FDA commissioner's drug review plan sparks alarm
AP News • • business
Key Points:
- The FDA commissioner Marty Makary’s National Priority Voucher program aims to drastically shorten drug review times to as little as one month, raising concerns about potential violations of legal, ethical, and scientific standards within the agency.
- FDA staff report confusion and anxiety due to unclear procedures and political interference, with some reviewers being told to skip standard regulatory steps to meet aggressive deadlines, notably in the review of a new anti-obesity drug.
- The program bypasses traditional FDA approval processes by having senior political appointees, rather than scientific reviewers, make final decisions, creating legal risks and undermining established scientific review protocols.
- The voucher program, initially a pilot for a few drugs, has expanded significantly without formal federal regulations, sparking questions about its legality and
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