somebody who is in 
the bush in Alaska versus somebody who is in an urban center.
    NIH is very much interested in trying to contribute more 
evidence to those other options using our Clinical Trials 
Network, and I think you've raised a very important issue that 
we should look at closely.
    Senator Murkowski. Well, I look forward to working with you 
on that.
    I do have a question about drugs over the Internet, but 
I'll wait for the second round.
    Thank you, Mr. Chairman.
    The Chairman. Thank you, Senator Murkowski.
    Senator Hassan.

                      Statement of Senator Hassan

    Senator Hassan. 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 who are here today because I 
know how hard you're working on this issue.
    The opioid epidemic, as you all know, is absolutely 
devastating my State of New Hampshire, and it's not something 
we're going to fix overnight. We didn't get here overnight, 
we're not going to fix it overnight.
    One of the things that I think we really have to continue 
to focus on is that addiction is a chronic disease, and we need 
to realize the long-term nature of it because the reality is 
that part of this disease is relapse. The disease is 
multifaceted, and it's often made worse by the underlying 
trauma and mental health disorders, and on top of that it is 
complicated by co-occurring medical diseases, like ones that 
are spread by injection drug use, like hepatitis C and HIV. I 
was on the phone with a friend of mine who lost her 34-year-old 
son about a week ago. We're not sure yet whether it was an 
overdose or a heart event, a cardiac event related to substance 
use disorder, but this is the type of ongoing issue, along with 
long-term societal issues. We have teachers now who have 
children in their classrooms whose parents have overdosed. We 
have grandparents who are raising their grandchildren.
    We are in this for the long haul, and so one of the things 
I want to emphasize is that while I appreciate greatly what the 
four of you and all of the people that you work with are doing, 
the Trump Administration's 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.
    I hope that while you're all doing this work, we realize 
that in the bigger picture the budget and the 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 disease.
    Dr. Gottlieb, I appreciate very much the work you've been 
doing. When you were last here before this Committee, you 
agreed that there was an outstanding question about the 
nomenclature we are using in the term ``abuse-deterrent 
formulation'' and whether it's 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 Risk 
Transparency Act, which was recently signed into law and really 
is intended to make sure that health care doctors and, in turn, 
patients are provided with information about the limitations 
and patient care implications of opioids with so-called abuse-
deterrent formulations. Now that the legislation has been 
signed into law and has given you the authorization, what steps 
has the FDA taken to use this authority provided by the Opioid 
Addiction Risk Transparency Act?
    Dr. Gottlieb. Thank you for the question, Senator. We set 
out probably about 3 weeks ago, 4 weeks ago, to undertake a 
formal study of the nomenclature that we use and the lexicon 
that we use in describing abuse-deterrent formulations, and you 
and I have had the opportunity to talk about this, to make sure 
that we're not conveying to providers and patients that a drug 
that has abuse-deterrent features is less prone to addiction, 
because we know it's not. The abuse-deterrent features on the 
current drugs make them less prone to manipulation that allows 
them to be abused through inhalation and injection, but they 
still can cause addiction.
    We're looking at this scientifically, and we should have 
that information back in a reasonable timeframe, and I'd be 
happy to come in and talk to you about our results.
    Senator Hassan. Well, I would appreciate that. 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 you're 
gathering data.
    Dr. Gottlieb. I firmly agree. I just want to make sure 
we're science based. We will move quickly.
    Senator Hassan. Thank you.
    Dr. McCance-Katz, we've talked a lot about the 2-year 
opioid State targeted response grants provided by Cures. I will 
say, like my colleague Senator Shaheen, who is not on this 
Committee but who has been leading the charge on this, I've got 
some real concerns about the formula used for 2017 because it 
didn't provide adequate resources to New Hampshire, a State 
with one of the highest per capita death rates in the Nation 
but that was only eligible for $3 million of the $500 million 
available under the formula that was used.
    In addition, addiction is a chronic condition, so we need 
long-term investments to address the crisis. Aside from the 
Cures money, there are other important Federal resources that 
we need to strengthen. As was described in your testimony, the 
Substance Abuse Prevention and Treatment block grant is 
fundamental, but it really hasn't kept up with inflation in 
terms of dollars.
    Because I see that I'm running out of time, I'll just ask 
you if you can briefly speak to what SAMHSA is trying to do to 
address the significant decrease in value of the block grant 
today, especially in light of staggering increase for the need 
of such services.
    Dr. McCance-Katz. Thank you, Senator Hassan. SAMHSA allows 
flexibility to the states to use the block grants for substance 
abuse prevention and treatment. States present us plans, we 
provide them technical assistance, and we allow them to 
implement as they wish to do in their communities. Every state, 
of course, is different.
    SAMHSA also works with the states in terms of pretty 
extensive ways of helping them to look at how they can best 
provide care. We have, in addition to funds in these block 
grants, as you know, which are the funds of last resort for 
individuals who are not covered by other third-party payers, 
including Medicaid----
    The Chairman. We need to stick with the 5-minute time rule.
    Dr. McCance-Katz. I'm sorry.
    Senator Hassan. Thank you. I'll wait for the second round 
and we'll follow-up then.
    The Chairman. Thank you very much, Senator Hassan.
    I'm going to call on Senator Young next, and then I believe 
Senator Bennet is next after that.
    I'm going to go vote, and Senator Murray is going to 
preside.
    Senator Young.

                       Statement of Senator Young

    Senator Young. Thank you, Chairman. I have a lot to cover 
in 5 minutes, so I'm going to go fairly quickly here.
    I'll begin with Dr. McCance-Katz. Doctor, good to see you 
again.
    A small Hoosier community of 4,300 people was catapulted 
into the national spotlight just 2 years ago. We have over 200 
of my fellow Hoosiers who were diagnosed with HIV and hep C 
primarily due to injection drug use. According to the CDC, 
injection drug use is now the primary cause of most hep C 
infections.
    Doctor, what role do you think the Federal Government 
should play in ensuring that people with opioid use disorders 
are linked to screening and treatment of hep C and HIV?
    A more narrow question. What do you think the Federal 
Government should do to prevent people who inject drugs from 
landing in jails and further escalating the hep C crisis in 
those facilities?
    Dr. McCance-Katz. We do recommend integrated care. We have 
been focusing on--as an agency, we have focused on integrated 
care, both bringing primary care into our community health 
treatment programs and bringing behavioral health care into 
primary care.
    We know that people--we advise that people should be 
screened. We've supported a program called Screening: Brief 
Intervention Referral to Treatment, for years now. We've done, 
I think, a pretty good job of getting that established 
nationwide, and by bringing those resources together we can 
identify early on, and hopefully before people get to the point 
of injection drug use, their needs for care and get them to the 
appropriate interventions.
    Senator Young. Do you have thoughts about local jails and 
things at the Federal level--I understand there are 
jurisdictional issues--we might be doing to help address what I 
would characterize as a crisis?
    Dr. McCance-Katz. I would just say that addiction is not a 
crime, and so we have programs that we support throughout the 
Nation that work toward establishing drug courts and ways to 
divert people from the jail system to treatment, and we 
continue to support those, and Congress has been very helpful 
to us in allowing us to do that.
    Senator Young. Thank you. I think I'll submit all these 
questions to each of you and give you the opportunity to 
respond as well.
    Dr. Gottlieb, I'd like to move to you, sir. To encourage 
the development of new treatment options like non-opioid 
alternatives, you have committed to using all the agency's 
authorities, including fast track and breakthrough therapy 
designations. Now, during your confirmation hearing, you and I 
discussed the imbalance in the application of expedited 
programs like those I just mentioned across the various review 
divisions of the FDA. What sort of progress in your short term 
there have you been able to make to ensure the FDA reviewers in 
all divisions are using the tools available to them, sir?
    Dr. Gottlieb. Thank you for the question. Within the 
context of the work that Dr. Janet Woodcock is doing with 
respect to the Office of New Drugs and some of the changes that 
she's implementing, structural changes that she's implementing, 
I think we have been able to bring more uniform adoption to 
certain policies, like the application of expedited programs, 
across different therapeutic areas. We're moving in that 
direction, in the direction you and I discussed.
    With respect to this clinical area particularly, there have 
been drugs for the treatment of pain that have been granted 
fast track status. There are no publicly acknowledged drugs 
that have been granted breakthrough therapy, but we would 
certainly be willing to grant a drug that meets the legal 
criteria breakthrough status, targeted toward the treatment of 
pain. If there were such drugs that existed right now, I 
wouldn't be able to speak to it, but we would do it.
    Senator Young. OK. I'm going to ask this question, ask one 
of you to pipe up if you feel impelled to do so. If you don't, 
I'll call on one of you.
    It relates to translating medical research to medical 
practice. I found out some years ago, when I was a member of 
the House of Representatives, it takes an average of 17 years 
for research evidence to reach clinical practice. Hoosiers 
don't have 17 years to wait for the best practices to be 
implemented in fighting and prevention of addiction.
    How are you all working together? Are you working with 
medical associations--maybe you could speak to that--to ensure 
that the best practices are indeed translated into clinical 
practice? What can be done, if anything, by your agencies or 
Congress to speed up this research-to-practice pipeline?
    Dr. McCance-Katz. We do work with collaboratively--SAMHSA 
works collaboratively with NIH. I think one of the real 
advantages of having an assistant secretary as the head of 
SAMHSA is that I can work collaboratively with other 
departments. Dr. Collins and I are already talking about the 
kinds of collaborations that will help us to disseminate best 
practices to communities.
    I'm going to say something else that I think needs to be 
done more of, that SAMHSA will start to do this, and that is 
you have to bring people together that have the right kinds of 
skills. What I mean by that is you have to bring people who are 
experts in the treatment of various disorders, in this case 
addiction, an opioid use disorder, and our State officials, 
because those are the people that are making the decisions 
about how practice is done in the various states and 
jurisdictions.
    When we bring these folks together, then we should be able 
to better disseminate practices.
    Senator Young. Thank you. I'd just note--and I know I'm 
over time. Thank you so much. As I travel around my State, it's 
pretty clear to me that no one is certain as to what current 
treatments and outreach strategies have been rigorously tested 
and evaluated and which ones are best, which ones they should 
implement. I'd like to dialog with a number of you about that 
serious issue.
    Senator Murray. [presiding] Thank you.
    Senator Bennet.

                      Statement of Senator Bennet

    Senator Bennet. Thank you, Madam Chair. Time, I know, is 
short because we're voting. I want to thank you and Chairman 
Alexander for holding this important hearing on a set of issues 
that touch every corner of our communities.
    Last year there were 442 deaths in Colorado related to 
opioid overdoses. That includes overdoses from prescription 
opioids and heroin, as well as synthetic fentanyl. That's more 
than quadruple the number in 1999. Our State is trying to make 
progress in turning the clock back by provider education and 
prevention, but we have a lot more work to do.
    Dr. Gottlieb, thank you for coming to Colorado. You're able 
to see some of that work in our emergency rooms and treatment 
centers when you visited in August. I'm grateful that you came 
to Colorado, and I want to thank all the witnesses who are here 
today for your work.
    I also want to talk about jails. Jails in Colorado have 
been overwhelmed by the influx of people suffering with opioid 
addiction. Recently in Freemont 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 where the sheriff took me to the cells and he said, 
``I want you to see this,'' and he went and opened up the door. 
I said, ``What do you want me to see?'' He said, ``I have women 
in my jails. I've never had women in my jails 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 in rural 
counties, like in Alamosa, how difficult it can be to provide 
this care when Medicaid is immediately terminated and they've 
got to stretch their budget somehow to meet this need.
    Dr. McCance-Katz, I wonder, in your role in SAMHSA, you 
oversee the administration of grants to close gaps in care, 
although not specifically for these settings, jails. I wonder 
what we can do to help states manage this population of 
patients who are essentially locked out of access to treatment.
    Dr. McCance-Katz. Absolutely, it's a huge issue that people 
lose their Medicaid as soon as they go into any kind of 
incarceration. We do have programs at SAMHSA where, as I 
mentioned before, we divert people through drug courts into 
treatment rather than into jail. We also have offender reentry 
programs. We don't have a lot of funding for that right now, 
but we do have those programs going on in various parts of the 
country. We try to promulgate best practices from those 
programs.
    There also is a large movement within the correctional 
system where people are being identified as opioid addicted and 
evaluated and started on medication-assisted treatments and 
hooked up to treatment as they're leaving the jail or prison, 
and that is a program that I hope we will be able to expand 
going forward.
    Senator Bennet. Do you think it makes any sense, though, 
for us to be cutting off Medicaid when you have a population in 
a jail where 100 out of 115 people are addicted to opioids? 
Does that make any sense for us to cutoff their access to 
treatment or their funds?
    Dr. McCance-Katz. Senator, I would say that that is a 
decision that would need to be made at the level of Congress 
and the President, and within HHS we will implement whatever 
Congress and the President agree upon. At this point, it is as 
you say.
    Senator Bennet. Is there anybody on this panel who thinks 
that a jail cell is an appropriate place to do treatment for 
opioid addiction, or a preferred place to do treatment for 
opioid addiction?
    Dr. McCance-Katz. It absolutely is not the place to do 
treatment for opioid addiction.
    Senator Bennet. Dr. Collins.
    Dr. Collins. I certainly agree that addiction is not a 
crime. It would be worth mentioning that we have an opportunity 
with those who have ended up in this difficult circumstance, in 
jail, that once they have become opioid free during the course 
of their time in jail, there's an opportunity to help them 
maintain that State by injectable naltrexone, which currently 
lasts about a month. We've done studies to look and see what 
the success rate of that is in terms of keeping people from 
slipping back into addiction, and it's substantially better 
than some of the other alternatives.
    One of the things we're working on right now with industry 
as a partner is could we come up with an injectable form that 
lasted for 6 months, because that would keep the momentum going 
in terms of somebody reentering the workplace and finding 
themselves on a better path. A month is good; 6 months would be 
a lot better.
    Senator Bennet. I understand you are working on that, and 
it cannot come soon enough, so I thank you for that.
    Senator Murray. Thank you.
    Senator Collins.

                      Statement of Senator Collins

    Senator Collins. Thank you very much, Madam Chairman.
    You like hearing those words, right? Again.
    [Laughter.]
    This morning's headline in the largest newspaper in the 
State of Maine says this: ``Portland, Falmouth Officials 
Deliver Bleak Report on Opioid Crisis: It's Getting Worse.'' 
This headline disturbed me greatly because I feel there's been 
so much focus on the opioid problem, the epidemic that is 
tearing apart our communities and costing the lives of so many. 
We've passed legislation. We've increased funding. We recognize 
that you have to focus on education and prevention, law 
enforcement, treatment and recovery. Yet we seem not to be 
making the kind of progress that we need to make.
    Already, for the first 6 months in the State of Maine, 185 
people died from overdose. That means that, if that number 
remains stable, we're 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 for 
every one overdose death, we have an enormous problem 
underneath.
    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?
    Dr. Gottlieb. I'll just briefly comment, Senator. I 
appreciate the question. I think that one of the places where 
FDA can have an outsized impact--and we all have different 
roles to play--is trying to reduce the rate of new addiction by 
taking steps to decrease the overall rate of exposure to 
opioids. We know this comes down to math. A certain percentage 
of patients who are exposed to opioids will become addicted, 
and the key to reducing the rate of new addiction is to reduce 
overall exposure.
    We're going to do that, first and foremost, by changing 
prescribing behaviors among physicians. Most people, as I 
mentioned, who become addicted will become medically addicted. 
They'll move on. Oftentimes it will be for an immediate-release 
formulation of a drug, Vicodin or Percocet. They'll move on to 
higher-dose formulations, and eventually the low-cost 
alternative, which is street drugs.
    We've taken steps in recent months to increase provider 
education, for example around immediate-release formulation 
drugs. We're looking at steps we can take to try to limit 
dispensing. I mentioned the proposal that we put out recently 
asking for comments from the public around this, and we're also 
looking at what we can do with respect to mandatory education. 
The key for us is to try to reduce overall exposure.
    Senator Collins. I think you're absolutely right, that we 
have to put more effort at the front end of this problem and 
reduce access by changing prescribing habits, and particularly 
by allowing partial fills, by training physicians that they 
should only give 10 pills, not 50, that sort of thing.
    Dr. Collins, do you have anything to add?
    Dr. Collins. I totally agree with what my colleague has 
just said. I also want to say we really need to push them into 
the space of having alternatives to opioids for those 25 
million people who do suffer daily from chronic pain. We can't 
leave them hanging with nothing to help them, and what they 
have right now is not helping them with chronic pain where 
opioids are really not the appropriate treatment. Yet, we do 
not at the present time have great alternatives.
    Certainly from NIH's perspective, putting our foot on the 
accelerator, working with industry in an unprecedented way to 
try to cut in half the time that it takes to develop that next 
generation of non-addictive but highly effective pain medicines 
is something that we now want to see happen.
    We're currently spending about $116 million a year on 
opioid use. We think that needs to be greatly increased by a 
factor of 4 or 5, and together with industry we can do 
something here to speed up this process of coming up with 
better alternatives.
    Senator Collins. Thank you.
    Dr. Houry.
    Dr. Houry. I would add that I think Washington has been one 
of the states that has really integrated their prescription 
drug monitoring programs with their ER records, and they've 
seen a lot of proactive reporting. We're preventing those 
people on that pyramid from getting addicted. It's identified 
people who are taking high-dose morphine doses and then sending 
alerts to physicians so they know to intervene and consider 
tapering that patient off.
    The flip side, too, I would say, is really to do more 
surveillance. We just started in Maine our syndromic 
surveillance, where we're using what we use in bioterrorism 
where you look at EMS or emergency department data to look at 
new trends, and this is how Maine and many other states here on 
this panel are being able to detect new community outbreaks. We 
did that in Georgia and we picked up five overdoses from the 
fake Percocet pills. Now you know where in communities to 
intervene more quickly.
    Senator Collins. Thank you.
    Dr. McCance-Katz.
    Dr. McCance-Katz. I agree with everything that my 
colleagues have said, but I'm also going to say that we still 
do not have adequate access to treatment, to evidence-based 
treatment for people who need it. As long as that situation 
occurs, we're going to continue to have the terrible kinds of 
tragedies that are the opiate epidemic.
    We need more specialty care. We need integration of 
addiction treatment into primary care. We need to use our 
certified community behavioral health centers to provide 
addiction treatment. We need to educate practitioners starting 
at the undergraduate level--medical school, nurse practitioner 
school, physician assistant school. That's just my view. 
Everybody should come out being eligible, having gotten the 
education, to get that data waiver.
    They need more than classroom experience. They need 
practical experience. The State that 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 of these things.
    Senator Collins. Thank you.
    The Chairman. [presiding] Thank you, Senator Collins.
    Senator Murray.
    Senator Murray. Thank you.
    We know that 2 million people suffer from opioid addiction 
nationwide, and there are targeted approaches like safer opioid 
prescribing practices and medication-assisted treatment, 
important parts of it. I hear so often that it's really 
important to make sure that everyone has access to appropriate 
health care to prevent and treat substance use disorders.
    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 eligible enrollees who are now 
accessing substance use disorder services because of Medicaid 
expansion. That's why it's so troubling, quite frankly, to see 
so often this going after Medicaid.
    I wanted to ask you, Dr. McCance-Katz, do you think 
coverage of preventive and treatment services for substance use 
disorders, including through Medicaid, is important to 
combatting the opioid crisis?
    Dr. McCance-Katz. Yes, I do.
    Senator Murray. I think that's really important, a short 
statement but really important, and I hear it from everyone, so 
thank you.
    The President's budget proposal cuts SAMHSA's budget for 
preventing substance use disorder. I'm sure you know that. How 
would those cuts affect your ability to serve affected people 
by this crisis?
    Dr. McCance-Katz. Well, we would have to, whenever 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 we hope will allow us to continue our programs.
    Senator Murray. OK. Well, I think this is really important, 
and we need more support, not less, and I've been working on 
the Appropriations Committee to increase our prevention 
activities, and I hope that we get support for that.
    I wanted to ask all of you, as you all know, this Committee 
worked very hard to pass the 21st Century Cures Act, which 
among other things provided a billion dollars, as you know, for 
funding for our states to respond to this crisis. I was really 
pleased that my State, Washington State, has used their part of 
this funding to partner with Washington State University to 
analyze evidence-based practices related to youth misuse and 
abuse of prescription drugs, including opioids.
    Can each one of you speak about how your agencies are 
currently using evidence-based practices for prevention and 
treatment, and the importance of the Federal Government 
promoting the use of evidence-based policies?
    I'll start down here with you, Dr. McCance.
    Dr. McCance-Katz. SAMHSA has a number of programs that 
address both prevention and treatment. Our block grants include 
a 20 percent set-aside for prevention interventions. We work 
closely with experts in the field and the states to provide 
them information and dissemination of best practices regarding 
prevention interventions, as well as for evidence-based 
treatment of substance use disorders.
    I think that your point is a very important one about 
youth. We learned from our National Survey on Drug Use and 
Health this year that transitional-age youth are really 
struggling both with increasing amounts of substance abuse, 
including alcohol, by the way, very troubling, but also with 
increases in depression and suicidality. One of the things that 
I've done since starting at SAMHSA is that 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-age youth.
    Senator Murray. OK.
    Dr. Houry.
    Dr. Houry. One of the things we're doing is we're working 
through the Heroin Response Strategy, so on the ground with a 
lot of the high-intensity drug trafficking areas. We're on the 
ground with public safety helping them develop public health 
interventions, things like academic dovetailing, where if 
there's a high prescribing area, you send somebody to counsel 
the physicians and learn more about that.
    We're also looking for more warm handoffs. If there's an 
overdose, the person is then linked to services, looking for 
ways to really integrate the primary care practices and 
prevention efforts along with public safety.
    The second thing is using the best available evidence as we 
have it, like when we developed our Chronic Pain Guideline, and 
making sure that then we can translate it into tools for 
providers. We have a mobile app, now downloaded 17,000 times, 
that providers can use the best available research to integrate 
into their own practice.
    Senator Murray. Dr. Collins, we have about 7 seconds.
    Dr. Collins. Very quickly, the NIH, of course, is in the 
business of generating the evidence, and there's a lot we still 
need to know.
    Very critical, we do not know the appropriate duration of 
MAT that provides the opportunity for people to actually remain 
free of opioids. That is a lot longer than many of the programs 
currently offer.
    I would also say we need to know more about non-drug 
approaches to treating pain, and that's another way to keep 
people from getting addicted to opioids. We just started an $81 
million program with the VA and the Department of Defense to 
look at this in terms of returning veterans and figure out what 
other kinds of things, such as transcranial magnetic 
stimulation, acupuncture, and so on, might turn out to be quite 
effective in this space and would keep people from getting into 
this terrible downward spiral.
    Senator Murray.
    Dr. Gottlieb.
    Dr. Gottlieb. I can do this in negative 15 seconds.
    [Laughter.]
    I'll mention three things we're looking at right now.
    We're evaluating the prescribing guidelines around current 
treatments, currently medically assisted therapy. We recently 
updated those guidelines to recommend, among other things, that 
the continuation of buprenorphine in particular might need to 
be done in perpetuity, so changing the duration of use.
    We're currently reevaluating the guidance that we give to 
drug developers around the development of different MAT. We'll 
be issuing soon, in some timeframe--I don't want to say soon, 
but within the next year certainly--updated guidance with 
respect to the development of MAT.
    We're also looking at steps we can take, and we've been 
taking active steps to try to bring naltrexone over the 
counter, naloxone over the counter--excuse me--and also what we 
can prescribe around the co-administration of that with 
opioids.
    Senator Murray. OK. Thank you all very much.
    The Chairman. Thank you, Senator Murray.
    Senator Cassidy.

                      Statement of Senator Cassidy

    Senator Cassidy. Thank you all.
    First, let me address a couple of comments Senator Murray 
made suggesting that the latest Republican effort to do 
something about Obamacare has cut resources. Actually, for non-
expansion states, there would be billions more. For example, 
Senator Baldwin's State of Wisconsin would have hundreds of 
millions, if not billions more to provide services for those 
who otherwise would not have. You can say that for every single 
non-expansion state. For expansion states, they're typically 
held harmless.
    Also, states are given the flexibility to move resources 
where they needed to be used. Folks who shake their head no 
haven't read the bill, and I say that not to be rude but just 
to point it out.
    Second, panel, thank you for your hard work.
    Dr. McCance-Katz, I understand that when I speak to 
practitioners of treatment programs, that there is great 
variability in outcomes. Some do it really well, some do it not 
so well, and a cynic would say some do it for profit but not 
for the patient's benefit. You nod your head gently yes, and 
that's what I get whenever 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 that SAMHSA has client-level 
data called Treatment Episode Data Sets. Can this be aggregated 
into a per-facility assessment? If not, why not?
    Dr. McCance-Katz. The Treatment Episode Data Set is a data 
set where the various facilities actually enter their data, and 
states can get information on those facilities, so that is 
possible to do. If there's any confusion about it, we are ready 
and able to help with doing that.
    Senator Cassidy. Now, you say states could do that. I'm 
told that some of the insurance companies--someone mentioned 
United. I don't know if it is United, but it does a very good 
job of finding out, based on outcomes data, which treatment 
center is doing well, which is not. Now, we're spending lots of 
money on this. I guess 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 isn't this just kind of automatic? If a State is 
applying for a grant, you have to show that you are monitoring 
outcomes data for treatment programs, and those that are doing 
well expand it, those not so well correct it. I'm asking that.
    Dr. McCance-Katz. What I would say is that with the 21st 
Century Cures Act and the STR money, 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, and they should 
be able to do it with things like TEDS.
    As far as the insurance data goes, this is something that I 
could look at with my staff to find out whether there's a way 
we can access that data through an agreement.
    Senator Cassidy. You know, after Hurricane Katrina, I found 
that the people who were aggregating all this data, suddenly 
the doctor in Oklahoma could access the records of the people 
in Louisiana. It was opened up. Now, I guess what I'm asking, 
maybe Dr. Houry for you, is there any kind of--does DEA or do 
you have access to these prescription data clearinghouses? It's 
my experience that there are certain physicians that are high-
intensity prescribers. Dr. Gottlieb mentioned it's just math. 
If somebody is writing higher scripts, there's going to be more 
people addicted. It seems like you should be able to figure 
out, whether it's a pain doctor or a cancer doctor, or whether 
it's an FP who is just moving between states with a pill mill, 
do we have access to that? If not, what do we need to give you 
access to it?
    Dr. Houry. Each State owns their own PDMP, or prescription 
drug monitoring program data. One of the things we've been 
doing is working with states to allow them to identify these 
prescribers and working with medical boards, because it's 
really driven at the State, not the Federal level.
    Senator Cassidy. I thought this was a DEA function. Is this 
entirely State, or is this also a Federal role?
    Dr. Houry. The prescription drug monitoring program can be 
owned by a board of health, a board of pharmacy. It can be 
owned by law enforcement. It varies who it's owned by. CMS, 
though, in partnership with CDC, this past year did issue 
letters to the top 5 percent of prescribers under Medicare. 
There's different ways we can do it at the Federal level. It's 
usually at the State level, and this is what we're working with 
State medical boards and with our State grantees to address.
    Senator Cassidy. What is the progress in that? Because when 
I used to write to controlled substances, you had my DEA 
number. You knew exactly it was me, and you knew my practice 
just by looking in the phone book. When I talk to drug detail 
folks, they say, oh, you know who the pill mill is because you 
go in and it's somebody writing a $500 check for a 5-minute 
visit and walking out with a big prescription pad, as opposed 
to a pain doctor who really does it right and you have a 
waiting room full of patients waiting to be seen. I'm thinking, 
well, the drug detail person knows it; how come we're having 
such a hard time figuring it out?
    Dr. Houry. DEA is the one that monitors it for illicit use. 
What I would say is on our website we now list by county 
prescribing rate. Anybody can go in and see where are the 
highest prescribing counties. That way state health departments 
can really intervene and see where the highest prescribers are.
    Senator Cassidy. Do we have a sense--I'm sorry, I'm almost 
over my negative 15. Do we have a sense of whether or not those 
counties are actually doing that? Because we have this data. We 
should be having those pill mill docs.
    Dr. Houry. I think it varies on the State. I know that 
actually Rhode Island was one of the ones that was doing 
academic detail, and New York State as well, to where they were 
identifying the high prescribers and sending them letters and 
visiting to go over evidence-based practices.
    Senator Cassidy. OK. I yield back.
    Senator Murray. [presiding] Thank you.
    Senator Murphy.

                      Statement of Senator Murphy

    Senator Murphy. Thank you very much. Thank you all for 
being here.
    Let me just note that Dr. McCance-Katz is our first 
Assistant Secretary for Mental Health and Substance Abuse. This 
Committee, in a bipartisan way last year, passed the Mental 
Health Reform Act, which eventually ended up part of the 21st 
Century Cures Act, which created the position, and we were all 
very excited to support Dr. McCance-Katz for that position. 
It's kind of wild that we did not have someone at HHS for all 
those years who was focused at the top level of leadership on 
these questions of mental health and substance abuse. We're 
very glad you're here.
    Senator Whitehouse. She's from Rhode Island.
    Senator Murphy. She's from Rhode Island.
    Thank you all for being here.
    I want to pose this question to Dr. Gottlieb and Dr. Houry 
to talk a little bit about what the data tells us with respect 
to the progress we're making on prescription patterns. For 
years, pain medication scripts were going up and up and up, and 
what I've seen the last few years tells us that we're finally 
bending the curve downward. SAMHSA has a document out that 
suggests that maybe the actual number of pills that are being 
prescribed may not be heading in the right direction as fast, 
but overall the number of prescriptions are going down. As 
you've 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 hold of the over-prescription, that you will make a big 
impact ultimately on the number of overdoses and addictions, 
but that doesn't seem to be the case.
    What does the data tell us about how we're doing on the 
over-prescription of medications, and why is this heading in 
the wrong direction if we're finally getting a handle on pain 
meds?
    Dr. Houry. What I would say is we are starting to go in the 
right direction. The amount of opioids prescribed has gone down 
about 10 to 15 percent. If you look at where we are, though, 
compared to 1999, we're still three times what we were. The 
slope is going down, but there's still tremendous progress that 
needs to be made.
    The second thing is I've actually got a paper coming out 
next week in JAMA that looks at how there's not a huge increase 
in the number of people injecting drugs, but what we're seeing 
is the fentanyl that's on the streets is very potent, and 
that's what's driving a lot of those fatalities. It's the 
potency of the drug. We're seeing that people are still 
continuing to get addicted to opioids in the first place and 
then move on to heroin and fentanyl. Now they're moving on to 
something that's even deadlier.
    Senator Murphy.
    Dr. Gottlieb.
    Dr. Gottlieb. I would just add--I agree with everything 
that was said. I would just add I think the scripts are a 
lagging indicator to the impact because people have become 
addicted and they're now to the point where they're moving on 
to low-cost alternatives, which are the street drugs that are 
increasingly laced with fentanyl and other things that can 
cause great harm.
    I'm also reluctant, quite frankly, Senator, to draw firm 
conclusions from the data points we have. It's encouraging that 
scripts are declining. I think we need some sustained data 
points to conclude that we've really started to impact 
prescribing patterns.
    Senator Murphy. Dr. Collins, what are the additional 
avenues for research on pain management? Drugs are not the only 
way to manage pain, and yet insurance companies seem to drive 
payment toward prescriptions rather than to other methods that 
maybe in the short term are more expensive but in the long term 
may keep you off of these dangerous drugs. What are the 
additional avenues we need to do to help give doctors and 
potentially insurance companies some different ways to manage 
pain other than the drug?
    Dr. Collins. It's a great question. I think the pain 
clinics that we used to have maybe 20 years ago which were 
multi-modality efforts to try to provide opportunities for 
people with chronic, significant pain ways to manage their pain 
gave a much better opportunity for something other than an 
opioid prescription to be the answer. Those pain clinics are 
harder to find now, in part because they weren't particularly 
well compensated for the doctors who were spending a lot of 
time with each patient trying to figure out what's the optimum 
approach.
    We do know that for people with chronic pain, if you work 
through this carefully, there are other alternatives such as, 
in many cases, cognitive behavioral therapy. Chiropractors, in 
fact, do provide benefit to people with low back pain. We've 
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, but there are relatively few practitioners now 
that have that full array of options available to them. All too 
often, the answer is to write that opioid prescription and send 
the patient out again.
    Senator Murphy. I would just very quickly note, I think 
that is, in part, because of the problem you identified, which 
is insurance reimbursement. Insurers are not willing to 
reimburse either for the scope of services or for the amount 
necessary to bring providers in, and it speaks to the way that 
risk allocation simply does not work for this population, 
because if you don't keep someone off of this pathway to 
addiction, you may not as the insurer actually bear the 
responsibility, because the cost to the individual is so 
catastrophic that they are likely going to come off your 
insurance plan because they end up in jail or they end up 
homeless or they end up out of work.
    We've got to have a conversation about how you structure 
risk allocation here to promote insurers to pay for the stuff 
that actually keeps you off of that pain medication pathway.
    Thank you, Mr. Chairman.
    Senator Young. [presiding] Thank you, Senator Murphy.
    Senator Kaine.

                       Statement of Senator Kaine

    Senator Kaine. Thank you, Mr. Chair, and thanks to the 
witnesses.
    In Virginia in 2016, 1,460 people died of overdoses, and 
that was a 38 percent increase over the previous year, even 
while everybody was paying attention to it. We've had a 
Governor's Emergency Task Force. We've been paying attention to 
it. Eighty percent of the deaths were overdoses related to 
opioids, and a significant reason for the increase is the 
increased presence of fentanyl, more potent opioids that are 
killing people.
    You are the pros, and so I want to ask you a big-picture 
question. When John F. Kennedy was president he said we're 
going to put a man on the moon by the end of the decade, and 
that was bold and audacious. A lot of people thought it wasn't 
possible, but we organized an awful lot of efforts around it, 
and we not only put a man on the moon but some of what we did 
to organize efforts produced all kinds of other great 
scientists and mathematicians, and even Tang orange drink, 
which I still enjoy.
    [Laughter.]
    Senator Kaine. I was with a group of technology leaders 
recently, and I asked them what should we be saying we want to 
do by 2030? As you might imagine, technologists, many of them 
said low and no-carbon energy, various strategies for dealing 
with climate, cures for cancer, but somebody said we should set 
the goal of being addiction free by 2030. That's not what I 
expected a technologist to tell me, but I was kind of 
interested and struck by that.
    I guess what I want to ask you first is you should set a 
bold and audacious goal that is at the very edge of human 
ability to reach but reachable and not one that is laughable. 
Would setting such a goal, addiction free by 2030, be doable 
even if incredibly difficult, or is it too far beyond our 
capacity so it's sort of not doable and hence not worth making?
    Dr. Collins. Well, I'll start. I love bold and audacious 
ideas, and that has served us well not just with going to the 
moon but also with other things like the Genome Project and now 
the Cancer Moonshot and other things. I do think a combination 
effort represented by the folks at this table, and many others, 
is just what is needed, and let's be bold about it.
    Certainly from NIH's perspective, there are things that we 
are thinking about, although they are hard to imagine pulling 
off without a lot more resources, the idea of building a 
partnership with industry to come up in a short time with 
better alternatives for medication-assisted treatment, with 
better antidotes for overdoses that actually work for people 
who have fentanyl or carfentanil in their system where the 
current Narcan doesn't always seem to have quite the long 
duration and potency it needs.
    Particularly to develop this new generation of non-
addictive but highly potent pain medicines where we have good 
drug targets lined up. We're years away from actually being 
able to bring those to the clinic, even with lots of help from 
FDA and speeding that regulatory process. We need to actually 
speed that up, put our foot down on the accelerator. That's 
going to take hundreds of millions of dollars over what's 
currently going into it.
    Then finally I would say it would be great if we could set 
up right now a few demonstration projects, maybe two or three 
states that would be put forward as the place to try to see 
could we actually, if we had all hands on deck both in terms of 
treatment and prevention and research, put the whole enterprise 
together in one coordinated way and see what we could achieve 
in terms of really changing the whole landscape of how we 
prevent and treat this.
    Dr. Gottlieb. You talked about an addiction-free society. I 
fear that people will always find things to abuse, but I think 
we can solve this problem. It's going to take a lot, and I 
think first and foremost--and Dr. Collins has talked about 
finding non-addictive alternatives for the treatment of pain. I 
think we also have to sharply change prescribing patterns. A 
whole generation of physicians, my generation, was taught to 
treat pain very differently than the generation before me, and 
probably the generation that's in school right now, and it's 
going to take a while to reeducate us.
    The final thing I'd say is--and we haven't focused as much 
on it today--I think we need to do much more to enforce the 
border and look inside the international mail facilities at how 
we're pulling packages and examining them to keep dangerous 
drugs out of the country. I will tell you I visited the IMF in 
New York, and the thin blue line between safety and risk in 
these IMFs is very tenuous, and it's unrelated to anything with 
respect to the work ethic of CBP or FDA and those facilities. 
They work very hard. This is simply a matter of resources, and 
I think we need to take a look at that.
    Dr. McCance-Katz. Senator, what I want to say is that I 
don't know that 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 that people can get the care that they 
need. We need to do that very quickly. We can certainly do it 
by 2030.
    Dr. Houry. I agree. I think we need to balance the 
treatment with the prevention. I think right now there's a lot 
of folks--absolutely what we need to do is treat those people 
who are addicted. When you look at the pipeline and you see 
that right now there are 92 million U.S. adults who took a 
prescription for opioids in the last year, I'm worried about 
that 3 percent that's going to 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 
that she had so many visits to the emergency department in the 
years prior, and if we could have prevented at any step along 
the way, we would have prevented that addiction, and we 
ultimately would have prevented her demise. To me, that's the 
value of being addiction free by 2030, is preventing people 
from getting addicted in the first place.
    Senator Kaine. Mr. Chair, thank you.
    Senator Young. Thank you, Senator Kaine.
    Senator Whitehouse.

