A bipartisan group in Congress has renewed its efforts to give the Food and Drug Administration more power to deny drug applications for opioids that are not clinically superior to currently available drugs.
Reps. David Trone (D-MD) and Dan Meuser (R-PA) on March 3 reintroduced an act that would allow the agency to require drug developers to demonstrate that new opioid candidates provides “material safety advantages over existing approved opioids” and are not “ineffective” in comparison, they said in a release.
The FDA currently lacks the authority to do so, and the aim of the bill, called the Ensuring the FDA Fully Examines Clinical Trial Impact and Vitalness before Endorsement (EFFECTIVE) Act, will help to limit the number of potentially unnecessary and possibly dangerous drugs on the market, they noted.
Opioid deaths increasing
Opioid use and overdoses are increasing, the lawmakers stated. “The 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,” they explained.
Meuser said that the 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.”
Drug companies may otherwise be unmotivated to develop opioids with fewer adverse side effects, such respiratory depression or addictive properties, Trone’s spokesperson Sasha Galbreath told Inside Health Policy.
“If this bill passes, drug manufacturers will be pressured to develop drugs that are an actual improvement on pre-existing ones,” she said.
In 2020, the rate of opioid-related overdose deaths among adults aged 65 and older were highest for those involving synthetic opioids (such as fentanyl, fentanyl analogs, and tramadol) other than methadone, according to the Centers for Disease Control and Prevention. These deaths increased by 53% from 2019 to 2020, the agency reported.
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