[Congressional Record Volume 163, Number 80 (Tuesday, May 9, 2017)]
[Senate]
[Pages S2833-S2841]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]
Drug Epidemic
Mr. PORTMAN. Mr. President, I rise today to continue a discussion we
have had on the floor over the last year or so on the issue of
opioids--that would be addiction to heroin, prescription drugs, and now
this new form of synthetic heroin coming into our communities called
fentanyl or carfentanil.
Sadly, I must say that things are not getting better. In fact, in the
States we represent, in our communities, we see more and more evidence
of not just addiction but overdoses and deaths. Fentanyl, in
particular, is more deadly than heroin--30 to 50 times more powerful--
and is resulting in not just more overdoses but more deaths per
overdose. This has become a crisis to the point that it is the No. 1
cause of death in my home State of Ohio and across the country,
surpassing car accidents.
This is the 35th time I have come to the floor to talk about this
issue and what we ought to do. We have made progress. In the last year
alone, we passed legislation, including the Comprehensive Addiction and
Recovery Act, to help with prevention, treatment, and recovery, and to
help our law enforcement and other first responders, with Narcan, be
able to reduce the number of deaths--this miracle drug that reverses
the overdoses--to be able to save lives.
We also passed the Cures legislation, which sent money straight back
to the States that would help to provide the treatment that is so badly
needed. Probably 8 out of 10 people who are addicted are not receiving
treatment. Sadly, there is a revolving door where people are coming
under the grip of this addiction, committing crimes, going to prison,
getting out, getting into the addiction again, and going back into the
criminal justice system once again.
This legislation we passed is now starting to be implemented. It
takes a little while for things to get moving around here. I am happy
to say that the States have now received some of this funding. Some of
the programs--about half of those in the Comprehensive Addiction and
Recovery Act are now implemented. I urge the administration to
implement the other half of the programs, and I have done that every
time I have come to the floor over the last few months.
Unfortunately, I also have to come to the floor today to talk about
something that is going to make it harder to address this issue should
it become reality. As some of you may know, recently it was reported
that there was a document from the White House Office of Management and
Budget saying that the White House is considering cutting funding
dramatically for the Office of National Drug Control Policy, the ONDCP.
This is the office that coordinates the drug issue for the White House,
the administration. The proposal that was leaked to the media said that
it would be a cut from $388 million a year to $24 million a year. That
is a cut of 95 percent. What does that mean? It means the staff would
be, obviously, reduced dramatically. They have 33 people who would lose
their jobs, people who are out there every day on the frontlines,
trying to use a relatively small number of people to expand this effort
all over the country. It would eliminate a lot of grant programs,
office administrators, including what is called the High Intensity Drug
Trafficking Areas Program, or HIDTA, and a program called the Drug-Free
Communities Support Program.
I want to touch on those two programs quickly and make the point as
to how important they are, hoping that the administration is hearing us
and hoping my colleagues on both sides of the aisle will help us ensure
that this proposal does not become reality, that we don't end up, at a
time when we have an unprecedented drug crisis in this country--the
worst drug epidemic we have had in our lifetime--pulling back on these
important programs.
Why does this matter? Again, having a drug czar, which is what the
Director of the Office of National Drug Policy is called, is very
important to coordinate the efforts. In fact, it is cost-effective to
have a drug czar rather than having different agencies and departments
competing and sometimes in duplication with each other, to have one
person in the White House in charge, talking about the importance of
this.
President Ronald Reagan and First Lady Nancy Reagan established the
drug czar. The reason they did it was they wanted to be sure America
and the White House were speaking with one voice on this issue. I have
known every drug czar since then. I have known every one of them over
the last--what would that be?--30 years. I think it is incredibly
important to have this job filled with the right person to get out
there and deliver this message that it is important that we work
together on prevention and education to try to keep people out of drugs
altogether, and should people become addicted, how do we maximize the
chances of their success by getting them into treatment and recovery?
The program I mentioned a minute ago, the High Intensity Drug
Trafficking Areas Program, is one that pretty much every Senator knows
about. Why? Because in pockets of every State, there are areas in which
there is a particular problem with drugs. This program, the High
Intensity Drug Trafficking Areas Program, does something unique. It
says: OK, we
[[Page S2834]]
are going to put Federal law enforcement together with State law
enforcement and local law enforcement to intensely focus on this issue
at the local level. As you know, that is necessary because so much of
this is interstate, even international, and by having this intense
focus, there has been enormous success in my State and States around
the country.
Under the program, you have to have one full-time law enforcement
officer at the Federal level, State level, and the local level. What I
have found back home is that typically you have a sheriff or a police
chief who runs this locally and has a lot of his officers involved but
really is able to maximize what he or she can do because you have this
involvement from the State highway patrol, you have this involvement
from the FBI, you have this coordination.
The Ohio HIDTA alone has removed $90 million worth of illicit drugs
from our streets. It has apprehended more than 4,000 fugitives involved
in drug trafficking operations. Think about the difference that makes.
It makes our communities safer; ultimately, of course, it is going to
save a lot of lives.
So I think this is one that is really working. If you ask your law
enforcement locally about it, they will tell you that if they don't
have a HIDTA grant, they probably wish they did. It is very
competitive; not everyone can get one. But if you can show that you can
use the money effectively and if you have a really serious drug problem
in your area, having that HIDTA program is important.
The second program I mentioned is called the Drug-Free Communities
Support Program. What does this do? This supports community anti-drug
coalitions all around the country. Often, people ask me: What is the
solution to this problem? Why are we in the situation we are in? I turn
to prevention and education because, if you think about it, once you
get into that funnel of addiction, it is very costly and very
difficult.
Wouldn't it be better if we had better programs out there? Frankly,
we did back in the 1980s and even the 1990s--to tell young people and
to tell others why it is such a mistake to get into this drug issue,
why they must do everything they can to avoid, in the case of heroin
and prescription drugs and other opioids, taking these painkillers,
these prescription drugs that are addictive, to the point that you
become addicted, which is so often where the heroin addiction and the
overdoses start.
Four out of five heroin addicts in the country started with
prescription drugs, they say. Getting that information out there, that
awareness, is incredibly important. That is what this Drug-Free
Communities Program is about.
I got involved in this program early on through a personal
experience. I was a first-year Member of the House of Representatives
23 years ago. A woman whose son had died of an overdose came to see me.
She came to see me because she wanted to talk about her experience and
what were we going to do about it.
At the time, Bill Clinton was President. I went to an event where
both President Clinton and I were given a gold ID bracelet by a young
man. The young man's name was Jeffrey Gardner. I put Jeffrey Gardner's
ID bracelet on, and then I prepared for my meeting with this mother,
who was obviously very upset.
She was there with her younger son. She came to my office. I was
prepared for her. My staff had done all the research, and we knew there
was about $15 billion a year being spent on drug interdiction,
interdicting drugs coming from other countries, incarcerations and
prosecutions, and the eradication of drugs overseas in places like
Colombia, where a lot of cocaine was being grown at that time. So I
told her that. I said: Your tax dollars are being used well to fight
this battle. This is what is happening with your dollars.
She looked at me and said: How does that help me? She said: I went to
my church. I went to my school to get them to help, to mobilize people,
to provide more prevention and education resources, to get the word
out. They were in denial. They said: This does not happen here.
She said: I went to my neighbors and tried to get a community meeting
together, and people did not show up.
She said: How does interdicting drugs help me? How does the work on
eradication overseas help me?
