07 March 2023- Today, U.S. Congressmen David Trone (D-MD) and Dan Meuser (R-PA) reintroduced the Ensuring the FDA Fully Examines Clinical Trial Impact and Vitalness before Endorsement (EFFECTIVE) Act to allow the FDA to deny a new drug application for an opioid if it is not clinically superior to other commercially available drugs.
In February 2023, the Food and Drug Administration (FDA) shared a report commissioned to review FDA’s opioid-related activities. In the report’s release, the FDA notes that the agency currently “lacks the statutory authority to require that drug developers seeking approval for the marketing of new opioid products demonstrate that their products offer material safety advantages over existing approved opioids.”
As opioid use and overdoses increase, this effort furthers the FDA’s authority to review the potential public health impact of every new opioid approval and deny applications for new drugs if they cannot prove their ability to serve as a safer or more effective option for patients.
This comes as more than 108,000 Americans died from drug overdoses in 2021— more than twice the number of U.S. traffic fatalities or gun violence deaths during that period. The opioid epidemic has continued to take the lives of Americans of all ages, but tragically, drug overdoses have become the leading cause of death for 18-to-45-year-olds in the U.S.
“The number of opioid-related deaths in this country is heartbreaking and, above all, it’s unacceptable,” said Congressman Trone. “As our nation’s leaders, we need to understand the impacts new drugs have on public health to better address this epidemic. With so many lives hanging in the balance, we cannot afford to wait for another Congress to pass the EFFECTIVE Act – let’s get the job done.”
“This legislation would help us avoid past tragic outcomes regarding the efficacy and safety of new drugs before they are on the market and prescribed to consumers,” said Congressman Meuser. “Giving the FDA authority to thoroughly vet new medications to make sure they can be prescribed to patients looking for the safe alleviation of pain will hopefully keep them from experiencing unintended and tragic consequences. This bill would ensure only superior and tested medications would make it to our medicine cabinets.”
The EFFECTIVE Act’s companion bill is led by Senators Joe Manchin (D-WV) and Mike Braun (R-IN) in the Senate.
“In the last year, more than 106,000 Americans and 1,400 West Virginians died from drug-related overdoses,” Senator Joe 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 Senator Manchin to introduce these three bipartisan bills to overhaul the FDA approval process for opioid medications. Opioid drugs are different from other pharmaceuticals, and carry very different risks, and how we approve and manage these drugs must change as well,” said Senator Mike Braun.
The bill has been endorsed by the following organizations: Community Anti-Drug Coalitions of America (CADCA), the SAFE Project, and National Association of Addiction Treatment Providers.
For bill text, click here.