FDA and Critics Differ on Status of Drug Voucher Program

The FDA has reportedly shelved the Commissioner’s National Priority Voucher program, launched in 2025 to speed review of treatments for urgent health needs, though applications remain open and are not advancing. No new vouchers have been issued since former Commissioner Marty Makary left in May, and the political appointee council overseeing the initiative has gone dormant; 12 of the 22 voucher recipients have had their drugs approved. Critics raised concerns about oversight and possible preferential treatment for companies responding to current President Donald Trump’s demands, while the FDA and HHS say the pilot is ongoing and that the agency is reviewing feedback. The program’s status leaves companies uncertain about whether existing vouchers will continue to receive accelerated reviews.