I did more research and looked into it further and talked to people
around the country who were experts on this and found out where there
was this community-of-support network, bringing in all sectors of the
community. It really made a difference to reduce drug abuse.
So we started this program. This program, the Drug-Free Communities
Act, has to be made up of all sectors of the community. We are talking
about the religious community, faith leaders--very important--but also
teachers, police officers, parents, doctors, other community leaders
who come together with this intense focus on education and prevention.
The program we put together has real accountability. You know, I am a
Republican. I believe in accountability. I want to be sure tax dollars
are being used wisely. To receive funding under this program,
coalitions are required to be in existence for 6 months before they can
even apply--get on their feet, be sure they are working. It is the only
Federal drug abuse prevention program that requires that, by the way.
The coalition is required to go through a year-long training academy
to ensure they have the skills necessary to effectively reduce drug
rates, and they have to have data to show that their efforts are
actually working. There have to be performance measures in place. In
these coalitions, there are surveys done in schools to see what the
results are.
These coalitions are made up of people who are on the front lines.
They know their communities better than anybody else does. That is why
they are more effective than anybody else. They know how to reach
people in that setting, know how to respond quickly when problems
begin.
In communities with these coalitions, use of alcohol, tobacco,
prescription drugs, marijuana, and cocaine by our young people have
declined: alcohol, 32-percent decline; tobacco, 38-percent decline;
other drugs, including prescription drugs, 21-percent decline. So these
things work.
I must say, I have seen it firsthand because, before drafting the
legislation, I started my own coalition called the Coalition for a
Drug-Free Greater Cincinnati. Twenty-three years ago, we started this
coalition, and we did it with, again, all members of the community.
In my case, I reached out to the first lady, Hope Taft of our State;
also to a religious leader in our community, Damon Lynch, Jr., one of
the most respected community leaders and at that time head of the
Baptist Ministers Conference; and the former CEO of Procter & Gamble,
John Petter, so we brought in the business community as well.
We established this coalition not thinking that we were going to end
up applying for Federal grant money because there was no Federal grant
program then, but that we would focus on how to ensure we could
actually make a difference. We set up a survey that went to two-thirds
of the schools in our community and asked questions about drug use, so
we would know if our efforts were working or not working, as the case
might be, and how to target our efforts toward parents and teachers. We
spent a lot of time in the faith community, but also with coaches and
athletic directors.
This program is still going. It is called Prevention First. I chaired
it for 9 years. I was on the board of the coalition again before I ran
for the Senate. I know it works because I have seen it. We have gotten
good results. The coalition tells me that since 2000, alcohol use among
young people they worked with in Cincinnati has gone down 46 percent;
tobacco use, 61 percent; marijuana use, 22 percent.
Since 2012, which is when we started focusing on the prescription
drug issue, there has been a decline by 29 percent in the use of
prescription drugs by our young people. So, I think, this program,
which by the way, cost about 90 million bucks last year--as someone who
was a distinguished military officer told me recently: That is about
what we charge to keep the lights on in part of the Pentagon every day,
not that I am not for more and smarter defense spending; I am, but $90
million is
[[Page S2835]]
what we are talking about for this program during the time of the worst
drug crisis in the history of our country.
I just think this impact, which I have seen, really works. It means
less crime, less strain on our healthcare system, more productivity in
school, more productivity at work, more people who can pass a drug test
and go to work. That benefits all of us, and it saves taxpayer dollars.
The success we had in this coalition, again, led me to the
legislation. A Democratic Representative from Michigan, Sandy Levin,
and I introduced the legislation, bipartisan in the House.
Here in the Senate, the leaders who were the leaders of this
legislation are still here and continue to support it; that is, Senator
Chuck Grassley and Senator Patrick Leahy--again a bipartisan group. The
bill, the Drug-Free Communities Act, is, again, based on these lead
documents from the administration, one of the programs they have
proposed defunding altogether.
I am hopeful that this legislation, the Drug-Free Communities Act,
which has really worked--it has provided funding that has spawned over
2,000 community coalitions around the country. Today, it currently
mobilizes 9,000 community volunteers all around the country. I am
hopeful that we will not be defunding this program but, instead,
focusing more on the issues of prevention and education. That is going
to be the long-term solution to this drug problem. Yes, we have to get
treatment to those who need it, but if we are not working on prevention
and awareness and education, the issues of drug addiction and drug
abuse are going to continue to get worse, in my view.
I am a former Budget Director. I understand it is a tough job to look
at all the different competing priorities when you are trying to save
taxpayer dollars. I get that. But I also get that we don't want to take
a program like this that is actually working, that has all of these
accountability measures in place to be sure that taxpayer dollars are
being spent right, and then get rid of it at a time that we have this
growing crisis in our country.
When I first got involved in this issue 22 years ago, I became
convinced pretty quickly that one reason the drug issue had raised its
ugly head in the 1990s is that we took our eye off the ball. I think in
the 1980s, under the leadership of President Reagan and First Lady
Nancy Reagan and Bill Bennett, who did an awesome job as drug czar, we
made real progress, particularly on the issue of cocaine.
I think there was sort of a sense that we had solved that problem,
and it was time to focus on other things. So we took our eye off the
ball. That is why you saw, in the 1990s when the Drug-Free Communities
Act legislation was necessary, there was a big increase in drug use,
particularly among our young people. So I was always worried that we
might do that again, that when there was a reduction in drug use, we
might say: Well, that problem is behind us; let's move onto the next
one.
The problem was never behind us, sadly. It is like the tide. It just
keeps coming in, so you have to keep your focus on it. But I will tell
you, I never expected that at a time when we would have a substantial
increase in drug use, in crime, in overdoses, in deaths--which is what
we have experienced in this country over the past few years--that we
would cut these programs. I just did not imagine it. So I am concerned
about it. We can't take our eye off the ball, particularly at a time
like this. We have to be sure that we are supporting these programs
that work.
Let me show you a chart that tells you where we are today. This is
the number of drug overdose deaths in our great country from 1999 to
2015, the most recent year for which we have data. Look at this line
here. This is opioid painkillers, this is fentanyl, and this is heroin.
You see this incredible increase. Sadly, I will tell you that in 2016
and 2017, it keeps going up.
This year, we have had more opioid overdose deaths over the first few
months than we had in the same period last year. In fact, here is one
example. In Cleveland, OH, in the last 10 months, we have had more
overdose deaths from fentanyl than we had in the previous 10 years. So
it is sad that it is not getting better; it is getting worse.
Drug overdoses are now the leading cause of accidental death in the
United States, surpassing car accidents. This is, again, a troubling
chart, but we need to look at it. We hear a lot about homicides, and
gun homicides, in particular. We hear about car crashes. Here is an
example of HIV/AIDS in 1995, a time that was the height of the HIV/AIDS
crisis, when all of us reacted appropriately.
Here we are in drug overdoses in 2015--far worse than any of these.
So between prescription painkillers, heroin, and synthetic forms of
heroin, drug overdose is now the leading cause of accidental death in
the United States of America.
According to CDC, the Centers for Disease Control and Prevention,
more Americans died from drug overdoses in 2015, again, than died in
the AIDS epidemic in 1995. A recent story in the New York Times said
there are more than four times as many people dying every day from this
epidemic than were dying at the peak of the crack epidemic.
Another way to look at it, sadly, is that more people died in the
last 3 years than died in the Vietnam War. Those are tough things to
compare, but the point is, this is not a time for us to be gutting
these programs. Fortunately, we have these programs in place to help.
