Senate bill would add hurdles to some opioid approvals

Sens. Joe Manchin (D-W.Va), David Vitter (R-La.), Shelly Moore Capito (R-W.Va) and Tim Kaine (D-Va.) introduced legislation Wednesday that would require FDA to hold advisory committee meetings for all opioids under review. The bill also would force FDA to publicly justify its approval of any opioid drugs not recommended by advisory committees for safety reasons.

The FDA Accountability for Public Safety Act stipulates that the FDA commissioner make a final decision regarding approval of opioids not recommended by the committees due to safety concerns, and testify before Congress if called upon. FDA also would have to submit a report to Congressional committees explaining why the agency approved an opioid against an advisory committee's vote, including scientific evidence related to patient safety. ...