                    Statement of Senator Whitehouse

    Senator Whitehouse. Thank you, Chairman.
    I'd like to ask the panel's help with a couple of things as 
we go forward. We've talked about prescription drug monitoring 
programs, the PDMPs. The problem that has long existed with 
them has been a lack of integration between states, a mish-mash 
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 is going to operate that, but I 
do think they will be looking for interagency support on all of 
that, and I hope that you will support PDMP grants that do a 
better job of crossing State lines. It is ridiculous for 
somebody to be able to go from Woonsocket to Attleboro and have 
it not picked up across the Rhode Island-Massachusetts border.
    We just went through a terrific fight at the State 
legislative level between the doctors and law enforcement about 
law enforcement access to PDMP records. In part, that was a 
fight because there had been such weak policy work done at the 
Federal level to sort out what makes sense for law enforcement 
to have and what maybe doesn't make sense for law enforcement 
to have.
    I hope that those two areas will be a focus of yours if 
you're consulted and as you deal with PDMPs.
    The second thing 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 that gets into the December 
funding bill. We shouldn't have to wait around for that.
    I hope also that you will 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. We sent a big bipartisan signal with that. It doesn't 
have to be a hard stop, but it ought to be part of the 
consideration 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. We're 
going to try to make sure that that gets into the funding 
measure, but I really think that those are important 
considerations, and I hope that we will have your support on 
those as we lobby for them toward the December spending.
    The last thing, and 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 who are properly 
trained, but if people don't have access to the treatment, then 
it really doesn't matter. You've got to catch them. The two 
places where I think we have the greatest frustration are 
emergency rooms. We just did a good program in Rhode Island so 
they actually do connect, and you don't 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, 
who come in and say I'm desperate, I finally need treatment. 
You can't tell somebody like that, sure, come back Tuesday 2 
weeks from now and we'll be able to see you. You might as well 
tell them to go--well, I won't use the term.
    I hope that we can think of ways to try to catch people 
when they're most amenable, because they've just had a horrible 
experience with an overdose and maybe had their lives saved in 
the ER. Part of that is the recovery coach. Part of that is 
also breaking through HIPAA. You know, it is bonkers that a mom 
and a dad may not know that a 22-year-old or 24-year-old 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 that we should be 
fixing that, I know my time is running short and it's a long 
thing, so feel free to make that a response for the record. We 
need to fix this. We cannot have people turned away at their 
time of openness to this or sent back out into the street after 
they've turned up in an ER.
    Dr. McCance-Katz, you've got Rhode Island privilege to 
answer.
    Dr. McCance-Katz. I'm going to talk about Rhode Island, 
Senator. We do have a program in Rhode Island that places 
recovery coaches with people who have overdosed. Here's the 
other thing that we're doing in Rhode Island that we will start 
talking to the rest of the states about. Here's what we've 
learned, and I know this because I have worked in Rhode Island 
hospital ED with some of these folks, and what we see is that 
when they come in and their overdose is reversed, one of the 
things we need to be aware of is that's often not the time 
they're interested in treatment because they're going through 
withdrawal and they really want to get out of the ED.
    What we are doing in Rhode Island is asking people to sign 
a consent form so that our recovery coaches can contact them a 
few days later, and we think that that is going to make a big 
difference in getting people to the care they need.
    Senator Whitehouse. I'm familiar with that. I just want to 
see it more of a national model.
    Dr. McCance-Katz. That's where SAMHSA comes in, and we will 
be disseminating those kinds of models, absolutely.
    Senator Whitehouse. Thanks.
    Senator Young. Thank you, Senator Whitehouse.
    Senator Franken.

                      Statement of Senator Franken

    Senator Franken. I'm going to go to a different line of 
questioning. To Senator Whitehouse's last question about being 
able to get people into recovery when they're at that moment, 
there aren't the beds, and we have to make sure that there are. 
That's another piece of this.
    I want to talk about my experience in my state within the 
Native American community. Neonatal abstinence syndrome has 
more than doubled in my state in the past 4 years, and Native 
American communities have been disproportionately affected. 
This condition, which is obviously related to maternal 
substance use during pregnancy, is characterized by feeding 
difficulties, hyper-irritability, seizures--you had this in 
your testimony, doctor--all these difficulties.
    Last year, Native American babies within Minnesota's 
Medicaid program were 10 times more likely to be born with 
neonatal abstinence syndrome than white children. For several 
years now, we've heard a growing and urgent cry for help from 
clinicians and tribal leaders about the epidemic and in 
particular its impact on Indian Country. That's why, in the 
Indian Affairs Committee, I asked Indian Health Services Acting 
Director Admiral Weahkee how the Administration could address 
this issue and the opioid epidemic in Indian Country more 
broadly, and he had two recommendations.
    First, bring tribes to the table. Second, consider 
community and culturally specific drug abuse prevention and 
treatment programs. Yesterday I sent a letter to Governor 
Christie, who is the chair of the President's commission on 
combatting this and asking him to consider these 
recommendations and specifically address how to combat this 
crisis in Indian Country in his final report to the President.
    My question for all of you, and I'd like to begin with Dr. 
McCance-Katz, can you speak to what your offices are doing to 
address substance use disorders, particularly opioid addiction, 
in Indian Country? As part of your answer, can you describe how 
you're engaging with tribal communities and working to develop 
and implement culturally specific programs?
    Dr. McCance-Katz. SAMHSA has a branch that is dedicated to 
issues in tribal communities. We're very well aware of the 
issues around the need to be culturally sensitive to Native 
American 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 
Native American people, and we will be awarding that very soon.
    In addition, we also have the Behavioral Health 
Coordinating Committee for HHS has worked on a plan to identify 
what the needs are for mothers and for infants that are opioid 
exposed, and the recommendations have come forward, and we are 
in the process now of putting together a plan to address what's 
in that report. That should be coming in the next few months.
    Dr. Houry. Some of the things we have done is we worked 
first with the Indian Health Service to have them adopt the CDC 
guideline in all the IHS clinics, so now they have the same 
evidence-based treatment. Then I went to the Northern Cheyenne 
reservations last month and spent time with the tribes to see 
how we could best provide technical assistance. To your point, 
that is really using their practices. We have a workgroup at 
CDC focused on American Indian tribal populations so that we 
can really have, I think, much more culturally aware 
treatments.
    The other thing I would say is we participate in the Epi-
Aid, or the outbreak investigation in Minnesota to look at some 
of the substance use issues that some pregnant women were 
having that were Native populations. Then we also have a 
program at CDC called Indian Health and Wellness, which is a 
very holistic approach to chronic diseases, as well as some 
substance issues, using culturally informed practices.
    Senator Franken. OK.
    Dr. Collins. Certainly, the National Institute on Drug 
Abuse, directed by Nora Volkow, has had a particular interest 
in trying to reach out to Indian communities. We're running 
several research projects to try to understand the differences 
and similarities about how the opioid crisis has affected these 
populations, with full engagement of tribal members because 
we've learned over many years that this is a circumstance where 
we need to do a lot of listening and not quite so much talking.
    Out of that has come, I think, some suggestions of 
different ways to try to achieve better prevention strategies, 
and I believe that maybe as soon as next week Dr. Volkow is 
meeting with the Chief Medical Officer of the Indian Health 
Service to discuss additional ways that we might get engaged in 
trying to help out with this very serious problem.
    Dr. Gottlieb. I'll just briefly note that we're taking 
steps to broaden inclusion criteria as part of our mandate 
under 21st Century Cures, and that includes culture-based 
criteria. We also certainly have taken and will continue to 
take steps to encourage the study of treatment in the prenatal 
setting, and particularly treatment for addiction.
    I will just quickly point you to a solicitation that Dr. 
Houry put out in July or August, recently, for a very large 
study that would look at MAT in a prenatal setting, and that 
may be another opportunity or vehicle to address some of these 
issues.
    Senator Franken. I'm not going to ask another question. I 
just want to bring up the connection between trauma. In Indian 
Country there's all kinds of trauma. There's historical trauma, 
which people talk about all the time, which is very real, but 
there's also the trauma of having a parent who has had 
addiction, domestic violence, just poverty, being exposed 
because of housing in Indian Country, being exposed to other 
families? traumas or behavior that is traumatic.
    This will be for the record, and I'm done. Dr. Collins, I'd 
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 
treating people and recovery--is addressing trauma. Thank you.
    Senator Young. Thank you, Senator Franken.
    Senator Baldwin.

                      Statement of Senator Baldwin

    Senator 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--you've 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 that has already exceeded the total number for last 
year. It's clear that 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 illicit entry of fentanyl in international mail 
facilities. We actually had a chance to talk a little bit about 
this earlier this week. Can you describe for the Committee the 
FDA's 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?
    Dr. Gottlieb. Thank you for the question, Senator. I 
appreciated 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 IMFs, the international mail facilities. In 
tripling that number, we only brought it from 8 to 22. As you 
can imagine, we still have a very small footprint. We have a 
mandate that we share with CBP to inspect packages and also do 
testing, which we're very good at, to look for opioid analogs 
in some of these packages that come in. That will increase our 
ability to inspect packages four-fold, but we're still 
inspecting a very small fraction of the packages that are 
carrying drugs.
    We know that the system is simply being overwhelmed with 
packages coming in with illegal narcotics. We're looking to 
what additional steps we can take in this regard to try to step 
up both our footprint in the IMFs, as well as how we go about 
doing our work. I recently met with the commissioner of CBP, 
and we committed to work together to try to look at these 
issues, and they've been very good partners to us.
    With respect to your question about authorities, we do have 
some specific ideas around certain seizure authorities that 
could help us, and I'd be happy to talk to Congress about that. 
A lot of our seizure authorities are based on old maritime law 
and they're sometimes hard to implement against a modern 
threat. I'd be happy to work with you and talk with you about 
how we may improve our footprint there.
    Senator Baldwin. Thank you.
    Dr. Houry, as we work to stem the tide of illegal opioids 
like heroin and fentanyl, obviously so many of my colleagues 
have referenced our need to continue focusing on the efforts to 
prevent. Unfortunately, as noted, addiction often begins with a 
prescription from a doctor for a broken bone, to address 
chronic pain, and it's why I strongly support the CDC's work in 
developing the Safe Opioid Prescribing Guidelines to ensure 
that our providers have access to the most updated scientific-
based tools to best care for their patients.
    The issue--and I'm certainly reminded of the 2012 article 
by Dr. Atul Gawande comparing driving changes of the Cheesecake 
Factory to changes in recipes, et cetera, to the slow pace of 
making changes in medicine. He famously said that in medicine, 
good ideas take an appallingly long time to trickle down, and 
he compared the example of the Cheesecake Factory driving 
changes in 7 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.
    Can you please provide me with an update on CDC's work 
supporting and educating providers in implementing and 
disseminating these guidelines, what's working well and what 
are the CDC's plans to develop new tools for providers and the 
public to educate about safe use?
    Dr. Houry. Absolutely, and we actually use a tool, Gawande, 
to develop a checklist, because we thought the author of the 
Checklist Manifesto was probably the person we should turn to. 
We have a checklist with his consultation on the guideline, and 
that has been downloaded I think over 20,000 times at this 
point.
    We're doing a lot more than that. We also have now worked 
with 60 different medical schools to get the guideline 
integrated into medical schools so that first-and second-year 
medical school students, as we were talking about, by the time 
they come out of medical school now understand about safe and 
effective pain management utilizing our guideline.
    We also developed a mobile app that has all the different 
guideline recommendations in it, but also things like brief 
motivational interventions, so how do you have those difficult 
conversations with patients. Then we're doing online trainings 
that medical schools or people like myself who still need that 
continuing education can use. We've developed six online 
trainings at this point for that.
    Then we're working with different pharmacy and insurance 
companies as well, and we've seen that Cigna adopted our 
guideline a year ago, a 12 percent reduction in prescribing 
already. Just last week, CVS has now announced that they are 
implementing our guideline in all their Caremark facilities. 
We're doing a lot to make sure that it's translated.
    For things like acute pain, we're also developing some 
additional materials based on our guideline recommendation 6. 
That way providers have that information. We've been talking 
with dentists and emergency physicians as well around that 
acute pain aspect.
    We're really excited. I did not want all the work that went 
into the guideline to become a document that went nowhere. We 
worked really closely with medical societies, pharmacists, 
nurses, et cetera, to make sure that this is used.
    Senator Young. Thank you, Senator Baldwin.
    Senator Warren.

                      Statement of Senator Warren

    Senator Warren. Thank you.
    About five people die every day in Massachusetts from an 
opioid overdose. Now, we think we're seeing the number of 
overdose deaths declining slightly, but we are seeing more and 
more overdose deaths that involve fentanyl. As you know, 
fentanyl is an incredibly potent synthetic opioid. It's about 
100 times stronger than morphine.
    Recently, the CDC collaborated with the Massachusetts 
Department of Public Health and the Office of the Chief Medical 
Examiner to study fentanyl overdoses. This study, which was 
released just last year, found that for opioid-related 
fatalities in the State in which it was possible to conduct a 
toxicology screen, 74 percent of individuals tested positive 
for fentanyl.
    Now, the assistance from the CDC means that we can now do a 
better job of responding to the epidemic. For example, when 
someone presents with an overdose involving fentanyl, it 
requires multiple doses of the overdose-reversal 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.
    The question I want to ask, Dr. Houry, 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?
    Dr. Houry. We're doing it in a few ways. The first is 
through our National and Vital Statistics system, and that's 
where we're now releasing preliminary overdose data. The lag 
time happened 2 years because of all the time it took to 
register death certificates and conduct toxicological analyses. 
We're now down to about a 7-month lag. That still wasn't good 
enough, so we're trying to see how we can get more data to 
states and localities quicker.
    Now we have what we call our Enhanced Syndromic 
Surveillance Program, which is where we use bioterrorism 
techniques where we're pulling data from our emergency 
departments, EMS, really the field, to look for trends and 
changes, and we now are funding 32 states and Washington, DC. 
to do that, thanks to the increase that Congress appropriated 
in Fiscal Year 2017.
    Senator Warren. Let's 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. Fentanyl is 100 times more 
potent than morphine, but carfentanil is 100 times more potent 
than fentanyl and is now starting to show up.
    The increasing role, I think, of these powerful drugs is 
part of the reason that a group of Democratic colleagues got 
together to press the congressional leadership for additional 
funding to fight the opioid epidemic in the last budget deal. 
Our pressure worked. We got additional money for the opioid 
epidemic, and some of this went directly to the CDC.
    Dr. Houry, could 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 the emergent problems, like 
the problems we have with fentanyl and carfentanil?
    Dr. Houry. Absolutely. We were able to get that 
surveillance system from 12 to 32 states. That was fantastic. 
In addition, we were able to get funding to coroners and 
medical examiners for the first time. All those states now have 
additional funding for toxicological testing and enhanced 
capacity, and we were also able to take our communications 
campaign and 22 additional states are now able to use it in 
their states.
    Senator Warren. Well, that's a lot out of what was really a 
pretty modest increase, but at least we got some money in 
there.
    You know, I'm really glad to hear this. This is why we 
fought for those funds, and why we're going to keep fighting 
for more money for you going forward.
    I recently conducted a survey of addiction treatment and 
recovery service providers in Massachusetts to try to better 
understand what's working in their fight and the challenges 
they face in combatting this epidemic, and the results of the 
survey are incredibly informative, but they shed light on only 
one piece of the opioid epidemic puzzle.
    We need the CDC's assistance so that we can understand the 
other emerging patterns and respond quickly to them.
    I just want to thank you and thank all of you for your work 
on this issue, and I continue to look forward to working with 
you.
    Dr. Houry. I do as well. Thank you.
    Senator Warren. Thank you.
    Thank you, Mr. Chairman.
    The Chairman. [presiding] Thank you, Senator Warren. Once 
again, you're below time. Thank you for that.
    Let me ask a couple of questions. I know Senator Murkowski 
stated she wanted a second round of questions.
    Dr. Collins and Dr. Gottlieb, you both testified in your 
statements about this, and you've answered questions about this 
today, but I wanted to reemphasize it, and that is the non-
addictive pain medicine.
    Dr. Collins, you said that 25 million Americans live with 
some pain every day, as they would in the hospital. Between 
zero and 10, what degree of pain do they have? Is that de 
minimis, or is it 3, 4, or 5? Or a 7, 8, or 9?
    Dr. Collins. It's sufficient to interfere with quality of 
life on a daily basis. That would be more than a 2 or a 3. I'm 
not sure that there's a precise digital rendition of that. 
Those are people who have daily pain that interferes with their 
daily experience.
    The Chairman. Well, that's maybe 1 out of every 12 
Americans.
    Dr. Collins. Yes, sir.
    The Chairman. A larger number have pain.
    Dr. Collins. Sure, on a more acute basis.
    The Chairman. Yes. 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 drugs and cures through the investment 
regulatory process fast enough to get in the hands of people.
    Let's take non-addictive pain medicine. You're taking some 
extraordinary steps, Dr. Collins, involving funding and 
involving organizing researchers and companies on non-addictive 
pain medicine. Dr. Gottlieb, on your side of the ledger, you 
have several tools--priority review, breakthrough 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?
    Dr. Gottlieb. Well, sir, I would just touch on one other 
area where we would need to make progress and new innovation. I 
think Congress, through the 21st Century Cures and CARA, gave 
us a lot of new tools to do this, and that's just with respect 
to the kinds of development tools that get used to evaluate 
these products, how we design clinical trials, how we measure 
outcomes in this setting, the kinds of scales we use to receive 
patient-reported outcomes, their reliability.
    We're making investments in all of those areas to try to 
make the standards by which we judge new products more 
rigorous, more efficient, so that we can move products through 
the development process while still applying our gold standard 
for an assurance of safety and effectiveness.
    I'll just briefly say that in addition to everything that 
we're talking about and doing with respect to trying to develop 
non-opioid and non-addictive alternatives to the current drugs, 
I would also just point to medical device alternatives that in 
many cases can treat pain more locally.
    Sometimes treating pain that's localized with a systemic 
therapy isn't the most efficient way to do that, and we've 
approved more than 200 devices for the treatment of pain and 
have approved about 10 that are highly novel. That pipeline 
also looks pretty rich.
    Dr. Collins. I can certainly say from NIH's perspective 
that the opportunity to move this forward, with now full 
engagement with industry, seems like something that we just 
have to do. At the present time, just in terms of resources, we 
have no special resources set aside for this, and that would 
certainly be something that would accelerate the process.
    Right now, as I mentioned earlier, we're spending about 
$116 million a year on opioid use disorder research. We need to 
ramp that up by a factor of 4 or 5 if we're going to fully put 
our foot down on the accelerator for this, and I'm not quite 
sure where that would be coming from.
    We also could use some help from Congress in a couple of 
other ways. It would be great if we had a way of very flexibly 
and rapidly funding research, something called Other 
Transaction Authority, something that we're using for the 
Precision Medicine Initiative with great benefit and which we 
don't have at the present time for opioid use disorder 
research. Working with companies, we could go a lot faster if 
we had some relief from some of the limitations of how quickly 
we can fund something that needs to happen.
    Finally I would say if we had the opportunity for relief 
from the very heavy restrictions on doing research that 
involves drugs that are in Schedule I, a research track, for 
instance, for that, that would help us as well. It has been 
sort of an inhibition.
    Finally, although I said finally before, I'll say finally 
one more time----
    [Laughter.]
    Dr. Collins. 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 room, the primary 
care physicians, the hospitals, everything to try to figure out 
if we were really serious about this and pulled all of the 
parties together that have a role in solving this particular 
crisis, we might learn something pretty interesting. That we 
could do also, although it would require substantial resources.
    The Chairman. Thank you, Dr. Collins.
    I'll ask staff to follow-up with Dr. Collins on all three 
of those suggestions, particularly the first two, to see if we 
need legislative language, and then we'll see if we can find a 
way to do that. Maybe opioids could be a pilot for Other 
Transaction Authority that we could then use in precision 
medicine and other areas. Thank you for the specific 
suggestions.
    Dr. Gottlieb, if you have any, we'll be glad to have those 
as well.
    Now, I have about 300 8th graders that are waiting for me 
at about 12:45 from Tennessee, and I don't want to miss them, 
but I want Senator Murkowski and Senator Hassan to have a 
chance to ask their questions. What I'll do is call first on 
Senator Murkowski and next on Senator Hassan. If I'm gone by 
the time you finish, if you could kindly wrap up the Committee 
hearing, whichever one of you goes last, I would appreciate it.
    Senator Murkowski.
    Senator Murkowski. Thank you, Senator Alexander. 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 drugs, illicit drugs or, 
unfortunately, in Alaska we're seeing the purchasing of drugs 
that have not been rescheduled, and so they're effectively 
legal to purchase over the Internet.
    I was at the healing center in Bethel just a few months ago 
and talking with folks about where are people getting their 
drugs in a community like Bethel, where the only way in and 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. 
Unfortunately, this is a reality that we're dealing with.
    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. 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. It's 
not like these folks are hiding these websites. I mean, one of 
the names of the websites is BuyHydrocodoneOnline.com. There is 
no secret there.
    The question that I have is whether or not that effort was 
successful, whether or not there's going to be an ongoing 
follow-up of this. I struggle with how I go back to people in 
these villages that are saying, hey, it's coming in the mail, 
it's coming in every day, how are you going to stop it?
    What's my response? What progress are we making?
    Dr. Gottlieb. Well, we're making progress, Senator, but not 
enough. These rogue operators, to your point, are hiding in 
plain sight. We'll have other operations. This was an operation 
we conducted recently with international partners, including 
Interpol, as you mentioned. We'll have other operations. We 
don't announce those in advance.
    I mentioned that we increased the number of FTEs, a request 
I made when I came to the agency, the number of personnel we 
had in the international mail facilities, from 8 to 22. We 
tripled our footprint. We physically maxed out our space in the 
IMFs. That's why I couldn't put more people in there, and 
that's in part why we're talking to our good partners in CBP 
about getting more space, so we can put more resources in.
    Having gone to the IMFs and having looked at the operations 
we have there and the hard-working people we have in these 
facilities, I can tell you that the people who are shipping 
drugs into this country aren't going to a lot of efforts to 
disguise their tracks because they know that only a small 
percentage are getting seized, and as soon as they find out 
that we're seizing drugs coming in from one route, they'll just 
change the route of delivery, and they are simply overwhelming 
the system. I think we need to be looking much harder at that.
    We also increased the number of personnel we have dedicated 
to our cyber crimes unit, looking at the dark web, where a lot 
of these drugs are being ordered. There, too, I think there's a 
lot more that we want to be doing.
    Senator Murkowski. Well, I'm certainly hopeful that within 
FDA it's kind of a multi-agency approach to how we're going to 
deal with this, working with Postal Service, working with DEA. 
Again, as you say, they're hiding in plain sight, and it 
doesn't take a genius to figure out how to access this and 
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 in 
our reservations in the lower 48. We've had some conversations 
about how in Alaska this 16-bed limit on Medicaid 
reimbursement, the IMDs, is a real limiting factor for us. I 
also appreciate that as much as we need inpatient, when we have 
outpatient treatment, a lot of the population that we're 
dealing with are individuals that are homeless. They don't have 
the alternate or transitional housing that they need. They're 
coming out of incarceration.
    You've got the housing piece of it, but it kind of speaks 
to the kind of treatment that goes on within the prison system 
itself. It's my understanding that the treatment for those that 
are incarcerated, they lose any preexisting Medicaid benefits 
when they are due to be released, when they come in, and then 
they have to reapply at the time of the release. You've got a 
situation where, at a time somebody might need the treatment 
most, they don't have that coverage.
    What are we doing as we're dealing with the need for 
treatment for those that are in this situation, which is really 
very much in flux? Whether you're in prison or you're 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?
    Dr. McCance-Katz. 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 substance use disorders or 
serious mental illness. It's also true that people, once 
they're incarcerated, they do lose any Medicaid benefits that 
they might have had.
    What needs to happen is--we know when people's sentences 
are going to flatten, when they're going to be released, and we 
have to be working with the justice system, with the Department 
of Corrections months ahead of that to make sure----
    Senator Murkowski. We're not doing that well right now.
    Dr. McCance-Katz. We're not doing it well, but there are 
models for it. My State of Rhode Island has a very nice model 
for that that SAMHSA actually does work to disseminate to other 
states, as well. We also provide technical assistance around 
other promising types of interventions of that type that other 
states are starting to explore.
    It's an issue that will require not only resources that we 
can provide through the government but also community 
resources. We have to be working with people in the community, 
recovery coaches, peers, faith-based groups and other types of 
support 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.
    Senator Murkowski. Unfortunately, I think that's where 
we've got a real big gap right now.
    Dr. McCance-Katz. We do. You are right.
    Senator Murkowski. Yes. Thank you.
    Senator Hassan. [presiding] Thank you, Senator.
    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.
    I wanted to focus on something that we are grappling with 
in New Hampshire. Dr. McCance-Katz, this is really a question 
for you in particular and SAMHSA's role in the substance misuse 
workforce, because when we discuss the opioid addiction 
epidemic, we talk a lot about improving access to treatment, 
but one thing I think we don't pay enough attention to is the 
insufficient infrastructure that makes expanding access to 
treatment such a challenge.
    Part of that infrastructure is the addiction treatment 
workforce. I hear often about the importance of integrating 
treatment into primary care, and while I agree that it's 
critically important, I also think we need to recognize that 90 
percent of the addiction treatment workforce are non-
physicians. All of these professionals are on the front lines 
of this opioid addiction epidemic. Stress is high. They are too 
often underpaid, and it means turnover can also be very high. 
In turn, it's very hard to build a workforce with experience 
and firsthand knowledge.
    I'm interested, Doctor, in your thoughts in particular. 
What can SAMHSA do to help recruit, train, employ and, most 
importantly, retain the frontline provider workforce we so 
desperately need to treat this epidemic?
    Dr. McCance-Katz. You're right, the vast majority of people 
who will provide services to those who have substance use 
disorders will be non-physicians. SAMHSA has a number of types 
of training programs that do not just focus on physicians. They 
focus on advanced practice clinicians such as advanced practice 
nurses, nurse practitioners, physician assistants.
    We also encourage interactions and collaboration with our 
colleagues at HRSA because they do have funding programs to 
train various types of health care professionals that SAMHSA 
does not have purview over, but we do work collaboratively with 
them, and we can offer different types of curricula for 
training.
    We work with national stakeholder groups that are involved 
in the credentialing of the various professions to make sure 
that training on recognition and treatment of substance use 
disorders gets into the curriculum, and we will continue all of 
those efforts.
    Senator Hassan. Well, thank you.
    Because it's 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 that your agency isn't doing right 
now that it could be doing or should be doing to help us combat 
this crisis. If you would be willing to submit that in writing, 
I would greatly appreciate it.
    I would also just add that 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 the mortality 
rates in particular in New Hampshire--is people ask me why we 
don't have more resources than we already do, knowing how hard 
everybody here is working. They do ask me the question that 
relates back to the stigma that you talked about, Dr. McCance-
Katz, 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?
    I think it's 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 that takes, and the courage it takes for 
people to come forward to their elected officials and say I'm 
in treatment right now, or I'm raising my granddaughter because 
my daughter died of an overdose last month.
    People have been willing to stand up and talk about this 
illness, and they're helping us understand it as the illness it 
is, but the stigma is still out there. I hope that with every 
piece of energy you all have and the jobs that you have been 
entrusted with, you will speak to the need for us to devote 
resources to what is an epidemic, a disease that will include 
relapse and have co-occurring problems that will challenge us 
moving forward, and that it's not something going away in a 
year or two.
    We will stop, we hope, the over-prescribing, and we'll get 
a better handle on training with our physicians. At the end of 
the day, this is an illness. There will be other substances 
that may trigger addiction and other kinds of addiction going 
forward, and I just thank you for the work you're already 
doing, but I hope I can ask you to be even greater champions 
for the notion that this is an illness and that people need 
care.
    With that, I'm going to turn over the gavel to Senator 
Warren, who will ask her second round and then close out the 
hearing. Thank you so much.
    Senator Warren. [presiding] Thank you. Thank you, Senator 
Hassan.
    Again, thank you all for being here and for staying late 
into the day.
    In Massachusetts, the opioid epidemic is devastating, but 
we are fighting back with everything we have. We're picking up 
every possible tool and trying to figure out how we can both 
reduce the number of people who are addicted or become addicted 
and how to deal with those who have addictions.
    One of the things we've been focused on is figuring out how 
to limit the number of pills left sitting in patients' medicine 
cabinets. From 2000 to 2015, the number of opioid prescriptions 
in Massachusetts increased by roughly 175 percent. It is a 
particular problem because, as you know, of the people who 
abuse prescription opioids, almost 80 percent of them started 
with pills that were prescribed legally to someone--themselves, 
friends, relatives.
    To reduce the number of pills in circulation, Senator 
Capito and I introduced a bill called the Reducing 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 worth of their opioid 
prescription, and then they can return for more if they still 
feel the need. If they don't, those pills never make it into 
anyone's medicine cabinet.
    Now, that bill was signed into law in 2016. Dr. Gottlieb, 
when you formed your Opioid Steering Committee at the FDA, I 
sent you a letter about the partial fill legislation that 
Senator Capito and I managed to get passed last year, and I 
want to thank you for your response on that.
    Let me just 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 number of opioids in circulation?
    Dr. Gottlieb. I do, Senator, and I've been on the record 
supporting various measures that we can try to rationalize 
dispensing. Anything that we can do in that regard that makes 
sense that can be implemented without untoward side effects, 
untoward consequences, I would support.
    Senator Warren. Good, good. Now that we have this new tool 
available to us to help tackle the opioid epidemic, we realize 
that for it to work, a lot of people need to know about it, and 
that means a lot of doctors need to know about it, a lot of 
pharmacists need to know about it, a lot of patients need to 
know about it.
    I wanted to ask you, Dr. McCance-Katz, you are the person 
in charge over at SAMHSA, and I want to ask whether or not 
SAMHSA has a role to play in engaging everyone on this issue so 
that patients actually can do partial fills and not end up with 
a medicine cabinet full of opioids that they don't need.
    Dr. McCance-Katz. Absolutely, SAMHSA does have a role to 
play. We do outreach and training and work with both providers 
and with communities. I would see this as something that would 
fall under the purview of some of our prevention activities, 
and this is definitely something that SAMHSA could play a role 
in.
    Also, we will continue to work with CDC because they have a 
very large role to play in this as well.
    Senator Warren. Good, good. That's what we all want to do. 
Senator Capito and I 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 Capito and I sent letters to Governors 
across the country and to a number of 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. We're making 
progress, but not enough has been done yet. I look forward to 
working with all of you on this as we go forward.
    Again, thanks from everyone on this Committee. Thanks from 
the people across America for your coming today and bringing us 
up to date on your efforts, for the work that you already have 
done, and for the work you will do in the future. We really 
need you out there fighting.
    With that, today's hearing is the first in a series of 
hearings this Committee intends to hold on the opioid crisis. 
We plan to hold a second hearing next month looking at the 
situation on the ground in the states. We'll hear State and 
local perspectives on the challenges they face and the 
successes they've had in combatting this crisis.
    The hearing record will remain open for 10 days. Members 
may submit additional information for the record within that 
time if they would like.
    The HELP Committee will meet again on Tuesday, October 
17th, to continue our hearings on examining the costs of 
prescription drugs.
    Thank you all for being here today.
    The Committee stands adjourned.

                          ADDITIONAL MATERIAL

Written testimony of Witnesses from the Department of Health and Human 
 Services (HHS): Elinore McCance-Katz, Deborah Houry, Francis Collins, 
                           and Scott Gottlieb
    Good morning Chairman Alexander, Ranking Member Murray, and Members 
of the Committee. Thank you for the opportunity to discuss the opioid 
crisis in the United states and the Federal response. From the start of 
his Administration, President Trump has made addressing the opioid 
epidemic a top priority, and at the Department of Health and Human 
Services (HHS) we share the President's commitment to bringing an end 
to this crisis, which is exacting a toll on individuals, families, and 
communities across the country. The Department has made the crisis a 
top clinical priority and is committed to using our full expertise and 
resources to combat the epidemic.

    Over the past 15 years, communities across our Nation have been 
devastated by increasing prescription and illicit opioid abuse, 
addiction, and overdose. According the Substance Abuse and Mental 
Health Services Administration (SAMHSA)'s National Survey on Drug Use 
and Health (NSDUH), in 2016, over 11 million Americans misused 
prescription opioids, nearly 1 million used heroin, and 2.1 million had 
an opioid use disorder due to prescription opioids or heroin. Over the 
past decade, the U.S. has experienced significant increases in rates of 
neonatal abstinence syndrome (NAS), hepatitis C infections, and opioid-
related emergency department visits and hospitalizations. Most alarming 
are the continued increases in overdose deaths, especially the rapid 
increase since 2013 in deaths involving illicitly made fentanyl and 
other highly potent synthetic opioids. Since 2000, more than 300,000 
Americans have died of an opioid overdose. Preliminary data for 2016 
indicate at least 64,000 drug overdose deaths, the highest number ever 
recorded in the U.S. Too many of our citizens are being robbed of their 
God-given potential in the prime of their life.

    The opioid epidemic in the U.S. is fundamentally tied to two 
primary issues. The first issue was the significant rise in opioid 
analgesic prescriptions that began in the mid-to-late 1990's. Not only 
did the volume of opioids prescribed increase, but well-intentioned 
healthcare providers began to prescribe opioids to treat pain in ways 
that we now know are high-risk and have been associated with opioid 
abuse, addiction, and overdose, such as prescribing at high doses and 
for longer durations. The second issue is a lack of health system and 
healthcare provider capacity to identify and engage individuals, and 
provide them with high-quality, evidence-based opioid addiction 
treatment, in particular the full spectrum of medication-assisted 
treatment (MAT). It is well-documented that the majority of people with 
opioid addiction in the U.S. do not receive treatment, and even among 
those who do, many do not receive evidence-based care. Accounting for 
these factors is paramount to the development of a successful strategy 
to combat the opioid crisis. Further, there is a need for more rigorous 
research to better understand how existing programs or policies might 
be contributing to or mitigating the opioid epidemic.

    In April 2017, HHS outlined its five-point Opioid Strategy, which 
provides the overarching framework to leverage the expertise and 
resources of HHS agencies in a strategic and coordinated manner. The 
comprehensive, evidence-based Opioid Strategy aims to:

          Improve access to prevention, treatment, and recovery 
        support services to prevent the health, social, and economic 
        consequences associated with opioid addiction and to enable 
        individuals to achieve long-term recovery;
          Target the availability and distribution of overdose-
        reversing drugs to ensure the broad provision of these drugs to 
        people likely to experience or respond to an overdose, with a 
        particular focus on targeting high-risk populations;
          Strengthen public health data reporting and 
        collection to improve the timeliness and specificity of data 
        and to inform a real-time public health response as the 
        epidemic evolves;
          Support cutting-edge research that advances our 
        understanding of pain and addiction, leads to the development 
        of new treatments, and identifies effective public health 
        interventions to reduce opioid-related health harms; and
          Advance the practice of pain management to enable 
        access to high-quality, evidence-based pain care that reduces 
        the burden of pain for individuals, families, and society while 
        also reducing the inappropriate use of opioids and opioid-
        related harms.

    To date, the Department has taken significant steps to advance the 
goals of our Opioid Strategy. While this statement does not represent 
an exhaustive list of HHS activities underway, SAMHSA, CDC, NIH, and 
FDA bring unique expertise and capabilities that enable HHS to take a 
comprehensive, complementary, and flexible approach to the opioid 
crisis.

    Substance Abuse and Mental Health Services Administration (SAMHSA)
    As HHS's lead agency for behavioral health, SAMHSA's core mission 
is to reduce the impact of substance abuse and mental illness on 
America's communities. SAMHSA supports a portfolio of activities that 
address all five prongs of HHS's Opioid Strategy.

        Improving Access to Prevention, Treatment, and Recovery Support 
        Services
        SAMHSA administers the Opioid State Targeted Response (STR) 
        grants, a 2-year program authorized by the 21st Century Cures 
        Act (P.L. 114-255). By providing $485 million to states and 
        U.S. territories in fiscal year (FY) 2017, this program allows 
        states to focus on areas of greatest need, including increasing 
        access to treatment, reducing unmet treatment need, and 
        reducing opioid overdose related deaths through the provision 
        of the full range of prevention, treatment and recovery 
        services for opioid use disorder. The President's Budget 
        requests $500 million for this program in fiscal year 2018, the 
        full level authorized by Congress.

        The Substance Abuse Prevention and Treatment Block Grant 
        (SABG), first authorized in 1992, is a vital source of funding 
        for states that accounts for approximately 32 percent of total 
        State substance abuse agency funding. For many people seeking 
        to recover from opioid addiction, this public funding 
        represents the only support for treatment. In addition, the 
        block grant's flexible structure enables states to use the 
        funds to address pressing challenges within their communities, 
        such as the opioid crisis.