Let's use them to try to encourage more prevention and more education.
Here is a chart that just shows where heroin and fentanyl are. Again,
from 1999 to 2015, this is heroin, this is fentanyl. Look at the rise
of this over the last few years. That is what we are dealing with. That
is the reality. That is what is happening in the communities and in our
streets.
You might ask yourself, why do we want to cut this back at this
point? My understanding is that some have argued we don't need the
program. They said this program is duplicative because we have other
programs now, including great legislation passed last year that I
mentioned earlier called the 21st Century Cures Act. In fact, the
author of that legislation just joined us on the floor, Senator
Alexander of Tennessee.
They have said the Drug-Free Communities Act may be a duplication of
that CURES Program. That is an entirely different program--again, $90
million a year. CURES is $500 million a year needed right now.
I was a strong supporter of the CURES Act, and I again thank my
colleague for working with some of us who have been focused on this
issue, as he has, to get that legislation passed on a bipartisan basis.
The 21st Century CURES Act provides $500 million, but it provides
that funding over this year and next, over 2 years. It is a temporary
increase in funding to deal with the real crisis. This will help fill
the gaps, but it does not ensure that $1 of that money goes toward this
evidence-based prevention we talked about today.
Second, these programs have distinct goals. The CURES grants can be
used however a State wants, and that is appropriate. In Ohio, I know
Governor Kasich and the State legislature are focused on using it in a
smart way, focused mostly on treatment which is badly needed. As I
noted, 8 out of 10 people who are addicted and need treatment are not
getting the treatment they need. We need more treatment facilities in
some communities where the treatment is not available.
The Drug-Free Communities Act is specifically focused on this
prevention through education at the community level. Funding goes
directly to these coalitions I talked about and their focus is on
prevention. It is not duplication. One is a prevention program focused
on the community level, and one is an open-ended grant to the States.
There is no other Federal program that funds evidenced-based prevention
at the community level and has these measures except this one.
The accountability measures we talked about are important, and that
distinguishes it from CURES or anything else. We require that
communities provide matching funds, a one-to-one match. So if a dollar
of Federal tax dollars goes out, it has to be matched by a dollar of
non-Federal tax dollars just to get the funding.
We put a cap on administrative expenses of 8 percent to ensure that
we maximize the amount of funding going into these programs. If you
want funding in your coalition, you have to keep
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your funding below 8 percent. That ensures that a maximum amount of
funding goes into these programs. We specifically included strict
accountability measures to ensure the highest level of support in
solving the substance abuse crisis every community faces. These
programs are effective. They use taxpayer dollars well, and cutting
them doesn't make sense.
One of the reasons I believe President Trump was elected was that he
had the courage and foresight to talk about this issue on the campaign
trail. He talked about addiction, whether he was in New Hampshire,
Ohio, or other States where we have a high level of heroin,
prescription drug, and fentanyl abuse and addiction. He spoke with a
passion about this and the toll it has on our citizens and devastation
to our communities. I think that was one reason he was elected. He
focused on how we would stop this epidemic. This proposal apparently
put forward by Members of his administration runs counter to what he
talked about during the campaign.
Earlier today, my original House cosponsor of the Drug-Free Community
Act, Congressman Sandy Levin, and I sent a letter to the Office of
Management and Budget Director, Mick Mulvaney, encouraging him not to
pursue this course of action.
More importantly, more than 219 nonpartisan public health groups--
experts like the American Academy of Pediatrics, the American Public
Health Association, the Northern Ohio Recovery Association, the
Community Anti-Drug Coalition of America, and other groups sent a
letter to the White House expressing their support for the work of the
Office of National Drug Control Policy.
Mr. President, I ask unanimous consent to have this letter printed in
the Record.
There being no objection, the material was ordered to be printed in
the Record, as follows:
May 8, 2017.
Re Revise OMB's proposed budget slashing drug control funding
Mr. Reed Cordish,
Senior Adviser to the President,
The White House.
Dear Mr. Cordish: We are thankful to the Trump
Administration for prioritizing the reduction of drug use,
drug trafficking, and its consequences. We represent former
and current federal, state, and local officials, hundreds of
community-based organizations, and tens of thousands of
people working in drug prevention, drug treatment, drug
treatment courts, mental health, recovery, medicine, law
enforcement, and millions of individuals in recovery from
alcohol and drug use disorders. Like the Administration, we
believe drugs are a serious issue.
In light of the Administration's prioritization, we write
in strong support of the Office of National Drug Control
Policy (ONDCP) and the critically important Drug Free
Communities (DFC) program, which provides funding directly to
communities to prevent drug use. DFC-funded coalitions are
proven to effectively reduce alcohol, tobacco, marijuana and
prescription drug misuse among middle and high school-aged
children. The High Intensity Drug Trafficking Area (HIDTA)
program, which coordinates federal, state, and local law
enforcement, streamlines efforts to dismantle drug
trafficking organizations and brings drug traffickers to
justice.
As we have written before, ONDCP brings essential expertise
to the table on complex drug issues, expertise that would
otherwise be missing or dispersed across multiple agencies.
ONDCP holds all federal, state, and local agencies
accountable for achieving specific goals to reduce drug
trafficking, use, and other consequences.
At a time when drugs now kill more people than firearms or
car crashes, it is more important than ever for ONDCP to
remain a strong voice in the White House and a visible
presence nationally. As plans are finalized for the
Administration's proposed FY 2018 budget, we once again ask
the Administration to maintain a strong commitment to ONDCP
by proposing the highest level of funding possible for the
agency and its programs given the importance of ONDCP's
mission and the current opioid crisis.
Sincerely,
A New PATH, Addiction Haven, Addiction Medicine Foundation,
Addiction Policy Forum, Advocates for Recovery Colorado,
Alabama Citizens Action Program, Alano Club of Portland,
American Academy of Addiction Psychiatry, American Academy of
Pediatrics, American Association for the Treatment of Opioid
Dependence, American Association of Child & Adolescent
Psychiatry, American Association of Colleges of Pharmacy,
American Congress of Obstetricians and Gynecologists,
American Correctional Association, American Osteopathic
Academy of Addiction Medicine, American Osteopathic
Association, American Psychiatric Association, American
Psychological Association, American Public Health
Association, American Society of Addiction Medicine.
AmerisourceBergen Corporation, Association for Behavioral
Health and Wellness, Association of Persons Affected by
Addiction (APAA), Association of Prosecuting Attorneys,
Association of Recovery Community Organizations, Association
of Recovery Schools, Association of Schools and Programs of
Public Health, Association of State and Territorial Health
Officials, Bangor Area Recovery Network, Inc., Big Cities
Health Coalition, California Academy of Family Physicians,
California Consortium of Addiction Programs and
Professionals, Capital Area Project Vox, Caron Treatment
Centers, Catholic Charities Maine, Center for Recovery and
Wellness Resources, Center for Substance Abuse Research,
University of Maryland, Chicago Recovering Communities
Coalition (CRCC), Collaborative for Effective Prescription
Opioid Policies, College on Problems of Drug Dependence.
