FDA May Scrap Makary's Priority Voucher Program

Reuters reports the FDA may end the Commissioner's National Priority Voucher program, which has produced around a dozen product approvals.

Updated on Nov. 12, 2026 in Biotech

FDA May Scrap Makary's Priority Voucher Program

The FDA may scrap the Commissioner's National Priority Voucher program launched under former Commissioner Marty Makary, according to a Reuters report citing six sources and internal FDA documents. The FDA has paused issuing vouchers since Makary's departure, and no drugs have been cleared under the scheme since then.

Why it matters

The program offers a route that can deliver regulatory decisions in weeks rather than months, so its fate affects how quickly new treatments reach the U.S. market. Critics argue its selection process is opaque and lacks statutory backing, making its future a live policy question.

The program's route can deliver regulatory decisions on marketing applications in weeks rather than months, and an executive council of political appointees oversaw drug reviews. Whether the FDA formally ends the program has not been confirmed.

The players

Marty Makary

Marty Makary is a former FDA Commissioner who launched the National Priority Voucher program during his 13-month tenure.

U.S. Food and Drug Administration

The U.S. Food and Drug Administration is the federal agency responsible for regulating drugs, medical devices, and food safety in the United States.

The details

The FDA published a request for comments in the Federal Register on the program's eligibility criteria, selection, and review procedures, and held a public hearing on it in June. An executive council of political appointees oversaw drug reviews and played a central role in speeding approvals.

June 2025: The Commissioner's National Priority Voucher program is announced.
June: The FDA holds a public hearing on the program.
Makary resigns as FDA Commissioner after 13 months in the role.
Since Makary's departure, the FDA has paused issuing vouchers and no drugs have been cleared under the scheme.

Roadmap

The possible end of the National Priority Voucher program would mark a shift in how the FDA accelerates drug reviews after leadership change. Its fate also bears on Democrats' scrutiny of Medicare Most Favored Nation pricing deals.

If the program continues, eligible drugs could reach patients in weeks rather than months after review. If it is scrapped, approval timelines for priority products would likely return to standard review periods.

The takeaway

The fate of a fast-track approval program can change how quickly patients access new treatments, so watching FDA policy decisions matters for anyone following drug access. Readers can track formal FDA notices in the Federal Register for confirmation of any change.