        SAMHSA also has several initiatives aimed specifically at 
        advancing the utilization of MAT for opioid use disorder, which 
        is proven effective but is highly underutilized. SAMHSA's 
        Medication Assisted Treatment for Prescription Drug and Opioid 
        Addiction (MAT-PDOA) program expands MAT access by providing 
        grants to states with the highest rates of treatment admissions 
        for opioid addiction. Twenty-two states are currently funded by 
        MAT-PDOA, and in September 2017, SAMHSA awarded $35 million 
        dollars over 3 years in additional MAT-PDOA grants to six 
        states.

        SAMHSA also provides critical funding for MAT for specific 
        high-risk and vulnerable populations, such as those involved 
        with the criminal justice system and pregnant and postpartum 
        women. SAMHSA's criminal justice grantees can use up to 20 
        percent of their grant awards for the purchase of FDA-approved 
        medications for treatment of opioid and alcohol addiction. 
        Since 2013, SAMHSA has seen a steady increase in the number of 
        drug courts integrating MAT into their programs with 57 percent 
        of active programs currently integrating MAT.

        Under SAMHSA's Pregnant and Postpartum Women's (PPW) program, 
        which serves women with opioid or other substance use disorders 
        who are pregnant and/or newly parenting, grantees are 
        encouraged to ensure access to MAT for opioid addiction, which 
        has been shown to improve birth outcomes. Last month SAMHSA 
        awarded $9.8 million over 3 years for new State Pilot PPW 
        grants authorized by the Comprehensive Addiction and Recovery 
        Act (CARA, P.L. 114-198) and $49 million over 5 years in new 
        PPW service grants to support the recovery of pregnant and 
        postpartum women struggling with substance abuse, including 
        opioid addiction.

        A well-documented challenge to improving access to opioid use 
        disorder treatment is a lack of providers who can provide MAT. 
        SAMHSA supports a number of training initiatives to increase 
        the number of qualified healthcare providers who can provide 
        treatment for opioid addiction. In the last 4 years, more than 
        62,000 medical professionals have participated in online or in-
        person trainings on MAT for opioid addiction through SAMHSA's 
        Provider's Clinical Support System (PCSS)-MAT. This program is 
        a national training and clinical mentoring project that 
        provides mentoring of newly trained physicians by experienced 
        specialists, maintains a library of evidence-based practice 
        materials, and offers at no cost to the trainee the required 
        DATA 2000 waiver training to enable providers to prescribe 
        buprenorphine for opioid addiction treatment.

        SAMHSA regulates opioid treatment programs (OTPs), which 
        dispense methadone and may also dispense and prescribe 
        buprenorphine and administer extended-release naltrexone. In 
        coordination with the Drug Enforcement Administration (DEA) and 
        states, territories, and the District of Columbia, SAMHSA 
        reviews new and renewal applications for OTPs through an 
        accreditation process that ensures programs have sound risk 
        management practices in place and are using evidence-based 
        treatments. SAMHSA also oversees physicians, nurse 
        practitioners (NPs), and physician assistants' (PAs) ability to 
        prescribe buprenorphine in office-based outpatient treatment 
        settings. Last year, SAMHSA published a final rule which allows 
        certain qualified physicians who have obtained a waiver to 
        prescribe buprenorphine for up to 100 patients for at least a 
        year, to now acquire a waiver to treat up to 275 patients. The 
        regulation provides that these licensed physicians can become 
        eligible for the patient limit of 275 either by being board 
        certified in Addiction Medicine or Addiction Psychiatry or by 
        practicing in a qualified practice setting.

        These physicians are required to complete a SAMHSA reporting 
        form each year to ensure that physicians prescribing at the 
        new, higher level are in compliance with safe and appropriate 
        prescribing practices. As of September 19th, 3,573 physicians 
        have obtained a waiver to treat up to 275 patients. Most 
        recently, SAMHSA began processing waivers to allow NPs and PAs 
        to prescribe buprenorphine in accordance with the requirements 
        of CARA. As of September 19th, 2,756 NPs and 773 PAs have 
        received a waiver.

        SAMHSA also promotes recovery through targeted grants, such as 
        last month's award of $4.6 million over 3 years in Building 
        Communities of Recovery program grants, created by CARA. The 
        purpose of this program is to mobilize resources within and 
        outside of the recovery community to increase the availability 
        and quality of long-term recovery supports for individuals in 
        or seeking recovery from addiction. These grants are intended 
        to support the development, enhancement, expansion, and 
        delivery of recovery support services as well as promotion of 
        and education about recovery. Programs will be principally 
        governed by people in recovery from substance abuse and 
        addiction who reflect the community served.

        Targeting Overdose-Reversing Drugs
        SAMHSA has been a leader in efforts to reduce overdose deaths 
        by increasing, through funding and technical assistance, the 
        availability and use of naloxone to reverse overdose. SAMHSA's 
        ``Opioid Overdose Prevention Toolkit,'' first released in 2013, 
        is one of SAMHSA's most downloaded resources. The Toolkit 
        provides information on risks for opioid overdose, recognition 
        of overdose, and how to provide emergency care in an overdose 
        situation. The Toolkit is intended for community members, first 
        responders, prescribers, people who have recovered from an 
        opioid overdose and family members, as well as communities and 
        local governments.

        SAMHSA provides a number of funding streams that can be used to 
        expand access to naloxone. States are able to use Opioid STR 
        funds to purchase and distribute naloxone, and some states are 
        also using a portion of their SABG funds for opioid overdose 
        prevention activities.

        SAMHSA is currently providing $11 million per year in Grants to 
        Prevent Prescription Drug/Opioid Overdose Related Deaths to 12 
        states. These grants are also being used to train first 
        responders on emergency medical care to be rendered in an 
        overdose situation and how to administer naloxone as well as 
        how to purchase and distribute naloxone.

        In September 2017, SAMHSA awarded funding for grants authorized 
        by CARA, including almost $46 million over 5 years to grantees 
        in 22 states to provide resources to first responders and 
        treatment providers who work directly with the populations at 
        highest risk for opioid overdose.

        Strengthening Public Health Data and Reporting
        SAMHSA's National Survey on Drug Use and Health (NSDUH) 
        provides key national and State level data on a variety of 
        substance use and mental health topics, including opioid 
        misuse. NSDUH is a vital part of the surveillance effort 
        related to opioids, and the data from NSDUH has been used to 
        track historical and emerging trends in opioid misuse, 
        including geographic and demographic variability.

        SAMHSA also works collaboratively with other agencies to better 
        understand the epidemic through sharing of data and assessing 
        the implications of that data and develops publications based 
        on NSDUH and other national surveys and data. Examples of 
        recent SAMHSA publications include: Trends in the Use of 
        Methadone, Buprenorphine, and Extended-release Naltrexone at 
        Substance Abuse Treatment Facilities; Trends in Average Days' 
        Supply of Opioid Medications in Medicaid and Commercial 
        Insurance; and Opioid Prescribing Trends for Adolescents and 
        Young Adults with Commercial Insurance and Medicaid.

        Supporting Cutting-Edge Research
        SAMHSA is building on existing partnerships with the NIH to 
        improve the research to practice pipeline and is committed to 
        promoting evidence-based practices and service delivery models. 
        The newly formed Office of the Chief Medical Officer and the 
        National Mental Health and Substance Use Policy Laboratory, 
        which were authorized through the 21st Century Cures Act to 
        promote evidence-based practices and service delivery models, 
        will be pivotal to these efforts. Additionally, the National 
        Mental Health and Substance Use Policy Laboratory will assist 
        in addressing the opioid crisis through its evaluation of 
        models that would benefit from further development and through 
        expanding, replicating, or scaling evidence-based practices 
        across wider areas as we seek to increase access to and 
        delivery of the best treatment services for opioid use 
        disorders across America.

    Centers for Disease Control and Prevention (CDC)
    As the Nation's public health and prevention agency, CDC's 
expertise and leadership is essential in reversing the opioid epidemic. 
It was CDC that first identified the increase in opioid overdose deaths 
in 2004, and since then the agency has applied its scientific expertise 
to track the epidemic and develop evidence-based prevention strategies. 
Through various programs and initiatives, CDC supports all five parts 
of the Secretary's Opioid Strategy:

        Strengthening Public Health Data and Reporting
        Timely, high-quality data help both public health officials and 
        law enforcement understand the extent of the problem and how it 
        is evolving, develop interventions, focus resources where they 
        are needed most, and evaluate the success of prevention and 
        response efforts. Understanding that data is crucial, CDC is 
        helping states build capacity to monitor the scope of the 
        epidemic and better focus their prevention activities through 
        several programs and activities.

        CDC's Overdose Prevention in states (OPIS) provides resources 
        and scientific support to 45 states and Washington, DC. through 
        three programs. The first two programs, Prescription Drug 
        Overdose: Prevention for states (PfS) and Data-Driven 
        Prevention Initiative (DDPI), provide states with the 
        resources, tools and technical expertise to execute and 
        evaluate prevention strategies to improve safe prescribing 
        practices and prevent prescription drug misuse, abuse, and 
        overdose. States use their funding to advance prevention in 
        four key areas: 1) Enhancing Prescription Drug Monitoring 
        Programs (PDMP) and leveraging them as public health tools; 2) 
        Improving health system and insurer practices for safer opioid 
        prescribing; 3) Evaluating policies that may have an impact on 
        the opioid epidemic (e.g.. naloxone distribution and Good 
        Samaritan laws); and 4) Quickly responding to emerging and 
        critical needs.

        CDC's Enhanced State Opioid Overdose Surveillance (ESOOS) 
        program, the third program under OPIS, funds 32 states and 
        Washington, DC. Started in 2016, ESOOS strives to improve the 
        timeliness of reporting both fatal and non-fatal opioid 
        overdoses and associated risk factors in order to inform public 
        health responses within and across states. What is particularly 
        unique and innovative about this program is the use of 
        emergency department and emergency medical services (EMS) data 
        to track and analyze morbidity data. ESOOS uses this data to 
        establish an early warning system to detect sharp increases 
        (e.g. potential outbreaks) or decreases (e.g. successful 
        intervention efforts) in non-fatal overdoses.

        CDC has made progress in improving the timeliness of data 
        reporting and is now releasing quarterly and, as of August 
        2017, monthly provisional counts of overall drug and opioid 
        overdose deaths in the Vital Statistics Rapid Release (VSRR) 
        series. CDC also relies on its existing infrastructure to 
        monitor rates of new cases of HIV and viral hepatitis in many 
        states. CDC is working with Coroners and Medical examiners to 
        improve both comprehensive toxicology efforts that help with 
        the detection of fentanyl analogs and the capacity for 
        mortality surveillance by identifying ways to help strengthen 
        case management systems to report data more easily and quickly. 
        While CDC has made progress, improvements are needed to build 
        infrastructure (medical examiners, coroners, toxicological 
        testing, additional electronic reporting, etc.). A stronger 
        disease detection system will identify potential problems 
        sooner.

        CDC is also tracking opioid use among pregnant and 
        reproductive-aged women and its impact on the mother and 
        newborn as a part of the Treating for Two: Safer Medication Use 
        in Pregnancy initiative. Pilot programs are underway to obtain 
        state-level estimates of NAS to better understand hospital 
        readmissions and long-term adverse outcomes among infants 
        identified with NAS.

        In addition to providing funding and technical assistance, CDC 
        conducts epidemiological investigations (Epi-Aids) in states, 
        providing on the ground assistance during a public health 
        crisis. Between 2012 and 2015, Massachusetts experienced a 
        surge of opioid-related deaths, from 698 to 1,747, with over 74 
        percent of these deaths involving fentanyl. The Massachusetts 
        Department of Public Health (MDPH) called on CDC to help 
        investigate the extent to which illicitly manufactured fentanyl 
        (IMF) contributed to the surge in opioid-related overdose 
        deaths. CDC worked closely with the MDPH, SAMHSA, and DEA to 
        determine whether IMF mixed with or sold as heroin was the 
        primary cause of the surge of deaths and found that 82 percent 
        of fentanyl-related overdose deaths were suspected to have 
        involved IMF.

        To stop the surge, CDC recommended that the MDPH train 
        physicians, treatment providers, and law enforcement on 
        overdose prevention, screen at-risk people for heroin or 
        fentanyl use, and expand access to naloxone. CDC also 
        recommended outreach to those who experienced an opioid 
        overdose, had a history of substance abuse, or were accessing 
        health programs for active users to link them to treatment and 
        educate them on the dangers of fentanyl.

        Often, CDC's work in states leads to further, national 
        initiatives. The 2015 response to an HIV and Hepatitis C (HCV) 
        outbreak in Scott County, Indiana, led to a CDC analysis which 
        identified over 220 U.S. communities that could be especially 
        vulnerable to HIV and HCV outbreaks among persons who inject 
        opioid drugs. One of those states, Tennessee, used CDC's 
        assessment to do further analysis of the state's 
        vulnerabilities. As a result, Tennessee is working to direct 
        its HIV and viral hepatitis resources where they are most 
        needed.

        In addition to working with states, a partnership across 
        sectors is necessary. CDC has been working on initiatives with 
        law enforcement agencies, like the DEA, to strengthen public 
        health and law enforcement collaboration on the Federal level.

        In addition, the Heroin Response Strategy (HRS), funded by the 
        Office of National Drug Control Policy (ONDCP) and deployed in 
        eight High Intensity Drug Trafficking Areas (HIDTAs), covering 
        20 states, links public health and public safety at the State 
        level. CDC works with the HIDTA directors to sharpen strategic 
        directions, ensure proper coordination and training, support 
        the 20 public health analysts embedded in the program, and 
        improve performance measurement. There is currently a shortage 
        of evidence to guide public health-law enforcement integrated 
        community response, thus as part of the HRS, CDC is launching 
        eight pilot projects across the 20-State initiative to build 
        scientific evidence about what works.

        Advancing the Practice of Pain Management
        Another of CDC's key focus areas is supplying health care 
        providers with the tools and resources necessary to advance the 
        practice of pain management. In March 2016, CDC released the 
        Guideline for Prescribing Opioids for Chronic Pain, which was 
        developed to help primary care doctors provide safer, more 
        effective care for patients with chronic pain outside of active 
        cancer, palliative, and end-of-life care. The Guideline 
        provides 12 voluntary recommendations for prescribing opioids 
        for patients 18 and older, in primary care settings, based on 
        the most current scientific evidence. This helps patients and 
        physicians better understand and assess risks and benefits of 
        opioid therapy and determine the optimal method for each 
        patient to manage their pain.

        CDC has created a number of resources for health care providers 
        to make the guideline easy to understand and access. Earlier 
        this year, CDC launched the first in a series of interactive, 
        online trainings which provide sample scenarios, feedback, and 
        resources for each recommendation. CDC is also capitalizing on 
        technology to help disseminate the Guideline through the 
        development of an Opioid Guideline Application (mobile app) 
        which contains all of the Guideline recommendations, a morphine 
        milligram equivalent (MME) calculator, and an interactive 
        interviewing feature to help providers prescribe with 
        confidence. Other materials developed for providers, 
        pharmacists, and patients include graphics, fact sheets, 
        posters, and podcasts, all available on CDC's website.

        CDC is also committed to educating consumers about the risks of 
        opioids and the importance of discussing safer, more effective 
        pain management options with their healthcare providers. In 
        September 2017, CDC released the Rx Awareness communications 
        campaign to increase awareness about the risks of prescription 
        opioids and deter inappropriate use. The campaign features 
        real-life accounts of individuals living in recovery, and those 
        who have lost someone to an overdose. CDC is running digital, 
        radio, and out-of-home campaign ads for 14 weeks in select 
        states (KY, MA, NM, and OH) with broader release anticipated in 
        22 additional OPIS funded states.

        Improving Access to Prevention, Treatment, and Recovery Support 
        Services
        CDC brings scientific expertise and leverages existing 
        relationships with health systems to link patients who need MAT 
        to the appropriate care. As part of the OPIS effort, several 
        states funded under the PfS program are supporting health 
        system approaches to link patients to treatment and recovery 
        services. For example, states are building systems that 
        facilitate better linkages to treatment, emergency room peer 
        patient navigators, and data dashboards to identify hot spots 
        for treatment needs.

        Additionally, CDC is conducting an epidemiologic study to 
        assess what type of MAT (methadone maintenance; buprenorphine; 
        naltrexone) or counseling and other non-medication 
        interventions is most effective, and which contextual, 
        provider, and individual factors influence implementation, 
        prevent relapse, and improve patient well-being over a 2-year 
        period. This study can help identify who may benefit from which 
        type of treatment to ensure individuals receive the treatment 
        best suited to their needs.

        Targeting Overdose-Reversing Drugs
        CDC is currently working with SAMHSA to evaluate its Grants to 
        Prevent Prescription Drug/Opioid Overdose-Related Deaths 
        program with the goals of describing and understanding the 
        scope and impact of naloxone education and distribution efforts 
        in high-need communities and to identify barriers and potential 
        solutions to increase program effectiveness. Additionally, 
        states funded under OPIS are evaluating practices to improve 
        the distribution and use of overdose reversing drugs and Good 
        Samaritan laws (policies that protect the victim and the 
        bystander from drug possession charges). States utilize CDC 
        data to identify communities experiencing a significant 
        increase in opioid overdose deaths, which helps to inform both 
        the targeted distribution of naloxone and the training of 
        community members, EMS, and law enforcement on naloxone 
        administration.

        Supporting Cutting-Edge Research
        To better understand the epidemic, identify risk and protective 
        factors, and determine effective interventions, CDC also funds 
        innovative research to prevent misuse and abuse. One CDC funded 
        project at the Carolinas Medical Center in Charlotte, North 
        Carolina, is working to assess and compare changes in 
        prescribing behaviors when providers are presented with 
        electronic alerts on potential misuse or abuse of opioids. This 
        research will inform efforts to improve clinical 
        decisionmaking. In addition, CDC funds academic research 
        centers to conduct translational research in order to better 
        understand how to get information into the hands of 
        practitioners. For example, the Johns Hopkins Injury Control 
        Research Center (ICRC) is working to reduce injured patients' 
        risk for opioid misuse through mobile health technology while 
        the West Virginia University (WVU) ICRC was instrumental in the 
        development and implementation of a pilot take-home program for 
        naloxone in rural communities. There were at least 25 overdose 
        reversals in the first 9 months of the program in 16 counties. 
        As part of a rapid response project using CDC funds, the WVU 
        ICRC distributed 8,250 naloxone kits to first response agencies 
        and take-home naloxone programs throughout the State in the 
        first half of 2017.

National Institutes of Health (NIH)
NIH is the lead HHS agency providing support for cutting-edge research 
on pain and opioid misuse, addiction, and overdose. Drug addiction is a 
complex neurological condition, driven by many biological, 
environmental, social, and developmental factors. Continued research 
will be key to understanding the crisis and informing future efforts. 
Pain is an equally complex condition. To this end, NIH supports a range 
of activities to advance research on pain and addiction.

        Supporting Cutting-Edge Research
        Because the most effective way to end opioid misuse and 
        addiction is to prevent it from beginning, NIH is supporting 
        innovative research to better understand what makes an 
        individual vulnerable to opioid misuse. For example, the 
        Adolescent Brain Cognitive Development (ABCD) study, the 
        largest long-term study of brain development and child health 
        in the U.S., will help build an evidence base to draw on for a 
        future of precision medicine approaches to prevent opioid 
        addiction.

        With the goal of bringing scientific solutions to the opioid 
        crisis, NIH is exploring ways to promote 1) new, innovative 
        medications and technologies to treat opioid addiction and 
        improve overdose prevention and reversal interventions, and 2) 
        safe, effective, non-addictive strategies to manage pain. In 
        April 2017, NIH Director Francis S. Collins, M.D., Ph.D., met 
        with research and development leaders from the world's leading 
        biopharmaceutical companies to discuss new ways for government 
        and industry to work together to address the opioid crisis. NIH 
        continued meetings throughout the summer. As part of these 
        ongoing discussions, NIH participated in a recent meeting with 
        Pharmaceutical CEOs convened by Governor Christie, co-chair of 
        the President's Commission on Combating Drug Addiction and the 
        Opioid Crisis, in Trenton, New Jersey, on September 18th. Some 
        advances NIH is working to promote may occur rapidly, such as 
        improved formulations of existing medications, longer-acting 
        overdose-reversal drugs, and repurposing of treatments approved 
        for other conditions. Others may take longer, such as novel 
        overdose-reversal medications and identifying biomarkers to 
        measure pain in patients. Our goal for these activities is to 
        cut in half the time needed to develop new safe and effective 
        therapeutics to help end the opioid crisis.

        NIH will continue to buildupon breakthroughs in the treatment 
        of opioid addiction and the reversal of opioid overdose and 
        find ways to advance the development of new products. For 
        example, buprenorphine, one of the three FDA-approved options 
        for MAT treatment, was developed through a partnership between 
        NIH and industry. The intramural program of the National 
        Institute on Drug Abuse (NIDA) conducted the early clinical 
        studies on buprenorphine and then later partnered with industry 
        to develop user-friendly and abuse deterrent formulations. In 
        addition, a NIH public-private partnership helped to develop 
        the only FDA-approved intranasal naloxone product to reverse 
        opioid overdose, an invaluable tool to those on the front lines 
        combating the opioid crisis. In 2013, NIDA funded a 
        biopharmaceutical company for clinical studies to evaluate the 
        pharmacokinetic properties--how much and how rapidly the 
        naloxone is absorbed--of an intranasal formulation. In 2015, 
        the intranasal naloxone was approved by the FDA. With knowledge 
        gained from neuroscience advances, NIH researchers now seek 
        ways to turn the tide in the opioid crisis through a wider 
        range of formulations of existing and new medications, as well 
        as innovative strategies to treat opioid use disorder and 
        prevent and reverse overdose.

        NIH is also working toward preventing the most serious health 
        consequences for infants born with NAS. Currently, NIH research 
        aims to determine more precise dosing of buprenorphine in 
        pregnant women, and to reduce the time to develop new 
        treatments. NIH is also launching a new effort on opioid use in 
        pregnancy, to study the effects of medically supervised opioid 
        withdrawal on mother and newborn, and better understand the 
        genetic or epigenetic factors associated with opioid use on 
        neonatal outcomes. NIH will also develop and pilot a common 
        study protocol to generate evidence for best practices in 
        treating newborns with NAS, through a partnership between the 
        NIH Neonatal Research Network and the new IDeA States Pediatric 
        Clinical Trials Network.

        NIH researchers are also working to build an understanding of 
        how to effectively integrate prevention and treatment services 
        within healthcare and community systems. For example, NIH is 
        studying strategies to improve the implementation of MAT for 
        people with opioid use disorder in the criminal justice system. 
        This research aims to optimize implementation of evidence-based 
        screening, assessment, and treatment services by juvenile 
        justice agencies and improve coordination with community 
        healthcare providers in a way that promotes long-term recovery 
        from opioid addiction in real-world settings.

        Advance the Practice of Pain Management
        Our mission to end the opioid crisis will not be successful 
        until we can provide patients with better options for the 
        treatment of pain, which touches 25 million Americans every 
        day. NIH funds a broad range of research on pain, from basic 
        research into the molecular, genetic, and bio-behavioral basis 
        of chronic pain to large-scale clinical studies of potential 
        treatments. NIH funded basic research has identified a myriad 
        of potential targets for future non-addictive therapies. 
        Pathological pain and addiction are classic disorders of brain 
        circuits and the neurotechnologies emanating from the US BRAIN 
        Initiative enable scientists to explore these circuits to 
        advance both diagnostics and therapeutics. Research efforts to 
        understand and alleviate pain depend on better objective 
        measures of the pain experience for patients. To address this, 
        NIH also supports development of resources to advance the 
        research agenda. One example is the Patient-Reported Outcomes 
        Measurement Information System (PROMIS). PROMIS provides a 
        rigorously tested patient-reported outcome measurement tool to 
        measure pain, fatigue, physical functioning, and emotional 
        well-being.

        NIH works with Federal partners across government to carry out 
        cutting-edge research on pain. Through the Interagency Pain 
        Research Coordinating Committee, NIH developed the Federal Pain 
        Research Strategy, a long-term strategic plan to coordinate and 
        advance the Federal research agenda on pain. The Strategy's 
        research priorities include prevention of acute and chronic 
        pain, management of acute pain, transition from acute to 
        chronic pain, and understanding the disparities that influence 
        pain and pain management. Ongoing projects that already are 
        advancing the goals laid out in the Strategy include the NIH-
        DoD-VA Pain Management Collaboratory program, which recently 
        announced $81 million in research funding to implement cost-
        effective large-scale clinical research in military and veteran 
        healthcare delivery organizations, focusing on non-
        pharmacologic approaches to pain management and other comorbid 
        conditions.

        Beyond research activities, NIH is engaged in efforts to 
        advance the HHS Opioid Strategy pillar of advancing the 
        practice of pain management. NIH worked with HHS and agencies 
        across government to develop the National Pain Strategy, the 
        government's first broad-ranging effort to improve how pain is 
        perceived, assessed, and treated, which highlights the need for 
        evidence based treatments. NIH is actively working with other 
        Departments and Agencies and external stakeholders to implement 
        the Strategy. In addition, NIH is supporting Centers of 
        Excellence for Pain Education that act as hubs for the 
        development, evaluation, and distribution of pain management 
        curriculum resources for medical, dental, nursing, pharmacy and 
        other schools to enhance education about pain and pain care.

    Food and Drug Administration (FDA)
    FDA, the Agency responsible for protecting the public health by 
ensuring the safety, efficacy, and security of human and veterinary 
drugs, biological products, and medical devices, is focusing on three 
broad areas to help address the opioid crisis: lowering overall 
exposure to opioid drugs and, in turn, reducing the number of new cases 
of addiction; enabling more opportunities for those currently addicted 
to opioid drugs to seek MAT that can help them recover; and helping 
expedite the development of progressively more-effective abuse 
deterrent formulations of opioid drugs, and better still, non-opioid 
alternatives for the treatment of pain. To advance these goals, FDA, 
earlier this year, established an Opioid Policy Steering Committee that 
brings together the Agency's most senior career leaders to explore and 
develop additional tools and strategies to confront the opioid crisis.

        Support Cutting-Edge Research
        Abuse Deterrent Formulations (ADF): FDA's emphasis on assessing 
        the full public health effects of opioids is reflected in the 
        Agency's ongoing work to support the development of forms of 
        prescription opioids that deter abuse. The Agency strongly 
        supports a transition from the current market dominated by 
        conventional opioids to one in which the majority of opioids 
        have meaningful abuse-deterrent properties. In support of this 
        transition and potential future actions against products 
        without these properties, FDA is focusing its efforts on 
        determining how effective the current abuse deterrent products 
        are in the real world. To assist this effort, the Agency 
        recently gathered independent experts for a scientific workshop 
        to discuss both the existing science and what else is needed to 
        properly assess the impact of opioid formulations with abuse-
        deterrent properties on misuse, abuse, addiction, overdose, and 
        death. Separately, FDA is working to support generic forms of 
        abuse deterrent opioids by issuing final guidance on their 
        development, in recognition of the important role generic drugs 
        play in the United States.

        Alternatives to Opioids for Pain: FDA strongly supports the 
        development of new treatment options for patients in pain, 
        especially treatments that do not have the same addictive 
        features of traditional opioids. To advance both non-addictive 
        and non-pharmacologic treatments for pain, FDA commits to using 
        all of the Agency's authorities. This includes programs such as 
        the Fast Track and Breakthrough Therapy Designations that are 
        intended to facilitate development and to expedite review of 
        products that, for example, are intended to treat a serious 
        condition for which there is an unmet medical need. As a part 
        of these efforts, FDA is meeting with innovators who are 
        pursuing non-opioid alternatives for the treatment of pain to 
        provide guidance on their individual products. Agency steps 
        also include a more careful consideration of non-drug 
        alternatives for pain, such as medical devices that can deliver 
        more localized analgesia. FDA is considering how to more 
        closely fit medical device alternatives into a comprehensive 
        approach to the development of treatments for pain.

        We know that developing non-opioid and non-addictive pain 
        medicines is challenging for many reasons; therefore, FDA is 
        interested in progressing the entire field of pain drug 
        development. To address the issues related to the trials needed 
        for approval, FDA has participated in a public-private-
        partnership (PPP) under the Critical Path initiative, the 
        Analgesic Clinical Trial Translation, Innovations, 
        Opportunities, and Networks (ACTTION). The ACTTION PPP is a 
        collaboration among a broad spectrum of national and 
        international groups aimed at advancing the science in this 
        area, including academia, FDA and other government agencies, 
        pharmaceutical and device companies, professional 
        organizations, and patient advocacy groups.

        At the same time as we are prioritizing work on non-opioid and 
        non-abusable pain medicines, FDA is also taking new steps to 
        help facilitate the development of medications that can help 
        patients with addiction recover as well as overdose reversal 
        drugs, such as naloxone. FDA is laying the groundwork for 
        naloxone to be available more broadly and is supporting 
        research aimed at encouraging the potential development of over 
        the counter naloxone products.

        Advance the Practice of Pain Management
        Changes in Prescribing: To reduce the rate of new opioid 
        addiction, we need to decrease overall exposure to opioids. For 
        many people, that first prescription will be for an immediate 
        release (IR) formulation of the drug. Some people will go on to 
        become addicted and abuse longer-acting formulations that can 
        deliver higher doses, especially when manipulated. Some of 
        these people will eventually move onto street drugs, such as 
        heroin, which are increasingly the low-cost alternative. We 
        know that this route of addiction correlates with exposure. A 
        certain percentage of patients exposed to opioids will go on to 
        develop an addiction to the drugs. One approach to reducing the 
        rate of new addiction, then, is to reduce exposure to 
        prescription opioid drugs. To accomplish this, we need to 
        explore ways to use our regulatory authorities to influence how 
        opioids are prescribed to make sure that only appropriately 
        indicated patients are prescribed opioids, and that the 
        prescriptions are written for durations and doses that properly 
        match the clinical reason for which the drug is being 
        prescribed in the first place. We are exploring whether FDA 
        should take additional steps to make sure that general 
        prescribing and the number of opioid doses that an individual 
        patient can be dispensed, is more closely tailored to the 
        medical indication. Among other steps, FDA is soliciting public 
        input on these questions in the form of a public docket that 
        was established the week of September 25.

        Expanded Education through Modification of Opioid REMS, and 
        Changes to the Education Blueprint: Since 2012, FDA has 
        required manufacturers of extended-release long-acting opioids 
        to make available educational materials through a Risk 
        Evaluation and Mitigation Strategy (REMS). We know that most of 
        the exposure to opioids is not from extended-release or long-
        acting formulations, but from IR formulations like hydrocodone 
        and acetaminophen or oxycodone and acetaminophen combinations. 
        In fact, about 90 percent of all opioid prescriptions in the 
        United States are written for IR formulations of these drugs. 
        IR opioid products serve as the gateway for patients and non-
        patients who may continue to use or misuse these products, 
        which could lead to new addiction. Given this fact, we need to 
        advance policies that rationalize the prescribing and 
        dispensing of IR opioid drugs.

        As one step, FDA has determined that a REMS to support 
        education is also necessary for the prescribing of IR opioid 
        products. This regulatory tool is needed to ensure that the 
        benefits of these drugs continue to outweigh the risks of 
        adverse outcomes (addiction, overdose, and death) resulting 
        from inappropriate prescribing, abuse, and misuse, and that 
        providers are properly informed about suitable prescribing and 
        the risks and benefits associated with opioid drugs. FDA has 
        announced its intention to update the existing REMS on 
        extended-release/long-acting opioid analgesics, and for the 
        first time, extend these same regulatory requirements 
        (including prescriber training) to the manufacturers of IR 
        opioid analgesic products. FDA is currently implementing that 
        plan. We have also announced plans to revise the Blueprint used 
        to create education materials to include broader information on 
        pain management, including the principles of acute and chronic 
        pain management; non-pharmacologic treatments for pain; and 
        pharmacologic treatments for pain (both non-opioid analgesic 
        and opioid analgesic). To start this process, the relevant 
        letters, detailing the new requirements, were recently sent to 
        sponsors that manufacture the IR drugs.
In addition to the efforts described above, HHS continues to engage 
with a broad range of stakeholders--State and local governments, 
addiction specialists, medical, nursing, dental, and pharmacy 
providers, community and faith-based organizations, private-sector 
partners, community organizations, and law enforcement partners--to 
share best practices, build collaborations, and identify barriers that 
could prevent success. We are committed to this fight and will continue 
to advance a multi-pronged strategy, never forgetting that behind all 
the statistics are individuals, families, and communities who are being 
torn apart each day. Our guiding vision must be to improve the lives of 
all Americans who have been touched by this crisis. That will be the 
true measure of our success.

    Last, HHS, through the President's fiscal year 2018 budget, has 
requested more than $800 million to continue to support the 
Department's critical opioid investments. We look forward to continuing 
to work with Congress to identify solutions and to secure the funding 
needed to turn the tide against the opioid crisis.

    Thank you again for inviting SAMHSA, CDC, NIH, and FDA to testify 
today. We look forward to answering your questions.
                                 ______
                                 
       Response by Dr. Gottlieb to Questions of Senator Alexander
    Question 1. Do you need additional authorities, on top of the 
modernizations for substance use disorders and opioid abuse programs 
and services in the 21st Century Cures Act and in the Comprehensive 
Addiction and Recovery Act (CARA), to fight the opioid crisis? If so, 
please provide specific authorities that would be helpful
    Answer 1. HHS is determining at the Department level what 
authorities or changes in statute would be helpful.

    Question 2. Section 319 of the Public Health Service Act gives the 
Secretary of HHS the authority to determine that a public health 
emergency exists, allows for waivers of various Medicare and Medicaid 
regulations, movement of volunteer and Federal medical and public 
health professionals to areas hardest hit by the emergency, ability to 
access resources traditionally used for the Strategic National 
Stockpile, and the ability of the FDA to allow drugs and devices to 
come to market prior to full approval under its Emergency Use 
Authorization. Are any of the authorities that are available under a 
Public Health Emergency Declaration necessary to help address the 
opioid abuse crisis? If any, please list, and provide specific examples 
of why such authority is helpful.
    Answer 2. HHS is thoroughly reviewing the available authorities and 
analyzing how they can be applied in the context of the opioid 
epidemic. As decisions are made, we will be happy to share them with 
you, but we are committed to carrying out our five-point strategy and 
stemming the tide of this epidemic.
    Under FDA's Emergency Use Authorization (EUA) authority (section 
564 of the Federal Food, Drug, and Cosmetic Act (FD&C Act)), FDA may 
authorize the use of an unapproved medical product, or an unapproved 
use of an approved medical product, in response to an actual or 
potential chemical, biological, radiological, or nuclear (CBRN) 
emergency.
    Before FDA may issue an EUA, several steps are required under 
section 564. The Secretary of Health and Human Services (HHS) first 
must declare that circumstances exist to justify issuance of the EUA 
(``EUA declaration''). This type of HHS declaration is specific to the 
EUA authority (i.e., it is distinct from a Public Health Emergency 
(PHE) declaration under section 319 of the Public Health Service Act) 
and must be based on one of four types of section 564 determinations 
issued by the Secretary of Department of Defense (DoD), Department of 
Homeland Security (DHS), or HHS. For example, a section 564(b)(1)(C) 
determination by HHS would be ``that there is a public health 
emergency, or a significant potential for a public health emergency, 
that affects, or has a significant potential to affect, national 
security or the health and security of United States citizens living 
abroad, and that involves a [CBRN] agent or agents, or a disease or 
condition that may be attributable to such agent or agents.''\1\ FDA 
also must determine whether the statutory criteria for issuance of an 
EUA are met before issuing an EUA (e.g., the benefits of the product 
for the emergency use outweigh its risks; there is no adequate, 
approved, alternative product available; etc.).
---------------------------------------------------------------------------
    \1\ Section 564(b)(1)(C) of the FD&C Act.
---------------------------------------------------------------------------
    Therefore, issuance alone of a PHE under section 319 is not 
sufficient for FDA to issue an EUA. The Secretary of HHS would need to 
determine whether to make an additional determination and appropriate 
declaration pursuant to FDCA Section 564 for a medical product or 
category of medical products. Also, an assessment would need to be made 
as to whether the opioid emergency would be considered an emergency 
under section 564 (e.g., as a chemical or biological threat), and which 
products might benefit from being authorized for use under an EUA (and 
whether there are existing available, alternative, and approved 
products).
    We are not aware of an unapproved product that could be used in 
response to the opioid emergency that would meet the relevant criteria. 
For example, an opioid antagonist would not meet the criteria because 
adequate and approved alternatives are available (e.g., naloxone 
injectors and nasal sprays).
    In addition to the EUA authority, FDA has other emergency use 
authorities under section 564A of the FD&C Act applicable to certain 
FDA-approved medical products, allowing for response flexibilities 
without FDA having to issue an EUA. For example, section 564A(d) allows 
FDA to authorize emergency dispensing of certain FDA-approved medical 
products without requiring an individual prescription for each 
recipient/patient, if: (1) permitted by State law, or (2) in accordance 
with an order issued by FDA (i.e., an ``emergency dispensing order''). 
Although FDA may grant such flexibilities without having to issue an 
EUA or without issuance of an EUA declaration, these authorities are 
only applicable to certain FDA-approved medical products intended for 
use (or used) when a CBRN emergency determination under section 
564(b)(1) is in place. Therefore, a determination of a public health 
emergency or of a significant potential for a public health emergency 
under section 564(b)(1)(C), as described above, or one of three other 
types of determinations made by the Secretary of DoD or Secretary of 
DHS under section 564(b)(1), is required.