Communities for Recovery, Community Alliances for Drug-Free
Youth, Community Anti-Drug Coalitions of America, Community
Oriented Correctional Health Services, Connecticut
Certification Board, Connecticut Community for Addiction
Recovery (CCAR), Council on Prevention and Education:
Substances, DarJune Recovery Support Services & Cafe, DC
Recovery Community Alliance, Delaware Certification Board,
Detroit Recovery Project, Inc., Dorchester Recovery
Initiative, Drug Free America Foundation, Drug Free Schools
Coalition, DUID Victim Voices, Easy Does It, Inc., El Paso
Alliance, Engaged Recovery Community Services, Entertainment
Industries Council, Inc., Faces & Voices of Recovery.
Facing Addiction, FAVOR Greenville, FAVOR Mississippi
Recovery Advocacy Project, FAVOR Pee Dee, FAVOR Tri-County,
FED UP Coalition to End the Opioid Epidemic, Fellowship
Foundation Recovery Community Organization, Florida Coalition
Alliance, Floridians for Recovery, Foundation for Recovery,
Friends of Recovery--New York, Friends Research Institute,
Inc., Gem County Recovery Community Center, Georgia Council
on Substance Abuse, Gerontological Society of America,
Greater Macomb Project Vox, Hazelden Betty Ford Institute for
Recovery Advocacy, HOPE for New Hampshire Recovery, Illinois
Alcohol and Other Drug Abuse Professional Certification
Association, Institute for Behavior and Health.
International Certification & Reciprocity Consortium,
International Nurses Society on Addictions, Jackson Area
Recovery Community, Johns Hopkins Bloomberg School of Public
Health, Juneau Recovery Community, Kentucky Office of Drug
Control Policy, Latah Recovery Center, Legal Action Center,
Life of Purpose Treatment, Lifehouse Recovery Connection,
Long Island Recovery Association (LIRA), Lost Dreams Awaken
Center, Inc., Lotus Peer Recovery/Sober Kerrville, Louisiana
Association of Substance Abuse Counselors & Trainers, Inc.,
Maine Alliance for Addiction Recovery, Maine Immigrant and
Refugee Services, Major Cities Chiefs Association, Major
County Sheriffs of America, Maryland Recovery Organization
Connecting Communities (M-ROCC), Massachusetts Organization
for Addiction Recovery (MOAR).
Message Carriers of Pennsylvania, Inc., Mi-HOPE--Michigan
Heroin & Opiate Prevention and Education, Michigan Recovery
Voices, Milestone Foundation, Minnesota Recovery Connection,
Missouri Recovery Network, Mothers Against Drunk Driving,
Mothers Against Prescription Drug Abuse, National Alliance of
State Drug Enforcement Agencies, National Alliance for
Medication Assisted Recovery, National Association for
Children of Alcoholics, National Association for Rural Mental
Health, National Association of City and County Health
Officials, National Association of Clinical Nurse
Specialists, National Association of Counties, National
Association of County Behavioral Health and Developmental
Disability Directors, National Association of Drug Court
Professionals, National Association of Police Organizations,
National Association of Social Workers.
National Association of State Alcohol and Drug Abuse
Directors, National Athletic Trainers' Association (NATA),
National Center on Addiction and Substance Abuse, National
Council for Behavioral Health, National Council on Alcoholism
and Drug Dependence, Inc. (NCADD), National Criminal Justice
Association, National District Attorneys Association,
National Families in Action, National Fusion Center
Association, National HIDTA Directors Association, National
Hospice and Palliative Care Organization, National Minority
AIDS Council, National Narcotics Officers Association
Coalition, National Safety Council, National Sheriffs'
Association, Navigate Recovery, New Evangelical Partnership
for the Common Good, New York Association of Alcoholism and
Substance Abuse Providers, Inc., Northern Ohio Recovery
Association (NORA), NAADAC, the Association for Addiction
Professionals.
Nurse Practitioner Healthcare Foundation, Oklahoma Citizen
Advocates for Recovery & Treatment Association (OCARTA),
Oklahoma Drug and Alcohol Professional Counselor Association,
P.E.E.R Wellness Center, Inc., Partnership for Drug-Free
Kids, PEER360 Recovery Alliance, Pennsylvania Certification
Board, Pennsylvania Recovery Organization--Achieving
Community Together--(PRO-ACT), Pennsylvania Recovery
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Organizations Alliance (PRO-A), People Advocating Recovery--
PAR, Phoenix House, Phoenix Multisport Boston, Physicians for
Responsible Opioid Prescribing, PLR Athens, Proove
Biosciences, RASE Project, Recover Project/Western MA
Training, Recover Wyoming, Recovery--Friendly Taos County,
Recovery Allies of West Michigan.
Recovery Cafe, Recovery Communities of North Carolina,
Recovery Community of Durham, Recovery Consultants of
Atlanta, Recovery Data Solutions, Recovery Idaho, Inc.,
Recovery is Happening, RecoveryATX, RecoveryNC (Governors
Institute on Substance Abuse), Regroup, Rhode Island
Certification Board, Rhode Island Communities for Addiction
Recovery Efforts (RICAREs), ROCovery Fitness, Rosenthal
Center for Addiction Studies, Safe Kids Worldwide, SAM
Action, Save Our Society from Drugs, Shatterproof, Smart
Approaches to Marijuana, SMART Recovery.
Solano Recovery Project, Spiritworks Foundation, Spread
Hope Like Fire, Springs Recovery Connection, STEP Industries,
Strengthening the Mid-Atlantic Region for Tomorrow (SMART),
Substance Abuse Librarians and Information Specialists,
T.O.R.C.H., Inc., Tennessee Overdose Prevention, Texas
Association of Addiction Professionals, The Addict's Mom, The
Alliance for Addiction and Mental Health Services, Maine, The
Bridge Foundation, The DOOR--DeKalb Open Opportunity for
Recovery, The Friends of NIDA, The MARS Project, The McShin
Foundation, The Moyer Foundation, The National Center on
Addiction and Substance Abuse, The Police Foundation.
Tia Hart Recovery Community Program, TASC of Illinois
(Treatment Alternatives for Safer Communities), Treatment
Communities of America, Trilogy Recovery Community, Trust for
America's Health, Utah Support Advocates for Recovery
Awareness (USARA), Verde Technologies, Vermont Recovery
Network, Virginia Association of Recovery Residences,
Virginia Certification Board, Voices of Hope for Cecil
County, Voices of Recovery San Mateo County, WAI-IAM, Inc.
and RISE Recovery Community, Washtenaw Recovery Advocacy
Project (WRAP), WestCare, Inc., WholeLife Recovery Community/
Arizona Recovery Coalition, Wisconsin Recovery Community
Organization (WIRCO), Wisconsin Voices for Recovery, Young
People in Recovery, Zoe's Story Fund.
Mr. PORTMAN. Mr. President, these groups know that the proposed cuts
would undermine our anti-drug efforts at a time when we need them more
than ever. So I ask my colleagues to join me in urging the OMB Director
and the folks in the White House who are making these decisions not to
take this course of action but rather to support our proven community
anti-drug coalition, to support ONDCP in doing the important work at a
time of a growing epidemic. We have never needed these programs more
than we do right now.
Thank you, Mr. President.
I yield back my time.
The PRESIDING OFFICER. The Senator from Tennessee.
Mr. ALEXANDER. Mr. President, I congratulate the Senator from Ohio
not just on his speech and his remarks but on his leadership on the
opioid epidemic in our country and its progression into other areas. He
speaks passionately about it publicly and privately to his colleagues,
just as he did today at our lunch as we discussed healthcare. He was a
leader last year when we passed the 21st Century Cures Act to try to
move these medical miracles that we know are coming through the
regulatory and investment process more rapidly and into medicine
cabinets and doctors' offices.
