By Patrick Wingrove and Yasmeen Abutaleb
NEW YORK, Nov 12 (Reuters) – The US Food and Drug Administration has shelved the fast-track drug review initiative launched during the Trump administration by former Commissioner Marty Makary, according to six sources familiar with the matter and internal documents.
Launched in June 2025, the Commissioner’s National Priority Voucher program aimed to slash drug review timelines to just one to two months for therapies addressing national priorities, such as urgent unmet health needs. However, critics pointed to possible preferential treatment for companies meeting demands of President Donald Trump, like offering drugs at lower prices.
Once touted as a bold fix for US pharmaceutical regulation, the program has been left adrift, offering a stark window into the internal chaos, infighting, and lack of steady leadership that have plagued the FDA, which has been without a commissioner since May.
Of the 22 drugs given a voucher, a dozen have been approved, including five since Makary left the FDA in May. For several drugs, the program sped approval by eight months or more.
However, no new drugs have gotten a voucher since Makary’s departure, and a key component of the program — an executive council of political appointees that oversaw drug reviews and had a central role in speeding approvals — has gone dormant, internal documents show.
Details of the voucher program being shelved have not been previously reported.
The pilot had drawn fierce criticism from regulatory experts over the handpicking of drugs and 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.
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, he 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.
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 requests for comment regarding the departure of the program’s lead or whether a new program coordinator had been appointed.
‘WORST OF BOTH WORLDS’
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.
During 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 is one example of the role the council played in the approval process. Tasked with evaluating the recommendation from the primary review team, Hoeg withheld her approval of the drug. At three separate executive council meetings between October 2025 and April, she repeatedly raised safety objections.
After she and Makary left, agency staff quickly granted accelerated approval in June.
Hoeg, a sports medicine physician who opposed COVID-19 vaccines and pandemic policies, 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 noted awards granted 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.
VOUCHER DRUGS MOVE FORWARD WITHOUT COUNCIL REVIEW
Of the two latest voucher applications for new drugs cleared since Makary left — Merck’s cholesterol pill Lipfendra and Revolution Medicines’ pancreatic cancer drug Rasonque — neither was 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.
Despite a high-profile Oval Office rollout with the company’s CEO last year to tout new fertility initiatives, Merck KGaA’s supposedly prioritized 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 on the review process, while US-based Merck did not respond to a comment request.
For the nine drugs still in the program, FDA career scientists have resumed overseeing review timelines, two sources said.
(Reporting by Patrick Wingrove in London and Yasmeen Abutaleb in Washington; Editing by Caroline Humer and Bill Berkrot)
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