    For additional information about these FDA authorities, please see:

         EUA:
        https://www.fda.gov/EmergencyPreparedness/Counterterrorism/
        ucm182568.htm.
         Emergency dispensing orders:
        https://www.fda.gov/EmergencyPreparedness/Counterterrorism/ 
        MedicalCountermeasures/MCMLegalRegulatoryandPolicyFramework/
        ucm495126.htm.
         Emergency use guidance:
        https://www.fda.gov/downloads/ EmergencyPreparedness/ 
        Counterterrorism/MedicalCountermeasures/
        MCMLegalRegulatoryandPolicyFramework/ UCM493627.pdf

    Question 3. How do you ensure coordination between the multiple 
divisions that review products indicated for pain, whether from a 
migraine, a joint injury, or chronic pain?
    Answer 3. FDA encourages collaboration among its organizational 
components. In line with these efforts, FDA established an opioid task 
force in 2013 to share information, buildupon existing initiatives, and 
develop new ones. Since inception, the task force has met regularly and 
embarked on a multi-pronged and targeted approach aimed at combating 
misuse, abuse, and addiction at critical points in the lifecycle of an 
opioid product, from development through use. Earlier this year, FDA 
established an Opioid Policy Steering Committee that brings together 
the Agency's most senior career leaders to explore and develop 
additional tools and strategies to confront the opioid crisis. In 
addition, review divisions within the Center for Drug Evaluation and 
Research (CDER) regularly consult one another when a product being 
developed for pain involves more than one area of expertise. For 
example, the Division of Anesthetic, Analgesia, and Addiction Products 
(DAAAP) reviews most of the products indicated for pain, and consults 
with the Division of Oncology Products for products under development 
for the pain associated with chemotherapy induced peripheral 
neuropathy. The Division of Bone, Reproductive, and Urological Products 
reviews products to treat pelvic pain syndromes and consults DAAAP to 
maintain consistency with relevant pain endpoints. In addition, FDA's 
Office of Regulatory Policy in CDER also assists with internal 
consistency. Also, FDA regulations aim to ensure consistency of 
clinical and regulatory programs and product quality measures. Types of 
documents used to promote consistency across Centers and among 
divisions also include guidances and Manuals of Policies and Procedures 
(MaPPs).
    Guidance documents represent the Agency's current thinking on a 
particular subject. These documents are prepared for FDA review staff 
and applicants/sponsors to provide information as to the processing, 
content, and evaluation/approval of applications and also provide 
information as to the design, production, manufacturing, and testing of 
regulated products. These establish policies intended to achieve 
consistency in the Agency's regulatory approach and identify inspection 
and enforcement procedures. The Agency has issued numerous draft and 
final guidance documents related to pain, analgesia, formulation, and a 
variety of other topics for industry, which are available to the public 
via our website: https://www.fda.gov/RegulatoryInformation/Guidances/
ucm122044.htm.
    CDER's MaPPs provide instructions for internal practices and 
procedures followed by CDER staff to help standardize the drug review 
process and other activities. MaPPs address external activities as 
well. All MAPPs are available for the public to review to get a better 
understanding of office policies, definitions, staff responsibilities, 
and procedures.

    Question 4. It would be beneficial for companies to be able to 
discuss with doctors how their drugs can help with the opioid crisis 
and potentially prevent or minimize the risk of addiction by avoiding 
opioid use, but it is not clear what studies would be necessary to make 
that claim. What studies are required for chronic pain labels to 
include information about how that drug may compare to, or spare the 
use of, opioids? Please provide information on how studies can make 
opioid sparing claims, and any plans the agency has to formalize that 
policy in a guidance document.
    Answer 4. FDA is focusing on data for modifying drug labeling that 
can then help drive more appropriate prescribing. Drug labeling is the 
primary communication tool about the safety and efficacy of approved 
drug products. Labeling changes are intended to inform prescribers 
about the risks associated with opioids including abuse, misuse, 
addiction, overdose, and death and to weigh the benefits for pain 
management against risks. Currently, FDA does not have a guidance 
document specifically regarding opioid sparing claims. However, 
sponsors wanting to add these claims to their drug labeling are 
encouraged to discuss their plans for data to support these findings 
during meetings with the review divisions. This would include meetings 
before the Investigational New Drug Application (IND) has been 
submitted (preIND meeting), meetings after initial data become 
available from Phase 2 clinical trials (End of Phase 2 meeting), and 
meetings throughout development.
    We recognize that there is a high level of interest regarding FDA's 
views on firms' communications about their medical products. We are 
committed to an ongoing dialog with industry and other stakeholders, 
and, when needed, providing guidance to clarify the agency's thinking 
on these issues. On January 19, 2017, FDA announced the availability of 
a draft guidance for industry entitled ``Medical Product Communications 
That Are Consistent With the FDA-Required Labeling--Questions and 
Answers.'' This draft guidance provides information for manufacturers, 
packers, and distributors and their representatives (collectively 
``firms'') of drugs and medical devices for humans, including those 
that are licensed as biological products, and animal drugs 
(collectively ``medical products''), about how FDA evaluates their 
medical product communications, including their promotional materials, 
that present information that is not contained in the FDA-required 
labeling for the product but that may be consistent with the FDA-
required labeling for the product. The draft guidance both describes 
FDA's thinking on the types of information that are consistent with the 
FDA-required labeling and provides general recommendations for how this 
information can be conveyed in a truthful and non-misleading way. The 
draft guidance also provides some examples to illustrate these 
concepts. The agency is considering the comments it received on this 
draft guidance and working to issue a final guidance on this topic. We 
encourage companies to read the guidance and talk to us about any study 
and product-specific questions they have in this area.
        Response by Dr. Gottlieb to Questions of Senator Murray
    Question 1. I was pleased that you have been fulfilling the promise 
you made at your confirmation hearing to act swiftly and decisively to 
stem the opioid crisis. In your testimony, you mention that FDA is 
examining the risk-benefit assessment of new and existing opioid 
products to take into account the public's health, not just the safety 
and efficacy of the drug to treat pain. How is FDA implementing this 
new framework to assess opioids, as well as non-addictive pain 
treatments in development, to help patients and families across the 
country?
    Answer 1. When it comes to regulating opioids, FDA assesses diverse 
risks and benefits to ensure that it is considering the full public 
health implications of any decisions. We recently sought the withdrawal 
of Opana ER from the market after determining that risks of its 
continued use outweighed the benefits. As an integral part of our 
efforts to address this epidemic, we're exploring how this risk / 
benefit mandate can be further defined in support of our commitments to 
help stem the tide of opioid addiction. FDA will continue to examine 
the risk-benefit profile of all approved opioid analgesic products and 
take further actions as appropriate as a part of our response to this 
public health crisis.

    2. Non-addictive pain treatments can reduce the need for opioids 
for many patients. FDA has several expedited approval pathways to speed 
safe and effective products that treat serious or life-threatening 
conditions to patients and families. Pain itself is not what we think 
of on its face as a life-threatening condition.

    Question 2a. Given the serious and life-threatening nature of 
opioid addiction, which non-addictive pain treatments seek to prevent, 
does FDA believe it has the authority to expedite products that meet 
the other criteria for one of the existing expedited approval pathways? 
Has FDA used any of these pathways for non-addictive pain products?
    Answer 2a. FDA is committed to working with sponsors and with 
researchers who are developing non-opioid and non-addictive pain 
medications to bring these new options to patients as expeditiously as 
possible. FDA has a number of programs, such as Fast Track and 
Breakthrough Therapy Designation, which are intended to facilitate the 
development and review of products that, for example, are intended to 
treat a serious condition for which there is an unmet medical need. 
Novel non-opioid medications with the potential to provide effective 
pain relief, and that satisfy the applicable legal criteria, may be 
appropriate candidates for such programs. Indeed, we have issued Fast 
Track Designation for more than 30 non-opioid analgesics and 
Breakthrough Therapy Designation for 12 non-opioid analgesics.

    Question 2b. How is FDA working with and guiding companies 
developing products intended to prevent opioid use and seeking an 
opioid-sparing indication on the drug label?
    Answer 2b. The Agency is actively working with, and assisting, 
sponsors with their drug development programs. Sponsors may encounter 
both clinical and nonclinical challenges specific to their drug 
development programs. In line with these challenges, the Agency is open 
to working with sponsors who are interested in developing new potential 
treatments, and we strongly encourage manufacturers and drug developers 
to contact the Division of Anesthesia, Analgesia, and Addiction 
Products in the Center for Drug Evaluation and Research so that we can 
provide targeted advice specific to their drug development programs. 
For more information, please see our draft guidance entitled Analgesic 
Indications: Developing Drug and Biological Products (https://
www.fda.gov/ Drugs/ Guidance Compliance Regulatory Information/ 
Guidances/ UCM384691), which, when finalized, will provide the Agency's 
recommendations on such development.
    Currently, FDA does not have a final guidance document regarding 
opioid-sparing claims. However, sponsors wanting to add these claims to 
their drug labeling are encouraged to discuss their plans to support 
these findings during meetings with the review divisions including 
meetings before the Investigational New Drug Application (IND) has been 
submitted (preIND meeting), meetings after initial data become 
available from Phase 2 clinical trials (End of Phase 2 meeting), and 
meetings throughout development.

    Question 2c. How is FDA coordinating among the different review 
divisions, charged with reviewing pain treatments with different 
mechanisms of action and indications, to ensure that developers of non-
addictive pain products are receiving consistent advice regarding trial 
and outcomes design?
    Answer 2c. FDA encourages collaboration among its organizational 
components. In line with these efforts, FDA established an opioid task 
force in 2013 to share information, buildupon existing initiatives, and 
develop new ones in. Since inception, the task force has met regularly 
and embarked on a multi-pronged and targeted approach aimed at 
combating misuse, abuse, and addiction at critical points in the 
lifecycle of an opioid product, from development through use. Earlier 
this year, FDA established an Opioid Policy Steering Committee that 
brings together the Agency's most senior career leaders to explore and 
develop additional tools and strategies to confront the opioid crisis. 
In addition, review divisions within the Center for Drug Evaluation and 
Research (CDER) regularly consult one another when a product being 
developed for pain involves more than one area of expertise. For 
example, the Division of Anesthetic, Analgesia, and Addiction Products 
(DAAAP) reviews most of the products indicated for pain, and consults 
with the Division of Oncology Products for products under development 
for the pain associated with chemotherapy induced peripheral 
neuropathy. The Division of Bone, Reproductive, and Urological Products 
reviews products to treat pelvic pain syndromes and consults DAAAP to 
maintain consistency with relevant pain endpoints. In addition, FDA's 
Office of Regulatory Policy in CDER also assists with internal 
consistency. Also, FDA regulations aim to ensure consistency of 
clinical and regulatory programs and product quality measures. Types of 
documents used to promote consistency across Centers and among 
divisions also include guidances and Manuals of Policies and Procedures 
(MaPPs).
    Guidance documents represent the Agency's current thinking on a 
particular subject. These documents are prepared for FDA review staff 
and applicants/sponsors to provide information as to the processing, 
content, and evaluation/approval of applications and also provide 
information as to the design, production, manufacturing, and testing of 
regulated products. These establish policies intended to achieve 
consistency in the Agency's regulatory approach and identify inspection 
and enforcement procedures. The Agency has issued numerous draft and 
final guidance documents related to pain, analgesia, formulation, and a 
variety of other topics for industry, which are available to the public 
via our website: https://www.fda.gov/ Regulatory Information/ 
Guidances/ ucm122044.htm.
    CDER's MaPPs provide instructions for internal practices and 
procedures followed by CDER staff to help standardize the drug review 
process and other activities. MaPPs address external activities as 
well. All MAPPs are available for the public to review to get a better 
understanding of office policies, definitions, staff responsibilities, 
and procedures.

    Question 3. In Washington state, we have standing orders and 
collaborative practice agreements which help to increase access to 
Naloxone through pharmacies, clinics, and first responders.\2\ However, 
these kinds of programs vary from State to state, and it is difficult 
to access naloxone as compared to over-the-counter availability. How is 
FDA working with naloxone manufacturers to assess the whether or not 
the science supports a change to over-the-counter status, and what are 
your next steps?
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    \2\ https://www.nwcphp.org/documents/training/hot-topics-1/
htip20150224notes.pdf.
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    Answer 3. Prevention and treatment of opioid overdose is an urgent 
public health priority, and FDA recognizes the need to improve access 
to naloxone for the emergency treatment of known or suspected overdoses 
until emergency medical help arrives. The Agency is focusing on: (1) 
expanding the utilization of naloxone; (2) accelerating the development 
and availability of new naloxone formulations and user friendly 
products; and (3) identifying and disseminating the best practice 
naloxone delivery models and strategies. FDA is reviewing options, 
including over-the-counter (OTC) availability, to make naloxone more 
accessible to treat opioid overdoses, building on the Agency's recent 
approval of intranasal naloxone. To lay the groundwork for naloxone to 
be available more broadly, FDA is supporting research to facilitate the 
development of labeling for a potential OTC version of naloxone aimed 
at encouraging manufacturers to develop over the counter naloxone 
products. In addition, FDA has contacted every maker of an approved 
naloxone product and offered to meet with them to discuss the OTC 
process, and several have taken FDA up on this offer.
    4. OTC Pain Products
    Over the counter (OTC) acetaminophen can provide a safe and non-
addictive pain management strategy for some patients, especially those 
for whom NSAIDs are contraindicated. In 2014, FDA took action to limit 
the amount of acetaminophen in combination prescription drug products 
to reduce the risk of inadvertent acetaminophen overdose. As a part of 
this action, FDA announced that the agency would take future regulatory 
action to restrict access to high-dose OTC acetaminophen. However, it 
seems that the agency has not initiated this action.

    Question 4a. Does FDA still intend to take regulatory action 
limiting the dose of OTC acetaminophen?
    Answer 4a. Yes, FDA remains focused on helping to ensure safe use 
of acetaminophen in adults and children. To achieve this goal, FDA is 
working on a proposed rule intended to reduce the recommended daily 
adult dose of acetaminophen in OTC pain relief products consistent with 
the previous action for prescription combination drug products 
containing acetaminophen to a dose that is still effective for pain 
relief, but will reduce the likelihood of liver damage. Acetaminophen 
is currently the most common cause of drug-induced liver injury in the 
US.
    FDA also is working on a proposed rule addressing acetaminophen 
dosing instructions in the labeling of OTC acetaminophen products for 
children that are based upon weight as well as age to reduce 
unintentional overdose. FDA has previously issued guidance recommending 
that the concentration of single-ingredient liquid acetaminophen 
products used in children be standardized to reduce dosing errors and 
to require warning statements on the labels of acetaminophen-containing 
prescription drugs to let consumers know that rare but serious skin 
reactions may occur with acetaminophen. In addition, manufacturers of 
OTC acetaminophen-containing products have voluntarily implemented 
safety-related changes to their labeling.
    While working on rulemaking on these issues, FDA has provided 
public advisories and guidance to industry to make the public and drug 
manufacturers aware of the risks discussed above. FDA has also worked 
to educate consumers about the risks of taking multiple acetaminophen-
containing products at the same time.

    Question 4b. Would OTC monograph reform legislation provide 
meaningful alternatives, such as labeling changes, to address issues of 
inadvertent overdose from OTC acetaminophen?
    Answer 4b. FDA is committed to enhancing its core mission, which 
includes efforts to ensure and improve the safety and effectiveness of 
OTC Monograph drugs. Americans use OTC drugs every day, and these 
products will become increasingly important as patients take greater 
control of their own health. Under the current regulatory framework, 
FDA faces significant challenges in completing monographs, addressing 
safety issues such as those raised by acetaminophen, and supporting 
innovation in the OTC marketplace. One of the administrative mechanisms 
under discussion in connection with monograph reform would enable FDA 
to use administrative orders, rather than lengthy and cumbersome 
rulemaking procedures, to implement needed changes in existing and 
proposed OTC monographs. We anticipate that this, and other regulatory 
alternatives, would materially advance FDA's ability to implement 
changes needed to better address urgent safety issues in a timely 
fashion and ensure the safety and effectiveness of OTC products while 
also promoting innovation and choice for patients and consumers. A wide 
range of stakeholders has come together to support these reforms and we 
hope to continue to work with Congress on legislation to make them a 
reality.

    5. Compounding
    Question 5. Some pharmacy compounders have suggested that they can 
play a role in reducing drug costs by offering less expensive copies of 
generic and brand drugs. In January, 2016, you wrote in a letter to the 
editor of the Wall St. Journal that allowing for ``a dual market--one 
for approved generics and one for widely marketed compounded drugs to 
compete with them... would undermine our generic drug model, without 
fixing the regulatory woes that are the real culprit in reducing 
generic drug competition.'' Is it still your view that compounding is 
not an appropriate solution to address drug pricing concerns?
    Answer 5. Yes. Compounded drugs are not a solution to drug pricing 
concerns. Compounded drugs are not FDA-approved and therefore lack the 
assurance of safety, efficacy, and quality that the drug approval 
process provides. Even after the 2012 fungal meningitis outbreak, in 
which contaminated compounded drugs led to more than 60 deaths and 750 
cases of infection from which patients continue to recover, FDA 
continues to frequently investigate serious adverse events associated 
with compounded drugs. FDA also routinely identifies egregious 
conditions in the production of sterile drugs during inspections of 
compounding pharmacies. Because of these and other risks, compounded 
drugs should only be used when an FDA-approved drug product is not 
available to meet patients' medical needs.
    We have been alerted to several examples of drug compounders who 
are making copies of FDA approved products. We are concerned that, 
unless FDA acts expeditiously to finalize the 503B regulatory 
framework, the agency will inadvertently create marketplaces of 
inadequately regulated compounded medications that run counter to the 
intent of the law.

    Question 5a. The FDA has not finalized the guidance entitled, 
Compounded Drug Products That Are Essentially Copies of Approved Drug 
Products Under Section 503B of the Federal Food, Drug, and Cosmetic 
Act\3\, which clarifies the agency's interpretation of the law on which 
products may not be compounded under 503B because they are 
``essentially a copy'' of a marketed product. When does FDA plan to 
finalize this guidance document?
---------------------------------------------------------------------------
    \3\ https://www.fda.gov/downloads/Drugs/
GuidanceComplianceRegulatoryInformation/Guidances/UCM510153.pdf.
---------------------------------------------------------------------------
    Answer 5a. While we cannot provide an exact timeframe, FDA is 
working diligently to issue the final guidance. Implementing the 
compounding provisions of the Drug Quality and Security Act, including 
this guidance, is a top priority for the Agency.

    Question 5b. The Interim Policy on Compounding Using Bulk Drug 
Substances Under Section 503B of the Federal Food, Drug, and Cosmetic 
Act \4\, and the current list of Bulk Drug Substances Nominated for Use 
in Compounding Under Section 503B \5\, have been taken together by some 
compounders as permissive to allow the production of copies of FDA 
approved products. Does the FDA plan to reform the guidance to provide 
clarity, and amend the bulk drug substances list to eliminate drugs 
approved by the FDA?
---------------------------------------------------------------------------
    \4\ https://www.fda.gov/downloads/Drugs/
GuidanceComplianceRegulatoryInformation/Guidances/UCM469122.pdf.
    \5\ https://www.fda.gov/downloads/Drugs/
GuidanceComplianceRegulatoryInformation/Guidances/UCM469122.pdf.
---------------------------------------------------------------------------
    Answer 5b. After enactment of the Drug Quality and Security Act, 
there was a great deal of uncertainty concerning the bulk drug 
substances that could be used in compounding by outsourcing facilities 
while FDA develops the list of bulk drug substances that can be used in 
compounding under section 503B. If FDA did not adopt the interim 
policy, nearly all compounding would have shifted to facilities 
operating under section 503A. This is because section 503A compounders 
may compound using bulk drug substances that are the subject of an 
applicable USP/NF monograph or, if an applicable monograph does not 
exist, drug substances that are components of FDA approved drugs. FDA 
did not believe such a policy was in the best interest of the public 
health because, unlike outsourcing facilities, facilities operating 
under section 503A are exempt from Current Good Manufacturing Practice 
requirements and are not subject to routine FDA oversight.
    However, FDA is also cognizant of concerns that the Agency's 
interim policy articulated in the guidance that you referenced could 
result in outsourcing facilities undermining the drug approval process 
by compounding large volumes of drugs that are similar to or that can 
be compounded from FDA-approved drugs. FDA is considering whether any 
revisions to its interim policy are appropriate in light of these 
concerns.

    Question 5c. Does FDA plan to take action against compounders who 
produce copies of approved FDA products?
    Answer 5c. The Agency plans to issue final guidances regarding the 
``essentially a copy'' provisions of sections 503A and 503B of the 
Federal Food, Drug, and Cosmetic Act as soon as possible. We hope that 
the guidance documents on this topic, once final, will yield voluntary 
compliance with these statutory provisions. In situations where we 
cannot achieve such voluntary compliance, we intend to consider 
appropriate action.
         Response by Dr. Gottlieb to Questions of Senator Burr
    1. Promising alternatives to pain management are underway in North 
Carolina, with some of these treatments completely changing the way we 
think about providing relief to those battling pain or addiction.
    Question 1a. Is the agency facing any barriers to reviewing data 
and information on innovative products that have the potential to help 
with this crisis?
    Question 1b. If so, do you believe additional tools are needed for 
these innovators to demonstrate the safety and effectiveness of their 
products to help those battling an opioid addiction?
    Answer 1a. and 1b. There is a critical need to encourage the 
development of novel treatments for chronic pain, including non-opioid 
alternatives, as well as new and innovative treatments for substance 
use disorders in order to augment our currently limited treatments. 
Encouraging the development of these products requires both scientific 
and translational development. FDA has previously, and is currently, 
working in these areas, including through our participation in the 
ACTTION \6\ public private partnership (PPP) and other PPP and 
consortia initiatives in a wide variety of areas relevant to pain 
treatment, opioids, substance use treatment, drug safety, and 
accelerated drug development. For example, the Consortium for Addiction 
Research on Efficacy and Safety (CARES) is working to create consensus 
on the design and analysis of addiction clinical trials, which would be 
a valuable step toward reducing barriers to drug development.

    \6\ ACTTION: Analgesic, Anesthetic, and Addiction Clinical Trial 
Translations, Innovations, Opportunities, and Networks
---------------------------------------------------------------------------
    That said, we are encouraged by the broad interest in research 
targeted to developing novel treatments to treat pain and opioid 
addiction. The Agency is also working with the National Institute on 
Drug Abuse (NIDA), discussing mechanisms to collect data and to support 
the use of new endpoints for trials of drugs intended to treat opioid 
use disorder. For instance, there is interest in exploring the novel 
endpoints, in addition to abstinence, that could be used to support 
approval of new therapies. FDA and NIDA are also working to encourage 
the development of non-opioid pain medications, and we have been 
involved in discussions with National Institutes of Health to 
facilitate development of non-addictive pain treatment. NIH has 
recently convened three meetings with industry and researchers to 
explore how to quickly bring new treatments for pain, addiction, and 
overdose to market. These meetings are the foundation of a public-
private partnership being explored by NIH with industry to formally 
advance these activities. These efforts will be pursued in partnership 
with FDA and the Centers for Medicare & Medicaid Services (CMS) to 
ensure that products can quickly move from discovery and development to 
approval and implementation in clinical practice.

    Question 2. How does the FDA communicate different levels of risks 
to providers for schedule II and schedule III opioids? If the agency 
does not provide warnings based on the different levels of risk 
according to their DEA assigned schedule, why is this the case?
    Answer 2. Practitioners who wish to prescribe medications that are 
controlled substances are required to have a DEA registration. The DEA 
provides a Practitioner's Manual \7\ which provides important 
information and instructions for practitioners seeking a DEA 
registration including definitions of the different schedules of the 
Controlled Substances Act, along with examples of products listed in 
each schedule. In Section 3 of the DEA Application for Registration 
(Form-224) practitioners are required to select the drug schedules for 
which they seek DEA registration. The choices include Schedule II 
Narcotic, Schedule II Non-Narcotic, Schedule III Narcotic, Schedule III 
Non-Narcotic Schedule IV and Schedule V. Based on this process, 
practitioners are expected to understand the schedules they select on 
their DEA registration. Information is provided at the top of the first 
page of the FDA approved product labeling in order to alert prescribers 
to whether a product is a controlled substance, and if so, under which 
schedule it is listed.
---------------------------------------------------------------------------
    \7\ https://www.deadiversion.usdoj.gov/ pubs/ manuals/ pract/ 
practmanual012508.pdf.
---------------------------------------------------------------------------
    In addition, any applicant or holder of an approved application for 
a drug that is scheduled under the Controlled Substances Act (whether 
classified as Schedule II, III, IV, or V) can discuss appropriate 
warning statements in labeling with FDA if they believe these 
statements should be modified.

    Question 3. The Drug Quality & Security Act was intended to place 
tight restrictions on the use of bulk active pharmaceutical ingredients 
for compounding. Is the FDA aware of situations in which outsourcing 
facilities are compounding the active pharmaceutical ingredients in 
opioids? If so, what is the clinical need for the bulk compounding of 
these products and how is the agency working with stakeholders to 
mitigate any risks that may result from such activity?
    Answer 3. In June 2017, outsourcing facilities submitted reports to 
FDA listing the drug products they compounded during the previous 6-
month period. This reporting included certain injectable drug products 
that contain the same active ingredient as certain drugs subject to the 
extended-release (ER) and long-acting (LA) opioid analgesics REMS (ER/
LA REMS). The ER/LA REMS is applicable to dosage forms intended for use 
with patients outside of the hospital setting including oral, 
transmucosal, and transdermal dosage forms. FDA recently announced that 
it will be expanding the REMS to include immediate-release (IR) opioid 
analgesics in dosage forms intended for use with outpatients. The 
existing REMS does not apply to injectable solutions, the products that 
outsourcing facilities are making according to the June 2017 reports, 
nor will the expanded REMS because these products are administered 
under the care of health care professionals in inpatient settings and 
not dispensed directly to patients.
    With respect to clinical need associated with bulk drug substances 
that are components of drugs approved with a REMS, as you may know, 
section 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act) 
directs FDA to develop a list of bulk drug substances for which there 
is a clinical need. The FD&C Act requires that FDA publish a proposed 
list in the Federal Register, seek public comment, and then issue a 
final list. FDA is in the process of developing its proposal for public 
comment and is prioritizing this effort.
    Our current assessment is that many of the opioid products 
compounded by outsourcing facilities are convenience forms--for 
example, prefilled syringes--that are widely used in outpatient 
surgeries and other medical procedures. One reason for establishing the 
outsourcing facility industry was the likelihood that production of 
sterile, injectable products under FDA standards and oversight would be 
safer than compounding at clinical sites or, as was the case before 
Drug Quality and Security Act passage, large-scale compounding by 503A 
facilities.
        Response by Dr. Gottlieb to Questions of Senator Collins
    Question. Dr. McCance-Katz and Dr. Houry [or whole panel], 
according to SAMHSA, in 2014 an estimated 28,000 adolescents had used 
heroin in the past year and an estimated 16,000 were current heroin 
users. One part of addressing this epidemic is ensuring that younger 
generations are informed about the dangers of opioids. The Drug 
Enforcement Agency is working with partners to provide science-based 
information to children about the risks of opioids, such as through its 
``360 Strategy'' on heroin and opioids and ``Operation Prevention.'' 
Could you speak about collaboration between SAMSHA and CDC on these law 
enforcement initiatives, particularly with respect to reaching young 
people?
    Answer. N/A
        Response by Dr. Gottlieb to Questions of Senator Franken
    Question 1. It is anticipated that President Trump may declare the 
opioid crisis a national emergency as soon as this week. How will this 
emergency declaration affect the ways in which your agency is 
addressing the opioid epidemic in the United States? How will the 
declaration affect the way that individuals with opioid addiction 
receive treatment services across the United States? Many states 
including Alaska, Arizona, Florida, Virginia, Maryland, and 
Massachusetts have also declared their own state-wide disaster or 
emergency declarations. How will a Federal declaration build on these 
State efforts? From your perspective, is there a State response that 
stands out as particularly effective or innovative at reducing opioid 
misuse and addiction?
    Answer 1. FDA is committed to taking additional steps to more 
forcefully confront the epidemic of opioid addiction. This includes 
taking aggressive action to prevent new addictions and opioid-related 
deaths, and help those currently addicted regain control and restore 
them to their communities. FDA is expediting existing efforts and 
actively reviewing potential actions to address this crisis.
    Consistent with its statutory authority and role, the Agency is 
focused on promoting the development of opioids that are harder to 
manipulate and abuse, and non-opioid pain treatments; supporting 
important efforts to increase the use of, and access to, the 
potentially life-saving antidote naloxone; encouraging the safe 
adoption, and more widespread use of, FDA-approved medically assisted 
treatments to help combat addiction; and working with Federal, state, 
and international partners to stop the flow of heroin and extremely 
potent, and often deadly, synthetic drugs like illicitly made fentanyl. 
In addition, FDA will use its platform to work to break the stigma 
associated with addiction and the use of medications that can help 
people live lives of sobriety.
    State responses are critical to addressing this crisis, and this 
effort requires an all-of-the-above approach that will require each of 
us to work together . FDA, other agencies, State governments, health 
care providers, industry, policymakers, patients, and their families.

    Question 2. Research shows a strong connection between a person's 
health and stable housing, despite the fact that they are often treated 
as separate issues. I'm interested in how supportive housing--housing 
with social service supports--can help to address the opioid crisis, 
particularly in Indian Country where this epidemic has hit communities 
especially hard. I have heard from Native American leaders in Minnesota 
who have explained that stable housing not only removes the stress of 
where someone is going to sleep at night, but also helps people avoid 
unhealthy situations, reducing the risk of relapse. I asked you all 
about this issue during the hearing. What specific initiatives does 
your agency have underway to better understand the connection between 
health, housing, and substance use disorders, and what actions are you 
taking to incorporate supportive housing programs into your work to 
address the opioid epidemic? And what more is needed to develop these 
supportive housing programs further, especially in rural and other 
underserved areas?
    Answer 2. No FDA Response
        Response by Dr. Gottlieb to Questions of Senator Hassan
    Question 1. In your view, what is the top action that your agency 
is not doing now that you think it should be doing to address the 
opioid epidemic?
    Answer 1. FDA is committed to fighting the opioid epidemic and will 
continue to push forward using a multi-pronged strategy as part of the 
overall HHS Opioid Strategy. To advance this strategy, FDA is working 
to break the stigma associated with medications used for addiction 
treatment, and is taking a more active role in speaking out about the 
proper use of these drugs.
    Another area FDA has committed to exploring further is how opioid 
drug products are packaged, stored, and ultimately--when no longer 
needed--discarded. Though FDA has already been working on several 
efforts to explore solutions in this area, FDA is committed to 
exploring its existing authorities to find new and impactful ways of 
regulating these product features to improve patient safety.
    FDA is reconsidering how it address risk and benefit to make sure 
it is taking appropriate measure of the risk associated with misuse and 
abuse of opioid drugs, both as part of our pre-and post-market review. 
As one part of this effort, we requested earlier this year that Endo 
Pharmaceuticals withdraw its reformulated Opana ER from the market, 
based on our analysis of the risks associated with that drug's illicit 
use.
    Finally, it's crucial that we buildupon our capacity to detect and 
disrupt the flood of illegal opioids and other products that are being 
imported through the international mail facilities. More than 340 
million packages reach the U.S. every year; given that massive volume, 
it's estimated that only a small percentage of the illicit drugs 
smuggled through the IMFs are being intercepted. FDA can and must do 
more to penalize and deter the criminal misconduct that contributes to 
and worsens this crisis. Criminal investigations and enforcement are 
just some the many different tools that FDA and others will need to 
bring to bear against the opioid crisis. The crisis has reached the 
point that we will need to take an aggressive, comprehensive, and all-
in approach to combatting it.

    Question 2. In your view, what is the most promising emerging 
research that can help address the opioid epidemic?
    Answer 2. Consistent with its statutory authority and role, FDA is 
focusing on three broad areas to help address the opioid crisis: 
lowering overall exposure to opioid drugs and, in turn, reducing the 
number of new cases of addiction; enabling more opportunities for those 
currently addicted to opioid drugs to seek medication assisted 
treatment (MAT) that can help them recover; and helping expedite the 
development of progressively more-effective abuse deterrent 
formulations of opioid drugs, and better still, non-opioid alternatives 
for the treatment of pain. To advance these goals, FDA is supporting 
cutting-edge research assessing abuse-deterrent formulations, 
alternatives to opioids for pain, and the development of medications 
that can help patients with addiction recover as well as overdose 
reversal drugs.

    Question 3. What is your and your agency's perspective on the 
recommendations from the president's bipartisan Commission on Combating 
Drug Addiction and the Opioid Crisis?
    Answer 3. FDA was pleased to see that the President's Commission on 
Combating Drug Addiction and the Opioid Crisis highlighted areas that 
are also a priority for HHS. HHS is currently reviewing the 
recommendations and assessing actions that may be taken beyond those 
already underway in support of the Department's five point HHS Opioid 
Strategy.
         Response by Dr. Gottlieb to Questions of Senator Hatch
    Question 1. Commissioner Gottlieb, I applaud the FDA's July 28th 
announcement on the comprehensive plan regarding tobacco and nicotine 
regulation and appreciate FDAs continued efforts to promote and protect 
public health. Harm reduction strategies are paramount to tobacco, as 
they are to opioids. Your remarks announced that a regulation would be 
forthcoming regarding the Substantial Equivalence (SE) application and 
approval process, which many would argue is badly needed, as the 
current process is unclear due to conflicting and shifting 
expectations. Can you give any estimate as to when the proposed rule 
will be published and opened for public comment?
    Answer 1. We agree that issuing a proposed rulemaking on the 
content and format of substantial equivalence reports is very 
important, and issuing that rule is one of the Center for Tobacco 
Product's highest priorities. We look forward to sharing more on this 
matter as we can.

    Question 2. Your announcement also suggested that the Center for 
Tobacco Products would be examining the resources currently dedicated 
to review of so-called provisional products and determining whether 
those resources would be better utilized in advancing the policy 
objectives outlined in your announcement. Can you please comment on the 
status of that review?
    Answer 2. FDA is currently assessing the current application review 
process for these products to ensure it makes the best use of resources 
to protect public health. Following this review, it may be possible 
that some products in the review queue could be excluded from review 
based on our understanding of their characteristics. We expect to 
complete our review in the coming months.
        Response by Dr. Gottlieb to Questions of Senator Roberts
    Question 1. In February 2014, the FDA published a draft guidance 
entitled, ``Analgesic Indications: Developing Drug and Biological 
Products'' to provide more clarity to sponsors on the development of 
prescription drugs for the management of acute, chronic and 
breakthrough pain. Does the FDA plan to respond to comments and 
finalize this guidance? If so, what is the expected timeline to do so?
    Answer 1. FDA published the draft guidance entitled, ``Analgesic 
Indications: Developing Drug and Biological Products'' in February 
2014. The draft guidance, when finalized, is intended to serve as a 
focus for continued discussions on relevant issues among the Division 
of Anesthesia, Analgesia, and Addiction Products, pharmaceutical 
sponsors, the academic community, and the public. Since FDA published 
this draft guidance, the Agency has received numerous comments and 
questions that raise complex issues requiring extensive review and 
analysis. There were questions regarding the appropriate length of 
efficacy studies for chronic pain drug development, specifically 
opioids. There were also questions about which chronic pain patient 
populations are appropriate for efficacy studies with respect to 
analgesic drug development. Currently, the guidance remains under 
discussion, and the Agency is actively working to respond to comments 
and finalize this guidance.

    Question 2. While the FDA has approved several abuse-deterrent 
formulations (ADF) in the last several years, ADFs continue to 
represent a very small portion of the market despite their benefits of 
deterring deliberate abuse of opioids. Several states have sought to 
eliminate barriers to access by placing ADFs on their formularies on a 
basis not less favorable than non-ADF products, and requiring coverage 
of ADFs at the same cost-sharing tier as non-ADFs. How does FDA work 
within HHS to ensure government payers are aware of the most recent 
approved products, as well as their clinical benefit to certain 
populations, to help appropriately determine coverage policies?
    Answer 2. Although insurance companies and other payors often rely 
in part on FDA's approval of medications in making their coverage 
decisions, the Agency does not have authority to intervene in such 
decisions. Regarding ADF formulations, the Agency strongly supports a 
transition from the current market dominated by conventional opioids to 
one in which the majority of opioids have meaningful abuse-deterrent 
properties. Recognizing the importance of generic drugs to ensure 
patient access, FDA expects to soon release the final version of a 
guidance document laying out the testing that generic sponsors should 
follow to bring generic versions of ADF opioids to market.
        Response by Dr. Gottlieb to Questions of Senator Warren
    1. Expanded access to Naloxone
    Access to naloxone, a prescription drug meant to reverse an opioid 
overdose, saves lives. However, more could be done to expand access to 
naloxone. In August 2016, the FDA outlined the steps it was taking to 
ensure greater access to naloxone, including ``helping manufacturers 
pursue approval of an OTC naloxone product, including helping to 
develop the package label that would be required for such a 
product.''\8\ The FDA indicated that it had created a model Drug Facts 
Label and accompanying pictogram that could provide consumers with 
necessary information about how to use naloxone safely, and was engaged 
in label comprehension testing of this model label. In your response to 
a question for the record about naloxone submitted after your 
nomination hearing in April, you said that you ``support increased 
access to drugs like naloxone, which can arrest or reverse opioid 
overdoses,'' and that if confirmed, you would ``commit to working with 
FDA to quickly get up to speed on [the] specific issue [of expanded 
access to naloxone].'' Given that you are now over 5 months into the 
job:
---------------------------------------------------------------------------
    \8\ Karen Mahoney, ``FDA Supports Greater Access to Naloxone to 
Help Reduce Opioid Overdose Deaths,'' FDA Voice (August 10, 2016) 
(online at: https:// blogs.fda/ gov/ fdavoice/index.php/ 2016/08/ fda-
supports-greater-access-to-naloxone-to-help-reduce-opioid-overdose-
deaths/).
---------------------------------------------------------------------------
    Question 1a. What is the current status of FDA efforts to develop 
and test a package label for an OTC naloxone product?
    Answer 1a. Prevention and treatment of opioid overdose is an urgent 
public health priority, and FDA recognizes the need to improve access 
to naloxone for the emergency treatment of known or suspected overdoses 
until emergency medical help arrives. The Agency is focusing on: (1) 
expanding the utilization of naloxone; (2) accelerating the development 
and availability of new naloxone formulations and user friendly 
products; and (3) identifying and disseminating the best practice 
naloxone delivery models and strategies. FDA is reviewing options, 
including over-the-counter (OTC) availability, to make naloxone more 
accessible to treat opioid overdoses, building on the Agency's recent 
approval of intranasal naloxone. FDA is facilitating the development of 
labeling for a potential OTC version of naloxone, which is currently 
only available by prescription.
    To help facilitate the potential availability of OTC naloxone, the 
FDA has developed a draft model naloxone drug facts label (DFL) and an 
accompanying simple pictogram that would be placed next to the DFL to 
correspond with the DFL directions, and the FDA has initiated label 
comprehension testing to determine whether consumers can easily 
understand the information. This study is currently ongoing.