Senator Portman and Senator Whitehouse and others, in a bipartisan
way, worked to add at least $1 billion more funding for States to deal
with opioids after they had passed the Comprehensive Addiction and
Recovery Act earlier that year. So the opioid epidemic and the families
who suffer from it have no more effective spokesman and advocate than
the Senator from Ohio, and I am glad I had an opportunity to hear his
remarks today.
Mr. President, I ask unanimous consent that the time until 4:30 be
equally divided in the usual form; further, that all postcloture time
on the Gottlieb nomination expire at 4:30 p.m. today; and that, if
confirmed, the motion to reconsider be considered made and laid on the
table, and the President be immediately notified of the Senate's
action.
The PRESIDING OFFICER. Is there objection?
Without objection, it is so ordered.
Mr. ALEXANDER. Mr. President, while the Senator from Ohio is here,
one more word on opioids.
Dr. Francis Collins, the head of the National Institutes of Health,
has testified before the Senate that in the next decade we could have--
we should have a discovery of a nonaddictive pain medicine.
I cannot think of anything that over the long run could deal more
with opioid addiction than to find a substitute for opioids that wasn't
addictive. So we have discussed that with the President, with the new
head of the FDA--after today, Dr. Gottlieb, I hope--with Dr. Price,
Senator Portman, and with others, and, hopefully, in a bipartisan way,
we can lean forward into accelerating the discovery of a nonaddictive
pain medicine, and we can make that contribution in this effort.
Mr. President, the Senate will vote shortly at 4:30 p.m. on the
President's nomination of Scott Gottlieb to serve as Commissioner of
the Food and Drug Administration. He is the right person to lead the
FDA in this vital mission and move the agency forward so America's
patients can benefit from the remarkable discoveries--one of which I
was just discussing--that our Nation's researchers are working on.
Dr. Gottlieb has impressive qualifications from every perspective. He
was a practicing physician and hospitalist for many years, received his
medical degree at Mount Sinai School of Medicine and completed his
residency there. He held three positions in the Department of Health
and Human Services, including two at the FDA as Deputy Commissioner,
from 2005 to 2007, and before that, in 2003 to 2004, as a senior
adviser to Commissioner Mark McClellan, and as the FDA's Director of
Medical Policy Development.
Dr. Gottlieb has studied health policy as a resident fellow at the
American Enterprise Institute. He is a prolific writer and speaker on
medical innovations. He has testified in front of Congress 18 times on
a variety of issues, including the drug approval process, drug costs,
drug shortages, importation, and healthcare reform.
Dr. Gottlieb is also a cancer survivor. He knows firsthand how
medical treatments affect patients and their families.
Dr. Gottlieb, like others who were nominated by Presidents, has been
through an exhaustive vetting process. The President announced the
Gottlieb nomination on March 10. We received the nomination March 27.
On April 5, Dr. Gottlieb testified for 2\1/2\ hours in our Senate HELP
Committee. I offered Senators an opportunity to ask any questions they
wished. Following his hearing, he answered 189 follow-up questions. If
you count all the subquestions, it was 372 questions.
On April 27, our committee approved his nomination by a vote of 14 to
9, readying that nomination for consideration by the full Senate today.
On March 28, more than a month ago, the independent Office of
Government Ethics concluded that Dr. Gottlieb ``is in compliance with
applicable laws and regulations governing conflicts of interest.''
Let me read from the Office of Government Ethics' website about what
that agency does. It says: ``OGE provides an independent review of the
financial disclosure reports of candidates for Senate-confirmed
nominees. OGE makes sure that these individuals have complied with the
extensive requirements for financial disclosure under the Ethics in
Government Act. OGE ensures compliance with financial disclosure
requirements and assists in the resolution of potential conflicts of
interest. It carefully evaluates nominees' financial disclosure reports
and works with agency ethics officials to prepare individualized ethics
agreements.''
The website continues: ``After confirming with the agency that there
are no unresolved conflicts of interest, OGE then transmits the
financial disclosure report, the ethics agreement, and a cover letter
directly to the Senate.''
That all arrived at our committee on March 28. So that should answer
any questions about whether Dr. Gottlieb has a conflict of interest
because the independent agency Congress set up to resolve that question
says he has none--or if he has any, he will resolve them according to
an agreement with that office.
I believe Dr. Gottlieb will help to move the FDA forward so patients
can benefit from the remarkable medical discoveries that researchers
are working on. The FDA affects nearly every
[[Page S2838]]
single American and regulates about a quarter of all consumer spending
in our country, over $4 trillion annually.
It is responsible for areas as diverse as prescription drugs for
humans and animals, medical devices, biologics, dietary supplements,
cosmetics, over-the-counter medications, food, and tobacco products. In
addition to drugs and medical devices, the FDA is responsible for
protecting our Nation's food supply and working to reduce the number of
people who get sick from foodborne illnesses.
Some of my Democratic colleagues have expressed concern about Dr.
Gottlieb's prior work with companies that are regulated by the Food and
Drug Administration, but the fact is, it is not so unusual to have an
FDA Commissioner who has consulted with the food and drug industry. Dr.
Califf, the distinguished former FDA Commissioner under President
Obama, consulted for many companies prior to his confirmation from the
Senate. That didn't disqualify Dr. Califf. I supported him. So did 89
other Senators. He was confirmed 89 to 4.
I think we should recognize the obvious fact that it is a good idea
to have people serving in government with some experience in the types
of industries they are in charge of. The other day we confirmed a
Secretary of Agriculture. I think it helps that he is a farmer and a
veterinarian. We confirmed the Secretary of Commerce. I think it helps
that he has some background in business. Some of the same people who
are criticizing Dr. Gottlieb for having a background in working with
companies that manufacture drugs criticized President Trump's Secretary
of Education because she had never been on the payroll of the people
she was about to be in charge of. So you can't have it both ways.
I believe Dr. Gottlieb's background in understanding how drugs are
manufactured, how they can be manufactured safely, how they can be
moved through the regulatory and investment process more rapidly is
vitally important to the opportunity we have in America--more than we
have ever had before--of finding these new medical miracles and putting
them in our medicine cabinets and our doctors' offices.
Dr. Gottlieb has broad support from an array of patient, industry,
and research organizations. The supporters include three former FDA
Commissioners and President Obama's Administrator of the Centers for
Medicare & Medicaid Services.
On Friday, I received a letter of support for Dr. Gottlieb from 10
State attorneys general who particularly praised the nominee as ``a
leader in the fight against opioid abuse,'' the subject Senator Portman
spoke on a moment ago.
Mr. President, I ask unanimous consent to have printed in the Record
a list of 93 groups that support Dr. Gottlieb's nomination at the
conclusion of my remarks.
Mr. President, here are a few examples of what some of these groups
had to say.
Dr. Jeff Allen, the President and CEO of Friends of Cancer Research,
said: ``Through his knowledge and experience, we have no doubt that Dr.
Gottlieb will be the right person to ensure FDA keeps pace with science
and innovation without sacrificing the safety and efficacy gold
standard established by FDA.''
The Healthcare Leadership Council said: ``Dr. Gottlieb's
qualifications to lead the FDA are extensive and indisputable. . . .
Dr. Gottlieb has consistently demonstrated his vision for accelerated
medical innovation in this country and greater patient access to the
drugs and devices that improve lives.''
