March 01, 2023

Manchin, Braun Introduce Three Bipartisan Bills to Overhaul FDA Opioid Regulations, Combat Drug Epidemic

Washington, DC – Today, U.S. Senators Joe Manchin (D-WV) and Mike Braun (R-IN) introduced three bipartisan bills to reform how the Food and Drug Administration (FDA) approves and manages opioid medications and combat the devastating drug epidemic that continues to ravage West Virginia, Indiana and every community across the United States. These commonsense pieces of legislation would strengthen scientific review throughout the opioid approval process, prioritize public health impacts over pharmaceutical interests and hold the FDA and its leadership accountable for their role in addressing the drug epidemic.
 
“In the last year, more than 106,000 Americans and 1,400 West Virginians died from drug related overdoses,” Senator Manchin said. “It’s heartbreaking to lose so many of our fellow Americans and West Virginians to this devastating epidemic and it’s far past time for Congress to take comprehensive, meaningful action to address the crisis. I’m proud to reintroduce these three bipartisan bills with Senator Braun to overhaul how the FDA approves and manages opioid medications and work towards a future where no family has to endure the pain of losing a loved one to substance use disorder. I encourage my colleagues on both sides of the aisle, along with FDA leadership, to support these critical, commonsense reforms to combat the drug epidemic that continues to ravage our nation.”
 
“The opioid epidemic continues to devastate communities and tear a hole through the Midwest. So many families are being robbed of their loved ones and communities robbed of their potential due to these addictive, deadly drugs. I’m proud to join with Senator Manchin to introduce these three bipartisan bills to overhaul the FDA approval process for opioid medications. Opioid drugs are different than other pharmaceuticals, and carry very different risks, and how we approve and manage these drugs must change as well,” said Senator Braun.
 
The Ensuring the FDA Fully Examines Clinical Trial Impact and Vitalness before Endorsement (EFFECTIVE) Act would:
 
  • Allow the FDA to deny a new opioid application on the basis of the drug not being clinically superior to other commercially available drugs.
  • Provide further authority to the FDA so they can review the public health impact of every new opioid approval.
  • Fulfill a request from FDA Commissioner Dr. Robert Califf to ensure that the FDA is able to fully implement the recommendations from the National Academies report.
 
A one-pager on the EFFECTIVE Act is available here.
The full text of the EFFECTIVE Act is available here.

The Changing the Culture of the FDA Act would:
 
  • Strengthen the FDA’s mission statement to include the agency’s responsibility for addressing the opioid epidemic.
    • Specifically, it would add: “The FDA is also responsible for protecting the public health by strongly considering the danger of addiction and overdose death associated with prescription opioid medications when approving these medications and when regulating the manufacturing, marketing, and distribution of opioid medications.”

A one-pager on the Changing the Culture of the FDA Act is available here.
The full text of the Changing the Culture of the FDA Act is available here.

The Protecting Americans from Dangerous Opioids Act would:
 
  • Require the FDA to remove one opioid medication currently on the market for every new opioid medication that they approve.
  • Instruct the FDA to prioritize revoking approval on non-abuse deterrent formulations and to consider the public health impact of the opioid being on the market.

A one-pager on the Protecting Americans from Dangerous Opioids Act is available here.
The full text of the Protecting Americans from Dangerous Opioids Act is available here.

A timeline of Senator Manchin’s work to combat the drug epidemic is available here.