The Health, Education, Labor, and Pensions has passed a bill by U.S. Senators Mike Braun (R-Ind.), Joe Manchin (D.-W.V.), and Tammy Baldwin (D-Wis.) to combat the opioid crisis. The bill, the Ensuring the FDA Fully Examines Clinical Trial Impact and Vitalness before Endorsement (EFFECTIVE) Act, would allow the Food and Drug Administration (FDA) to deny a new drug application for an opioid analgesic drug on the basis of the drug not being clinically superior to other commercially available drugs.
Braun
“The opioid epidemic has permeated every corner of Indiana and left communities devastated from the loss of life and opportunity,” Sen. Braun said. “Drug overdoses are now one of the most common causes of death in Indiana. I’m proud we were able to pass this bill out of committee because it’s a much-needed bipartisan solution to slow the growth of the crisis by tightening up the FDA approval process for opioid drugs by taking efficacy into account when approving new ones.”
Background
The EFFECTIVE Act would allow the FDA to deny a new drug application for an opioid analgesic drug on the basis of the drug not being clinically superior to other commercially available drugs.
This bill would provide further authority to the FDA so they can review the public health impact of every new opioid approval and deny new drug applications even if the pharmaceutical company sponsored clinical trials show that a particular drug is “safe.” Importantly, this bill fulfills a request to ensure that the FDA is able to fully implement the recommendations from the National Academy of Sciences, Engineering and Medicine’s (National Academies) 2017 report, Pain Management and the Opioid Epidemic.