[Congressional Record Volume 162, Number 21 (Thursday, February 4, 2016)]
[Senate]
[Pages S654-S655]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]
PRESCRIPTION DRUG ABUSE
Mr. LEAHY. Mr. President, I had planned to be in the Senate Judiciary
Committee today, debating and pushing for passage of the Comprehensive
Addiction and Recovery Act, or CARA. Unfortunately, the markup was
postponed. I wish it had not been. So I hope next week we can make
progress on this important bill. We have a need for this legislation,
and we also need the money for it. Senator Shaheen has an emergency
supplemental appropriations bill. These are actually both urgent
matters.
States such as mine, Vermont, and our neighboring State of New
Hampshire have been deeply affected by this wave of addiction. The
media has covered this very personal and ravaging epidemic as never
before. We have seen a transformation in how we talk about this issue
and the need for solutions. It used to be that if you had a drug
problem, they would bring in the police to straighten it out. We have
removed the stigma of drug addiction, but we need more than talk. I
have visited many of these communities. They are devastated by this
epidemic and need resources for prevention and treatment. It is time
for Congress to act.
For years I have been convening field hearings and sitting at kitchen
tables, listening to Vermonters discuss innovative approaches to
confront drug abuse and related crimes. I have also sat at kitchen
tables and listened to tragic stories about a member of the family who
had been hit with opioid addiction. What I have heard in the meetings I
have had with the police, doctors, family members, faith community, and
educators is that we cannot arrest or jail our way out of this problem.
We have lost the war on drugs--if we were ever winning it--because we
relied primarily on unnecessarily harsh sentencing laws.
I spent 8 years in law enforcement, and I know that law enforcement
practices will always play an important role. That is why I have worked
to secure funding for State-led, anti-heroin task forces. But if we
want to find lasting solutions to these problems, we have to identify
and support effective
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prevention, treatment, and recovery programs. CARA does just that. This
legislation would support innovative, evidence-based solutions--best
practices that are already showing great progress in States like mine.
We need to do all we can to prevent and treat the abuse of
prescription opioids. I have pushed for years to have the FDA promote
safer alternatives to powerful prescription pain killers and to remove
from the market the older, less safe drugs. The FDA's announcement to
expand access to abuse-deterrent formulations of these powerful drugs
is a step in the right direction in response to my concerns, but the
FDA can and must do more.
Mr. President, I ask unanimous consent to have printed in the Record
the April 28, 2014, Leahy-Blumenthal letter to the FDA Commissioner.
There being no objection, the material was ordered to be printed in
the Record, as follows:
U.S. Senate,
Washington, DC, April 28, 2014.
Hon. Margaret A. Hamburg,
Commissioner, Food and Drug Administration, Silver Spring,
MD.
Dear Commissioner Hamburg: We are writing to urge the
expedited review of New Drug Applications for abuse-deterrent
formulations of single-entity hydrocodone products. Zohydro
ER was the first pure hydrocodone product to receive FDA
market approval. The drug was approved despite lacking any
abuse-deterrent properties and over strong objections from
the FDA's own independent advisory committee. We share the
concerns of the many governors and state attorneys general
who believe this powerful drug is all but certain to
exacerbate our nation's addiction to opioid analgesics, which
results in tens of thousands of overdose deaths each year.
Given their potency and ease of abuse, we have little doubt
that pure opioid products may lead more Americans to
addiction, some even to heroin. The FDA has already
recognized the heightened risks of overdose and death with
Zohydro ER, even at recommended doses. Drug developers
continue to seek regulatory approval for other easy to abuse
opioids, such as Moxduo IR. To the extent that pure opioid
products fill a necessary niche in responsible pain
management practices, the FDA must now take all available
measures to ensure that patients are soon provided safer
alternatives. This process begins by prioritizing review of
abuse-deterrent formulations. Such formulations are much more
difficult to crush or dissolve, two preferred methods of
abuse.
As safer, abuse-deterrent opioids are approved, the FDA
should act swiftly to remove any older, less safe versions.
In the past, it has taken up to three years for the FDA to
ban products that lack abuse-deterrent properties when a
safer equivalent exists. Americans should not have to wait
this long with Zohydro ER.
We also request that the FDA brief our staff on your plans
to monitor the use of Zohydro ER, including what metrics will
be used to potentially reevaluate its status as an approved
drug if widespread problems develop. We also ask that you
share your planned efforts to curb prescription drug abuse
generally, including the development and approval of
effective non-opioid painkillers that may finally break the
cycle of opioid addiction. Each year, the opioid epidemic
seeps into more communities and takes more lives. We are
eager to learn how we can assist the FDA to finally get ahead
of this scourge.
Thank you for your prompt attention to this matter. We look
forward to hearing from you.
Sincerely,
Richard Blumenthal,
U.S. Senator.
Patrick J. Leahy,
U.S. Senator.
Mr. LEAHY. I am also concerned that rural communities are in
desperate need of the lifesaving drug naloxone so that opioid overdoses
can be stopped. I have heard from law enforcement officers and grateful
families what a miracle this drug can be, so we need to make sure we
have it supplied where it can literally save lives. I have had police
officers tell me that they arrived at a scene with an overdose, and
because they had that with them, they saved the life of the person. If
they had not had it, the person would have been dead by the time the
ambulance arrived.
In Vermont, we have seen a 65 percent increase in the number of
Vermonters getting treatment for their addiction over the past 2 years.
This is encouraging progress and reflects the fact that our Governor
and also State legislators of both parties have stepped up. But we know
that there are hundreds more who are on waiting lists, and patients in
the very rural corners of my State travel hours just to get their
medication. We need to do more about this real threat to our
communities.
I am very proud to cosponsor Senator Shaheen's emergency supplemental
appropriations bill. I want to be able to fund additional public health
outreach, treatment, recovery, and law enforcement efforts. We have
passed much larger emergency supplemental bills to address swine flu
and Ebola. We passed huge supplemental bills on Ebola when we did not
have a single case of Ebola originate here in the United States. We
were worried about it coming in, but it did not originate here. But
here, we have tens of thousands in the Presiding Officer's State, in my
State, and in every other State. We have to take the health epidemic
already in our communities just as seriously as we did those diseases
that did not originate on our shores.
(The remarks of Mr. Leahy and Mr. Franken pertaining to the
introduction of S. 2506 are printed in today's Record under
``Statements on Introduced Bills and Joint Resolutions.'')
The PRESIDING OFFICER. The Senator from Indiana.
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