Health

FDA shelves fast-track drug review voucher program

Washington, D.C. • November 12, 2026 • By Press Pass USA

The entrance to the Food and Drug Administration headquarters

Photo: U.S. Food and Drug Administration headquarters (file photo)

The Food and Drug Administration has shelved its fast-track drug review initiative, the Commissioner's National Priority Voucher program, Reuters reported Thursday, citing six sources familiar with the matter and internal documents. The program, launched in June 2025 under former Commissioner Marty Makary, promised to cut drug review times to just one to two months for therapies addressing national priorities.

No new drugs have received a voucher since Makary left the agency in May, and a key part of the program — an executive council of political appointees that oversaw drug reviews and played a central role in speeding approvals — has gone dormant, according to the report. The FDA has been without a commissioner since May.

A source familiar with the process said companies were told by FDA leadership that the agency is not moving forward with the program but is keeping applications open. "When companies submit them, they don't advance," the source said.

Rich Danker, a former assistant secretary at the Department of Health and Human Services, said the initiative is quietly being phased out, pointing to the departure of the program's top administrator. "No new vouchers have been awarded," he said.

The department pushed back on that account. HHS spokesperson Emily Hilliard said the pilot is ongoing and that the FDA is reviewing feedback from a June public hearing on it 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.

Of the 22 drugs given a voucher, a dozen have been approved, including five since Makary left in May. For several drugs, the program sped approval by eight months or more, Reuters reported.

The pilot drew fierce criticism from regulatory experts over the handpicking of drugs and the makeup of the council, which included former acting drug center director Tracy Beth Hoeg and former biologics chief Vinay Prasad. Both left the FDA earlier this year. Holly Fernandez Lynch, a health policy professor at the University of Pennsylvania, described the program as "the worst of both worlds," combining serious risks of political influence with potentially limited practical benefit, since many drugs might have qualified for other speedy review pathways.

At the June public hearing on the pilot, former FDA executive Peter Lurie criticized the program for ceding review decisions to political appointees, risking consumer safety with compressed timelines and lacking transparency, echoing other medical experts, patient groups and industry figures.

The review of Sanofi's diabetes drug Tzield showed the role the council played. Tasked with evaluating the recommendation from the primary review team, Hoeg withheld her approval of the drug and repeatedly raised safety objections at three executive council meetings between October 2025 and April. After she and Makary left, agency staff quickly granted accelerated approval in June. Hoeg told Reuters she is concerned about children being prescribed Tzield, saying a clinical trial showed "minimal at most" benefit when weighed against the product's safety risks. Sanofi said the FDA concluded the drug's benefits outweighed the risks and detailed its scientific rationale in a public memo.

Critics also noted that vouchers went to companies that reached drug-pricing deals with the White House, such as Eli Lilly and Novo Nordisk. Germany's Merck KGaA said in August it received a voucher for its fertility treatment Pergoveris as part of its drug-price agreement with the administration this year. Lilly, Novo and Merck KGaA declined to comment.

The two latest voucher drugs cleared since Makary left — Merck's cholesterol pill Lipfendra and Revolution Medicines' pancreatic cancer drug Rasonque — were not vetted by the executive council, documents show. Rasonque was approved on a swift timeline typical for breakthrough cancer therapies using the agency's preexisting oncology review mechanisms. Merck KGaA's Pergoveris, despite a high-profile Oval Office rollout last year, remains unapproved three months after the FDA accepted its final application following an eight-month rolling review.

For the nine drugs still in the program, FDA career scientists have resumed overseeing review timelines, two sources said — a return to the agency's standard process after a year in which political appointees held the pen on the fastest reviews.

Sources: Reuters, "US FDA shelves commissioner's voucher program for speedy drug reviews, sources say" by Patrick Wingrove and Yasmeen Abutaleb (Nov. 12, 2026, full text verified); Reuters syndication via WNCY, 98.5 The River and others (Nov. 12, 2026). Note: as of publication, no second independent outlet had published its own report on the program's status; the account above is attributed to Reuters and its sources throughout, and includes the Department of Health and Human Services' on-the-record response that the pilot is ongoing. Event date verified: the Reuters exclusive was published Thursday, November 12, 2026.