Drug makers and patient groups call on FDA to suspend fast‑track voucher program
The FDA held a town‑hall listening session on its Commissioner’s National Priority Voucher program, hearing from 17 speakers that included patient advocates, pharmaceutical companies and academic researchers.
The voucher scheme, introduced by former commissioner Marty Makary about a year ago, promises one‑to‑two‑month review timelines for drugs that can demonstrate alignment with so‑called national priorities such as health emergencies.
While a few participants praised the accelerated pathway for drugs already cleared under the program, the majority urged the agency to pause the initiative and reinstate the standard, transparent regulatory process that incorporates public feedback.
Critics also noted that the program appears to have been leveraged to reward companies whose actions support the current administration’s political objectives, raising concerns about the integrity of the fast‑track system.
This writeup was produced by pharmadog from original reporting by STAT.
Original headline: “STAT+: Drug companies, patient groups urge FDA to pause commissioner’s voucher program”
read at STAT ↗
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