    Question 1b. What efforts does the FDA have underway to encourage 
physicians to co-prescribe naloxone with opioid medications?
    Answer 1b. Naloxone and co-prescribing is a multi-agency, multi-
sector priority, bringing together the National Institutes of Health 
(NIH)/the National Institute on Drug Abuse (NIDA), the Centers for 
Disease Control and Prevention (CDC), the Substance Abuse and Mental 
Health Services Administration (SAMHSA), and the Health Resources and 
Services Administration (HRSA). The Agency has spoken to members of the 
community-based organizations that first pioneered lay administration 
of naloxone, medical professionals, policymakers, public health 
officials, first responders, product developers, researchers, and, of 
course, patients and their families, to explore and discuss issues 
surrounding the use of naloxone. In addition, the draft revisions to 
the FDA Education Blueprint for Health Care Providers Involved in the 
Management or Support of Patients with Pain emphasizes the importance 
of having naloxone available.

    Question 1c. What additional steps could the FDA take to safely 
facilitate increased rates of co-prescribing of naloxone with opioid 
medications?
    Answer 1c. FDA will continue to use the information from its 
discussions to help inform its work moving forward, including 
considering the development of naloxone co-prescribing guidelines and 
OTC access to naloxone.

    Question 1d. What additional steps can the FDA take to work with 
interested manufacturers to continue expanding access to naloxone?
    Answer 1d. FDA has initiated consumer behavior studies to develop a 
model drug facts label (DFL) that will help with self-selection and 
provide basic instructions for use. The sponsor of specific products 
will be responsible for developing a DFL for the instructions of use 
that are unique for their product. While the FDA does not yet know the 
outcome of the studies, it believes the availability of the results of 
these studies will lessen the burden on sponsors to develop a DFL, and 
could encourage sponsors to switch their products over the counter. 
Once the study has been completed, FDA plans to make the results 
publicly available to aid development of over the counter naloxone 
products.

    In addition, FDA has contacted every maker of an approved naloxone 
product and offered to meet with them to discuss OTC. Several have 
taken FDA up on this offer. FDA will continue to work with these 
sponsors as they move forward in development.
    2. Safe Drug Disposal
    Safe drug disposal options are an important tool to help limit the 
volume of unused medications in circulation. Twice a year, the U.S. 
Drug Enforcement Agency holds National Prescription Drug Take Back 
Days, meant to help individuals dispose of unused medicines. 450 tons 
of drugs were disposed of in the last national take-back day in May.\9\ 
In September 2014, the DEA released the final rule on ``Disposal of 
Controlled Substances,''\10\ aimed at making it easier to for 
individuals to dispose of unused medicines and allow for more 
continuous collection opportunities. Over a year ago, Massachusetts 
announced its ``first statewide safe medication disposal program with 
Walgreens to fight substance misuse,''\11\ and today in Massachusetts, 
in addition to semi-annual national take-back days, there are a number 
of permanent kiosks where individuals can go to dispose of unused 
medications.\12\
---------------------------------------------------------------------------
    \9\ ``DEA Brings in Record Amount of Unused Prescription Drugs on 
National Prescription Take Back Day,'' U.S. Drug Enforcement 
Administration (May 8, 2017) (online at: https://www.dea.gov/ 
divisions/ hq/2017/ hq050817a.shtml).
    \10\ Federal Register, Vol. 79, No. 174 (September 9, 2014) (Online 
at: https://www.deadiversion.usdoj.gov/fedregs/ rules/ 2014/ 2014-
20926.pdf).
    \11\ ``Baker-Polito Administration Announces First statewide Safe 
Medication Disposal Program with Walgreens to Fight Substance Misuse,'' 
The Official Website of the Governor of Massachusetts (September 7, 
2017) (online at: http://www.mass.gov/Governor/ press-office/ press-
releases/ fy2017/statewide-safe-medication-disposal-program-
launched.html).
    \12\ ``Safely Dispose of Prescription Drugs,'' Mass.gov (online at: 
https://www.mass.gov/safely dispose-of-prescription-drugs) (accessed 
October 25, 2017).

    Question 2a. In its efforts to reduce the volume of unused 
medications in circulation, what is the FDA doing to study safe drug 
disposal technologies?
    Answer 2a. Combating opioid misuse, abuse, and addiction has long 
been both a public health priority and a priority for the Agency. FDA 
has established an Opioid Policy Steering Committee that is actively 
exploring a wide range of options for addressing the opioid epidemic, 
including take-back programs. Additionally, FDA is exploring innovative 
designs for drug packaging, storage, and/or disposal, options that may 
enhance opioid safety.
    FDA is hosting a public workshop on December 11-12, 2017, entitled 
``Packaging, Storage, and Disposal Options to Enhance Opioid Safety-
Exploring the Path Forward.'' The purpose of the public workshop is to 
host a scientific discussion with expert panel members and interested 
stakeholders regarding the role of packaging, storage, and disposal 
options within the larger landscape of activities aimed at addressing 
abuse, misuse, or inappropriate access of prescription opioid drug 
products (opioids); guiding principles and considerations for the 
design of packaging, storage, and disposal options for opioids; 
integrating packaging, storage, and disposal options into existing 
health care and pharmacy systems, including both open and closed health 
care systems (e.g., a closed system such as the U.S. Department of 
Veterans Affairs); data needs and how to address challenges in 
assessing the impact of packaging, storage, and disposal options in 
both the premarket and postmarket settings; and ways in which FDA could 
encourage the development and assessment of packaging, storage, and 
disposal options for opioids that have the potential to enhance opioid 
safety.

    3. Women and opioids
    The 21st Century Cures Act included a provision that I worked on to 
support the inclusion of women and minorities in clinical trials at the 
NIH. The FDA has also been working to support efforts to diversify 
clinical trials.\13\ CDC data shows the rate of deaths from 
prescription opioids is increasing ``471 percent among women, compared 
with an increase of 218 percent among men.''\14\
---------------------------------------------------------------------------
    \13\ Califf, Robert, ``2016: The Year of Diversity in Clinical 
Trials,'' U.S. Food & Drug Administration (January 27, 2016) (online 
at: https://blogs.fda.gov/fdavoice/ index.php/ 2016/ 01/ 2016-the-year-
of-diversity-in-clinical-trials/).
    \14\ ``Final Report: Opioid Use, Misuse, and Overdose in Women,'' 
U.S. Department of Health and Human Services Office on Women's Health 
(July 13, 2017) (online at: https://www.womenshealth.gov/ files/ 
documents/ final-report-opioid-508.pdf).

    Question 3a.. How could the FDA's efforts to promote diversity in 
clinical trials help address the disproportionate increase in opioid 
death rates experienced by women?
    Question 3b. What other steps can the FDA take to address the 
increasing impact of the opioid epidemic on women?
    Answer 3b. FDA has a long history of efforts to help ensure that 
clinical trials are designed to evaluate the effects of drugs on men 
and women. FDA encourages industry to consider separately the effects 
of drugs on men and women to determine whether sex differences exist 
and whether we need more information to assess variations. FDA, 
including its Office of Women's Health, is dedicated to advancing 
women's health through policy, science, and outreach to advocate for 
the inclusion of women in clinical trials and for subgroup data 
analysis by sex. There are decades of research on the question of how 
females respond differently to drugs, including opioids, and sex 
differences in addiction, including to opioids.
    In addition, FDA-approved labeling for many drugs already include 
information on dose considerations or side effect profiles related to 
age, health problems, or sex. When findings suggest safety issues that 
FDA thinks are important, it requires companies to put that information 
in labeling, and, sometimes, to do additional studies. For opioid 
analgesic applications, FDA regularly evaluates the pharmacokinetic, 
safety, and efficacy data for differences based on sex.
    Furthermore, FDA's MedWatch program enables FDA to learn about 
adverse experiences that may be associated with the use of a drug post-
approval. FDA uses MedWatch reports filed by consumers and health 
professionals, and mandatory adverse event reports filed by 
manufacturers, to identify problems in marketed products. The 
information received from a report of an adverse drug experience is 
added to the FDA Adverse Event Reporting System data base. The 
collected reports are monitored and observed for emerging patterns. In 
the event that there may be potential for a widespread product problem, 
the Agency will initiate action as needed.
    Scientific publications by FDA review scientists are an additional 
source of relevant demographic information for approved drugs, 
biologics, and medical devices. Depending on the safety concerns, FDA 
may decide to exercise its authority under section 505(o)(4) of the 
Federal Food, Drug, and Cosmetic Act (FD&C Act) to require certain 
holders of approved applications for prescription opioid drug products 
to make safety labeling changes, thus better communicating drug risks 
in labeling to patients and prescribers.
      Response by Dr. Gottlieb to Questions of Senator Whitehouse
    1. The 21st Century Cures Act authorized $1 billion over 2 years to 
support efforts to combat the opioid epidemic. The second half of that 
money is expected to be made available as part of the fiscal year 2018 
appropriations bill. Though I was pleased to see the first $500 million 
get out to states quickly, I think we can improve how the next $500 
million is used and allocated.
    Question. First, we could allow grantmakers approving applications 
for these funds to consider whether the proposed uses of this funding 
are aligned with the goals of the Comprehensive Addiction and Recovery 
Act (CARA). Second, in evaluating applications for this funding, more 
consideration could be given to states most affected by the epidemic. 
Do you support aligning the uses of the next tranche of 21st Century 
Cures Act opioid funding with the best practices set forth in CARA and/
or prioritizing funding to states most affected by the opioid epidemic?
    Answer. FDA defers to SAMHSA. Please see SAMHSA's response.

         Response by Dr. Gottlieb to Questions of Senator Young
    Question 1. Some researchers have found that it takes an average of 
17 years for research evidence to reach clinical practice. How are you 
all working together to ensure our best practices actually reach the 
patient in a reasonable amount of time? Are you working with medical 
associations and boards to ensure that best practices are translated 
into clinical practice? What can be done at the Federal level to speed 
up this research to practice pipeline?
    Answer 1. FDA has participated in a public-private-partnership 
(PPP) under the Critical Path initiative, the Analgesic Clinical Trial 
Translation, Innovations, Opportunities, and Networks (ACTTION). The 
ACTTION PPP is a collaboration among a broad spectrum of national and 
international groups aimed at advancing the science in this area, 
including academia, FDA and other government agencies, pharmaceutical 
and device companies, professional organizations, and patient advocacy 
groups. FDA is also engaging with other stakeholders outside of the 
drug approval process, such as pharmacy benefit managers and provider 
groups, to determine what role FDA can play in impacting prescribing 
behaviors.
    We know that developing non-opioid and non-addictive pain medicines 
is challenging for many reasons. Therefore, FDA is interested in 
progressing the entire field of pain drug development, and FDA supports 
cutting-edge research aimed at encouraging the potential development of 
these products. At the Federal level, the Agency is also working with 
the National Institute on Drug Abuse to encourage the development of 
non-opioid pain medications, and has been involved in discussions with 
National Institutes of Health in a series of meetings to facilitate 
development of non-addictive pain treatments.

    Question 2. Too many unused opioids dangerously remain in medicine 
cabinets throughout America. They pose a real threat to health and 
safety--especially to young Americans. Will drug take back programs be 
a component of our government's response to this national emergency?
    Answer 2. FDA is actively exploring a wide range of options for 
addressing the opioid epidemic, including take-back programs. In 
addition, the Agency is exploring how opioid drug products are 
packaged, stored, and ultimately--when no longer needed--discarded. FDA 
is committed to exploring its existing authorities to find new and 
impactful ways of regulating these product features to improve patient 
safety. One area it is exploring is packaging innovations that could 
work to improve storage and encourage prompt disposal to reduce the 
available supply and reduce the risk for third-party access, such as a 
child accidentally ingesting pills he or she found in a medicine 
cabinet.
    FDA held a public workshop on December 11 and 12, 2017, to explore 
these issues. The purpose of the public workshop is to host a 
scientific discussion with expert panel members and interested 
stakeholders regarding the role of packaging, storage, and disposal 
options within the larger landscape of activities aimed at addressing 
abuse, misuse, or inappropriate access of prescription opioid drug 
products (opioids); guiding principles and considerations for the 
design of packaging, storage, and disposal options for opioids; 
integrating packaging, storage, and disposal options into existing 
health care and pharmacy systems, including both open and closed health 
care systems (e.g., a closed system such as the U.S. Department of 
Veterans Affairs); data needs and how to address challenges in 
assessing the impact of packaging, storage, and disposal options in 
both the premarket and postmarket settings; and ways in which FDA could 
encourage the development and assessment of packaging, storage, and 
disposal options for opioids that have the potential to enhance opioid 
safety.
                                 ______
                                 
       Response by Dr. Collins to Questions of Senator Alexander
    Question 1. Do you need additional authorities, on top of the 
modernizations for substance use disorders and opioid abuse programs 
and services in the 21st Century Cures Act and in the Comprehensive 
Addiction and Recovery Act (CARA), to fight the opioid crisis? If so, 
please provide specific authorities that would be helpful.
    Answer 1. The Department of Health and Human Services (HHS) is 
undergoing a department-wide process to identify what authorities or 
changes in statute would be helpful.

    Question 2. Section 319 of the Public Health Service Act gives the 
Secretary of HHS the authority to determine that a public health 
emergency exists, allows for waivers of various Medicare and Medicaid 
regulations, movement of volunteer and Federal medical and public 
health professionals to areas hardest hit by the emergency, ability to 
access resources traditionally used for the Strategic National 
Stockpile, and the ability of the FDA to allow drugs and devices to 
come to market prior to full approval under its Emergency Use 
Authorization. Are any of the authorities that are available under a 
Public Health Emergency Declaration necessary to help address the 
opioid abuse crisis? If any, please list, and provide specific examples 
of why such authority is helpful.
    Answer 2. HHS is thoroughly reviewing the available authorities and 
analyzing how they can be applied in the context of the opioid 
epidemic. As decisions are made, we will be happy to share them with 
you, but we are committed to carrying out our five-point HHS Opioid 
Strategy and stemming the tide of this epidemic.
         Response by Dr. Collins to Questions of Senator Murray
    1. While opioids are commonly used for pain management, we know 
that doctors, patients, and their families must weigh the risks and 
benefits of such potentially addictive medication when a loved one is 
in pain. This is particularly concerning since your agency's own 
analysis published in 2015 found that more than one in ten adults in 
the U.S. experienced chronic pain, and nearly 40 million suffered from 
severe pain.
    In your May 2017 article with Dr. Volkow on the role of biomedical 
research in combatting the opioid epidemic [in the New England Journal 
of Medicine], you acknowledge that a factor driving this crisis is the 
limited number of alternative treatments available for pain, 
particularly for managing chronic pain.
    Question 1a. How is NIH working to identify opportunities to 
develop alternatives to opioids for pain management? Which treatments 
are most promising? What are their risks and benefits?
    Answer 1a. In 2016 NIH spent $483 million on pain research ranging 
from cellular and molecular mechanisms of acute and chronic pain to 
safe, effective therapy development, to large scale clinical trials. 
The portfolio includes many projects that address the pressing need to 
develop new non-opioid, non-addictive pain treatments. Studies range 
from early stage drug target discovery focused on molecular pathways of 
pain signaling including exploration of receptors and channels as 
potential non-addictive analgesic targets to testing in behavioral 
models. A number of targets identified through NIH basic science, such 
as the nerve growth factor receptor and pain-related ion channels, are 
now being pursued in industry sponsored clinical trials of non-
addictive treatments.
    NIH is developing opioids with reduced risk of addiction and abuse. 
NIH supported investigators are developing new compounds that exhibit 
novel properties as a result of their combined activity at different 
opioid receptors (mu, delta, and kappa). Compounds with combined 
activity at the mu and delta receptors or at all three receptors can 
induce strong analgesia without producing tolerance or dependence in 
animal models. In addition, discovery of adjunct medications that can 
be combined with opioids to reduce the needed dose promise to result in 
lower potential for dependence and addiction. Innovative methods are 
being explored for drug delivery to increase specificity and efficacy 
and to reduce analgesic side effects, as well as modified formulations 
to enhance delivery.
    NIH supports an initiative, the Blueprint Neurotherapeutics 
Program, for small molecule drug discovery and development. For 
example, NINDS funds studies through this program that aim to develop 
non-addictive kappa opioid receptor antagonists for migraine and a 
safe, non-opioid analgesic that can be taken orally to reduce diabetic 
nerve pain.
    Other non-pharmacological approaches show promise for pain 
management. A tissue--based tool for screening potential migraine drugs 
is under development and a library of small molecules is being 
leveraged to screen for candidates for optimization as analgesics. 
Tissue engineering and regeneration to create tissue scaffolding and 
microenvironments to promote wound healing, and joint cartilage and 
intervertebral disc replacements is being applied to relieve pain. 
Neural stimulation technologies for chronic intractable pain are being 
improved. For example, wearable ultrasound devices and implantable 
micro-stimulators are being tested for peripheral and central nervous 
system targets to relieve pain.
    Evaluation and dissemination of complementary and integrative 
health approaches are a crucial component of quality pain management. 
NIH supported studies include mechanism-based clinical studies on 
cognitive behavior therapy, exercise, yoga, acupuncture, massage and 
fitness, and mindfulness practices are important component of the NIH 
Federal pain research portfolio.

    Question 1b. In my role as the top Democrat on the Labor-H 
Appropriations Subcommittee, I was pleased that Chairman Blunt and I 
were able to secure an additional $2 billion for NIH in our bipartisan 
bill. What more do you need from Congress to bolster this work?
    Answer 1b. NIH is grateful for the funding and modernizations under 
21st Century Cures Act that have streamlined research and enabled new 
creative approaches to support research as part of the NIH mission. The 
Department of Health and Human Services is undergoing a department-wide 
process to identify what authorities or changes in statute would be 
helpful and funding to carry them out.

    2. NIH has been instrumental in supporting and testing treatments 
for opioid addiction. NIH also has focused research efforts on the 
prevention of opioid addiction, which will also be important in our 
fight.
    Question 2a. Can you describe NIH's current research efforts and 
how they may impact the prevention and treatment of opioid use 
disorder?
    Answer 2a. Addressing the opioid crisis is a top priority for the 
Department of Health and Human Services, including NIH and NIDA. NIH 
supports a broad portfolio of research to develop and test strategies 
for the prevention and treatments of opioid use disorder (OUD). In 
addition, NIH is launching a public-private collaborative research 
initiative to address the opioid crisis. The initial plan for this 
initiative was recently described by Drs. Collins and Volkow in the New 
England Journal of Medicine and includes three major areas for 
advancement: (1) safe, more effective, and non-addictive strategies for 
chronic pain management to prevent misuse of and addiction to 
prescription opioids; (2) new and innovative opioid addiction 
treatments to reduce drug use and support recovery; and (3) overdose 
reversal interventions to reduce mortality and promote access to 
treatment.\1\
---------------------------------------------------------------------------
    \1\ Volkow, N. D. and F. S. Collins (2017). ``The Role of Science 
in Addressing the Opioid Crisis.'' New England Journal of Medicine 
377(4): 391-394.
---------------------------------------------------------------------------
    To identify the scientific strategies with the greatest potential, 
NIH brought together innovative experts from government, industry, and 
academia for a series of three cutting-edge science meetings. Plans are 
underway to develop a draft strategy for collaborative activities 
including major goals of the initiative, action steps, key partners, 
deliverables, timeline, and resources (in-kind and financial costs) to 
fully carry out the proposed action steps. The Foundation for the 
National Institutes of Health will solicit input on the final draft 
from participants including Federal partners as well as other relevant 
stakeholders. Upon final approval of the plan, it will be posted on the 
NIH website at: https://www.nih.gov/opioid-crisis.
    Promising potential action steps related to OUD treatment and 
overdose prevention include:
    1. Develop new formulations, combinations, and means to deliver 
existing medications to increase treatment effectiveness and support 
long-term recovery.
        a. Medications for opioid addiction (e.g. extended release 
        buprenorphine and naltrexone)
        b. Overdose prevention and reversal (e.g. increased potency 
        naloxone for fentanyl and carfentanil overdoses)
        c. New technologies (e.g. implants, pumps, neural stimulation) 
        to enhance treatments for pain and substance use disorder, and 
        to prevent/reverse overdose.

    NIDA also continues to fund a robust prevention portfolio that 
builds upon solid epidemiological findings and insights from genetics 
and neuroscience research, applying this knowledge to develop effective 
strategies to prevent initiation of drug use and escalation of use to 
addiction among youth. Highly effective evidence-based drug use 
prevention interventions and drug addiction treatment approaches have 
been developed and tested. These are well detailed in the Surgeon 
General's Report on Alcohol, Drugs and Health.\2\ NIH's current 
prevention portfolio encompasses a broad range of research to (1) 
increase our understanding of the factors --including genetic, 
psychological, and environmental--that enhance or mitigate an 
individual's risk for drug use and substance use disorders; and (2) 
develop and test intervention strategies targeted to high-risk 
populations. For example, KEEP SAFE is a family based and skill-focused 
program designed to prevent substance use and other related health 
risking behaviors among youth in foster care. Research indicated that 
the intervention significantly reduced substance use in foster youth at 
18 months post-baseline and that the intervention influenced substance 
use through two processes: youths' improved quality of relationships 
with caregivers at 6 months post-baseline and fewer associations with 
deviant peers at 12 months post-baseline. This suggests that these two 
processes may be important targets in substance use prevention programs 
for foster youth.
---------------------------------------------------------------------------
    \2\ Surgeon General's Report on Alcohol, Drugs, and Health. 2016. 
at https://addiction.surgeongeneral.gov/
---------------------------------------------------------------------------
    Broad adoption of evidence-based prevention interventions has been 
limited due to implementation challenges that span financial, 
regulatory, geographic, attitudinal, and logistical issues. Ongoing 
research is working to develop strategies to translate evidence-based 
practices in a way that confers population-level impact,\3\ including 
for developing implementation capacity, and implementation and 
sustainability of evidence-based practices across systems and settings. 
For example:
---------------------------------------------------------------------------
    \3\ Spoth R, Rohrbach LA, Greenberg M, et al. Addressing core 
challenges for the next generation of type 2 translation research and 
systems: the translation science to population impact (TSci Impact) 
framework. Prev Sci 2013;14:319-51.
---------------------------------------------------------------------------
         Organizational and system supports for evidence-based 
        implementation
         Work-force development and training
         Ongoing fidelity monitoring
         Continuous quality improvement
         Financing

    In addition, NIH supports basic research to understand the impact 
of drug use during adolescence on brain development. Adolescence is a 
period of intense brain and cognitive development. During this time, 
one's environments, experiences, and exposures shape brain structure 
and function, and ultimately adult identity. Brain research, 
particularly in the last decade, has opened new windows to 
understanding the adolescent brain, but there is much we still do not 
know about the normal trajectory of brain development during 
adolescence and the many experiences that may enhance or disrupt it, 
such as substance use. To address this gap, NIH, in partnership with 
CDC, is funding the landmark Adolescent Brain Cognitive Development 
(ABCD) Study \4\, a multi-site, longitudinal investigation of 10,000 
children from ages nine and ten into early adulthood. As of October 
2017, 5,433 youth have enrolled in the study. The actionable 
information coming out of this study will be a foundation upon which to 
develop and refine substance use prevention and treatment as well as 
other health promotion interventions that are rooted in a deep 
understanding of the neurobiological and psychosocial factors that 
influence adolescent health and wellness to optimize the well-being and 
success of our Nation's children.
---------------------------------------------------------------------------
    \4\ http:// abcdstudy.org/index.html.
---------------------------------------------------------------------------
    Finally, NIH would like to note that this year, a new study called 
the Advancing Clinical Trials in Neonatal Opioid Withdrawal Syndrome 
(ACTNOW) will evaluate treatment options and improve clinical care of 
infants with NA/NOWS. The study is collaboration between The Eunice 
Kennedy Shriver National Institute of Child Health and Human 
Development's (NICHD) Neonatal Research Network (which has 30 years of 
experience in conducting clinical trials with newborns) and the new 
Idea States Pediatric Clinical Trials Network (within the NIH Office of 
the Director's Environmental Influences on Child Health Outcomes (ECHO) 
Program), with sites located in rural and medically underserved 
communities. This joint research effort will use the reach of both 
networks to assess the communities they serve, determine the prevalence 
of NAS, understand current approaches to managing NOWS cases (including 
non-pharmacological approaches), and develop protocols for conducting 
large scale studies across the country to inform clinical care for 
affected infants.

    Question 2b. We know there are medications for treating opioid 
addiction, but how can we make sure these treatments are properly 
utilized to give every patient the best chance of achieving and 
maintaining recovery for the long term?
    Answer 2b. NIDA supported the development of all three medications 
approved for the treatment of OUD--buprenorphine, methadone, and 
naltrexone. NIDA funds a broad portfolio of research to develop and 
test strategies to increase access to these lifesaving drugs. For 
example, NIDA's Juvenile Justice Translational Research on 
Interventions for Adolescents in the Legal System (JJ-TRIALS) program 
is working to improve prevention and treatment of SUD among criminal 
justice involved youth. The JJ-TRIALS cooperative was established in 
2013 and is composed of six research centers and one coordinating 
center. The main study is a randomized trial that involves 36 sites in 
seven states and is testing the effectiveness of two implementation 
strategies for promoting system-wide improvements in SUD prevention and 
treatment services. Thus far, JJ-TRIALS has led to the development of 
the Juvenile Justice Behavioral Health Services Cascade, a framework 
for measurement of unmet substance use treatment needs to identify 
services delivery needs and develop strategies to address them.
    In addition, NIDA's Clinical Trials Network (CTN) conducts research 
to develop and test strategies for integrating OUD treatment in general 
healthcare settings including primary care and emergency departments. 
Ongoing and planned studies of relevance to the opioid crisis will be 
testing:
         A collaborative care model for management of OUD in 
        primary care with engagement of multiple healthcare systems \5\
---------------------------------------------------------------------------
    \5\ https://www.drugabuse.gov/ about-nida/organization /cctn/ctn/
research-studies/ primary-care- opioid-use-disorders- treatment-trial
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         Models for addressing OUD in emergency departments,\6\ 
        including utilization of a long-acting depot formulation of 
        buprenorphine that was recently approved by the FDA \7\
---------------------------------------------------------------------------
    \6\ https://www.drugabuse.gov/about-nida/organization/cctn/ctn/
research-studies/ opioid-use- disorder-in emergency- department.
    \7\ http://www.indivior.com/ investor-news/indivior-submits-new-
drug-application-u-s-fda-rbp-6000-buprenorphine-monthly depot/.
---------------------------------------------------------------------------
         Pilot usability testing of clinical decision support 
        tools for treating OUD in primary care settings \8\
---------------------------------------------------------------------------
    \8\ https://www.drugabuse.gov/ about-nida/organization/ cctn /ctn /
research-studies/clinical-decision-support-opioid-use- disorders-in-
medical-settings-pilot-usability-testing-in-emr.
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         A pilot model of coordinated care management between 
        physicians and pharmacists for buprenorphine treatment \9\
---------------------------------------------------------------------------
    \9\ https://www.drugabuse.gov/ about-nida/ organization/cctn/ ctn/
research-studies/ pharmacy-screening-collaborative-opioid-use-disorder-
care-pharm-oud-care.

Other ongoing research is examining the strategies that are being used 
to increase access to OUD medications through the SAMHSA State Targeted 
Response to the Opioid Crisis Grants that were funded through the 21st 
Century Cures Act. Five NIDA-funded research projects will help 
evaluate:
         The creation and deployment of the Patient Decision 
        Aid for Medication-Assisted Treatment (PtDA-MAT), a patient-
        centered decision tool to promote the use of medications, 
        assess patient values and preferences, and incorporates 
        scientific evidence to increase patients' understanding of 
        possible medication risks, benefits, alternatives, and their 
        associated outcomes. \10\
---------------------------------------------------------------------------
    \10\ https://projectreporter.nih.gov/ 
project_info_description.cfm?aid= 9513338&icde= 
36846083&ddparam=&ddvalue= &ddsub=&cr=1&csb= default&cs= ASC&pball=.
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         The Recovery Initiation and Management after Overdose 
        (RIMO) protocol for individuals who are revived from an opioid 
        overdose. The protocol is initiated within a week of nonfatal 
        overdose and includes assertive recovery supports and 
        facilitates linkage with evidence-based treatment for OUD using 
        medications.\11\
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    \11\ https://projectreporter.nih.gov/
project_info_description.cfm?aid= 9511074&icde=36846131& 
ddparam=&ddvalue=&ddsub=&cr=1&csb= default&cs= ASC&pball=.
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         Planned Outreach, Intervention, Naloxone, and 
        Treatment (POINT), an emergency department-based outreach 
        program for engaging opioid overdose survivors in Indiana with 
        treatment. Recovery coaches are deployed to emergency 
        departments to assist patients with accessing medication-
        assisted treatment after discharge from the emergency 
        department.\12\
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    \12\ https:// projectreporter.nih.gov/ project_ info 
_description.cfm?aid= 9513197&icde= 36846207& ddparam=&ddvalue= 
&ddsub=&cr= 1&csb=default&cs=ASC&pball=.
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         A Rhode Island initiative is focused on expanding the 
        medication assisted treatment workforce by developing and 
        testing a pharmacist-delivered intervention for the management 
        of patients who are stable on medications. This model will also 
        be refined and tested to provide continuity in medication 
        assisted treatment for patients who are being released from 
        incarceration.\13\
---------------------------------------------------------------------------
    \13\ https:// projectreporter.nih.gov/ 
project_info_description.cfm?aid= 9513201&icde= 36846245&ddparam= 
&ddvalue= &ddsub=&cr= 4&csb=default&cs= ASC&pball=.
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         The Hub & Spoke model for provision of medication 
        assisted treatment in primary care settings. This model is 
        being tested in Washington State with a study that focuses on 
        adults with OUD who are covered by Medicaid.\14\
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    \14\ https:// projectreporter.nih.gov/ 
project_info_description.cfm?aid= 9513139&icde= 36846292&ddparam= 
&ddvalue= &ddsub=&cr= 2&csb= default&cs= ASC&pball=.
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        Response by Dr. Collins to Questions of Senator Collins
    Question 1. Dr. McCance-Katz and Dr. Houry [or whole panel], 
according to SAMHSA, in 2014 an estimated 28,000 adolescents had used 
heroin in the past year and an estimated 16,000 were current heroin 
users. One part of addressing this epidemic is ensuring that younger 
generations are informed about the dangers of opioids. The Drug 
Enforcement Agency is working with partners to provide science-based 
information to children about the risks of opioids, such as through its 
``360 Strategy'' on heroin and opioids and ``Operation Prevention.'' 
Could you speak about collaboration between SAMSHA and CDC on these law 
enforcement initiatives, particularly with respect to reaching young 
people?
    Answer 1. NIH defers to SAMHSA and CDC.

    Question 2. Dr. Collins, I want to hone in on pain--how we measure 
and communicate pain. This has long been a problem for individuals with 
Alzheimer's disease and those with certain intellectual and 
developmental disabilities. Perhaps--as the over-prescription of 
opioids over the past several years suggests--the one through ten 
smiley face system to indicate level of pain is not working. What is a 
three for one person might be a nine for another. Could you give us an 
update on research to improve how we measure pain, so that we can 
appropriately and adequately treat it?
    Answer 2. Quantitative and reliable measures of pain are a crucial 
component of pain management and essential to quality research. The 
National Pain Strategy and the Federal Pain Research Strategy call for 
improved objective measures for pain, especially in populations with 
cognitive and communication impairment, and non-verbal children. As 
pain is a perception mediated by specific neural circuits, 
investigators are making progress detecting pain circuit activity in 
human subjects using techniques such as functional MRI. The Brain 
Research through Advancing Innovative Neurotechnologies (BRAIN) 
Initiative is focused on developing tools to monitor and modulate brain 
circuits which could transform how we measure pain and guide how we 
treat patients suffering from pain.
    NIH is developing approaches to address the need for improved pain 
assessment. The NIH Patient-Reported Outcomes Measurement Information 
System (PROMIS) program provides rigorously tested patient reported 
outcome (PRO) measurement tools that use information technology, 
psychometrics, and qualitative, cognitive, and health survey research 
to measure PROs on pain and associated conditions of fatigue, physical 
function, sleep, and depression.
    NIH supported studies have validated quantitative sensory testing 
to measure pain sensitivity, threshold, and modulation as physiologic 
indicators of chronic pain in children https:// www.ncbi.nlm.nih.gov/ 
pubmed/ 28151835 and adults https://www.ncbi.nlm.nih.gov/ pubmed/
24275224.
    Current NIH Funding Opportunity Announcements call for the 
development of a technology or device that objectively indicates the 
presence and level of pain:RFA-DA-18-012 and RFA-DA-18-013.
    Assessing and measuring pain in people with communication deficits 
including dementia and other cognitive impairment, and young non-verbal 
children is complex. For these populations, it is necessary to use 
observational tools based on behavioral cues as an indicator of pain. 
One such tool is based on guidelines from the American Geriatrics 
Society and uses facial expression, negative vocalization, body 
language, changes in activity, and social interactions and mental 
status https://www.ncbi.nlm.nih.gov/ pubmed/ 25519741. This is a 
complex approach and further evidence to support its validity is 
needed. Another tool for assessment of pain in older adults with 
cognitive impairment is the Pain Assessment in Advanced Dementia scale. 
NIH funded investigators provided a case study on the tool for pain 
management https:// www.ncbi.nlm.nih.gov/pmc articles/ PMC4443668/
figure/F1 /. Pain assessment tools for newborns and infants similarly 
rely on behavioral indicators. For example, the Neonatal facial coding 
system and the Premature Infant Pain Profile have been validated in 
newborns. The latter uses video recordings to monitor facial expression 
and quality of sleep.
    The Eunice Kennedy Shriver National Institute for Child Health and 
Human Development (NICHD) actively supports research on pain and pain 
measurement. The NICHD is presently co-funding, with the National 
Institute of Nursing Research (NINR), a study to develop an objective, 
automated way of measuring pain by analyzing facial, head, and body 
movement. Other studies are assessing ways of measuring pain related to 
specific conditions, to better understand how different types of pain 
may affect individuals during illness and recovery. In one study, 
NICHD-funded investigators are assessing pain measures in women 
undergoing hysterectomy. Another study focusing on gynecological pain 
is assessing a variety of pain testing tools including psychological 
evaluation. The NICHD has active Funding Opportunity Announcements 
specifically focusing on vulvodynia or chronic vulvar pain. Children 
and adolescents are being studied prospectively to determine if 
predictors of the transition from acute to persistent musculoskeletal 
pain can be identified. For individuals with intellectual or 
neurodevelopmental disabilities, e.g., cerebral palsy, who may be 
nonverbal or have difficulty self-reporting, NICHD has funded a small 
pilot study to identify biomarkers in saliva from children with 
cerebral palsy with and without chronic pain. This noninvasive test 
showed that that children with and without pain had different levels of 
several types of molecules in saliva.
        Response by Dr. Collins to Questions of Senator Franken
    Question 1. It is anticipated that President Trump may declare the 
opioid crisis a national emergency as soon as this week. How will this 
emergency declaration affect the ways in which your agency is 
addressing the opioid epidemic in the United States? How will the 
declaration affect the way that individuals with opioid addiction 
receive treatment services across the United States? Many states 
including Alaska, Arizona, Florida, Virginia, Maryland, and 
Massachusetts have also declared their own state-wide disaster or 
emergency declarations. How will a Federal declaration build on these 
State efforts? From your perspective, is there a State response that 
stands out as particularly effective or innovative at reducing opioid 
misuse and addiction?
    Answer 1. Subsequent to this October 5, 2017, hearing President 
Trump directed HHS to declare and HHS did declare the opioid crisis and 
a nationwide national public health emergency.
    NIH is the lead HHS agency providing support for cutting-edge 
research on pain and opioid misuse, addiction, and overdose and to that 
end NIH will continue to use its resources and expertise to support the 
Federal response to combat the opioid crisis.
    In terms of how individuals with opioid addiction receive treatment 
services and the State responses, NIH defers to SAMHSA and CDC.