Dr. Mark McClellan, FDA Commissioner from 2002 to 2004, said: ``He's
a very good nomination,'' adding ``he is very dedicated to finding
better ways to protect and improve the health of the public, all of
which are great prerequisites for FDA Commissioner.''
Andy Slavitt, who just stepped down as the Administrator of the
Centers for Medicare & Medicaid Services under President Obama, said
that Dr. Gottlieb is ``a very good choice.''
The FDA has always been important, but there never has been a more
important time for this agency. It is responsible for making sure
patients benefit from the promising research driven by significant
funding Congress has given to medical research in last year's 21st
Century Cures Act, which the majority leader called ``the most
important legislation of the year.''
I don't want it to go unnoticed that last year Congress increased
funding for the National Institutes of Health by $2 billion. Last week,
Congress increased funding for the National Institutes of Health by
another $2 billion. The 21st Century Cures Act, which Congress also
passed last year, authorized a $4.8 billion increase in funding for the
National Institutes of Health for President Obama's Precision Medicine
Initiative and for the Cancer Moonshot the Vice President worked on.
Speaker Ryan and Majority Leader McConnell, President Obama, Vice
President Biden, all of us want to see these medical miracles move
forward, and having competent leadership in the FDA is absolutely
essential to that effort.
I am very excited about the prospect of having Dr. Gottlieb and Dr.
Francis Collins, who is the head of the National Institutes of Health,
at the head of these two lifesaving agencies, which are important to
every single American family.
The reason 21st Century Cures is such an important bill is that it
will drive forward this extraordinary research, and Dr. Collins talked
about some of the discoveries that will be possible in the next decade.
I mentioned the possibility of nonaddictive pain medicine. Dr. Collins
said that we will also have hearts that will be rebuilt from our own
stem cells. We will have a universal flu vaccine. Did you know that the
flu kills between 12,000 and 56,000 Americans a year? There will be a
universal flu vaccine. There will be an HIV/AIDS vaccine and an
artificial pancreas for patients with diabetes who have spent decades
injecting themselves with insulin. These are the discoveries that are
just over the horizon, not to mention medicine that will identify
Alzheimer's before there are symptoms and then slow the progression of
the disease. Think of the grief it would save families and the billions
it would save the country. We have invested in that.
We have competent leadership to be approved by the Senate today, in
working with Dr. Collins and Dr. Price, who can make sure those dreams
become a reality perhaps even more rapidly.
The FDA plays a key role in this. At the committee hearing, I asked
Dr. Gottlieb about the subject Senator Portman and I just talked about.
I asked him how the FDA can be forward-leaning in accelerating the
finding of new nonaddictive pain medicines--the ultimate cure for the
opioid epidemic. It is a heartbreaking issue that almost every Senator
knows about. Dr. Gottlieb said that the opioid epidemic is ``having
staggering human consequences.''
He also said:
I think it's the biggest crisis facing the agency. It's
going to require dramatic action by whoever steps into the
agency. I think it's going to require an all-of-the-above
approach that does include reevaluating the framework for how
we can develop alternatives to opioid drugs. I think it also
includes looking at device alternatives to opioid drugs and
looking at devices in the context of drugs.
Dr. Gottlieb's first order of business will be to work with us on the
reauthorization of the FDA user fee agreements, which experts at the
FDA told members of our HELP Committee at one of the two bipartisan
hearings on the agreements, are integral to helping patients and
continuing the implementation of the 21st Century Cures Act.
Before September 30, four different agreements need to be
reauthorized. They fund $8 billion to $9 billion over the next 5 years,
which is about a quarter of the Food and Drug Administration's budget.
If we do not move quickly to pass these agreements in late July, the
FDA will be forced, by law, to send layoff notices to more than 5,000
FDA employees and notify them that they may lose their jobs in 60 days.
A delay in reauthorizing these agreements would delay the reviews of
drugs and devices that were submitted after April 1--1 month ago. For
example, if we do not pass these user fee reauthorizations on time, an
FDA reviewer who gets started in reviewing, say, a cancer drug that was
submitted to the agency in April would be laid off on October 1, which
would be before the reviewer is able to finish his or her work.
In addition to harming patients and families who rely on medical
innovation, a delay in reauthorization would
[[Page S2839]]
threaten America's global leadership in biomedical innovation.
After reviewing the recommendations from industry and the FDA, I
believe these are good agreements for patients. The sooner we pass the
legislation, the better so as to give patients, doctors, FDA reviewers,
and companies' certainty.
At this moment, Washington, DC, is not a very bipartisan town on many
issues, but on this issue--the issue of user fees to support the Food
and Drug Administration--it has been.
I compliment Senator Patty Murray and her staff. Senator Murray is
the ranking Democrat on the HELP Committee. Our staffs have been
working together for 15 months in a bipartisan way and working with the
House of Representatives to try to make sure we can present to the full
Senate our FDA user fee agreements. We have had two bipartisan
hearings. Tomorrow, we have a markup at which we hope those agreements
will be reported to the Senate floor.
The FDA has a vital and important mission, and I am confident Dr.
Gottlieb is the right person to be leading the agency. We are fortunate
that he is willing to serve. I look forward to the Senate's approving
Dr. Gottlieb's confirmation this afternoon.
There being no objection, the material was ordered to be printed in
the Record, as follows:
Dr. Gottlieb's nomination has received support from 93
groups--including a broad array of patient, industry, and
research organizations.
Full list of supporters: Advanced Medical Technology
Association (Advanced); Aduro Biotech; Alliance for Aging
Research; Alliance for Patient Access; Alliance for
Regenerative Medicine; Alliance of Specialty Medicine;
American Academy of Facial & Plastic Reconstructive Surgery;
American Association for Cancer Research; American
Association of Neurological Surgeons; American Bakers
Association; American Beverage Association; American
Enterprise Institute; American Frozen Food Institute;
American Society for Radiation Oncology; American Society of
Cataract and Refractive Surgery; American Society of
Echocardiography; American Society of Plastic Surgeons;
Association for Accessible Medicines (AAM); Association of
American Cancer Institutes (AACI).
Association of Black Cardiologists; Association of Clinical
Research Organizations; Calorie Control Council; Can
Manufacturers Institute; CancerCare; Cancer Support
Community; CEO Roundtable on Cancer; The Children's Cause for
Cancer Advocacy; Cigar Association of America; CNF Pharma
LLC; Coalition of Cancer Cooperative Groups; Coalition of
State Rheumatology Organizations; Community Oncology
Alliance; Congress of Neurological Surgeons; Corn Refiners
Association; EveryLife Foundation; FasterCures, a center for
the Milken Institute; Fight Colorectal Cancer; Food Marketing
Institute.
Friedrich's Ataxia Research Alliance (FARA); Friends of
Cancer Research; Global Genes; Global Healthy Living
Foundation; Grandparents in Action; Grocery Manufacturers
Association (GMA); Healthcare Leadership Council; Healthcare
Nutrition Council; Healthy Women; Hematology/Oncology
Pharmacy Association; Independent Bakers Association; Infant
Nutrition Council of America; International Bottled Water
Association; International Dairy Foods Association;
Intemational Food Additives Council; International Premium
Cigar and Pipe Retailers; Kids v. Cancer; Kidney Care
Association; The Leukemia & Lymphoma Society.
