FDA quietly shelves Trump’s flagship drug fast-track program amid reports of agency chaos

Résumé détaillé

The Food and Drug Administration has shelved the fast-track drug review initiative launched during the Trump administration by former Commissioner Marty Makary

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No new drugs have been given a voucher under the FDA's fast-track review program since Marty Makary left the agency in May. According to internal documents and six sources familiar with the matter, the initiative has now been shelved. The shelving of the National Priority Voucher program has not been previously reported.

The Commissioner's National Priority Voucher program was launched in June 2025, during the Trump administration. Its aim was to compress drug review timelines to as little as one to two months for therapies addressing national priorities, such as urgent unmet health needs. Once presented as a bold fix for U.S. pharmaceutical regulation, the initiative has effectively stalled.

Critics, however, pointed to possible preferential treatment for companies meeting President Donald Trump's demands, such as offering drugs at lower prices. The program has been left adrift, offering a stark window into the internal chaos, infighting, and lack of steady leadership that has plagued the FDA, which has been without a commissioner since May.

A key component of the scheme, an executive council of political appointees that oversaw drug reviews and had a central role in speeding approvals, has gone dormant, internal documents show. Of the 22 drugs given a voucher, a dozen have been approved, including five since Makary's departure. For several drugs, the program sped approval by eight months or more.

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. 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.

He said no new vouchers have been awarded.

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