[Congressional Record (Bound Edition), Volume 162 (2016), Part 1]
[Senate]
[Pages 1378-1379]
[From the U.S. 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 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

[[Page 1379]]

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.

                          ____________________