March 02, 2023

Manchin, Braun, King Introduce Bipartisan FDA Accountability for Public Safety Act

Washington, DC – Today, U.S. Senators Joe Manchin (D-WV), Mike Braun (R-IN) and Angus King (I-ME) introduced the bipartisan FDA Accountability for Public Safety Act to combat the drug epidemic that continues to ravage communities across the United States. The legislation would strengthen scientific and Congressional review throughout the opioid approval process, as well as hold FDA leadership accountable for final decisions regarding these dangerous and highly addictive substances.
“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 this bipartisan legislation with Senators Braun and King to strengthen accountability at the FDA 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 this commonsense reform to combat the drug epidemic that continues to ravage our nation.”
“The opioid crisis is the number one cause of death for young Hoosiers. It’s destroying families and robbing our state and our world of the good those young men and women would have created. Something desperately needs to change with how the FDA approaches evaluating and approving these drugs. I’m proud to join this strong, substantial, bipartisan solution to tackle the opioid crisis,” said Senator Braun.
“The opioid epidemic is devastating communities across our country. With Maine experiencing a 300% increase in overdose deaths over the past decade –– 716 last year alone – it’s clear Congress must take comprehensive action to address this crisis from every possible angle,” said Senator King. “The bipartisan FDA Accountability for Public Safety Act would be an important step to stop dangerous opioids from coming to the market and reaching consumers. There is no one solution to the epidemic, but through improved drug approval oversight and expanded accountability at the FDA, I hope we can prevent more needless deaths.”

The FDA Accountability for Public Safety Act would:
  • Strengthen the language included in the Comprehensive Action and Recovery Act (CARA) to ensure that new opioids and already-approved opioids seeking expanded labeling are subject to an advisory committee review and recommendation before the FDA makes an approval decision.
  • Require the FDA Commissioner to make the final decision regarding drug approval if the advisory committee does not approve of an opioid due to concern over consumer health and safety.
  • Require the FDA to submit a report to Congress that includes medical and scientific evidence regarding patient safety that clearly justifies why they ignored the advisory committee’s recommendation.
  • Prohibit the marketing of the drug until the report is submitted to Congress.

A one-pager on the FDA Accountability for Public Safety Act is available here.
The full text of the FDA Accountability for Public Safety Act is available here.

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