The FDA's Commissioner's National Priority Voucher program, launched June 2025, has been effectively shelved by November 2026. No new drugs have received a voucher since former Commissioner Marty Makary left in May 2026, and the political-appointee executive council overseeing reviews has gone dormant. Of 22 drugs granted vouchers, 12 were approved as of November 2026. FDA career scientists have resumed overseeing the nine remaining applications.
Voucher program collapse
- ▪Two sources said that for the nine drugs still in the Commissioner's National Priority Voucher program, launched in June 2025, FDA career scientists have resumed overseeing review timelines as of November 2026
- ▪The FDA's Commissioner's National Priority Voucher program, launched in June 2025, has been shelved as of November 2026
- ▪No new drugs have received a Commissioner's National Priority Voucher since former FDA Commissioner Marty Makary left the FDA in May 2026
- ▪Companies submitting applications to the Commissioner's National Priority Voucher program were told by FDA leadership that the FDA is not moving forward with the program but is keeping applications open
FDA leadership vacuum
- ▪Former acting FDA drug center director Tracy Beth Hoeg left the FDA in 2026
- ▪The FDA has been without a commissioner since May 2026
- ▪Former FDA Commissioner Marty Makary left the FDA in May 2026
- ▪Former FDA biologics chief Vinay Prasad left the FDA in 2026
Political influence concerns
- ▪Critics noted that Commissioner's National Priority Vouchers were awarded to companies that reached drug-pricing deals with the White House, including Eli Lilly, Novo Nordisk, and Germany's Merck KGaA
- ▪Holly Fernandez Lynch, a health policy professor at the University of Pennsylvania, described the Commissioner's National Priority Voucher program as combining serious risks of political influence with potentially limited practical benefit
- ▪Former FDA executive Peter Lurie criticized the Commissioner's National Priority Voucher program for ceding review decisions to political appointees and risking consumer safety with compressed timelines
- ▪Critics pointed to possible preferential treatment under the Commissioner's National Priority Voucher program for companies meeting demands of President Donald Trump, such as offering drugs at lower prices
Drug approval outcomes
- ▪Revolution Medicines' pancreatic cancer drug Rasonque was approved on a swift timeline using the FDA's preexisting oncology review mechanisms without being vetted by the Commissioner's National Priority Voucher executive council
- ▪Of the 22 drugs given a Commissioner's National Priority Voucher, 12 had been approved as of November 2026, including five approved after Makary left the FDA in May 2026
- ▪For several drugs in the Commissioner's National Priority Voucher program, launched in June 2025, the program sped approval by eight months or more
- ▪Tracy Beth Hoeg withheld approval of Sanofi's diabetes drug Tzield and raised safety objections at three separate executive council meetings between October 2025 and April 2026
- ▪Germany's Merck KGaA's fertility treatment Pergoveris remained unapproved three months after the FDA accepted its final application following an eight-month rolling review, as of November 2026
- ▪Sanofi's diabetes drug Tzield received accelerated FDA approval in June 2026 after Tracy Beth Hoeg and Marty Makary left the FDA
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