US FDA shelves commissioner's voucher program for speedy drug reviews
XLV•The FDA has shelved its fast-track drug voucher program, six sources and internal documents say, though HHS says the pilot is ongoing. Of 22 drugs awarded vouchers, 12 have been approved; no new vouchers have been awarded since former Commissioner Marty Makary left in May.
1. Program stalled
Launched in June 2025, the Commissioner's National Priority Voucher program aimed to shorten reviews to one or two months for therapies addressing national priorities. Six sources familiar with the matter and internal documents say the FDA is no longer moving forward with the program, while keeping applications open; one source said submitted applications are not advancing.
2. Approvals and oversight
Twelve of the 22 drugs awarded vouchers have been approved, including five since Makary left in May. For several drugs, the program sped approval by eight months or more. No new vouchers have been awarded since his departure, and the executive council of political appointees that oversaw reviews has gone dormant. Two sources said FDA career scientists have resumed overseeing review timelines for the nine drugs still in the program.
3. Disputed status and criticism
HHS spokesperson Emily Hilliard said the pilot is ongoing and the FDA is reviewing feedback from a June public hearing to refine its framework. Critics raised concerns about political influence, safety and transparency. The FDA approved Sanofi's Tzield in June after former council member Tracy Beth Hoeg had raised safety objections; Sanofi said the agency concluded the drug's benefits outweighed its risks.
