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# Manchin, Braun Introduce Opioids Superiority Bill
- URL: https://www.fdaweb.com/manchin-braun-introduce-opioids-superiority-bill/
- Published: 2022-05-26T12:00:00.000Z
- Updated: 2026-09-14T17:46:20.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5151919

U.S. Senators **Joe Manchin** (D-WV) and **Mike Braun** (R-IN) 5/26 introduced the Ensuring the FDA Fully Examines Clinical Trial Impact and Vitalness before Endorsement (EFFECTIVE) Act that would give FDA authority to deny a new drug application for an opioid analgesic drug if it isn’t clinically superior to other available drugs. The lawmakers noted that their bill was drafted in response to comments by FDA commissioner **Robert Califf**, who requested the additional authority to aid the agency as it considers whether to approve new and more powerful opioids.  

“The EFFECTIVE Act would address gaps in the FDA’s approval process by allowing them to take efficacy into account when approving new opioids to the market, limiting the approval of redundant, more harmful drugs,” Manchin said in a [release](https://www.manchin.senate.gov/newsroom/press-releases/manchin-braun-introduce-bipartisan-bill-to-address-gaps-in-opioid-approval-process?ref=fdaweb.com).