    Question 2. Research shows a strong connection between a person's 
health and stable housing, despite the fact that they are often treated 
as separate issues. I'm interested in how supportive housing--housing 
with social service supports--can help to address the opioid crisis, 
particularly in Indian Country where this epidemic has hit communities 
especially hard. I have heard from Native American leaders in Minnesota 
who have explained that stable housing not only removes the stress of 
where someone is going to sleep at night, but also helps people avoid 
unhealthy situations, reducing the risk of relapse. I asked you all 
about this issue during the hearing. What specific initiatives does 
your agency have underway to better understand the connection between 
health, housing, and substance use disorders, and what actions are you 
taking to incorporate supportive housing programs into your work to 
address the opioid epidemic? And what more is needed to develop these 
supportive housing programs further, especially in rural and other 
underserved areas?
    Answer 2. Unstable housing is associated with a range of negative 
health outcomes including mental illness and substance use 
disorder.\15\ Thus, addressing housing instability is a major component 
of effective prevention, treatment, and recovery supports and is an 
ongoing subject of research. NIDA is currently funding several projects 
on supportive housing, drug use, and associated health outcomes in 
homeless adults, youth, and women. Ongoing studies are:
---------------------------------------------------------------------------
    \15\ Tsai J, Rosenheck RA. Risk Factors for Homelessness Among US 
Veterans. Epidemiologic reviews. 2015;37:177-195.

         Comparing supportive housing models for HIV-positive 
        and at-risk chronically homeless adults in Chicago;\16\
---------------------------------------------------------------------------
    \16\ https://projectreporter.nih.gov/
project_info_description.cfm?aid=9188535&icde 
=36727330&ddparam=&ddvalue=&ddsub=&cr= 1&csb= default&cs=ASC&pball=.
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         Examining how to better engage substance using 
        homeless youth in drop-in center services;\17\
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    \17\ https://projectreporter.nih.gov/project_info 
_description.cfm?aid=9060915.
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         Evaluating Ecologically Based Treatment (EBT) 
        interventions with young, substance-using homeless mothers in 
        Ohio;\18\
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    \18\ https://projectreporter.nih.gov/
project_info_description.cfm?aid=9188535&icde= 36727330&ddparam= 
&ddvalue=&ddsub=&cr= 1&csb= default&cs= ASC&pball=.
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         Exploring HIV risk, drug use, and social networks 
        among homeless persons transitioning to housing in Los Angeles 
        and Long Beach, CA;\19\
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    \19\ https://projectreporter.nih.gov/
project_info_description.cfm?aid=9220823&icde=36727292&
ddparam=&ddvalue=&ddsub=&cr=1&csb=default&cs=ASC&pball=.
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         Pilot testing an e-learning version of an evidence-
        based intervention called the Housing First Technical 
        Assistance and Training program in Chicago and central 
        Indiana;\20\
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    \20\ https://projectreporter.nih.gov/project--info--
description.cfm?aid=9086316T1.
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         Studying health outcomes and effects on healthcare 
        utilization of a Chicago homelessness-prevention intervention 
        utilizing Homelessness Prevention Call Center (HPCC) to connect 
        individuals to emergency financial assistance;\21\ and
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    \21\ https://projectreporter.nih.gov/ 
project_info_description.cfm?aid=9220271T1.
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         Conducting a clinical trial of a mindfulness-based 
        cognitive-behavioral intervention to reduce substance use and 
        victimization (robbery, assault) among homeless youth.\22\
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    \22\ https://projectreporter.nih.gov/projectG7XinfoG7Xdescription. 
cfm?aid=8875452T1.
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    Some studies are also focused on improving housing and other health 
outcomes among criminal-justice-involved individuals re-entering the 
community after incarceration, including:
         A study of the use of case management and motivational 
        interviewing in sober living homes to reduce HIV risk among 
        offenders;\23\ and
---------------------------------------------------------------------------
    \23\ https://projectreporter.nih.gov/
project_info_description.cfm?aid= 
9231408&icde=36846571&ddparam=&ddvalue=&ddsub=&cr=1&csb= 
default&cs=ASC&pball=T1.
---------------------------------------------------------------------------
         A study of the impact on substance use and recidivism 
        of a needs-focused intervention for homeless female ex-
        offenders.\24\
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    \24\ https://projectreporter.nih.gov/
project_info_description.cfm?aid=9420456&icde= 
36846537&ddparam=&ddvalue=&ddsub=&cr=1&csb=default&cs=ASC&pball=T1.
---------------------------------------------------------------------------
         Response by Dr. Collins to Questions of Senator Hassan
    Question 1. In your view, what is the top action that your agency 
is not doing now that you think it should be doing to address the 
opioid epidemic?
    Answer 1. There is an urgent need to expand the number of treatment 
options for individuals experiencing pain, misusing opioids, and those 
with opioid use disorders. To identify research priorities to help 
address this problem, NIH convened innovative experts from government, 
industry, and academia for a series of three cutting-edge science 
meetings this summer. These meetings are informing the launch of a new 
public-private collaborative research initiative on pain and opioid 
addiction. The initial plan for this initiative was recently described 
by Dr. Collins and Dr. Volkow in the New England Journal of Medicine 
and includes three major areas for advancement: (1) safe, more 
effective, and non----addictive strategies for chronic pain management 
to prevent misuse of and addiction to prescription opioids; (2) new and 
innovative opioid addiction treatments to reduce drug use and support 
recovery; and (3) overdose reversal interventions to reduce mortality 
and promote access to treatment.\25\
---------------------------------------------------------------------------
    \25\ Volkow, N. D. and F. S. Collins (2017). ``The Role of Science 
in Addressing the Opioid Crisis.'' New England Journal of Medicine.
---------------------------------------------------------------------------
    Plans are underway to develop a draft strategy that will include 
major goals of the initiative, action steps, key partners, 
deliverables, timeline, and resources (in-kind and financial costs) to 
fully carry out the proposed action steps. The Foundation for the 
National Institutes of Health will solicit input on the final draft 
from participants including Federal partners as well as other relevant 
stakeholders. Upon final approval of the plan, it will be posted on the 
NIH website at: https://www.nih.gov/opioid-crisis

    Question 2. In your view, what is the most promising emerging 
research that can help address the opioid epidemic?
    Answer 2. Drs. Collins and Volkow recently published an article in 
the New England Journal of Medicine that discusses priorities for 
advancement as well as promising emerging research toward the 
development of: safe, more effective, and non-addictive strategies for 
chronic pain management to prevent misuse of and addiction to 
prescription opioids; (2) new and innovative opioid addiction 
treatments to reduce drug use and support recovery; and (3) overdose 
reversal interventions to reduce mortality and promote access to 
treatment.\26\
---------------------------------------------------------------------------
    \26\ Volkow, N. D. and F. S. Collins (2017). ``The Role of Science 
in Addressing the Opioid Crisis.'' New England Journal of Medicine 
377(4): 391-394.

    These promising strategies included:
         Approaches to reverse or prevent opioid induced 
        respiratory depression and overdose, such as new targets like 
        5-hydroxytryptamine type 1A (5-HT1A) agonists, ampakines, and 
        phrenic-nerve-stimulation devices.
         Wearable devices that can detect an overdose when it 
        is occurring and signal for help, automatically inject 
        naloxone, or both.
         Treating opioid addictions with agents already in use 
        for other indications, such as Lorcaserin, an FDA-approved diet 
        drug that was found to reduce opioid seeking in a rodent model, 
        and Lofexidine, an a2A-adrenergic-receptor agonist that is 
        currently used in the United Kingdom for opioid detoxification.
         Novel pharmacologic approaches to treat OUD, including 
        medications that target neurokinin-1 receptors or kappa-opioid 
        receptors.
         Vaccines against prescription opioids, heroin, and 
        fentanyl, which induce antibodies to opioids in the bloodstream 
        to keep them from entering the brain.
         Modified opioid drugs, such as  -opioid rector biased 
        agonists (e.g. TRV130) that may treat pain while reducing the 
        risk for addiction and overdose associated with common opioid 
        pain medications.
         New pharmacological approaches to treating pain 
        including:

                Y kappa-opioid antagonists
                Y cannabinoids
                Y sodium channel Nav1.7 antagonists
                Y tumor necrosis factor inhibitors
                Y monoclonal antibodies that target nerve growth factor
                Y Antibodies that target calcitonin gene--related 
                peptide for treating migraine

         High-frequency repetitive transcranial magnetic 
        stimulation for the treatment of pain or addiction.
         Viral-based gene therapies and transplantation of 
        progenitor cells to treat pain.

    Question 3. What is your and your agency's perspective on the 
recommendations from the president's bipartisan Commission on Combating 
Drug Addiction and the Opioid Crisis?
    Answer 3. NIH was pleased to see that the President's Commission on 
Combating Drug Addiction and the Opioid Crisis highlighted areas that 
are also a priority for HHS. HHS, in collaboration with the White 
House, is currently reviewing the recommendations and assessing actions 
that may be taken beyond those already underway in support of the 
Department's five point HHS Opioid Strategy. The Commission's 
recommendations could be grouped into eight or nine main areas, 
including expanding access to evidence-based addiction treatment and 
overdose treatment, as well as better use of strengthening of public 
health surveillance data. NIH is working with the Department and the 
administration to achieve these ends.
        Response by Dr. Collins to Questions of Senator Roberts
    Question 1. A June 2016 article titled, ``The effect of an abuse-
deterrent opioid formulation (OxyContin) on opioid abuse-related 
outcomes in the postmarketing setting'' is available on the NCBI/NIH 
data base and indicates a reduction in abuse, misuse, overdose, 
addiction and other outcomes with the use of abuse-deterrent 
formulations (ADFs). Do you believe ADFs should be used more broadly to 
address the opioid epidemic?
    Answer 1. Abuse-deterrent formulations can be useful tools for 
reducing misuse of prescription opioids. While prescription opioids can 
be misused through oral consumption, misuse through injection drug use 
and/or snorting crushed pills often occurs and presents a higher risk 
for adverse consequences, including addiction and overdose due to the 
more rapid delivery of the drug to the brain. Abuse-deterrent 
formulations can make snorting and injection drug use less feasible, by 
making it harder to prepare the medication for ingestion through 
snorting or injection. These formulations can also be made less 
rewarding by combining them with an opioid antagonis --such as naloxone 
or naltrexone--that is only released to block the effects of the opioid 
agonist if the pill is injected or snorted. In addition, abuse-
deterrent formulations can make it harder to break or chew an extended 
release pill for oral ingestion with immediate release. This makes it 
more difficult to ingest a large and potentially dangerous dosage of 
opioids immediately that was intended to be released into the body over 
the course of several hours.
    The June 2016 article titled ``The effect of an abuse-deterrent 
opioid formulation (OxyContin) on opioid abuse-related outcomes in the 
post-marketing setting'' is a review article that highlights promising 
findings from ten studies that indicate that an abuse-deterrent 
formulation of OxyContin had three types of impacts: reduced misuse, 
reduced doctor-shopping, and reduced fatalities.\27\ Depending on the 
measure used, misuse of OxyContin fell by between 27 and 48 percent. 
So-called ``doctor-shopping,'' where patients receive prescriptions 
from multiple prescribers, went down by 50 percent, and overdose 
fatalities dropped by 65 percent.
---------------------------------------------------------------------------
    \27\ Coplan, P. M., et al. (2016). ``The effect of an abuse-
deterrent opioid formulation (OxyContin) on opioid abuse-related 
outcomes in the postmarketing setting.'' Clinical Pharmacology and 
Therapeutics 100(3): 275-286.
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         Response by Dr. Collins to Questions of Senator Warren
    1. Syringe Exchange Problems & Supervised Injection Facilities
    Syringe Exchange Programs, also known as Syringe Services Programs 
(SSPs), are locations where individuals can go to get sterile needles 
and syringes, safely dispose of used items, and get education on safer 
practices and even treatment for other medical, social, or mental 
health needs. The CDC and the Institute of Medicine, among other 
scientific organizations, report that needle exchanges are ``highly 
effective in preventing the spread of HIV/AIDS.''\28\ While Federal 
funds can support SSPs, they cannot be used to specifically purchase 
needles or syringes. In order to receive Federal funding for SSPs, 
states or local communities must get permission from the CDC, and then 
they can redirect other Federal funds to support SSPs.\29\
---------------------------------------------------------------------------
    \28\ Wadman, Merideth, ``Drug, HIV crises hit HHS nominee Price 
close to home,'' Science (December 2, 2016) (online at http://
www.sciencemag.org/news/2016/12/drug-hiv-crises-hit-hhs- nominee-price-
close-home).
    \29\ ``Syringe Services Programs,'' Centers for Disease Control and 
Prevention (online at: https://www.cdc.gov/hiv/risk/ssps.html). (page 
last updated September 28, 2017).
---------------------------------------------------------------------------
    Question 1a. What is the NIH doing to study Syringe Exchange 
Programs, also known as Syringe Services Programs?
    Answer 1a. The National Institute on Drug Abuse (NIDA) has a long 
history of supporting research related to SSPs. The science regarding 
SSPs and their effectiveness for HIV prevention is well established. 
Current NIDA-funded research is used to extend and test ways that these 
programs can provide a range of services to reduce drug use and HIV 
risk and promote entry into treatment for drug use disorders and 
related comorbidities like HIV and HCV. SSPs sites often serve as a 
bridge to perform outreach to otherwise unreached populations. In 
addition, these sites are often integrated into research studies as 
venues for recruiting out of treatment drug users.
    The NIH supported ten projects on SSPs in fiscal year 2017 that 
evaluated the feasibility and efficacy of novel community-supported 
risk-reduction groups to expand drug-free social networks;\30\ assessed 
clinical outcomes from onsite treatment delivery,\31\ HIV/HCV testing, 
and linkage to are for SSP participants;\32\ determined SSP uptake 
patterns in rural, resource-poor areas;\33\ and developed complementary 
intervention strategies for enhancing access to evidence-based 
structural HIV prevention interventions for highly vulnerable persons 
who inject drugs.\34\
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    \30\ https:// projectreporter.nih.gov/ project_info_description. 
cfm? aid=9310470.
    \31\ https:// projectreporter.nih.gov/project_info_description. 
cfm?aid=9411340.
    \32\ https://projectreporter.nih.gov/
project_info_description.cfm?aid=9482514, 
https://projectreporter.nih.gov/
project_info_description.cfm?aid=9412019, 
https://projectreporter.nih.gov/
project_info_description.cfm?aid=9231414, 
https://projectreporter.nih.gov/
project_info_description.cfm?aid=9220762,
    \33\ https://projectreporter.nih.gov/
project_info_description.cfm?aid=9481503
    \34\ https://projectreporter.nih.gov/
project_info_description.cfmaid=9410729,https://
projectreporter.nih.gov/project_info_description.cfm?aid=9341537,https:/
/projectreporter.nih.gov/project_info_description.cfm?aid=9502152.

    Question 1b. Research has also shown the benefits of Supervised 
Injection Facilities (SIFs), where people can use their own drugs, 
under medical supervision.\35\ Research indicates that SIFs help lower 
risks of HIV and hepatitis transmission, limit overdose deaths, and 
increase the number of people seeking out addiction treatment. Would 
you support studying supervised injection facilities to determine how 
they might best be used as a tool in the fight against the opioid 
epidemic?
---------------------------------------------------------------------------
    \35\ Frakt, Austin, ``JAMA Forum: Safe Injection Facilities Reduce 
Individual and Societal Harms,'' JAMA (April 5, 2017) (online at: 
https://newsatjama.jama.com/2017/04/05/jama-forum- safe-injection-
facilities- reduce-individual-and- societal-harms/).
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    Answer 1b. Supervised Injection Facilities (SIFs) are new in the 
U.S., and research is needed to evaluate their impact on local drug use 
and related health consequences, such as overdose and the transmission 
of infectious diseases (HIV, HCV, etc.). These sites sometimes test 
drugs for content, which enables a surveillance of illicit drugs that 
can be difficult to perform otherwise.
    Because there is only one SIF in the US, located in Seattle, WA 
(and a small number that are in the planning stage), it is not feasible 
to propose a research funding initiative.

    2. Safe disposal
    Safe drug disposal options are an important tool to help limit the 
volume of unused medications in circulation. Twice a year, the U.S. 
Drug Enforcement Agency holds National Prescription Drug Take Back 
Days, meant to help individuals dispose of unused medicines. 450 tons 
of drugs were disposed of in the last national take-back day in 
May.\36\ In September 2014, the DEA released the final rule on 
``Disposal of Controlled Substances,''\37\ aimed at making it easier to 
for individuals to dispose of unused medicines and allow for more 
continuous collection opportunities. Over a year ago, Massachusetts 
announced its ``first statewide safe medication disposal program with 
Walgreens to fight substance misuse,''\38\ and today in Massachusetts, 
in addition to semi-annual national take-back days, there are a number 
of permanent kiosks where individuals can go to dispose of unused 
medications.\39\
---------------------------------------------------------------------------
    \36\ ``DEA Brings in Record Amount of Unused Prescription Drugs on 
National Prescription Take Back Day,'' U.S. Drug Enforcement 
Administration (May 8, 2017) (online at: https://www.dea.gov/ 
divisions/hq/2017/ hq050817a.shtml).
    \37\ Federal Register, Vol. 79, No. 174 (September 9, 2014) (Online 
at: https://www.deadiversion.usdoj.gov/ fed_regs/rules/2014/2014-
20926.pdf).
    \38\ ``Baker-Polito Administration Announces First statewide Safe 
Medication Disposal Program with Walgreens to Fight Substance Misuse,'' 
The Official Website of the Governor of Massachusetts (September 7, 
2017) (online at:http://www.mass.gov/Governor/ press-office/ press-
releases/ fy2017/statewide-safe-medication-disposal-program-launched. 
html).
    \39\ ``Safely Dispose of Prescription Drugs,'' Mass.gov (online at: 
https:// www.mass.gov/safely- dispose-of-prescription- drugs) (accessed 
October 25, 2017).
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    Question 1a. In its efforts to reduce the volume of unused 
medications in circulation, what is the NIH doing to study safe drug 
disposal technologies?
    Answer 1a.. Safe disposal of unused prescription drugs is a crucial 
part of efforts to prevent opioid misuse, and it depends not only on 
the availability of disposal opportunities but also patient education 
about the necessity of safe drug storage and disposal. Permanent drug 
disposal boxes, being tried in various communities, may be more 
convenient than scheduled Take-Back events, and also may be perceived 
as more anonymous.
    NIDA is currently funding a project studying the usage and impact 
of permanent prescription drug disposal boxes in central Appalachia. A 
2-year study of eight collection sites in five Tennessee counties 
yielded on average 1.39 pounds or 618.5 units of controlled substances 
per 1,000 residents; the most commonly disposed substances were 
hydrocodone, tramadol, oxycodone, and alprazolam;\40\ these are the 
first reported outcomes associated with permanent drug donation boxes. 
This project is part of a larger project at East Tennessee State 
University to build institutional substance use disorder research 
infrastructure, and to develop strategies to mitigate the negative 
impact of prescription drug misuse in Appalachia and elsewhere. The 
researchers are also studying pharmacist-patient communication around 
the need for safe drug storage and disposal.
---------------------------------------------------------------------------
    \40\ Gray, J., et al. (2015). ``Prescription Disposal Practices: A 
2-Year Ecological Study of Drug Drop Box Donations in Appalachia.'' 
American Journal of Public Health 105(9): e89-e94.

    3. Maternal Mental Health & Opioids
    In August, the Massachusetts Executive Office of Health and Human 
Services released a report on opioid overdoses that revealed that 
``mothers with [opioid use disorder] had a significantly higher co-
occurrence of mental health diagnoses.'' They also found that ``Rates 
of opioid-related overdose decrease during pregnancy and are lowest 
during the second and third trimesters, but significantly increase in 
the postpartum period, with the highest rates 6 month--one year after 
delivery.''\41\ The National Institute of Mental Health has 
acknowledged that ``drug abuse problems'' were a risk factor for 
postpartum depression,\42\ and the CDC has shown that ``1 in 9 women 
experiences postpartum depression.''\43\ In an effort to address a lack 
of screening tools for postpartum depression, a provision was included 
in the 21st Century Cures Act that created a grant program to support 
screening of postpartum depression services \44\ --but moms are not yet 
routinely screened.
---------------------------------------------------------------------------
    \41\ ``An Assessment of Fatal and Nonfatal Opioid Overdoses in 
Massachusetts (2011-2015),'' 
Massachusetts Department of Public Health, 55-57 (August 2017) (online 
at: http://www.mass.gov/eohhs/docs/dph/stop-addiction/legislative-
report-chapter-55-aug-2017.pdf).
    \42\ ``Postpartum Depression Facts,'' National Institutes of Mental 
Health (online at:https://www.nimh.nih.gov/health/publications/
postpartum-depression-facts/ index.shtml) (accessed October 25, 2017).
    \43\ ``Depression Among Women,'' Centers for Disease Control and 
Prevention (online at: https://www.cdc.gov/ reproductivehealth/ 
depression/ index.htm) (accessed October 25, 2017).
    \44\ See Sec. 10005: 21st Century Cures Act (online at:https://
www.Congress.gov/114/plaws/publ255/PLAW-114publ255.pdf).
---------------------------------------------------------------------------
    Question 3a. What is the NIH doing to help address this issue?
    Question 3b. Does NIH collect dual diagnosis data on substance use 
and maternal mental health for the pregnant and postpartum opioid user 
population?
    (Answers. both a. and b.): The National Institutes of Health (NIH) 
supports research on prevention, treatment, and mental health services 
to inform the work of other Federal agencies in their efforts to 
provide evidence-based treatment and service delivery. These research 
efforts help to inform clinical practice, such as the American College 
of Obstetricians and Gynecologists' recommendation that clinicians 
screen patients at least once during the perinatal period for 
depression and anxiety symptoms using a standardized, validated 
tool.\45\
---------------------------------------------------------------------------
    \45\ https://www.acog.org/-/media/Committee-Opinions/Committee-on-
Obstetric-Practice/co630.pdf?dmc=1&ts=20171109T1840330384
---------------------------------------------------------------------------
    In 2015, the National Institute of Mental Health (NIMH) issued a 
notice prioritizing research on women's mental health during pregnancy 
and the postpartum period.\46\ NIMH-funded efforts to address and 
understand maternal mental health range from basic research, including 
understanding biological risk factors, to establishing an evidence-base 
for effective services and interventions, such as connecting a diverse 
population of women to appropriate treatment. One such study followed 
more than 3,000 first-time mothers and identified six trajectories of 
depression from the third trimester of pregnancy through the first year 
postpartum.\47\ A history of anxiety or depression, unattached marital 
status, and inadequate social support were significantly associated 
with higher odds of experiencing greater depression. NIMH also funded a 
study to better understand the genetic contribution to the risk of 
postpartum mood disorders using novel smart phone technology for 
participant recruitment.\48\ Study findings support the need for 
tailored treatments that improve outcomes for women with perinatal 
depression. Findings from a third NIMH-funded study indicated 
collaborative care for perinatal depression improves outcomes (e.g., 
reduced depression severity and increased remission rates) in 
socioeconomically disadvantaged women.\49\ These findings demonstrate a 
collaborative care model can be integrated into a local public health 
care system; NIMH is currently funding a clinical trial examining how 
to most effectively implement collaborative care for perinatal 
depression on a large scale in primary care clinics serving low-income 
women.\50\
---------------------------------------------------------------------------
    \46\ https:// grants.nih.gov/ grants/guide/notice-files/ NOT-MH-15-
013.html.
    \47\ https:// www.ncbi.nlm.nih.gov/pubmed/?term=27310295.
    \48\ https://projectreporter.nih.gov/
project_info_description.cfm?aid= 9269581&icde=36779139.
    \49\ https://www.ncbi.nlm.nih.gov/pubmed/26345179.
    \50\ https://projectreporter. nih.gov/ project_info_description. 
cfm?aid= 9256545&icde= 36817899.
---------------------------------------------------------------------------
    The emergent public health opioid epidemic that is affecting 
individuals across the country includes pregnant women and infants who 
were exposed prenatally to opioids. One study supported by the Eunice 
Kennedy Shriver National Institute of Child Health and Human 
Development (NICHD), for example, is determining whether more accurate 
prescribing of buprenorphine is possible based on how pregnant women 
metabolize the drug. In addition to supporting investigator-initiated 
grants, NICHD has two new research efforts specifically aimed at 
addressing the health outcomes of opioid use disorder in pregnancy. A 
new funding opportunity, with the National Institute on Drug Abuse 
(NIDA), will support clinical studies of medically supervised 
withdrawal, research on how pregnant and postpartum women metabolize 
medications used to treat opioid use disorder, and studies on how 
genetic factors may interact with the effects of opioid use during 
pregnancy. Applications for funding are expected to include grants that 
will collect information about depression and other mental health 
issues, since these conditions affect the success of treatment. NIDA 
also is partnering with the Appalachian Regional Commission on a 
toolbox for use by local health departments in rural areas to implement 
service delivery plans that address the opioid epidemic. To assist the 
Department of Health and Human Services with its implementation of the 
Protect Our Infants Act of 2015 (P.L. 114-91), NIDA is coordinating 
with other HHS divisions on several action steps, including collecting 
substance-and diagnosis-specific data about prenatal substance use to 
help determine adequate treatment capacity, and to identify unmet 
service and care-coordination needs and disparities in access.
    NICHD also is leading the Task Force on Research Specific to 
pregnant women and lactating women \51\ established by the 21st Century 
Cures Act. The Task Force will be looking at prescription medications 
used by pregnant and lactating women and their effects. These 
medications include opioids prescribed to pregnant and lactating women. 
The Task Force has held three meetings, the first of which was in 
August 2017. Subsequent to the date of this hearing, two other meetings 
have been held, one in November 2017 and another in February 2018. As 
directed, the report of the Task Force findings and recommendations 
will be submitted to the HHS Secretary in September 2018.
---------------------------------------------------------------------------
    \51\ https://www.nichd.nih.gov /about/ advisory/ PRGLAC.
---------------------------------------------------------------------------
    Finally, NIH would like to note that in 2017, a new study called 
the Advancing Clinical Trials in Neonatal Opioid Withdrawal Syndrome 
(ACT NOW) will evaluate treatment options and improve clinical care of 
infants with NAS/NOWS. The study is a collaboration between NICHD's 
Neonatal Research Network (which has 30 years of experience in 
conducting clinical trials with newborns) and the new IDeA States 
Pediatric Clinical Trials Network (within the NIH Office of the 
Director's Environmental Influences on Child Health Outcomes (ECHO) 
Program), with sites located in rural and medically underserved 
communities. This joint research effort will use the reach of both 
networks to assess the prevalence of NAS, understand current approaches 
to managing NOWS cases, including non-pharmacological approaches, and 
develop protocols for conducting large scale studies across the country 
to inform clinical care for affected infants.

    4. Marijuana research
    Currently, 28 states and D.C. have laws providing for the use of 
marijuana for medical purposes, or ``medical marijuana.'' As more 
Americans use marijuana for treatment as prescribed by their physician, 
it is critical that the Federal Government reduce barriers to research 
on the drug.
    In particular, it is critical that we accelerate research on 
effective alternatives to opioids for pain treatment in light of the 
opioid epidemic--including marijuana and its components. A 2014 JAMA 
Internal Medicine study showed that in states that passed legislation 
allowing for the use of medical marijuana, the fatal opioid overdose 
rate is 25 percent lower than in other states.\52\ This is one of many 
promising studies that show marijuana as a potential alternative pain 
treatment with an impact on the opioid epidemic. NIH and the National 
Institute on Drug Abuse
---------------------------------------------------------------------------
    \52\ Marcus A. Bachhuber, Brendan Saloner, Chinazo Cunningham et 
al., ``Medical Cannabis Laws and Opioid Analgesic Overdose Mortality in 
the United States, 1999-2010,'' Journal of the American Medical 
Association (October 2014) (online at http:// jamanetwork.com/ 
journals/ 
jamainternalmedicine/fullarticle/1898878).
---------------------------------------------------------------------------
    Question 4a. What specific actions have you taken, in consultation 
with Director Nora Volkow, to encourage qualified research applications 
on the potential health benefits of marijuana and its components?
    Answer 4a.. While there is a growing body of research suggesting 
the potential therapeutic value of cannabinoids for pain, epilepsy, and 
other health conditions, promising early findings do not always 
translate to effective treatments,\53\ and in general, adequate and 
well-controlled trials are lacking. Patients across the country are 
using marijuana strains and extracts that have not undergone rigorous 
clinical trials and are not regulated for consistency or quality.
---------------------------------------------------------------------------
    \53\ Gloss, D. and B. Vickrey (2014). Cannabinoids for epilepsy. 
Cochrane Data base of Systematic Reviews. C. The Cochrane. Chichester, 
UK, John Wiley & Sons, Ltd.
---------------------------------------------------------------------------
    NIH shares the Committee's concerns in this area and believes that 
more research is needed on both the harms associated with marijuana use 
and the therapeutic potential of marijuana and its constituent 
compounds. NIH welcomes investigator-initiated research proposals for 
pre-clinical and clinical research evaluating marijuana and its 
constituent cannabinoids for treating disease. In addition, to 
facilitate more research on the therapeutic potential of cannabinoids, 
NIH has released funding opportunity announcements (FOAs) on:

         Fast-Track Development of Medications to Treat 
        Cannabis Use Disorders\54\
---------------------------------------------------------------------------
    \54\ https:// grants.nih.gov/grants/guide/pa-files/PAR-15-267.html.
---------------------------------------------------------------------------
         Effects of Cannabis Use and Cannabinoids on the 
        Developing Brain \55\
---------------------------------------------------------------------------
    \55\ https://grants.nih.gov/grants/ guide/pa-files/PA-14-162.html
---------------------------------------------------------------------------
         Developing the Therapeutic Potential of the 
        Endocannabinoid System for Pain Treatment \56\
---------------------------------------------------------------------------
    \56\ https:// grants.nih.gov/grants/guide/pa-files/pa-15-188.html.
---------------------------------------------------------------------------
         Blueprint Neurotherapeutics Network Small Molecule 
        Drug Discovery and Development for Disorders of the Nervous 
        System\57\
---------------------------------------------------------------------------
    \57\ https:// grants.nih.gov/ grants/guide/ pa-files/ PAR-17-
205.html.
---------------------------------------------------------------------------
         Clinical Evaluation of Adjuncts to Opioid Therapies 
        for the Treatment of Chronic Pain \58\
---------------------------------------------------------------------------
    \58\ https:// grants.nih.gov/ grants/ guide/ pa-files/ PAR-14-
225.html.

    Despite efforts to stimulate research on marijuana, the progress of 
therapeutics development and clinical trials has been slow, in part due 
to the increased time, costs, and administrative efforts associated 
with the regulatory framework for conducting research on these and 
---------------------------------------------------------------------------
other Schedule I compounds. Specifically:

    Single source of marijuana for research purposes: Currently, there 
is one registration for marijuana cultivation in the US--the University 
of Mississippi, which, through a contract with NIDA, supports the 
cultivation and distribution of research-grade marijuana for the 
country. While the NIDA supply of marijuana has diversified to include 
different strains of interest to researchers, it is not possible to 
provide access to the diversity of strains and products currently 
available through State dispensaries.
    Making marijuana for research available from other sources 
potentially could both speed the pace of research and afford individual 
developers and researchers more options in formulating marijuana-
derived investigational products for eventual marketing.\59\
---------------------------------------------------------------------------
    \59\ https://report.nih.gov/
categorical_spending_project_listing.aspx? 
FY=2016&ARRA=N&DCat=Cannabinoid%20Research.
---------------------------------------------------------------------------
    Widespread perceptions of the difficulty of doing research on 
Schedule I drugs: The perception throughout the scientific community of 
barriers to Schedule I research can dis-incentivize scientists from 
engaging in this type of research. Most biomedical research in the 
country is conducted by graduate students and postdoctoral fellows, who 
are under significant pressure to complete their research projects in a 
few years. Many avoid research areas where barriers may pose 
significant or unpredictable delays in the initiation of their 
research.
    Discrepancies between Federal and State laws: NIH is unable to fund 
researchers to analyze marijuana products available in State 
dispensaries, since obtaining these samples would violate Federal law. 
Understanding the characteristics of the marijuana that is being 
dispensed, including the potency (i.e., amount of THC) and 
concentration of other components (e.g., CBD), is important for 
studying the impact of medical and recreational marijuana on individual 
and public health. In addition, there are open questions about the 
legality of state-funded research using marijuana from State 
dispensaries. Universities and researchers are concerned about the 
potential impact of this type of research on their ability to obtain 
DEA licenses or Federal funding, even if they are not using Federal 
funds.
    Path from use of NIDA-supplied marijuana to market: The University 
of Mississippi, under the contract with NIDA, currently produces a 
limited supply of marijuana extracts for researchers to use in drug 
development. Drug developers would need to transition from using NIDA-
supplied marijuana products to other sources before FDA approval and 
market entry. It may be challenging for a pharmaceutical company to 
demonstrate equivalency between the marijuana used in the clinical 
trials and the drug product that will be marketed. While FDA has 
provided guidance on how this should occur,\60\ the process requires 
additional time and resources of the developer.
---------------------------------------------------------------------------
    \60\ https://report.nih.gov/
categorical_spending_project_listing.aspx?FY=2016&ARRA=N&DCat=Cannabinoi
d %20Research
---------------------------------------------------------------------------
    NIH is committed to working with Congress and our Federal partners 
to facilitate more research on both the harms, and therapeutic 
potential, of marijuana and cannabinoids, and to reduce barriers to 
research. NIH will continue working closely with the ONDCP, DEA, and 
FDA to explore ways to streamline these processes to facilitate 
research.

