April 29, 2021

Manchin, Capito, King Bill To Prioritize Public Safety When FDA Approves New Opioids

Washington, DC – Today, U.S. Senators Joe Manchin (D-WV), Shelley Moore Capito (R-WV) and Angus King (I-ME) introduced the FDA Accountability for Public Safety Act which would ensure experts are heard when the Food and Drug Administration (FDA) considers new, dangerous opioid medications. In 2020, over 90,000 Americans died from drug overdoses, and it is likely that 51% of those deaths involved opioids or synthetic opioids.

“In 2020, over 246 Americans died every day from drug overdoses – the deadliest year ever recorded. We must address the drug epidemic that has taken over 90,000 Americans in the last year and ravaged so many states like my home state, West Virginia,” Senator Manchin said. “Our bipartisan bill will ensure the FDA listens to the experts when they consider and approve new, dangerous opioids that can harm countless Americans and West Virginians so the FDA never approves an opioid that puts public health at risk again. I urge my bipartisan colleagues to join our legislation to address the FDA’s longstanding involvement in the drug epidemic.”

“One of the main contributors to West Virginia’s opioid crisis was the addictive opioids that were aggressively marketed, and overprescribed to our citizens,” Senator Capito said. “It is essential we listen to the experts on the advisory committees during the FDA drug approval process, especially for opioids. This legislation would hold the FDA more accountable and protect future generations from the scourge of addiction, which has only worsened during the COVID-19 pandemic.”

“2020 was Maine’s deadliest year on record for drug overdoses – and so far, 2021’s numbers look even worse. The epidemic of substance use disorders continues to devastate communities throughout Maine and across the country,” said Senator King. “I’m for any solution that helps us address this crisis – including increasing accountability at the FDA to prevent dangerous, addictive opioids from coming to market in the first place. We’ve lost too many loved ones and neighbors to overdoses; it’s time to revisit the process that makes these preventable deaths possible.”

The FDA convenes an advisory committee of scientific experts when a matter is of significant public interest, highly controversial, or in need a specific type of expertise. In recent years, however, the FDA has either ignored its advisory committee’s recommendations or failed to seek its counsel. In 2013, the FDA approved the very powerful opioid, Zohydro, despite the advisory committee voting 11-2 against approval of the drug due to their concerns about the safety of the drug. And since that time, two new opioid medications, Targiniq and Hysingla, have been approved without an advisory committee meeting at all.

The FDA Accountability for Public Safety Act would:

  • Strengthen the language included in CARA to ensure that both new opioids and already-approved opioids seeking approval for expanded labeling are subject to advisory committee review and recommendation before the FDA makes a decision about approval.
  • 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. It must also include any conflicts of interest that FDA officials involved in the decision may have.
  • Prohibit the marketing of the drug until the report is submitted to Congress.

Background information can be found here.

Bill text can be found here.