Lung Cancer Alliance; LUNGevity; Lupus and Allied Diseases
Association, Inc.; Lymphoma Research Foundation; Manhattan
Institute; Men's Health Network; National Association of
Chemical Distributors; National Automatic Merchandising
Association; National Coalition for Cancer Research (NCCR);
National Coalition for Cancer Survivorship; National
Confectioners Association; National Consumers League;
National Fabry Disease Foundation; National Grocers
Association; National Health Council; National Infusion
Center Association (NICA); National Kidney Foundation;
National Pasta Association; National Patient Advocate
Foundation (NPAF).
National Restaurant Association; Natural Products
Association; The Nicholas Conor Institute; North American
Millers Association; Ovarian Cancer Research Fund Alliance;
Personal Care Products Council; Pharmaceutical Manufacturers
and Manufacturers Associations of America (PhRMA); Prevent
Cancer Foundation; Produce Marketing Association;
Research!America; Sarcoma Foundation of America; SNAC
International; Society of Hospital Medicine; The Sugar
Association; Susan G. Komen; Swifty Foundation; United Fresh
Produce Association.
Mr. ALEXANDER. Mr. President, I yield the floor.
The PRESIDING OFFICER. The Senator from Washington.
Mrs. MURRAY. Mr. President, before I discuss why the nominee before
us, Dr. Scott Gottlieb, is the wrong choice to lead the Food and Drug
Administration, I want to take a minute to talk about the FDA's impact
on the health and safety of patients and families nationwide and how
that impacts my perspective on this nomination.
Our constituents rely on the FDA's work every single day. They trust
that the food they buy from the grocery store is safe. They trust that
when they go to the emergency room, the drugs and medical devices that
are used in their care have been held to the highest standards of
approval and that the FDA's decisions are based on science, not
politics or ideology. In other words, they trust in FDA's gold standard
of approval. So it is critical that the FDA continue to have strong,
independent leadership, especially in light of President Trump's
radical priorities.
Like many, I am deeply concerned by this administration's efforts to
roll back the progress we have made to strengthen the FDA and to
improve public health. Let me give two recent examples from last week
alone. First, the FDA delayed the implementation of a rule on menu
labeling requirements, which would have provided families access to
critical nutritional information about the food they buy and eat. These
requirements have been worked on for years by several Senators and the
Obama administration, with the support of public health groups and
restaurants. The rule was less than 1 week away from going into effect.
On the very same day, the FDA announced that it would delay the
enforcement of a rule to ensure greater oversight over tobacco
products, including cigars, pipe tobacco, and e-cigarettes. Now is not
the time for the FDA to be taking its foot off the gas when it comes to
protecting our children and youth from harmful marketing and flavoring
tactics. These are significant steps in the wrong direction.
Families have every reason to be worried about this administration,
and they are making it clear that they want leaders who are prepared to
stand up for them, which brings us back to Dr. Gottlieb.
At our HELP Committee hearing, after scrutinizing his past record,
asking where he stands on key policy issues, and reviewing his answers
to many of my questions, it has been made clear to me that Dr. Gottlieb
is not that leader. He has not convinced me that he can withstand
political pressure from this administration or that he will be truly
committed to putting our families' health first. For these reasons, I
will be voting no on Dr. Gottlieb's nomination today.
In reviewing Dr. Gottlieb's professional history and background, I
have grown increasingly concerned about whether he can lead the FDA in
an unbiased way given his unprecedented industry ties. On numerous
occasions, Dr. Gottlieb has invested in or advised a company and then
used his public platform to promote policies that will benefit that
company in the future.
I know that, if confirmed, Dr. Gottlieb has agreed to recuse himself
for 1 year from decisions involving some companies in which he has
invested or held positions, but Dr. Gottlieb will still be allowed to
weigh in on matters that involve other companies in which he had been
previously invested. His complicated relationships with a venture
capital firm and an investment bank specifically raise many questions,
and he will not be recused from matters that involve a number of their
clients. Companies Dr. Gottlieb has invested in have more than 60 drugs
in development that could come before the FDA for approval, and the
companies Dr. Gottlieb will be recused from have over 120 drugs in
development.
The extent of these entanglements is unprecedented, and they are
particularly troubling given this administration's clear willingness to
skirt ethics rules and pressure Federal employees in order to jam their
agenda through. Yet, as troubling as these entanglements are, they are
not my only problems with this nomination. I am equally concerned about
where Dr. Gottlieb stands on key policy issues.
For one, I do remain unconvinced that Dr. Gottlieb will ensure
independent, science-based decisionmaking at the FDA if he is
confirmed. While Dr. Gottlieb was at the FDA under the Bush
administration, I was working very hard to ensure that, consistent
[[Page S2840]]
with expert recommendations, emergency contraception known as Plan B
would be sold over the counter to all age groups. Yet the Bush
administration ignored the science and made a decision, based on purely
ideological grounds, on a so-called behind-the-counter option for Plan
B, which allowed politics to interfere directly with women's access to
the healthcare services that they need, and that was a position which
Dr. Gottlieb defended.
I have had the opportunity to discuss this matter with Dr. Gottlieb
on several occasions now, but regrettably my concerns remain unchanged.
When I asked Dr. Gottlieb about this at our hearing--whether he would
allow this administration to use the FDA to further its political
agenda against women's health--Dr. Gottlieb said he would ``not
relitigate settled approval decisions'' on this matter. When I made
clear that I was asking about the future and how he would respond to
future pressure from this administration to undermine women's health,
Dr. Gottlieb did not give a clear answer. Given the Trump
administration's commitment to undermining women's reproductive rights,
which we have seen so clearly in these past 100 days, I find this
aspect of Dr. Gottlieb's professional history especially troubling.
I have also raised concerns regarding Dr. Gottlieb's published
positions on a number of important issues that focus on drugs and
medical devices.
As I stated at the beginning of my remarks, I find the
administration's recent decision to delay oversight on tobacco products
to be especially concerning, which makes it all the more important that
the next FDA Commissioner have a clear position on this issue. I asked
Dr. Gottlieb about this at our hearing, specifically as it relates to
flavored e-cigarettes that have flooded the markets in recent years. I
have to say that I was disappointed by his response. I think it is
clear that a line has been crossed when tobacco companies prey on
children by coming out with e-cigarette flavors like gummy bear and
cookies and cream. Yet, during his hearing, when I asked Dr. Gottlieb
about this, he said he was not quite sure where that line gets drawn.
That speaks volumes to me, and it is a pattern I have seen in Dr.
Gottlieb's answers, whether I have asked him about off-label
communications by drug companies or combating the opioid epidemic and
what the FDA can do to help rein in drug costs.
I could go on, but I want to make one related point, which is that we
still have many questions about where Dr. Gottlieb stands on pressing
policy questions he will have to confront when he is confirmed.
As I said during our HELP Committee markup, we submitted many
questions to Dr. Gottlieb following his hearing, and I was encouraged
that in his answers to these questions, Dr. Gottlieb committed to
upholding the gold standard and working with me on a number of
priorities, like improving the postmarket surveillance of medical
devices. Yet, in large part, I have to say we were left disappointed
with the lack of specificity in his answers. Many of them were vague,
and some questions were flatout ignored.
I just came back from hearing from families in my home State, and I
can tell you that people are looking at what President Trump is doing.
They are appalled, and they are looking for leaders to step up. Whether
it is Dr. Gottlieb's unprecedented financial entanglements, his
inability to withstand political pressure from the Bush administration
in order to ensure science and not ideology drives decisionmaking at
the FDA, or whether he will truly prioritize patient and consumer
safety and the public health over the interests of corporations that
stand to gain financially, I continue to doubt whether Dr. Gottlieb
will be able to stand up to President Trump.
