Key facts
- Of 22 drugs given a voucher, a dozen were approved, including five after Makary left in May 2026.
- No new drugs have received a voucher since Makary's departure, internal documents show.
- The executive council of political appointees that oversaw voucher reviews has gone dormant.
- A source said FDA leadership told companies the agency is not moving forward but is keeping applications open.
- HHS spokesperson Emily Hilliard said the pilot is ongoing and the FDA is reviewing feedback from a June hearing.
- Nine drugs remain in the program, with FDA career scientists overseeing their review timelines, two sources said.
The US Food and Drug Administration has shelved the Commissioner's National Priority Voucher program, the fast-track drug review initiative launched in June 2025 under former Commissioner Marty Makary, according to six sources familiar with the matter and internal documents, Reuters reported on November 12, 2026.
The pilot aimed to cut review timelines to one to two months for therapies addressing national priorities such as urgent unmet health needs. Of the 22 drugs given a voucher, a dozen have been approved, including five since Makary left the FDA in May 2026, and for several drugs the program sped approval by eight months or more, the report said.
No new drugs have received a voucher since Makary's departure, and the executive council of political appointees that oversaw voucher reviews has gone dormant, the internal documents showed. A source familiar with the process said FDA leadership told companies the agency is not moving forward with the program but is keeping applications open, and that submissions do not advance.
Rich Danker, a former assistant secretary at the Department of Health and Human Services, said the initiative is being quietly phased out, pointing to the departure of the program's top administrator and the absence of new vouchers. HHS spokesperson Emily Hilliard said the pilot is ongoing and that the FDA is reviewing feedback from a June public hearing to refine the framework. The agency did not respond to questions about the departure of the program's lead or whether a new coordinator had been appointed.
The program drew criticism from regulatory experts over the handpicking of drugs and the council's makeup, which included former acting drug center director Tracy Beth Hoeg and former biologics chief Vinay Prasad. Both left the FDA in 2026. Holly Fernandez Lynch, a health policy professor at the University of Pennsylvania, called the program "the worst of both worlds," citing risks of political influence and limited practical benefit.
Sanofi's diabetes drug Tzield illustrates the council's role. Hoeg withheld approval and raised safety objections at three executive council meetings between October 2025 and April 2026, and agency staff granted accelerated approval in June 2026 after she and Makary left. Hoeg told Reuters she is concerned about children being prescribed Tzield, saying a clinical trial showed "minimal at most" benefit against the product's safety risks. Sanofi said the FDA concluded the drug's benefits outweighed its risks and detailed its rationale in a public memo.
Critics noted awards to companies that reached drug-pricing deals with the White House, including Eli Lilly and Novo Nordisk. Merck KGaA said in August 2026 it received a voucher for its fertility treatment Pergoveris as part of its drug-price agreement with the administration. Lilly, Novo and Merck KGaA declined to comment.
The two latest voucher applications cleared since Makary left, Merck's cholesterol pill Lipfendra and Revolution Medicines' pancreatic cancer drug Rasonque, were not vetted by the executive council, the documents showed. Rasonque was approved on a timeline typical for breakthrough cancer therapies under the agency's existing oncology review mechanisms. Pergoveris remains unapproved three months after the FDA accepted its final application following an eight-month rolling review. Merck KGaA and Revolution declined to comment, and US-based Merck did not respond to a request. For the nine drugs still in the program, FDA career scientists have resumed overseeing review timelines, two sources said.