        Question 4b. Please describe in detail all of the current NIH 
        research occurring on the therapeutic benefits of marijuana as 
        an alternative pain treatment.
    Answer 4b. NIH supports a broad portfolio of research on 
cannabinoids and the endocannabinoid system (ECS). In fiscal year 2016, 
NIH supported 292 projects totaling over $115 million \61\ on 
cannabinoid research including 53 projects ($28 million) on research 
evaluating the therapeutic potential of cannabinoids.\62\ Research on 
the therapeutic potential of cannabinoids included 26 studies related 
to pain. These studies include:
---------------------------------------------------------------------------
    \61\ https://report.nih.gov/
categorical_spending_project_listing.aspx? 
FY=2016&ARRA=N&DCat=Cannabinoid %20Research
    \62\ https://report.nih.gov/
categorical_spending_project_listing.aspx?FY=2016&ARRA=N&DCat=Therapeuti
c%20Cannabinoid %20Research.
---------------------------------------------------------------------------
         A randomized controlled trial of dronabinol (THC) and 
        vaporized cannabis for neuropathic low back pain.\63\
---------------------------------------------------------------------------
    \63\ https:// projectreporter.nih.gov/
project_info_description.cfm?icde=0&aid=8964406
---------------------------------------------------------------------------
         An observational study of the effects of edible 
        cannabis and its constituent cannabinoids on pain, 
        inflammation, and cognition.\64\
---------------------------------------------------------------------------
    \64\ https://projectreporter.nih.gov/ project_ 
info_description.cfm?icde= 0&aid=9361825
---------------------------------------------------------------------------
         Research on the use of cannabinoid receptor type 2 
        (CB2) agonists for treating breast cancer induced bone 
        pain.\65\
---------------------------------------------------------------------------
    \65\ https:// projectreporter.nih.gov/ roject_info_ 
description.cfm?icde=0&aid= 9329913.
---------------------------------------------------------------------------
         Cannabinoid based therapeutics for pain in sickle cell 
        disease.\66\
---------------------------------------------------------------------------
    \66\ https:// projectreporter.nih.gov/project_ info_ description. 
cfm?icde=0&aid=9301005.
---------------------------------------------------------------------------
         Studies exploring the therapeutic potential of 
        compounds that modulate the ECS such as diacylglycerol kinase, 
        fatty acid amide hydrolase (FAAH), fatty acid binding proteins 
        (FABPs), and G-protein receptor 55.\67\
---------------------------------------------------------------------------
    \67\ https://projectreporter.nih.gov/
project_info_description.cfm?icde=0&aid=9205939, 
_info_description.cfm?icde=0&aid9328534,_info_description.cfm?icde=0&aid
 =9222649,https://projectreporter.nih.gov/project_info 
_description.cfm?icde=0&aid=9040444,https://projectreporter.nih.gov/
project_info_description.cfm?icde=0aid8878443,https://
projectreporter.nih.gov/project_info_description.cfm?icde=0&aid=9247769
---------------------------------------------------------------------------
         Research on the use of cannabinoid compounds as 
        adjunct therapies with opioids or non-steroidal anti-
        inflammatories (NSAIDs) to improve pain control and reduce 
        adverse events.\68\
---------------------------------------------------------------------------
    \68\ https://projectreporter.nih.gov/
project_info_description.cfm?icde=0&aid=9329184, https://
projectreporter.nih.gov/
project_info_description.cfm?icde=0&aid=9324176,https://
projectreporter.nih.gov/project _info_description. cfm?icde= 
0&aid=9557937.
---------------------------------------------------------------------------
         Studies of the therapeutic effects of cannabis and 
        cannabinoids on HIV-related pain.\69\
---------------------------------------------------------------------------
    \69\ https://projectreporter.nih.gov/
project_info_description.cfm?icde=0&aid=9271603.
---------------------------------------------------------------------------
         Studies of the efficacy of peripherally restricted 
        cannabinoids for cancer and chemotherapy-induced pain.\70\
---------------------------------------------------------------------------
    \70\ https://projectreporter.nih.gov/
project_info_description.cfm?icde=0&aid=9056010.
---------------------------------------------------------------------------
         Basic research on:
                Y the mechanisms through which cannabinoids and the ECS 
                modulate pain,\71\
---------------------------------------------------------------------------
    \71\ https:// projectreporter.nih.gov/project _info_ 
description.cfm?icde=0&aid=9309675, https://projectreporter.nih.gov/
project_info_ description.cfm?icde=0&aid=8918260.
---------------------------------------------------------------------------
                Y the role of cannabinoids in modulating hyperalgesia 
                \72\
---------------------------------------------------------------------------
    \72\ https://projectreporter.nih.gov/ project _ info_ 
description.cfm? icde=0&aid =9107004.
---------------------------------------------------------------------------
                Y the role of CB2 receptors in peripheral neuropathy 
                \73\
---------------------------------------------------------------------------
    \73\ https:// projectreporter.nih.gov/ project _info_ 
description.cfm?icde= 0&aid=9 279120.
---------------------------------------------------------------------------
                Y the role of the ECS in the efficacy of spinal 
                manipulation therapy for neuropathic pain \74\
---------------------------------------------------------------------------
    \74\ https://projectreporter.nih.gov/ project_ info _description. 
cfm?icde= 0&aid= 9377578.
---------------------------------------------------------------------------
       Response by Dr. Collins to Questions of Senator Whitehouse
    The 21st Century Cures Act authorized $1 billion over 2 years to 
support efforts to combat the opioid epidemic. The second half of that 
money is expected to be made available as part of the fiscal year 2018 
appropriations bill. Though I was pleased to see the first $500 million 
get out to states quickly, I think we can improve how the next $500 
million is used and allocated.
    Question. First, we could allow grant makers approving applications 
for these funds to consider whether the proposed uses of this funding 
are aligned with the goals of the Comprehensive Addiction and Recovery 
Act (CARA). Second, in evaluating applications for this funding, more 
consideration could be given to states most affected by the epidemic. 
Do you support aligning the uses of the next tranche of 21st Century 
Cures Act opioid funding with the best practices set forth in CARA and/
or prioritizing funding to states most affected by the opioid epidemic?
    Answer. NIH fully supports the goals of the Comprehensive Addiction 
and Recovery Act (CARA), in particular the importance of providing 
support for prevention, treatment and recovery services that are 
evidence-based and targeted to areas of need. As resources provided 
through the 21st Century Cures Act are allocated, NIH endorses 
approaches to use these funds to support evidence-based and effective 
prevention and treatment strategies. In alignment with the goals of 
CARA, NIDA plans to fund research projects that test approaches for 
expanding access to medication for the treatment of opioid use disorder 
in the context of states' plans for use of funds authorized under the 
21st Century Cures Act that were disseminated under SAMHSA's State 
Targeted Response to the Opioid Crisis Grants. These efforts will 
generate additional evidence about effective strategies for the 
implementation of medication-assisted treatment in specific communities 
and geographic areas most affected by the opioid crisis.
         Response by Dr. Collins to Questions of Senator Young
    Question 1. Some researchers have found that it takes an average of 
17 years for research evidence to reach clinical practice. How are you 
all working together to ensure our best practices actually reach the 
patient in a reasonable amount of time? Are you working with medical 
associations and boards to ensure that best practices are translated 
into clinical practice? What can be done at the Federal level to speed 
up this research to practice pipeline?
    Answer 1. Implementation science is a vital piece of NIDA's 
research portfolio that seeks to determine the most effective ways to 
translate research into clinical practice. A recent area of focus has 
been to determine the most effective implementation strategies for the 
specific needs of communities hit hardest by the opioid crisis, 
including research specific to New Hampshire, Appalachian regions, and 
rural communities. NIDA will also be funding projects to test 
approaches for expanding access to medication for the treatment of 
opioid use disorder in the context of states' plans for use of funds 
authorized under the 21st Century Cures Act that were disseminated 
under SAMHSA's State Targeted Response to the Opioid Crisis Grants.
    For direct clinician engagement, NIDA leads an initiative, NIDAMED, 
that focuses on development and dissemination of science-based 
resources to educate health professionals and those in training about 
substance use disorders (SUD) prevention and treatment; and enhancing 
awareness of addiction as a treatable brain disorder. Among other 
things, the NIDAMED initiative brings the latest science to clinicians 
by hosting a centralized Web Portal where relevant resources can be 
accessed, including continuing medical education (CME). In 2012, 
NIDAMED created two CME courses to train providers on safe opioid 
prescribing practices, entitled Safe Prescribing for Pain and Managing 
Pain Patients Who Abuse Prescription Drugs. More than 100,000 
clinicians completed these modules and were certified while they were 
available.
    The current phase of the NIDAMED initiative was developed with a 
Coalition of Health Professions Organizations, and resulted in the 
latest CME, the Adolescent Substance Use and Rx Medication Misuse CME/
CE, launched in June 2017 on the NIDAMED Web Portal. As of October 
2017, over 1,000 primary care clinicians have completed the course. 
Through this project, NIDA has created multiple online modules that 
focus on: (1) prescription opioids; (2) marijuana; (3) screening for 
substance use; (4) key messaging to communicate to adolescents and 
their caregivers about drugs; (5) successful ways for clinicians to 
engage in conversations with adolescents (ages 13-18), and their 
parents; and (6) how best to address issues such as privacy and 
confidentiality. This CME also provides clinician/patient communication 
tools which include brochures/handouts and an in-office, mobile ready 
game or app that clinicians can use with adolescents to help initiate a 
conversation about substance use and provide information about the 
consequences of use.
    To encourage the translation of research into clinical practice, 
NIH is also engaged in efforts to expand the addiction medicine 
workforce. NIAAA, NIDA, and SAMHSA are focused on improving physician 
training in diagnosis, prevention, and treatment of alcohol and other 
drug misuse across the continuum of medical training, from medical 
school through residency, fellowship, and beyond. For example, NIAAA 
supported the development of model programs for residency training in 
addiction medicine and accreditation of new addiction medicine 
fellowship training programs. These and other efforts have paved the 
way for integrating addiction medicine into graduate medical education 
at more than 40 academic medical centers across the country and laid 
the groundwork for addiction medicine being recognized as a medical 
subspecialty. NIAAA and its Federal partners are also engaging with 
medical education groups to design and implement national standards for 
training in addiction medicine for medical students and residents.
    NIAAA is also working to close the treatment gap by encouraging 
integration of addiction medicine into routine medical care. To assist 
healthcare professionals in implementing alcohol screening and brief 
intervention in their practices, NIAAA developed Helping Patients Who 
Drink Too Much: A Clinician's Guide for adults and Alcohol Screening 
and Brief Intervention for Youth: A Practitioner's Guide. These tools 
are designed to help health care providers overcome barriers to alcohol 
screening such as lack of familiarity with the process and time 
constraints.

    Question 2. Too many unused opioids dangerously remain in medicine 
cabinets throughout America. They pose a real threat to health and 
safety--especially to young Americans. Will drug take back programs be 
a component of our government's response to this national emergency?
    Answer 2. NIH defers to the Drug Enforcement Administration (DEA), 
the component of the government that manages and coordinates the 
National Prescription Drug Take Back Day.

    Question 3. What are the current gaps in research focused on 
preventing addiction? What have we learned about preventing and 
treating addiction that we are not putting into practice? What are the 
barriers to deployment?
    Answer 3. While many evidence-based drug use prevention strategies 
have been developed, they remain highly underutilized. Ongoing research 
is working to develop strategies for implementation and to develop new 
strategies targeted to high-risk populations. Increased evidence about 
the neurobiological mechanisms underlying effective prevention 
interventions could inform more targeted approaches, and increased 
evidence about the specific populations for whom interventions are 
effective could lead to more efficient and optimized strategies.
    More research is needed to improve strategies for prevention of 
risky drug use among those aged 18-30, and to develop evidence-based 
strategies for the prevention of opioid misuse that preserve access to 
effective pain management. In addition, more research is needed to 
develop strategies for transforming health systems and other public and 
private service platforms for successful integration of sustainable, 
evidence-based drug use prevention interventions.
    Highly effective evidence-based drug use prevention interventions 
and drug addiction treatment approaches have been developed and tested. 
These are well detailed in the Surgeon General's Report on Alcohol, 
Drugs and Health,\75\ and notably include school, family, and 
community-based drug use prevention. For prevention, broad adoption of 
evidence-based interventions has been limited due to implementation 
challenges that span financial, regulatory, geographic, attitudinal, 
and logistic issues. Ongoing research is working to develop strategies 
to translate evidence-based practices in a way that confers population-
level impact,\76\ including for developing implementation capacity, and 
implementation and sustainability of evidence-based practices across 
systems and settings--for example:
---------------------------------------------------------------------------
    \75\ Surgeon General's Report on Alcohol, Drugs, and Health. 2016. 
at https://addiction.surgeongeneral.gov/.
    \76\ Spoth R, Rohrbach LA, Greenberg M, et al. Addressing core 
challenges for the next generation of type 2 translation research and 
systems: the translation science to population impact (TSci Impact) 
framework. Prev Sci 2013;14:319-51.

         Organizational and system supports for evidence-based 
        implementation
         Work-force development and training
         Ongoing fidelity monitoring
         Continuous quality improvement
         Financing

    As models are developed for efficient scale-up of evidence-based 
approaches that demonstrate community-level impact, adaptation will be 
required for specific settings and systems (e.g. criminal justice, 
child welfare, military, rural areas) based on their unique needs. 
Effective deployment of evidence-based prevention and treatment would 
benefit from coordinated Federal, State and local level implementation 
strategies to achieve population-level impact.

    Question 4. While increasing access to treatment is important, we 
also need to make sure people in treatment are receiving services that 
really work. What current treatments and outreach strategies have been 
proven through rigorous evaluation to work best? Do we need more 
research and innovation in this area?
    Answer 4. Abundant evidence shows that the medications methadone, 
buprenorphine, and extended release naltrexone all reduce opioid use 
and opioid use disorder-related symptoms, and they reduce the risk of 
infectious disease transmission as well as criminal behavior associated 
with drug use. These medications also increase the likelihood that a 
person will remain in treatment, which itself is associated with lower 
risk of overdose mortality, reduced risk of HIV and HCV transmission, 
reduced criminal justice involvement, and greater likelihood of 
employment. While these medications, in combination with psychosocial 
supports (medication-assisted treatment or MAT) are the standard of 
care for opioid use disorder (OUD), most patients who need them don't 
receive them.\77\ Evidence-based behavioral treatments are also 
effective in the treatment of substance use disorders (SUD), and 
include such approaches as cognitive behavioral therapy and contingency 
management; best practices for treatment of SUD are comprehensively 
reviewed in the Surgeon General's Report on Alcohol, Drugs and 
Health.\78\
---------------------------------------------------------------------------
    \77\ https://www.drugabuse.gov/publications/ research-reports/
medications-to-treat-opioid- addiction/efficacy-medications-opioid-use-
disorder
    \78\ Surgeon General's Report on Alcohol, Drugs, and Health. 2016. 
at https:// addiction.surgeongeneral.gov/.
---------------------------------------------------------------------------
    Continued innovation will be vital to develop new treatments and to 
determine which treatments are most effective for which patients. 
Equally important is the advancement of implementation science to 
ensure that those who need treatment receive it efficiently and 
effectively. NIDA supports implementation research to develop 
strategies to address the specific needs of communities hit hardest by 
the opioid crisis, including research specific to New Hampshire, 
Appalachian regions, and rural communities. NIDA will also be funding 
projects to test approaches for expanding access to medication for the 
treatment of opioid use disorder in the context of states' plans for 
use of funds authorized under the 21st Century Cures Act that were 
disseminated under SAMHSA's State Targeted Response to the Opioid 
Crisis Grants.
    For dissemination of best practices to clinicians, NIDA leads an 
initiative, NIDAMED, that focuses on development and dissemination of 
science-based resources to educate health professionals and those in 
training about prevention and treatment of SUDs; and enhancing 
awareness of addiction as a treatable brain disorder. Among other 
things, the NIDAMED initiative brings the latest science to clinicians 
by hosting a centralized Web Portal where relevant resources can be 
accessed, including continuing medical education (CME) relevant to 
primary care and treatment providers. In addition to the NIDAMED CME's 
for health care providers, curriculum resources were developed for 
current medical students and resident physicians to help prepare 
physicians and clinicians for the challenge of addressing substance use 
disorders in their patients.
     Response by Dr. McCance-Katz to Questions of Senator Alexander
    Question 1. Do you need additional authorities, on top of the 
modernizations for substance use disorders and opioid abuse programs 
and services in the 21st Century Cures Act and in the Comprehensive 
Addiction and Recovery Act (CARA), to fight the opioid crisis? If so, 
please provide specific authorities that would be helpful.
    Answer 1. The Department of Health and Human Services (HHS) is 
undergoing a department-wide process to identify what authorities or 
changes in statute would be helpful.

    Question 2. Section 319 of the Public Health Service Act gives the 
Secretary of HHS the authority to determine that a public health 
emergency exists, allows for waivers of various Medicare and Medicaid 
regulations, movement of volunteer and Federal medical and public 
health professionals to areas hardest hit by the emergency, ability to 
access resources traditionally used for the Strategic National 
Stockpile, and the ability of the FDA to allow drugs and devices to 
come to market prior to full approval under its Emergency Use 
Authorization. Are any of the authorities that are available under a 
Public Health Emergency Declaration necessary to help address the 
opioid abuse crisis? If any, please list, and provide specific examples 
of why such authority is helpful.
    Answer 2. HHS is thoroughly reviewing the available authorities and 
analyzing how they can be applied in the context of the opioid 
epidemic. As decisions are made, we will be happy to share them with 
you, but we are committed to carrying out our five-point HHS Opioid 
Strategy and stemming the tide of this epidemic.

    Subsequent to the date of the hearing, on October 26, then Acting 
HHS Secretary Hargan signed a Public Health Emergency Declaration. The 
action allows, with the concurrence of the Drug Enforcement 
Administration, for expanded access to telemedicine services, with 
respect to designated persons, designated locations and designated 
drugs, including services involving remote prescribing of medicine 
commonly used for substance abuse or mental health treatment. It may 
also help overcome bureaucratic delays and inefficiencies in the hiring 
process by allowing HHS to more quickly make temporary appointments of 
specialists with the tools and talent needed to respond effectively to 
our Nation's ongoing public health emergency if the Department 
determines that such hiring is necessary and subject to the 
availability of funds for such hiring. Finally, the action allows for 
the shifting of resources within HIV/AIDS programs to help people 
eligible for those programs receive substance abuse treatment, which 
may be important given the connection between HIV transmission and 
substance abuse.
      Response by Dr. McCance-Katz to Questions of Senator Murray
    1. Researchers have made many advances in our understanding of how 
the brain develops and responds to drug addiction. We have learned 
about biological, epidemiological, and social factors that contribute 
to our understanding of this disease. Sadly, we are still combating the 
stigma that addiction is a moral failing, rather than a health care 
issue. Rhetoric from the Trump Administration suggesting that 
prosecution has been prioritized over treatment is very concerning.
    Question 1a. Can you address the consequences of stigmatizing 
mental health and substance use disorder?
    Answer 1a. Failure to recognize and respond to addiction and other 
mental health diagnoses as neuro-biological disorders may discourage 
patients and their families from seeking treatment and other needed 
social services. Fear and shame may drive patients to hide their 
illness from health professionals treating them for other medical 
conditions. This practice has likely contributed to treatment services 
being separate from the rest of health care, has made it difficult to 
open and operate treatment programs due to public objections, and may 
deter health care professionals from pursuing career paths that involve 
or focus on treating people with addiction or mental illness. Under 
President Trump's leadership, HHS is determined to improve access to 
treatment and recovery services.

    Question 1b. What role does SAMHSA have in helping to ensure the 
criminal justice system does not lead to the mistreatment of those with 
substance use disorder?
    Answer 1b. SAMHSA promotes early intervention and treatment as 
healthier alternatives to detaining people with behavioral health 
conditions in the U.S. justice system. SAMHSA's role in the criminal 
justice system is to bring about strategic linkages with community-
based behavioral health providers, the criminal justice system, and 
community correctional health programs; promote effective diversion and 
reentry programs; and foster policy development at the intersection of 
behavioral health and justice issues.
    SAMHSA carries out its role through a variety of mechanisms, 
including administering grant programs, such as drug court grants, 
which the Administration has requested an expansion of in the Fiscal 
Year 2019 Budget Request, which was released subsequent to this 
hearing, and offender re-entry program grants; convening policy 
academies and expert meetings; providing training and technical 
assistance to the field; and developing and disseminating information 
resources. SAMHSA approaches this work through the identification of 
individuals with mental illness and addiction; pre-and post-
adjudication diversion using evidence-based screening and assessment to 
ensure comprehensive treatment, supports, and services; diversion of 
individuals from the justice system into community-based treatment; and 
the provision of training and technical assistance for law enforcement 
officers, juvenile and family court judges, probation officers, and 
other judicial decisionmakers. To accomplish this, SAMHSA collaborates 
and coordinates with other Federal agencies (e.g., Department of 
Justice), the Office of National Drug Control Policy, and national, 
state, and local organizations (e.g., National Association of Drug 
Court Professionals, Treatment Alternative for Safe Communities and 
Bexar County, Texas).

    Question 2. We know that many states terminate Medicaid eligibility 
for those who become incarcerated. Many of those in jails and prisons 
have significant health care needs, and coordinating coverage leads to 
better health outcomes. Requiring those just released from 
incarceration to enroll in Medicaid, along with finding housing and a 
job, adds to an already stressful situation and may lead to relapse. 
Are there ways to better facilitate their transition back into the 
community? What role can SAMHSA play in this process?
    Answer 2. SAMHSA uses a two-pronged approach to help meet the needs 
of individuals returning to the community and the needs of the 
community. First, SAMHSA supports grant programs, such as the Offender 
Reentry Program, which develops models to expand and enhance substance 
use treatment services for individuals reintegrating into communities 
after being released from correctional facilities. Second, SAMHSA 
actively partners with other Federal agencies to address issues related 
to offender reentry through the implementation of policy changes and 
making recommendations to states and local governments.
    For example, SAMHSA has worked closely with the Federal Interagency 
Reentry Council (FIRC) to address the important issue of Medicaid 
termination for those incarcerated, as well as the barriers to finding 
housing and jobs. Through FIRC, SAMHSA has worked with the Department 
of Labor, Department of Housing and Urban Development, and many other 
Federal agencies to address these issues through policy and by 
producing ``Reentry Myth Busters.'' ``Reentry Myth Busters'' is a 
series of fact sheets intended to clarify existing Federal policies 
that affect formerly incarcerated individuals and their families. These 
documents are available to the public and target states, SAMHSA 
grantees, and those who are incarcerated to assist with reentry 
challenges.
    CMS released clarifying guidance in 2016 on Medicaid eligibility 
and suspension during incarceration and has encouraged states to 
suspend rather than terminate Medicaid while individuals are 
incarcerated and then immediately restart their benefits post-release. 
SAMHSA-funded grantees and Regional Administrators work with states to 
inform them of these possibilities. SAMHSA is exploring ways to better 
collaborate and coordinate across different grant programs to leverage 
resources and to increase and improve client access to community 
resources. For example, SAMHSA's current grantees with grants in the 
areas of criminal justice and homelessness were provided information 
about each other's programs, including contact information, so that 
they can collaborate to strengthen service provision.
    SAMHSA is looking into extending this approach through partnerships 
with other Federal agencies.

    Question 3. I spoke briefly about some of the positive impacts that 
SAMHSA ``State Targeted Response to the Opioid Crisis'' grants have had 
on our communities in Washington State. SAMHSA also awards block grants 
for substance abuse prevention and treatments, as well as community 
mental health services. These grants fund treatments for individuals 
without insurance, support services that may not be covered by 
insurance, and encourage prevention. There have also been changes in 
recent years to integrate effective interventions to address serious 
mental illness by focusing on evidence-based practices as part of the 
application process to receive a grant. What assistance is SAMHSA 
providing to the states to ensure that the block grants are being used 
as effectively as possible to address the opioid crisis in a 
comprehensive way?
    Answer 3. States identify technical assistance (TA) needs in their 
block grant plans submitted to SAMHSA each year, or they can contact a 
State Project Officer to request TA at any time. On April 2, 2014, 
SAMHSA provided guidance to the recipients of the Substance Abuse 
Prevention and Treatment Block Grant (SABG) funds on the use of such 
funds to provide training and education regarding the prevention of 
prescription drug and heroin overdose and the purchase of naloxone and 
related materials to assemble overdose prevention kits. In December 
2015, the Consolidated Appropriations Act provided states with the 
flexibility to utilize SABG funds to support certain services provided 
by syringe services programs under specific conditions. As a result, in 
March 2016 the HHS Office of HIV/AIDS and Infectious Disease Policy, in 
collaboration with CDC, HRSA, and SAMHSA, developed guidance on 
implementation of the current policy.
    In addition, SAMHSA's Addiction Technology Transfer Center (ATTC) 
Network deploys a variety of methods to accelerate the adoption and 
implementation of evidence-based and promising treatment and recovery-
oriented practices and services by heightening the awareness, 
knowledge, and skills of the workforce addressing the needs of people 
with substance or other co-occurring health disorders; and fostering 
regional and national alliances among culturally diverse practitioners, 
researchers, policymakers, funders, and the recovery community. The 
ATTC grantees work directly with SAMHSA and states on activities aimed 
at improving the quality and effectiveness of treatment and recovery, 
and work directly with providers of clinical and recovery services, and 
others that influence the delivery of services, to improve the quality 
of service delivery across the Nation.
       Response by Dr. McCance-Katz to Questions of Senator Burr
    Question 1. When you came before this Committee for your 
confirmation hearing, you mentioned the need for innovative approaches 
to health care provider training to better address pain management and 
identification of substance abuse in the patients they are treating. 
What work is underway at SAMHSA to make these changes?
    Answer 1. The SAMHSA funded Providers' Clinical Support System for 
Medication Assisted Treatment (PCSS-MAT) provides trainings on pain 
management and addiction. It also hosts podcasts, and provides up-to-
date information on pain medicine and addiction topics designed to 
increase the general education of healthcare providers often with 
conferencing available at no cost.
    The Medication-Assisted Treatment--Prescription Drug and Opioid 
Addiction, or MAT-PDOA program has engaged providers about pain 
management and identification of addiction through a variety of 
mechanisms since the program's inception. This engagement has been 
conducted through technical assistance activities such as onsite 
provider training, virtual provider training (webinars and online 
courses), strategic communication plan development, and public-facing 
product development (e.g. newsletters, toolkits, guides, white papers, 
etc.).
    SAMHSA, through outreach by the Assistant Secretary, is meeting 
with national healthcare practitioner stakeholders to encourage them to 
add substance abuse screening and addiction recognition and treatment 
approaches to their curriculum. SAMHSA will assist with providing the 
curriculum at no cost to these groups. Encouraging Drug Addiction 
Treatment Act (DATA) waiver education in all medical education programs 
for practitioners eligible to obtain the DATA waivers (physicians, 
nurse practitioners, and physicians' assistants) would rapidly expand 
the workforce needed to treat patients with opioid use disorder and 
other addictions.
       Response by Dr. McCance-Katz to Questions of Senator Casey
    Question 1. Increasingly grandparents and other relatives are 
stepping in to raise children when their parents cannot and we continue 
to see the numbers rise as a result of the opioid crisis. By stepping 
in to keep children out of foster care, grandparents and other 
relatives keep children with family and save taxpayers 4.5 billion 
dollars each year. Because of this, earlier this year Senator Collins 
and I introduced the Supporting Grandparents Raising Grandchildren Act. 
This bill will create a Federal Task Force, including Federal agencies 
like SAMHSA, to serve as a ``one-stop-shop'' of resources and 
information for grandparents raising grandchildren. We have bipartisan 
support for this legislation and support from many outside groups 
including Generations United, AARP and the American Association of 
Pediatrics. How do you think improved coordination and collaboration 
across the government and with experts will help these heroic 
grandparents?
    Answer 1. Improved coordination and collaboration across government 
will be a tremendous benefit to these grandparents and other relatives. 
Benefits that could be found with better coordination may include 
enhanced integration of care with child-serving agencies that provide 
services. In addition, improved coordination and collaboration could 
result in providing better support to meet the grandparents' emotional, 
social, and physical well-being so that they are positioned to 
effectively parent and support the needs of their grandchildren 
(accessing existing services they might not be aware of).

    Question 2. One of the major concerns of the opioid epidemic has 
been its impact on children. Following concerning reports in the media 
about infant deaths tied to maternal opioid use or abuse, I was proud 
to work with members of this Committee to pass the Plan of Safe Care 
Improvement Act, which was eventually included in the Comprehensive 
Addiction and Recovery Act in 2016. We strengthened the requirements 
under the Child Abuse Prevention and Treatment Act for states to ensure 
that health and child welfare professionals develop a plan of safe 
care, to ensure that we address the needs of both the infant and the 
affected family or caregiver when a child is born affected by either 
illegal or legal substances. States must now track the number of 
infants for whom a ``Plan of Safe Care'' has been developed and the 
Federal Government must monitor implementation of these plans. Can you 
update the Committee on how implementation of that effort is going, and 
what financial and technical resources states need to effectively 
implement this policy?
    Answer 2. The Administration for Children and Families (ACF) has 
the authority and responsibility for the implementation of the Child 
Abuse Prevention and Treatment Act (CAPTA), including the amendments 
made by the Comprehensive Addiction and Recovery Act (CARA) (P.L. 114-
198). At the same time, SAMHSA is pleased to continue our long 
partnership with ACF's Administration on Children, Youth and Families 
(ACYF) on the National Center for Substance Abuse and Child Welfare 
(NCSACW), which is supporting the implementation of CARA's provisions 
regarding infant plan of safe care. In September, the NCSACW began a 
review of the CAPTA State plans submitted to ACYF in fiscal year 2017 
to better understand how states have implemented the CAPTA State plan 
requirements regarding the identification, notification, and response 
to infants with prenatal substance exposure. A summary report will be 
prepared from this review. The NCSASW will provide technical assistance 
that all states can use, as well as help individual states that want or 
need additional support.

    3. I worked with the Majority Leader to pass the Protecting Our 
Infants Act, to improve the Federal Government's response to the needs 
of infants born with neonatal abstinence syndrome. That law directed 
HHS, with significant input from your agency, to develop the Protecting 
Our Infants Act Final Strategy. On Wednesday, October 4, the Government 
Accountability Office released a report, as required by the 
Comprehensive Addiction Recovery Act, into Federal activities relating 
to neonatal abstinence syndrome. That report said: ``HHS should 
expeditiously develop a plan for implementing the recommendations 
included in its strategy related to addressing NAS. HHS concurred that 
it should expeditiously address NAS, but noted implementation of the 
strategy is contingent on funding.''
    Question 3a. Could you please comment on what the next steps are 
for HHS to implement the strategy?
    Answer 3a. HHS has convened a department-wide workgroup that is 
developing an implementation plan based on the strategy. These 
recommendations will represent the best, most comprehensive thinking of 
experts from across the Department and are expected to support 
decisionmaking by departmental leadership with regard to specific 
agency priorities and funding, if needed.

    Question 3b. What level of funding would HHS require to fully 
implement the strategy it developed?
    Answer 3b. The workgroup is still in the process of formulating the 
implementation plan. The level of funding required will depend on the 
components of the final implementation plan.
      Response by Dr. McCance-Katz to Questions of Senator Cassidy
    Question 1. In the interim report from the Presidents Commission on 
Combating Drug Addiction and Opioid Crisis, the Commission called for 
an increase use of screening measures to identify patients at high risk 
for developing Substance Use Disorder (SUD). They also reference the 
CDC finding that 40 percent of patients with a SUD also have a mental 
health issue. Realizing there is large overlap between SUD and Mental 
Health Disorders, what are you prepared to do to identify the mental 
health issues in patients at a high risk for developing an SUD?
    Answer 1. SAMHSA collects and distributes the most comprehensive 
national and State data available over time on this issue through the 
National Survey on Drug Use and Health. In 2016, 43.2 percent of adults 
with a substance use disorder also met criteria for a mental illness. 
The high rate of co-occurrence of substance use disorders with mental 
illnesses argues for a comprehensive approach to intervention that 
identifies and evaluates each disorder concurrently and provides 
treatment as needed. This approach includes the need for broad 
screening and assessment tools that are less likely to result in a 
missed diagnosis. Accordingly, individuals entering treatment for 
mental illnesses should also be screened for addiction and vice versa. 
In response, SAMHSA has identified tools, such as the Alcohol Use 
Disorders Identification Test (AUDIT), the Mental Health Screening Form 
III, and the Beck Depression Inventory-II and is sharing these 
resources with states, providers, and others. SAMHSA is also committed 
to identifying people with, and at risk for, mental illness and 
addiction, and has identified tools for the screening and assessment of 
co-occurring disorders for those in the justice system, who are at 
elevated risk for both mental illness and addiction.
    SAMHSA was the lead Federal agency, along with NIDA and NIMH, that 
documented the prevalence, treatment, and unmet treatment needs of U.S. 
adults with mental health and substance use disorders in a recent 
publication, Prevalence, treatment, and unmet treatment needs of U.S. 
adults with mental health and substance use disorders (Han et al, 
2017). SAMHSA encourages the use of a core set of behavioral health 
measures and screening tools. These measures include screening and 
brief interventions for unhealthy alcohol use, tobacco use, 
prescription drug abuse, and depression. Integrating these behavioral 
health measures into standard medical practice will identify 
individuals at risk for these disorders. Providing preventive care 
through screening and early intervention can reduce the prevalence and 
healthcare costs associated with undiagnosed and untreated behavioral 
health disorders.
    SAMHSA's Screening, Brief Intervention and Referral to Treatment 
(SBIRT) program has recognized the role of co-morbidity since the 
inception of the SBIRT initiative and has encouraged grantees to 
include mental health (MH) screening as part of the regular substance 
use disorder screening and brief intervention for the past 11 years of 
the grant program. The grantees have been encouraged to utilize valid 
MH screening tools, such as the PHQ-2 and PHQ-9 when appropriate.
    The substantial co-occurrence of mental illness and addiction 
speaks to the importance of integrated care--both integration of 
behavioral health services into primary care and integration of 
physical healthcare into behavioral health services. SAMHSA has a 
program addressing each of these approaches to collaborative care in 
its Primary and Behavioral Health Care Integration program and the 
Section 223 of the Protecting Access to Medicare Act Certified 
Community Behavioral Health Clinic program, a State demonstration with 
enhanced Medicaid funding on which SAMHSA has partnered with CMS 
extensively. These programs also seek to link to primary care for those 
receiving services.

    Question 2. The CDC has found that less than half of the SUD 
patients with comorbid mental health issues have ever received 
treatment for their mental health issue. The Commission suggests this 
is due to lack of access, fear of shame and discrimination, and lack of 
motivation to seek treatment. Can you discuss with us how you plan on 
expanding access to programs and treatments and education/awareness to 
address the Commission's findings regarding patients with untreated 
mental health disorders?
    Answer 2. SAMHSA is working to address the comorbid mental health 
issues of individuals with an addiction in a number of our treatment 
grant programs. Below we have highlighted these efforts within two 
grant programs and some of SAMHSA's training and technical assistance 
programs.

    Programs
    Answer 2a. Section 223 of the Protecting Access to Medicare Act 
Certified Community Behavioral Health Clinic (CCBHC) program. This 2 
year demonstration program began on July 1, 2017 and involves eight 
states who are using SAMHSA developed criteria and a newly established 
CMS Prospective Payment System to increase access and provide quality 
mental and substance use treatment and recovery evidence-based 
practices for individuals with substance use and mental disorders. 
Treatment services for individuals with mental illness and/or addiction 
are integrated along with primary care screening in this demonstration 
program. Care coordination is a core service of this program, ensuring 
that people are connected to the services and treatment they need and 
that the community behavioral health clinic providing those services is 
accountable for that care. The national evaluation of the CCBHC 
demonstration is being managed by the HHS Office of the Assistant 
Secretary for Planning and Evaluation. The evaluation will examine how 
the demonstration impacts access to care; the scope of services 
provided; the quality of care; inpatient, emergency, and ambulatory 
service utilization; and how the prospective payment systems 
established by states cover the cost of care.

    Answer 2b. Promoting Integration of Primary and Behavioral Health 
Care grant program. In fiscal year 2017, three states received funding 
to provide integrated treatment services for individuals with mental 
illness and/or addiction in conjunction with primary care services in 
clinics within each state. Primary recipients of these services are 
individuals with addiction including opioid use, individuals with a 
serious mental illness, and those with both a mental illness and an 
addiction. Funding is used by the states to focus on increasing access 
and engagement in treatment for individuals with behavioral health 
conditions. Embedding addiction treatment within primary care at some 
clinics decreases the stigma of seeking services. Providing health 
education and wellness activities including nutrition, exercise, and 
smoking cessation are all part of the grant program.

    Training and Technical Assistance
    Answer 2b. The Center for Integrated Health Solutions (CIHS) is a 
national training and technical assistance center in the Center for 
Mental Health Services on the bi-directional integration of primary and 
behavioral health care and related workforce development. CIHS provides 
an array of training and technical assistance services to improve the 
effectiveness, efficiency, and sustainability of work to achieve the 
bi-directional integration of primary and behavioral health care to 
address the health care needs of individuals with mental illnesses, 
substance use, and co-occurring disorders. As a national resource, CIHS 
provides technical assistance for a national audience, as well as 
grantees in the Primary Care and Behavioral Health Integration (PBHCI) 
and Promoting Integration of Primary and Behavioral Health Care 
(PIPBHC) programs, Minority AIDS Initiative Continuum of Care (MAI CoC) 
grant programs, and entities funded through the Health Resources and 
Services Administration (HRSA), such as safety net providers and 
training and education programs. Two of the three states awarded PIPBHC 
grant funding are focusing their integration efforts on adults with 
mental illness and addiction including individuals using opiates. CIHS 
is providing technical assistance and training to these states and 
their grant funded clinics on implementing expanded integrated 
behavioral health and primary care treatment and supports to this 
population. In addition, CIHS directly and through its website, 
provides a wealth of information to the grantees and the Nation on 
multiple critical topics including, but not limited to, screening tools 
to identify mental illness and addiction, information on medication-
assisted treatment, SAMHSA's Opioid Overdose Prevention Toolkit, and 
the management of chronic pain which includes links to guidelines for 
prescribing.

    Answer 2c. SAMHSA's Providers' Clinical Support System-Medication 
Assisted Treatment (PCSS-MAT) is a national training and clinical 
mentoring project developed in response to the opioid use disorder 
crisis. The overarching goal of PCSS-MAT is to provide the most 
effective evidenced-based clinical practices in the prevention, 
identification, and treatment of opioid use disorders. The following 
are some modules specific to co-occurring disorders offered, at no 
cost, through PCSS-MAT: Primary Care Providers Working in Mental Health 
Settings; Managing Acute & Chronic Pain with Opioid Analgesics in 
Patients on Medication Assisted Treatment (MAT); and Integrated 
Management of Post-Traumatic Stress Disorder (PTSD) and Opioid Use 
Disorders.

    Answer 2d. The SAMHSA Addiction Technology Transfer Center (ATTC) 
Network program strives to improve the quality of addictions treatment 
and recovery services by facilitating alliances among front line 
counselors, treatment and recovery services agency administrators, 
faith-based organizations, policymakers, the health and mental health 
communities, consumers, and other provider organizations in order to 
improve the ability of health care workers to be able to screen and 
diagnose co-occurring disorders . In the new 5-year cycle that started 
on September 30th 2017, the expected outcome of the ATTC program is to 
increase the capacity of specialized behavioral and primary health care 
providers to provide high quality, effective services for clients with 
addiction and co-occurring disorders.

    Question 3. According to the Surescripts 2016 National Report, 98 
percent of pharmacies and more than 64 percent of prescribing 
clinicians have adopted e-prescribing technologies in their practice 
settings. When it comes to controlled substances, uptake of e-
prescribing is behind the curve, but growing rapidly in the last few 
years. Do you believe e-prescribing technologies can be further 
leveraged to provide prescription monitoring data around the Opioid 
crisis to healthcare providers, and patients at the point of care?
    Answer 3. Yes. For example, the 2016 Surescript report found that 
there was a significant increase in the volume of e-prescriptions for 
naloxone (25,143) across all three dosage formulations (including 
traditional syringe injection). Therefore, this could be an important 
component in addressing overdose prevention. As states move to real-
time uploads from the pharmacies to State prescription drug monitoring 
program (PDMP) data bases, e-prescribing of controlled drugs will 
increase timeliness and improve the accuracy of the prescription data, 
including proper identification of the patients in the state-controlled 
PDMP data base. Prescribers/pharmacists would have access to more 
reliable, up-to-date information to provide support in clinical 
judgment and to improve the quality of care for the patient. In 
addition, accurate identification of the patient helps prevent ``doctor 
shopping'' by a patient who may use multiple names and addresses.