I believe that families and patients, rightly, expect more. They want
independent, science-based leadership at the FDA. I stand with them and
will oppose this nomination.
Mr. DURBIN. Mr. President, I wish to express concern with President
Trump's nominee to serve as next Commissioner of the Food and Drug
Administration, FDA.
The FDA Commissioner is responsible for overseeing our Federal agency
tasked with protecting and promoting the public health through the
regulation of food, tobacco products, dietary supplements, drugs,
medical devices, cosmetics, and veterinary products. I am not convinced
that Dr. Scott Gottlieb is the right person for this job, based
primarily on his less than impressive record of defending women's
access to healthcare, his association with an ecigarette--or vaping--
company that has produced and marketed tobacco products to youth, his
stated desire to expand ``off-label'' communications between drug
companies and health providers, and his long-standing and vocal
opposition to the Affordable Care Act, ACA. If confirmed, I hope he
proves me wrong.
Of particular concern to me is protecting our Nation's food safety. I
was pleased that, in 2001, then-President Obama signed into law the FDA
Food Safety Modernization Act, marking the most comprehensive reform of
our Nation's food safety system in decades. Every year, 48 million
Americans suffer from preventable foodborne illness. More than 120,000
people are hospitalized each year because of food contamination and
3,000 die. Every 4 minutes, someone is rushed to the hospital because
the food they ate made them sick, and at the end of the day, eight will
die--which is why I have spent much of my career working on various
bills to strengthen food safety structures at FDA and the U.S.
Department of Agriculture, to create a single food safety agency, and
to support increased inspection and protection of foreign food imports.
Even with passage of the FDA Food Safety Modernization Act, more work
remains to be done. We must further beef up both foreign and domestic
facility inspections. We must ensure the FDA has sufficient staff and
resources to carry out their responsibilities. We must do a better job
of effectively tracking and tracing high-risk foods in the event of a
foodborne illness outbreak.
In addition, the FDA can and must do more to better regulate dietary
supplements. I was pleased that, in 2015, the FDA announced creation of
the Office of Dietary Supplement Programs to increase focus on and
regulation of the ever-growing dietary supplement industry. It is my
hope that this FDA office continues to receive the funding they so
desperately need to carry out their mission of regulating a $35 billion
dietary supplement industry and aggressively pursue wrongdoing.
Finally, ecigarette products continue to be a growing threat to our
Nation's youth. Last year, then-Surgeon General Vivek Murthy released a
report, calling the skyrocketing use of ecigarettes among youth ``a
major public health concern.'' Ecigarettes are now the most commonly
used form of tobacco among young people in the United States. Over the
past 5 years, the number of middle school and high school students who
have used ecigarettes has tripled. Among young adults aged 18 to 24,
the number has doubled. While some research indicates that ecigarettes
contain fewer toxic substances than ecigarettes, vape from ecigarettes
is not harmless, and these products are a gateway to smoking. The
popularity of ecigarettes stems in part from aggressive marketing and
products aimed at youth, including the marketing of bubble gum, tutti
frutti, and marshmallow flavorings. The FDA must aggressively oversee
these products and ensure that they are not being marketed to children
or young adults. Any attempt to exempt these products from FDA
regulation will be met with extreme resistance from me.
Mr. LEAHY. Mr. President, as the Senate continues to consider
nominees to lead our Nation's top agencies, we are once again faced
with the difficult decision to confirm an individual whose interests
run counter to the mission of the agency he or she will be tasked to
lead. Dr. Scott Gottlieb, the nominee for Commissioner of the U.S. Food
and Drug Administration, FDA, is another such nominee.
Dr. Scott Gottlieb is a physician and current medical consultant for
pharmaceutical, medical device, and other healthcare companies. From
2003 to 2007, Dr. Gottlieb was a senior adviser to the FDA Commissioner
for Medical Technology. He was also the Deputy Commissioner for Medical
and Scientific Affairs under two different FDA Commissioners. In 2013,
Dr. Gottlieb served on the Federal Health IT Policy Committee for the
Department of Health and Human Services. He also
[[Page S2841]]
worked as an adviser to Mitt Romney during his 2012 Presidential
campaign.
While I appreciate that Dr. Gottlieb has qualifying experience, I
remain concerned about his policies and conflicts of interest. For
instance, while serving as the FDA's Deputy Commissioner, Dr. Gottlieb
defended the Bush administration's position to deny the availability of
certain contraceptive care drugs over-the-counter, despite the science
that pointed to lifesaving benefits from such drugs. Additionally,
while serving with Kure, a company that operates vaping and ecigarette
products, Dr. Gottlieb was noncommittal in supporting regulations over
commerce in such products, which directly targets young kids through
marketing, when there is a lack of appropriate medical science to
suggest vaping and ecigarettes are less harmful than tobacco products.
He has also historically sought ways to ensure that the Family Smoking
Prevention and Tobacco Control Act of 2009 can better support the
industry instead of better protecting patients and their families. This
is especially problematic, given that the law provided the FDA with the
authority to regulate tobacco in order to further curb smoking.
I am also concerned with Dr. Gottlieb's public disagreement with
proposals that would allow patients to access affordable medications
through drug importation. I have always supported policies that would
allow patients to access safe and affordable medications from Canada
because this is a cost-effective method to provide patients with the
resources they need to manage their health needs. Of course, Dr.
Gottlieb has long been an outspoken critic of the Affordable Care Act,
ACA, making troubling assertions along the way. He has been quoted as
opposing the ACA's medical loss ratio, which ensures that the dollars
consumers pay on their healthcare go to just that and not to CEO
salaries and overhead costs. He has also publically opposed the
individual mandate and has supported converting the ACA's premium tax
credits from an income-based to an age-based rating system, which would
significantly bar patient access to quality, affordable care.
Most concerning are Dr. Gottlieb's undeniable ties to some of the
largest pharmaceutical companies in the marketplace. As an adviser for
New Enterprises Associates, Dr. Gottlieb currently manages more than 40
drugs now in development that could come before the FDA for approval.
He has also received compensation from many of these companies, earning
more than $400,000 from multiple pharmaceutical and medical device
companies from 2013 to 2015 alone. Dr. Gottlieb also served on six
pharmaceutical company boards, two insurance company boards, one
medical laboratory company board, and several other similar boards, all
of which have hundreds of drugs currently awaiting FDA approval.
Without proper recusal, which Dr. Gottlieb has not committed himself to
in full, these conflicts are in direct contradiction to the ethics and
objective work required of the Commissioner of the FDA.
The leader of the FDA has a firm responsibility in promoting policies
and overseeing drug development with the purpose of enhancing the
health and well-being of the American people. We should put ourselves
in the shoes of the American people, our constituents, in evaluating
nominees to head agencies that bear directly on the public's healthcare
needs. Given Dr. Gottlieb's significant conflicts of interest, combined
with his ideological approaches to public health policy, which suggest
that he would rather deny patients access to lifesaving resources than
support ways to improve healthcare and promote prevention efforts for
all, I cannot in good conscience support his nomination.
Mrs. MURRAY. Mr. President, I yield the floor.
I suggest the absence of a quorum.
The PRESIDING OFFICER. The clerk will call the roll.
The bill clerk proceeded to call the roll.
Mr. HOEVEN. Mr. President, I ask unanimous consent that the order for
the quorum call be rescinded.
The PRESIDING OFFICER (Mr. Cruz). Without objection, it is so
ordered.