[Senate Hearing 115-636]
[From the U.S. Government Publishing Office]
S. Hrg. 115-636
THE FEDERAL RESPONSE TO THE OPIOID CRISIS
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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
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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
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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
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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?
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\3\ https://www.fda.gov/downloads/Drugs/
GuidanceComplianceRegulatoryInformation/Guidances/UCM510153.pdf.
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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?
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\4\ https://www.fda.gov/downloads/Drugs/
GuidanceComplianceRegulatoryInformation/Guidances/UCM469122.pdf.
\5\ https://www.fda.gov/downloads/Drugs/
GuidanceComplianceRegulatoryInformation/Guidances/UCM469122.pdf.
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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
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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.
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\7\ https://www.deadiversion.usdoj.gov/ pubs/ manuals/ pract/
practmanual012508.pdf.
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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:
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\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/).
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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\
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\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\
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\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\
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\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.
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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
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
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\
---------------------------------------------------------------------------
\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\
---------------------------------------------------------------------------
\12\ https:// projectreporter.nih.gov/ project_ info
_description.cfm?aid= 9513197&icde= 36846207& ddparam=&ddvalue=
&ddsub=&cr= 1&csb=default&cs=ASC&pball=.
---------------------------------------------------------------------------
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=.
---------------------------------------------------------------------------
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\
---------------------------------------------------------------------------
\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:
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\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\
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\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
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\23\ https://projectreporter.nih.gov/
project_info_description.cfm?aid=
9231408&icde=36846571&ddparam=&ddvalue=&ddsub=&cr=1&csb=
default&cs=ASC&pball=T1.
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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.
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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\
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\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\
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\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/).
---------------------------------------------------------------------------
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\
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\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).
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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\
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\45\ https://www.acog.org/-/media/Committee-Opinions/Committee-on-
Obstetric-Practice/co630.pdf?dmc=1&ts=20171109T1840330384
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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\
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\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.
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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.
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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.
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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.
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Effects of Cannabis Use and Cannabinoids on the
Developing Brain \55\
---------------------------------------------------------------------------
\55\ https://grants.nih.gov/grants/ guide/pa-files/PA-14-162.html
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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\
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\59\ https://report.nih.gov/
categorical_spending_project_listing.aspx?
FY=2016&ARRA=N&DCat=Cannabinoid%20Research.
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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.
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\60\ https://report.nih.gov/
categorical_spending_project_listing.aspx?FY=2016&ARRA=N&DCat=Cannabinoi
d %20Research
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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:
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\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.
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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
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An observational study of the effects of edible
cannabis and its constituent cannabinoids on pain,
inflammation, and cognition.\64\
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\64\ https://projectreporter.nih.gov/ project_
info_description.cfm?icde= 0&aid=9361825
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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.
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Cannabinoid based therapeutics for pain in sickle cell
disease.\66\
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\66\ https:// projectreporter.nih.gov/project_ info_ description.
cfm?icde=0&aid=9301005.
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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
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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\
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\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.
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Studies of the therapeutic effects of cannabis and
cannabinoids on HIV-related pain.\69\
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\69\ https://projectreporter.nih.gov/
project_info_description.cfm?icde=0&aid=9271603.
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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.
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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.
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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.
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\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\
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\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)
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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.
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\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).
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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]