    Question 4. A Journal of Opioid Management study suggested that 89 
percent of prescriptions written by hand deviated from ``best 
practice'' guidelines and were missing at least two forms of patient 
identification information. Could e-prescribing facilitate the creation 
of the type of whole, accurate and reliable information that would 
strengthen PDMPs?
    Answer 4. Yes, e-prescribing could increase the accuracy and 
reliability of information to the PDMPs, particularly with regard to 
the patient's address of record.
      Response by Dr. McCance-Katz to Questions of Senator Collins
    Question. Dr. McCance-Katz and Dr. Houry [or whole panel], 
according to SAMHSA, in 2014 an estimated 28,000 adolescents had used 
heroin in the past year and an estimated 16,000 were current heroin 
users. One part of addressing this epidemic is ensuring that younger 
generations are informed about the dangers of opioids. The Drug 
Enforcement Agency is working with partners to provide science-based 
information to children about the risks of opioids, such as through its 
``360 Strategy'' on heroin and opioids and ``Operation Prevention.'' 
Could you speak about collaboration between SAMSHA and CDC on these law 
enforcement initiatives, particularly with respect to reaching young 
people?
    Answer. SAMHSA manages the Drug Free Communities grant program for 
the Office of National Drug Control Policy. SAMHSA's Drug Free 
Communities and its Strategic Prevention Framework (SPF) grantees, 
including SPF for Prescription Drug grantees, often coordinates with 
the DEA on the local level to reach young people. Several of our grant 
award recipients are working with and attending the 360 Strategy 
sessions/summits across the country.
      Response by Dr. McCance-Katz to Questions of Senator Franken
    Question 1. It is anticipated that President Trump may declare the 
opioid crisis a national emergency as soon as this week. How will this 
emergency declaration affect the ways in which your agency is 
addressing the opioid epidemic in the United States? How will the 
declaration affect the way that individuals with opioid addiction 
receive treatment services across the United States? Many states 
including Alaska, Arizona, Florida, Virginia, Maryland, and 
Massachusetts have also declared their own state-wide disaster or 
emergency declarations. How will a Federal declaration build on these 
State efforts? From your perspective, is there a State response that 
stands out as particularly effective or innovative at reducing opioid 
misuse and addiction?
    Answer 1. Subsequent to the date of the hearing, on October 26, 
then Acting HHS Secretary Hargan signed a Public Health Emergency 
Declaration. The action allows, with the concurrence of the Drug 
Enforcement Administration, for expanded access to telemedicine 
services, with respect to designated persons, designated locations and 
designated drugs, including services involving remote prescribing of 
medicine commonly used for substance abuse or mental health treatment. 
It may also help overcome bureaucratic delays and inefficiencies in the 
hiring process, by allowing HHS to more quickly make temporary 
appointments of specialists with the tools and talent needed to respond 
effectively to our nation's ongoing public health emergency if the 
Department determines that such hiring is necessary and subject to the 
availability of funds for such hiring.

    Question 2. Research shows a strong connection between a person's 
health and stable housing, despite the fact that they are often treated 
as separate issues. I'm interested in how supportive housing-housing 
with social service supports-can help to address the opioid crisis, 
particularly in Indian Country where this epidemic has hit communities 
especially hard. I have heard from Native American leaders in Minnesota 
who have explained that stable housing not only removes the stress of 
where someone is going to sleep at night, but also helps people avoid 
unhealthy situations, reducing the risk of relapse. I asked you all 
about this issue during the hearing. What specific initiatives does 
your agency have underway to better understand the connection between 
health, housing, and substance use disorders, and what actions are you 
taking to incorporate supportive housing programs into your work to 
address the opioid epidemic? And what more is needed to develop these 
supportive housing programs further, especially in rural and other 
underserved areas?
    Answer. SAMHSA recognizes the value of recovery housing toward 
supporting an individual's recovery from addiction and promoting long-
term recovery. SAMHSA has sent a clear message to its grantees that 
recovery housing and other forms of recovery support services ought to 
be part of their equation for addressing the needs of those with opioid 
use disorders (OUDs). Many states have responded in kind, and others 
are planning activities next year. SAMHSA has informed states that the 
Substance Abuse Prevention and Treatment Block Grant and State Targeted 
Response to the Opioid Crisis Grant funds can be used for recovery 
housing as one component of a treatment plan when the individual is in 
treatment as long as a State judges that there is a need in their 
jurisdictions.
    SAMHSA is also providing technical assistance to recovery housing 
managers, and State and local communities engaged in the provision of 
access to, or management of, recovery or sober housing. This effort 
includes providing informational webinars, white papers, technical 
expert panels, and State policy academies on emerging best practices in 
the management and oversight of recovery housing, which are 
disseminated nationally. Moreover, SAMHSA is working with the National 
Alliance for Recovery Residences to develop a white paper on the use of 
recovery housing for those with OUDs who have been prescribed 
medication assisted treatment. In particular, rural and frontier areas, 
as well as Tribal Nations, have benefited from this work.
    Through SAMHSA's work with the U.S. Interagency Council on 
Homelessness, we collaborate with over 19 Federal agencies to design 
and implement strategies, and provide guidance on the efficient use of 
resources to end homelessness. In doing so, we engage with the 
Department of Housing and Urban Development (HUD) on technical 
assistance and program development activities as they relate to the 
housing components of our homeless programs. This includes requiring 
our grantees to develop linkages to HUD's Coordinated Entry System. We 
also engage HUD in policy discussion related to recovery housing.
      Response by Dr. McCance-Katz to Questions of Senator Hassan
    Question 1. In your view, what is the top action that your agency 
is not doing now that you think it should be doing to address the 
opioid epidemic?
    Answer 1. SAMHSA was pleased to see that the President's Commission 
on Combating Drug Addiction and the Opioid Crisis highlighted areas 
that are also a priority for HHS. HHS, in collaboration with the White 
House, is currently reviewing the recommendations and assessing actions 
that may be taken beyond those already underway in support of the 
Department's five point HHS Opioid Strategy.

    Question 2. In your view, what is the most promising emerging 
research that can help address the opioid epidemic?
    Answer 2. The most important recent research is that which 
underscores effective treatment of opioid use disorder (OUD). For 
example, a paper (Tanum, et. Al. 2017) published after the hearing in 
December 2017 shows that both injectable naltrexone and buprenorphine-
naloxone are effective in treatment of OUD. This is important because 
both of these medications can be prescribed by providers in the 
outpatient or office-based setting, and patients should have access to 
all medication assisted treatment options in determining what will be 
most effective for their recovery. A second publication (Strong et al.. 
2017) shows that those completing 28 day residential detoxification 
programs had higher death rates than program non-completers. This is 
very important in considering how to best provide care to individuals 
with OUD.

    Question 3. What is your and your agency's perspective on the 
recommendations from the president's bipartisan Commission on Combating 
Drug Addiction and the Opioid Crisis?
    Answer 3. SAMHSA was pleased to see that the President's Commission 
on Combating Drug Addiction and the Opioid Crisis highlighted areas 
that are also a priority for HHS. HHS is currently reviewing the 
recommendations and assessing actions that may be taken beyond those 
already underway in support of the Department's five point Opioid 
strategy. The Commission's recommendations could be grouped into eight 
or nine main areas, including expanding access to evidence-based 
addiction and overdose treatment, as well as better use and 
strengthening of public health surveillance data. We strongly support 
these goals and are working with the Department and the Administration 
to achieve the same ends. .

    Question 4. In order to control costs, insurance companies often 
require utilization practices like prior authorization or fail-first 
policies for medication assisted treatment. While these are important 
measures to control costs, they also can be barriers to access to 
treatment for patients. What are your views about utilization review 
practices in the context of opioid use disorder treatment, like 
medication assisted treatment?
    Answer 4. Research on the use of prior authorization requirements 
with psychiatric medications has revealed that prior authorization can 
reduce medication expenditures. However, these requirements also can 
have the unintended consequence of preventing proper and timely access 
to treatment. For example, these practices may deter providers from 
delivering care and patients from seeking it or remaining engaged in 
treatment. Thus, it is important that policies such as utilization 
review should be based on evidence and appropriate clinical criteria, 
not cost. In addition, ``fail-first'' protocols or similar non-
quantitative limitations to coverage, when applied to addiction 
services, but not to comparable medical-surgical services, are 
potentially Mental Health Parity and Addiction Equity Act violations 
and therefore may be violations of law.

    Question 5. How is SAMHSA working to ensure that the Substance Use 
Prevention and Treatment block grant is funding the most effective, 
evidence-based care? How is SAMHSA supporting block grant recipients to 
maximize the block grant's value in a State (for example, is SAMHSA 
helping states conduct needs assessments, program evaluations, and 
track patient outcomes)?
    Answer 5. The Substance Abuse Prevention and Treatment Block Grant 
(SABG) plans are carefully reviewed by SAMHSA to ensure states are 
adhering to requirements. By statute, the states submit annual plans 
detailing how they propose to comply with program requirements and 
reports describing expenditures of program funds and activities 
conducted. These plans and reports are reviewed by SAMHSA staff to 
ensure SABG funds are being spent appropriately. SAMHSA staff works 
with the states and jurisdictions to make any adjustments necessary to 
help ensure that the funding is providing the most effective, evidence-
based care based on community needs and resources available on the 
State and local levels. Prevention and treatment performance and 
outcome measures are reported annually by states and jurisdictions and 
are used to help improve services and assess the efficiency and 
effectiveness of funded activities.

    Question 6. A Boston Globe article from October 7th entitled 
``Young victims of opioid crisis pay high price'' explored the impact 
of opioid epidemic on children who have lost their parents to overdose 
and are now being raised by grandparents or are in the foster care 
system. Many of these children experienced severe trauma, and the full 
impact may not be realized until adulthood.
    A What resources and guidance does SAMHSA have available to help 
practitioners and families address the long-term mental health and 
developmental issues that may arise in children who witnessed a parent 
or loved one overdose or who have been displaced from their immediate 
families because of an opioid use disorder?
    Answer 6. SAMHSA and the Administration for Children and Families 
jointly fund the National Center on Substance Abuse and Child Welfare 
(NCSACW), a national resource center providing information, expert 
consultation, training and technical assistance to child welfare, 
dependency court, and substance abuse treatment professionals to 
improve the safety, permanency, well-being, and recovery outcomes for 
children, parents, and families. The NCSACW also provides webinars, 
assessment instruments, training and program toolkits, resource lists, 
and other publications.

    In addition, SAMHSA's National Child Traumatic Stress Initiative 
(NCTSI) raises awareness about the impact of trauma on children and 
adolescents as a behavioral health concern. NCTSI's goal is to 
transform mental health care for children and adolescents affected by 
trauma throughout the country by improving the quality of community-
based trauma treatment and services and increasing access to effective 
trauma-focused interventions. NCTSI develops and implements:

         Evidence-based interventions to reduce the mental 
        health impact of traumatic experiences on children and 
        adolescents
         Collaborations with all systems of care where children 
        and adolescents who have experienced trauma receive services
         Successful education and training approaches, 
        including training practitioners in trauma-informed and 
        evidence-based treatment and services
         Data collection and evaluation activities
         Education and awareness raising with policymakers 
        regarding trauma, resilience, and recovery
         Product development for professionals, policymakers, 
        families, youth, and the public
         Partnerships with youth, families, and other 
        consumers.

    Question 7. What resources and guidance does SAMHSA have available 
to caregivers, including grandparents and foster parents, who are now 
taking care of these traumatized children?
    Answer 7. Through SAMHSA's National Child Traumatic Stress 
Initiative, a range of resources have been developed to provide 
information and guidance to caregivers of children who have experienced 
traumatic events. Following is a list of resources for caregivers that 
have been created specifically for supporting child and family recovery 
in response to traumatic separation and grief, and substance abuse. 
Each is either hyperlinked or has the pdf link attached.
    Helping Young Children with Traumatic Grief: Tips for Caregivers
    This resource outlines the feelings of children struggling with the 
death of someone meaningful and what you can do to help.
    Helping School-Age Children with Traumatic Grief: Tips for 
Caregivers
    This resource explains the thinking of school-age children with 
traumatic grief and ways you can help.
    Helping Teens with Traumatic Grief: Tips for Caregiver
    This resource describes how teens may feel when struggling with the 
death of someone close and what caregivers can do to help.
    Guiding Adults in Talking with Children about Death and Attending 
Services
    This resource assists adults in talking to children about death and 
addresses issues around attending funeral or memorial services.
    National Child Traumatic Stress Network (NCTSN) Speaker Series: The 
Role of Trauma Among Families Struggling with Substance Abuse: http://
learn.nctsn.org/ course/ index.php?categoryid=46.
    In this series, members of the NCTSN Trauma and Substance Abuse 
Collaborative Group, as well as presenters with real-life experience, 
offer perspectives on the intersections between trauma, caregiver 
substance use, parenting, and pre-natal substance use exposure.

         Supporting Caregivers of Youth with Substance Use 
        Problems Affected by Trauma (2015)
         Opiate Exposed Newborns: Development, Assessment and 
        Treatment (2014)
         Prenatal Exposure to Substances and Trauma: Fostering 
        Parent and Child Well-being (2012)
         Understanding and Treating Caregiver Substance Abuse 
        and Trauma: A Focus on the Family (2012)

      Response by Dr. McCance-Katz to Questions of Senator Warren

    1. Understanding the Needs of Providers
    Earlier this year, I sent a survey to behavioral health providers 
across Massachusetts to improve my understanding of how those on the 
front lines are dealing with the opioid epidemic. Over 50 organizations 
responded to the ``Massachusetts Substance Use Disorder Treatment and 
Recovery Services Survey,'' and were able to provide insight into the 
services they provide and the challenges they face.
    In August, my office compiled the results of the survey and 
released a report, ``Fighting Back: Massachusetts Health Care Providers 
and the Opioid Crisis.''\1\ The report concluded that: (1) 
Massachusetts facilities that offer behavioral health services deliver 
affordable, high-quality care made possible by high rates of insurance 
coverage and access to treatment; (2) Massachusetts addiction treatment 
centers continue to face challenges in providing care, including long 
waiting lists, offering adequate referral services, hiring and 
retaining staff, and parity in behavioral health coverage; and (3) Many 
Massachusetts facilities rely on Federal financial support to carry out 
their critical work.
---------------------------------------------------------------------------
    \1\ ``Fighting Back: Massachusetts Health Care Providers and the 
Opioid Crisis,'' Office of Senator Elizabeth Warren (August 2017) 
(online at:https://www.warren.senate.gov/ files/ documents/ 20170824_ 
Opioid_Survey_Report.pdf).
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    Hearing directly from providers, as well as other stakeholders on 
the front lines like hospitals, first responders, community advocates, 
and other public health officials has been critical to informing my 
Senate work on the opioid crisis.
    Question 1a. Please describe any steps you have taken to 
communicate with behavioral health providers to learn more about their 
efforts to combat the opioid crisis and the challenges they face in 
providing quality addiction treatment.
    Answer 1a. The SAMHSA Regional Administrators (RAs) are in constant 
communication with substance use, mental health, and other providers, 
in order to discuss methods to combat the opioid crisis. Many of the 
RAs have joined advisory councils and Committees, presented at multiple 
conferences, chair opioid consultation teams, and work closely with 
local individual providers, hospitals, substance use prevention and 
treatment providers, and primary care providers in order to understand 
the challenges of the opioid crisis and to develop strategies to 
overcome some of these challenges.
    Some of the most common challenges include: 1) transforming the way 
pain is perceived, judged, and treated; 2) igniting community 
engagement in order to strengthen the response to the opioid epidemic; 
3) understanding of outcome measures for medication assisted treatment 
in primary care settings; 4) clarifying ``setting'' and ``level of 
care'' within various payment schemes to resolve operational and policy 
barriers to billing for emergency care, regardless of the status of the 
patient; 5) education of ``non-substance use providers'' such as 
dentists; and 6) addiction workforce barriers such as State reciprocity 
of licensing, lack of providers in rural areas, telehealth 
capabilities, and reimbursement.
    Question 1b. Please describe any steps you have taken to 
communicate with other public health stakeholders, including State 
Departments of Public Health, to learn more about their efforts to 
combat the opioid crisis and the challenges they face.
    Answer 1b. In order to combat the opioid crisis, the SAMHSA 
Regional Administrators have developed partnerships and Committees with 
stakeholders ranging from Single State Agencies, State Departments of 
Health, police departments, regional Offices of Minority Health, 
schools of medicine and dentistry, State Supreme Courts, and county-
based Opiate Task Forces. These stakeholder partnerships have helped 
states and counties to develop strategic plans, create new resources, 
change policies and develop new, effective programs. Some of the 
efforts to combat the opioid crisis include: (1) plans to increase the 
number of medication-assisted treatment (MAT) providers; (2) conducting 
policy academies to help support the regulation of MAT for patients 
with Opioid Use Disorder (OUD); (3) creating the ability to purchase 
naloxone in certain stores without a patient specific prescription; (4) 
widely disseminating resources to providers, agencies, states, and 
local communities; (5) the use of a Regional Office Opioid Field Manual 
developed as a model by which Federal regional offices can collaborate 
and work directly with state, tribal, and local communities to address 
the opioid crisis; and (6) developing criminal justice offender re-
entry programs that focus on opioid use issues.
    Some of the ongoing challenges include: (1) determining the best 
way to use MAT in drug courts and incorporate recovery-orientated 
systems of care; (2) locating resources and programs for overdose 
prevention; (3) the inability of emergency department physicians to 
find placement for individuals desiring treatment; (4) Drug Abuse 
Treatment Act-waivered prescribers' inability to initiate, expand, and 
sustain practices due to lack of availability of staff with training or 
experience in OUD treatment; and (5) data collection.
    In addition, SAMHSA staff discusses with State and local grantees 
their efforts to combat the opioid crisis and the challenges they face. 
For example, SAMHSA's Strategic Prevention Framework--Partnerships for 
Success, Strategic Prevention Framework for Prescription Drugs, and 
First Responder grantees are required to either develop or join an 
existing advisory council that collaborates/coordinates across State 
agencies to include State Departments of Health. These advisory 
councils allow for a collective voice in addressing the priority needs 
of the State around issues of substance use and abuse. Also, through 
ongoing communication with the Single State Authorities regarding the 
Substance Abuse Prevention and Treatment Block Grant, the Medication-
Assisted Treatment--Prescription Drug and Opioid Addiction program, and 
the State Targeted Response to the Opioid Crisis Grants (STR), SAMHSA 
maintains regular contact with State agencies regarding their efforts 
in combatting the opioid crisis. The focus of the contacts is to ensure 
that the states have adequate data to develop good plans and that 
appropriate evidence-based programs and services are included in the 
plans for the State grantees. In addition, SAMHSA staff work with the 
states to address any challenges they are facing in implementing their 
plans and provides training and technical assistance to address these 
issues.
    Finally, in August 2017, SAMHSA partnered with CMS and CDC to host 
a meeting for State teams that included State Medicaid officials, 
public health officials, and substance abuse authorities. The goal of 
the meeting was to bring together teams from each State that included 
State substance abuse authorities, Medicaid leadership, and other 
public health officials to develop comprehensive plans to address the 
opioid crisis that included all of the sources of funding available 
(both Federal and State dollars). The meeting was designed to support 
the states in learning effective strategies from each other and from 
national experts and to provide time for the State teams to meet and 
discuss strategy development. These plans were the foundation of the 
STR strategic plans that were submitted in September and also formed 
the basis of some State Medicaid waiver plans and work plans related to 
various state's opioid task forces.

    2. Safe Drug Disposal
    Safe drug disposal options are an important tool to help limit the 
volume of unused medications in circulation. Twice a year, the U.S. 
Drug Enforcement Agency holds National Prescription Drug Take Back 
Days, meant to help individuals dispose of unused medicines. 450 tons 
of drugs were disposed of in the last national take-back day in May.\2\ 
In September 2014, the DEA released the final rule on ``Disposal of 
Controlled Substances,''\3\ aimed at making it easier to for 
individuals to dispose of unused medicines and allow for more 
continuous collection opportunities. Over a year ago, Massachusetts 
announced its ``first statewide safe medication disposal program with 
Walgreens to fight substance misuse,''\4\ and today in Massachusetts, 
in addition to semi-annual national take-back days, there are a number 
of permanent kiosks where individuals can go to dispose of unused 
medications.\5\
---------------------------------------------------------------------------
    \2\ ``DEA Brings in Record Amount of Unused Prescription Drugs on 
National Prescription Take Back Day,'' U.S. Drug Enforcement 
Administration (May 8, 2017) (online at:https://www.dea.gov/ divisions/
hq/ 2017/ hq050817a.shtml).
    \3\ Federal Register, Vol. 79, No. 174 (September 9, 2014) (Online 
at: https://www.deadiversion.usdoj.gov /fed_regs/ rules/ 2014/2014-
20926.pdf).
    \4\ ``Baker-Polito Administration Announces First statewide Safe 
Medication Disposal Program with Walgreens to Fight Substance Misuse,'' 
The Official Website of the Governor of Massachusetts (September 7, 
2017) (online at: http://www.mass.gov/Governor/ press-office/press-
releases/ fy2017/ statewide-safe-medication-disposal-program-
launched.html).
    \5\ ``Safely Dispose of Prescription Drugs,'' Mass.gov (online at: 
https://www.mass.gov/safely dispose-of-prescription-drugs)
---------------------------------------------------------------------------
    In its efforts to reduce the volume of unused medications in 
circulation, what can SAMHSA do to raise awareness about these safe 
drug disposal opportunities?
    Answer 2. SAMHSA promotes safe drug disposal opportunities (e.g., 
DEA's National Drug Take Back Day events) via all of its communications 
channels, such as social media posts and e-blasts, direct communication 
with grantees and national organizations, and dissemination of this 
strategy in its public information products (e.g., Rx Pain Medications. 
Know the Options. Get the Facts.).

    3. Maternal Mental Health & Opioids
    In August, the Massachusetts Executive Office of Health and Human 
Services released a report on opioid overdoses that revealed that 
``mothers with [opioid use disorder] had a significantly higher co-
occurrence of mental health diagnoses.'' They also found that ``Rates 
of opioid-related overdose decrease during pregnancy and are lowest 
during the second and third trimesters, but significantly increase in 
the postpartum period, with the highest rates 6 month-one year after 
delivery.''\6\ The National Institute of Mental Health has acknowledged 
that ``drug abuse problems'' were a risk factor for postpartum 
depression,\7\ and the CDC has shown that ``1 in 9 women experiences 
postpartum depression.''\8\ In an effort to address a lack of screening 
tools for postpartum depression, a provision was included in the 21st 
Century Cures Act that created a grant program to support screening of 
postpartum depression services \9\--but moms are not yet routinely 
screened.
---------------------------------------------------------------------------
    \6\ ``An Assessment of Fatal and Nonfatal Opioid Overdoses in 
Massachusetts (2011-2015),'' Massachusetts Department of Public Health, 
55-57 (August 2017) (online at: http://www.mass.gov/ eohhs/docs/dph/
stop-addiction/ legislative-report-chapter-55-aug-2017.pdf.
    \7\ ``Postpartum Depression Facts,'' National Institutes of Mental 
Health (online at: https://www.nimh.nih.gov/ health/ publications/ 
postpartum-depression-facts/ index.shtml) (accessed October 25, 2017).
    \8\ ``Depression Among Women,'' Centers for Disease Control and 
Prevention (online at: https://www.cdc.gov/ reproductivehealth/ 
depression/index.htm) (accessed October 25, 2017)..
    \9\  See Sec. 10005: 21st Century Cures Act (online at: https://
www.Congress.gov/114/plaws/publ255/PLAW-114publ255.pdf).
---------------------------------------------------------------------------
    Question 3a. Does SAMHSA's work to support pregnant and postpartum 
mother with opioid use disorder include screening women for perinatal 
depression? If so, what diagnostic tool is being used and how is this 
tool typically being administered?
    Answer 3a. Yes, SAMHSA's Pregnant and Postpartum Women (PPW) 
grantees are required to screen and assess clients for the presence of 
co-occurring addiction, depression, anxiety, and other mental 
disorders, as well as trauma. The PPW Program does not collect 
information on the diagnostic tools used.
    Question 3b. Does SAMHSA collect dual diagnosis data on substance 
use and maternal mental health for the pregnant and postpartum opioid 
user population?
    Answer 3b. PPW program grantees are required to collect the 
following information related to dual diagnosis.
    Was the client screened by your program for co-occurring mental 
health and substance use disorders?
    [IF YES] Did the client screen positive for co-occurring mental 
health and substance use disorders?
    Response by Dr. McCance-Katz to Questions of Senator Whitehouse
    Question 1. The 21st Century Cures Act authorized $1 billion over 2 
years to support efforts to combat the opioid epidemic. The second half 
of that money is expected to be made available as part of the fiscal 
year 2018 appropriations bill. Though I was pleased to see the first 
$500 million get out to states quickly, I think we can improve how the 
next $500 million is used and allocated.
    First, we could allow grant makers approving applications for these 
funds to consider whether the proposed uses of this funding are aligned 
with the goals of the Comprehensive Addiction and Recovery Act (CARA). 
Second, in evaluating applications for this funding, more consideration 
could be given to states most affected by the epidemic. Do you support 
aligning the uses of the next tranche of 21st Century Cures Act opioid 
funding with the best practices set forth in CARA and/or prioritizing 
funding to states most affected by the opioid epidemic?
    Answer 1. The funding opportunity announcement (FOA) for the State 
Targeted Response to the Opioid Crisis Grants (STR) is consistent with 
the goals of its authorizing statute, the 21st Century Cures Act. The 
program aims to address the needs of individuals with opioid use 
disorders through the provision of evidence-based prevention, 
treatment, and recovery support services.
    Subsequent to the date of the hearing, on October 30, 2017, 
notification was sent to all Governors indicating that the funding 
allocation for the program will remain the same as it was in the first 
year of the program. Specifically, the letter stated, ``[a]lthough 
there are some new data that could be factored into the funding 
formula, we have heard from many states that changing the formula at 
this juncture could potentially disrupt services and slow states' 
progress in addressing this crisis. Therefore, we have decided that the 
funding allocation formula for the second year of the grant program 
will remain the same as the first year.'' The letter also notes that 
SAMHSA will be working closely with states/territories to ensure the 
provision of evidence-based practices.
    At the same time, states are using STR funds in ways that align 
with the best practices set forth in CARA. For example, Kentucky is 
working with three hospitals in its highest-risk urban regions to 
implement an emergency department (ED) intervention that includes a 
Bridge Clinic and peer support specialist. Individuals who present to 
an ED after an opioid overdose will be provided the opportunity to 
initiate treatment, including medication assisted treatment induction, 
at the ED or in close proximity at a Bridge Clinic. In addition, the 
coordinated response team administers screening tools and refers 
willing and eligible patients for a full clinical assessment by 
practitioners with expertise in addiction assessment and treatment. 
Peer Support Specialists and other staff follow-up with patients post 
ED discharge as part of an assertive engagement effort. Also, 
Massachusetts is using their existing recovery-oriented systems of care 
(ROSC) framework to support comprehensive, coordinated ``wrap-around'' 
services for individuals by building connections throughout its entire 
prevention, treatment and recovery service system with the goal of 
addressing opioid misuse, abuse and overdose that will evolve over 
time.

    2. As you know, prescription drug monitoring programs (PDMPs) are 
helpful tools in identifying potential opioid abuse and educating 
prescribers, but there is room for improvement. Technical and legal 
barriers continue to limit interstate information sharing among PDMPs 
and the integration of PDMP information into electronic health records 
and pharmacy systems. And there isn't consensus on the amount of access 
law enforcement agencies should have to PDMPs.
    Question 2a. What are SAMHSA and CDC doing to improve the ability 
of PDMPs to exchange information across State lines and to integrate 
information into providers' and pharmacists' health IT systems? What 
resources are your agencies using to support that work?
    Answer 2a. SAMHSA has awarded 25 Strategic Prevention Framework for 
Prescription Drugs grants to states and tribal organizations to develop 
capacity and expertise in the use of data from State run prescription 
drug monitoring programs (PDMPs). These awards fund State grantees to 
utilize PDMP and epidemiological (EPI) data to target prevention 
programming in high prevalence areas in the State or tribe. PDMP and 
EPI data are used to develop a community-level response to their 
identified substance use issues. Grantees are encouraged to expand 
efforts across State lines where relevant and associated laws permit. 
SAMHSA technical assistance and education initiatives describe PDMPs 
and encourage their use by providers as a best practice.
    We strongly urge every State to work together toward interoperable 
PDMP as quickly as possible.

    Question 2b. Are there best practices for access to and the use of 
PDMP information by law enforcement agencies? If not, does SAMHSA or 
CDC plan to work with stakeholders to develop best practices on access 
and use of PDMP information by law enforcement?
    Answer 2b. SAMHSA supports ensuring that public health and law 
enforcement agencies use best practices for access to and use of the 
PDMP information. CDC continues PDMP work under the agency's Overdose 
Prevention in States (OPIS) effort.

    Question 3. Do regulations limiting the disclosure of patient 
records related to the diagnosis and treatment of substance use 
disorders impede access to treatment? What are the best practices for 
notifying parents of a patient who recently experienced an overdose 
that an overdose has occurred? Does HIPAA prohibit such notification?
    Answer 3. The Federal regulations at 42 C.F.R. Part 2 (Part 2) 
allow substance use disorder (SUD) patient information to be shared 
among providers in certain circumstances. For example, a patient can 
give written consent to authorize the sharing of his or her SUD 
treatment record with any treating provider. Part 2 typically does not 
apply to entire hospitals, emergency rooms (ER)/departments, or trauma 
centers. Accordingly, Part 2 is not an impediment to the sharing of SUD 
treatment records among providers in these settings, where the HIPAA 
Privacy Rule would continue to apply.
    With regard to general medical facilities or staff within such 
facilities, Part 2 applies only to an identified unit in the facility 
that provides SUD services, or to staff within the facility whose 
primary function is the provision of SUD services. When Part 2 applies, 
it allows sharing without a patient's consent in medical emergencies, 
such as opioid overdoses. The determination of whether a medical 
emergency exists is made by the treating/disclosing provider. 
Information disclosed by a Part 2 program during a medical emergency 
can be further shared with medical providers as needed in order to 
diagnose or treat the patient during the emergency.
    HHS' Office for Civil Rights has jurisdiction over HIPAA and 
recently released guidance related to whether and how health care 
providers can disclose protected health information to the family or 
friends of a patient who recently experienced an overdose. The guidance 
can be found at: https://www.hhs.gov/sites/default/files/hipaa-opioid-
crisis.pdf.
    At the same time, there are statutory limitations related to 
sharing protected SUD patient information absent written consent, and 
the exceptions to the consent requirements are limited. The statute has 
been an impediment to sharing addiction records in care coordination 
settings. Within the constraints of the statute, SAMHSA has been 
working diligently to issue clarifications and education providers 
about what information sharing is permissible under both the statute 
and the regulation.
    As required by the 21st Century Cures Act (section 11002), SAMHSA 
held a public meeting on January 31, 2018, to obtain input about the 
impact of Part 2 on ``patient care, health outcomes, and patient 
privacy.'' The information gathered during this Part 2 public meeting 
can help policymakers better assess what changes can and should be made 
under current regulations or whether statutory changes are required to 
accomplish such objectives.

    Question 4. As you know, Rhode Island's innovative peer recovery 
coach program, AnchorED, has now been replicated by a number of states. 
Please summarize the current funding mechanisms at SAMHSA that can be 
used to support the training, certification, and hiring of peer 
recovery coaches.
    Answer 4. Currently, SAMHSA funds several grant programs through 
which peers can be hired by Recovery Community Organizations (RCOs) 
like Anchor Recovery Community Centers to be trained in/on, such as: 
(1) the Targeted Capacity Expansion--Peer-to-Peer program; (2) the 
CARA-funded Building Communities of Recovery; (3) Medication-Assisted 
Treatment--Prescription Drug and Opioid Addiction; and (4) State 
Targeted Response to the Opioid Crisis (STR) grant programs. In 
addition, under the Substance Abuse Prevention and Treatment Block 
Grant authorization, states and jurisdictions have the flexibility to 
use funds for peer support services and professional development such 
as pre-employment education and post-employment training. Responsive to 
the needs of those with addiction and the national opioid epidemic, 
many grantees have begun using SAMHSA grant dollars, and SAMHSA-funded 
technical assistance to implement peer-based interventions in hospital 
emergency departments (EDs) within their own communities modeled after 
the AnchorED program. In addition, the Opioid STR grant program 
requires states to include recovery supports as part of the plan to 
address opioid use disorders and most states are supporting peer 
services to provide those recovery supports.
    SAMHSA continues to provide technical support to states through 
policy academies, many of which have been supported to develop a peer 
recovery certification program and attendant training curricula. Over 
the course of the last several years, 41 states have developed a peer 
recovery certification, in large part because of this work. RCOs and 
other community-based organizations (e.g. Family Heroin Coalitions) 
continue to hire peer recovery coaches to assist those who may be 
pursuing recovery in the absence of treatment or before, during and 
after treatment at community-based RCOs.

       Response by Dr. McCance-Katz to Questions of Senator Young

    Question 1. Some researchers have found that it takes an average of 
17 years for research evidence to reach clinical practice. How are you 
all working together to ensure our best practices actually reach the 
patient in a reasonable amount of time? Are you working with medical 
associations and boards to ensure that best practices are translated 
into clinical practice? What can be done at the Federal level to speed 
up this research to practice pipeline?
    Answer 1. SAMHSA works collaboratively with NIH to follow best 
practice development. In addition, SAMHSA promulgates best practices, 
treatment guidelines, and evidenced-based approaches adopted by the 
major stakeholder groups (e.g., American Society of Addiction Medicine 
and the American Psychiatric Association). SAMHSA monitors grantees to 
assist them with implementation of evidence-based practices.
    SAMHSA is also in the process of strengthening its evaluation 
efforts to be better positioned to identify best practices in its 
discretionary grant programs. SAMHSA's Center for Behavioral Health 
Statistics and Quality (CBHSQ) is transitioning with the formation of a 
centralized evaluation office, which will oversee program evaluations 
across the Agency. CBHSQ also adopted a policy of posting results from 
all significant program evaluations on SAMHSA's publicly available 
website. SAMHSA evaluation policy now requires either an executive 
summary or a full report be posted for all significant evaluations at 
the end of an evaluation contract. This effort will help to ensure that 
evaluation findings, including best practices, are shared with the 
field and the public in a timely manner.
    Finally, SAMHSA's National Mental Health and Substance Use Policy 
Lab taken over the identification of, and responsibility for, posting 
evidence-based programs and practices. SAMHSA expects that the new 
website for this information will be online soon. In the meantime, the 
National Registry of Evidence-based Programs and Practices remains 
available should an organization wish to use it.

    Question 2. Too many unused opioids dangerously remain in medicine 
cabinets throughout America. They pose a real threat to health and 
safety-especially to young Americans. Will drug take back programs be a 
component of our government's response to this national emergency?
    Answer 2. Yes. Proper medication disposal provides a safe way for 
people to get rid of prescription drugs kept in their homes. Take-back 
programs, a popular proper medication disposal strategy, provide 
avenues to reduce the supply available for diversion. SAMHSA will 
continue to assist with informing American communities about drug take 
back days led by the Drug Enforcement Administration.

    Question 3. While increasing access to treatment is important, we 
also need to make sure people in treatment are receiving services that 
really work. What current treatments and outreach strategies have been 
proven through rigorous evaluation to work best? Do we need more 
research and innovation in this area?
    Answer 3. Medication-assisted treatment (MAT) in the context of 
psychosocial services, such as counseling, has proved to be clinically 
effective in treatment of opioid use disorder (OUD).
    The ultimate goal of these services is full recovery, which 
includes the ability to live a self-directed life and can include long-
term or even life-long medication to support recovery. This treatment 
approach has been shown to:
         Improve patient survival;
         Increase retention in treatment;
         Decrease illicit opiate use and other criminal 
        activity among people with addiction;
         Increase patients' ability to gain and maintain 
        employment; and
         Improve birth outcomes among women who have addiction 
        and are pregnant.
    Research also shows that these medications and therapies can 
contribute to lowering a person's risk of contracting HIV or hepatitis 
C by reducing high risk practices such as injection drug use.
    We need to use approaches to treat OUD shown to be effective 
including comprehensive MAT, which includes a combination of medication 
and psychosocial services, as well as recovery supports.

    Question 4. Sec. 303 of the Comprehensive Addiction and Recovery 
Act (CARA) requires that all office-based providers of addiction 
treatment have ``the capacity to provide directly, by referral, or in 
such other manner as determined by the [HHS] Secretary all drugs 
approved by the [FDA] for the treatment of opioid use disorder...and 
appropriate counseling and other appropriate ancillary services.'' What 
has been SAMHSA's role in implementing this particular statute in CARA? 
What is the current status for its full implementation?
    Answer 4. SAMHSA convened a meeting of training organizations in 
September 2016 to review the required elements of the Drug Abuse 
Treatment Act waiver training, based on CARA. All of the organizations 
who are allowed by statute to provide this training were invited to 
participate in that meeting, and all that participated agreed to a 
curriculum plan and set of learning objectives to meet the changes to 
the curriculum required by CARA. In July 2017, SAMHSA released a 24-
hour MAT waiver course (an 8-hour and 16-hour component) for Nurse 
Practitioners and Physicians Assistants. It is a fully online course 
that will fulfil the 24-hour requirement established in CARA. The 8-
hour component of the 24-hour MAT waiver course training is currently 
under revision. This curriculum includes information on all medications 
approved by FDA for the treatment of OUD, as well as information on the 
use of psychosocial interventions to support recovery as well.

    [Whereupon, at 12:52 p.m., the hearing was adjourned.]

                                 [all]