The FDA has shelved the Commissioner’s National Priority Voucher program, which former Commissioner Marty Makary launched in 2025 to cut drug review times to one to two months, according to a Nov. 12 Reuters report citing six sources and internal documents. HHS disputes that characterization, saying the pilot is ongoing.
No new drugs have received a voucher since Dr. Makary left the agency in May, and an executive council of political appointees that oversaw the reviews has gone dormant, Reuters reported. Of the 22 drugs given a voucher, a dozen have been approved, including five since Dr. Makary’s departure. For several drugs, the program sped approval by eight months or more, according to the report.
One source told Reuters that FDA leadership told companies the agency is not moving forward with the program but is keeping applications open, and that applications submitted now do not advance. For the nine drugs still in the program, career scientists have resumed overseeing review timelines, two sources said.
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, according to Reuters. The agency did not respond to questions about the departure of the program’s lead or whether a new coordinator has been named.
The two most recent voucher drugs approved since Dr. Makary left, Merck’s cholesterol pill Lipfendra and Revolution Medicines’ pancreatic cancer drug Rasonque, were not vetted by the council. Rasonque was approved on a timeline typical for breakthrough cancer therapies under existing oncology mechanisms, according to Reuters. Germany-based Merck KGaA’s fertility treatment Pergoveris, which received a voucher as part of a drug-pricing agreement, remains unapproved three months after the FDA accepted its final application.
