FDA Lets Makary's Fast-Track Drug Voucher Pilot Go Dormant

Six sources and internal documents say the FDA has set aside the Commissioner's National Priority Voucher program, a Trump-era initiative pitched by former Commissioner Marty Makary. No new drugs have received a voucher since Makary departed in May, and the executive council of political appointees that oversaw reviews and drove speedy approvals has gone dormant. The details haven't been reported before.

Launched in June 2025, the pilot promised to compress drug review timelines to one or two months for therapies targeting national priorities like urgent unmet health needs. It handed vouchers to 22 drugs; a dozen have been approved, including five after Makary left. For several of them, the program shaved eight months or more off the clock, while critics warned it could reward companies that cut drug-pricing deals with President Donald Trump.

Rich Danker, a former assistant secretary at the Department of Health and Human Services, said the initiative is quietly being phased out and pointed to the exit of the program's top administrator. A source familiar with the process said FDA leadership told companies the agency isn't moving forward with the program but is keeping applications open — and that submissions don't advance. HHS spokesperson Emily Hilliard countered that the pilot is ongoing and the FDA is reviewing feedback from a June public hearing to refine it. The agency didn't answer questions about the program lead's departure or a new coordinator.

Sanofi's diabetes drug Tzield shows how the council operated. Former acting drug center director Tracy Beth Hoeg withheld her approval and raised safety objections at three executive council meetings between October 2025 and April. After she and Makary left, agency staff granted accelerated approval in June. Hoeg, a sports medicine physician who opposed COVID-19 vaccines and pandemic policies, told Reuters she worries about children being prescribed Tzield, saying a trial showed "minimal at most" benefit against the product's risks. Sanofi said the FDA concluded benefits outweighed risks and laid out its reasoning in a public memo.

Critics flagged vouchers handed to companies with White House drug-pricing deals, including Eli Lilly and Novo Nordisk. Germany's Merck KGaA said in August it got a voucher for fertility treatment Pergoveris as part of its pricing agreement; Lilly, Novo and Merck KGaA declined to comment. The two newest voucher drugs cleared since Makary's exit — Merck's cholesterol pill Lipfendra and Revolution Medicines' pancreatic cancer drug Rasonque — were never vetted by the council, and Rasonque rode the FDA's preexisting oncology review path. Pergoveris is still unapproved three months after the FDA accepted its final application, following an eight-month rolling review, despite an Oval Office rollout with the company's CEO.

For the nine drugs still in the program, FDA career scientists have resumed overseeing review timelines, two sources said. Holly Fernandez Lynch, a health policy professor at the University of Pennsylvania, called the program "the worst of both worlds" — political influence risk paired with limited practical upside, since many drugs could have qualified for other fast pathways anyway.