FDA Listens to 17 Critics on Makary’s Voucher Program
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- Commissioner’s National Priority Voucher program offers one‑to‑two‑month FDA reviews for drugs that can demonstrate alignment with vague “national priorities.”
- FDA hosted a listening session on its White Oak Campus with 17 speakers representing patient groups, drug companies, and academic organizations.
- Marty Makary launched the voucher program about a year ago, and critics say its vague priority criteria expose it to political interference.
- Patient groups urged the FDA to pause the program and revert to standard review processes that require public comment.
- Some drug companies noted that the program has already enabled accelerated approval of certain drugs.
Why it matters: The pause request from 17 speakers means drug firms and patients could lose the one‑to‑two‑month review advantage, forcing the FDA to revert to standard timelines and public comment, which may delay new therapies.
