HELP Committee OKs EFFECTIVE Opioid Bill

The Senate HELP Committee has passed the Ensuring FDA Fully Examines Clinical Trial Impact and Vitalness before Endorsement (EFFECTIVE) Act that would allow the agency to deny an NDA for an opioid analgesic based on the drug not being clinically superior to other commercially available drugs. The measure is sponsored by Sens. Mike Braun (R-IN), Joe Manchin (D-WV), and Tammy Baldwin (D-WI).

A statement issued by Braun says the bill would provide further authority to FDA to review the public health impact of every new opioid approval and deny NDAs even if the company sponsored clinical trials showing the drug is safe.

“Importantly,” Braun says, “this bill fulfills a request from [FDA commissioner Robert] Califf to ensure that FDA is able to fully implement the recommendations from the National Academy of Sciences, Engineering, and Medicine’s report ‘Pain Management and the Opioid Epidemic.’”