Legal questions swirl around FDA's new expedited drug program, including who should sign off
Yahoo • • business
Key Points:
- The FDA commissioner's new National Priority Voucher program aims to drastically shorten drug review times to as little as one month, raising concerns among agency staff about potential violations of legal, ethical, and scientific standards.
- The program bypasses traditional scientific review processes by involving political appointees and senior leaders in approval decisions, causing confusion and anxiety among FDA reviewers, especially regarding a high-profile anti-obesity drug.
- Legal uncertainties persist, with key FDA officials declining to sign off on approvals due to potential liability, leading to an unusual approval process managed by senior leaders rather than career scientists.
- The voucher program, initially a pilot for five drugs, has expanded to 18 awards amidst significant staff turnover and internal upheaval, with some drugmakers pressuring the
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