The U.S. 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 reviewed by Reuters.
Launched in June 2025, the Commissioner's National Priority Voucher program aimed to slash drug review timelines to one or two months for therapies addressing national priorities, such as urgent unmet health needs. Critics pointed to possible preferential treatment for companies meeting demands of President Donald Trump, like offering drugs at lower prices.
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. But no new drugs have received a voucher since his departure, and the executive council of political appointees that oversaw reviews and played a central role in speeding approvals has gone dormant, internal documents show.
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. 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 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. For the nine drugs still in the program, FDA career scientists have resumed overseeing review timelines, two sources said.
