April 26, 2021

Manchin Bill To Change FDA Culture, Address Role In Drug Epidemic

Washington, DC – Today, U.S. Senator Joe Manchin (D-WV) reintroduced the Changing the Culture of the FDA Act, which would amend the Food and Drug Administration (FDA) mission statement to include the agency’s responsibility for addressing the ongoing drug epidemic.

“In 2020, more than 87,000 Americans died from drug overdoses, and we can safely assume that 51% of those deaths involved opioids or synthetic opioids. The FDA must acknowledge their involvement in this national crisis that has taken far too many West Virginians and Americans from their families, friends, and loved ones. As the federal agency overseeing the approval of opioids and synthetic opioids, the FDA played and continues to play an essential role in the drug epidemic.

“My bill would change the FDA mission statement to include language that addresses the agency’s need and responsibility to address the epidemic that has ravaged our nation and my home state of West Virginia. The COVID-19 pandemic continues to worsen this already heartbreaking drug epidemic, it is imperative now more than ever that our Federal agencies take responsibility for addressing this crisis. I look forward to working with my colleagues on both sides of the aisle to address this continuing crisis that has impacted each and every one of us.”

Senator Manchin’s recent efforts to address the drug epidemic:

  • On April 22nd, Senators Manchin and Tim Scott introduced the bipartisan Non-Opioid Directive (NOD) Act, which would establish a non-opioid directive form that allows patients to notify health professionals that they do not wish to be treated with opioids.
  • On April 21st, Senator Manchin delivered remarks on the Senate Floor urging Congress to pass his bipartisan bill, FIGHT Fentanyl Act, which would permanently reschedule fentanyl and fentanyl related substances.
  • On March 26th, Senator Manchin led seven Senators in calling on President Joe Biden to bring in new FDA leadership to address the growing opioid epidemic that has been exacerbated by the COVID-19 pandemic.

Background information can be found here.

Bill text can be found here.