Life Science Compliance Update

« Previous article | Home| Next article »

April 05, 2018

House of Representatives Holds Two-Day Hearing on Opioids


Recently the Committee on Energy and Commerce Subcommittee on Health held a hearing entitled, “Combating the Opioid Crisis: Prevention and Public Health Solutions.” During the hearing, representatives and witnesses alike discussed a total of twenty-five bills that have been introduced or drafted and address the opioid crisis.

The Subcommittee on Health heard from four different panels of witnesses, including federal agency heads, recovering addicts, and opioid rehabilitation medical experts.

Opening Statements

During opening statements, Committee Chairman Greg Walden praised the President’s plans to address the opioid crisis and said that Congress is “ready to work in tandem” with the administration to come up with additional solutions. Referencing the importance of the hearing, Rep. Walden said that the proposed legislation would help strengthen the FDA’s ability to understand the epidemic. Rep. Walden specifically referenced The INFO Act (H.R. 4284), and H.R. 3545, as effective bills to help combat the opioid crisis.

Committee Ranking Member Rep. Frank Pallone discussed his support for the Addiction Treatment Access Improvement Act of 2017 (H.R. 3692) which revises the qualifications for physicians to “administer, dispense, or prescribe narcotic drugs for maintenance or detoxification treatment.”

Health Subcommittee Chairman Michael Burgess stated that legislation like the Comprehensive Addiction and Recovery Act (CARA) and 21st Century Cures Act have been impactful, but additional legislation is needed. He expressed concern with how little of the 21st Century Cures Act funding has been used by the states to date. He also highlighted H.R. 4284 and the FDA packaging and disposal discussion draft as two important pieces of legislation.

Subcommittee Ranking Member Gene Green spoke to the FDA Misuse/Abuse discussion draft legislation he authored which would clarify the FDA’s authority to consider tendencies for misuse and abuse as part of the drug approval and assessment process for opioids. He also noted the importance for expanding healthcare access to patients.

Testimony and Discussion

With the four panels and two days of hearings, the Committee had wide-ranging discussions on the bills, sometimes vigorously debating and other times listening intently to the witnesses before them.

Members of the Committee debated the merits of the Overdose Prevention and Patient Safety Act (H.R. 3545), which would address concerns with existing rules governing the privacy of patient medical records related to substance abuse treatment. Democrats claimed the bill would increase instances of discrimination against patients with substance use disorders (SUDs) while Republicans argued it would encourage coordinated and exemplary care for patients seeking treatment.  

More specifically, Representative Walden acknowledged that while this issue is “deeply sensitive” it is important to ensure that patients receiving these services get the same quality of treatment that patients with other chronic diseases get by protecting patient privacy and reducing stigma towards those with SUDs. Representative Pallone on the other hand, stated his belief that the legislation could potentially act as a barrier to patients seeking and receiving treatment. He further stated that Congress should instead focus efforts on eliminating stigma around drug use and pass laws to protect patients with a history of opioid abuse from discrimination.

The Advancing Cutting Edge (ACE) Research Act (H.R. 5002), authored by Debbie Dingell and Fred Upton, would provide authority to fast track research on new non- addictive pain treatments. FDA Commissioner Scott Gottlieb said that the FDA is currently gathering data on pain medication with abuse-deterrent capabilities that will soon be released to the public. Mr. Gottlieb also told the Committee that the FDA currently has the legal authority to address the side effects of illicit drug use but having the authority to explore and expand risk assessment capabilities to drugs outside of the controlled substance category would be helpful to the public. Such authority is proposed in the discussion draft of the FDA Accelerated Approval and Breakthrough Therapy Status Act.

Members agreed on a variety of legislative topics, including proper disposal of unused opioids and an increase in the Food and Drug Administration’s (FDA) authority to seize and destroy packages carrying suspicious and unlabeled pills in international mail facilities (IMFs). Questions did arise, however, regarding legislation that would allow the FDA to consider the risks of misuse and abuse when approving a new drug and to apply the authority for the agency to expedite the approval process for pain and addiction treatments.


This hearing was one of several opioid-related hearings and developments that have occurred recently and Congress currently seems to be working in a bipartisan manner to develop thoughtful legislative packages should they opt to take up new opioid-related legislation in advance of the 2018 midterm elections.

The Subcommittee is preparing for a third hearing about the opioid crisis in April, which will cover Medicare, Medicaid and payer issues and plans. Committee Chairman Walden has said he wants the Committee to complete consideration of bills to address the opioid crisis by Memorial Day. On the Senate side, the Health, Education, Labor and Pensions (HELP) Committee is continuing to review several proposals before finalizing plans to convene a hearing sometime this spring.

« Previous article | Home| Next article »


Feed You can follow this conversation by subscribing to the comment feed for this post.

Verify your Comment

Previewing your Comment

This is only a preview. Your comment has not yet been posted.

Your comment could not be posted. Error type:
Your comment has been saved. Comments are moderated and will not appear until approved by the author. Post another comment

The letters and numbers you entered did not match the image. Please try again.

As a final step before posting your comment, enter the letters and numbers you see in the image below. This prevents automated programs from posting comments.

Having trouble reading this image? View an alternate.


Post a comment

Comments are moderated, and will not appear until the author has approved them.


Preview | Powered by FeedBlitz


April 2018
Sun Mon Tue Wed Thu Fri Sat
1 2 3 4 5 6 7
8 9 10 11 12 13 14
15 16 17 18 19 20 21
22 23 24 25 26 27 28
29 30