FDA's National Priority Voucher programme stalled since Makary's exit, sources say

Mixed · 2The FDA has shelved the fast-track drug review initiative that former Commissioner Marty Makary launched during the Trump administration, according to a Reuters report carried by The Independent and relayed by STAT. 1 2 Mixed · 2The Commissioner's National Priority Voucher programme began in June 2025 and aimed to cut review times to as little as one to two months for therapies addressing national priorities, such as urgent unmet health needs. 1 2 Mixed · 2No new drugs have received a voucher since Makary left the agency in May, and the executive council of political appointees that oversaw drug reviews and had a central role in speeding approvals has gone dormant, internal documents show. 1 2

Left · 1Of the 22 drugs given a voucher, a dozen have been approved, including five since Makary's departure, and for several the programme sped approval by eight months or more. 1 Left · 1One source said FDA leadership told companies the agency is not moving forward with the programme but is keeping applications open, and that submitted applications do not advance. Rich Danker, a former HHS assistant secretary, said it is being quietly phased out. 1 Left · 1HHS 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 agency did not answer questions about the departure of the programme's lead or a new coordinator. 1

Mixed · 2Critics, including regulatory experts, argued the programme risked preferential treatment for companies meeting President Trump's demands, such as lower drug prices; awards went to companies that struck pricing deals with the White House, such as Eli Lilly and Novo Nordisk, and Merck KGaA received a voucher for Pergoveris under its deal. Lilly, Novo and Merck KGaA declined to comment. 1 2 Left · 1At a June public hearing, former FDA executive Peter Lurie criticised the programme for ceding review decisions to political appointees, risking safety with compressed timelines and lacking transparency; University of Pennsylvania professor Holly Fernandez Lynch called it "the worst of both worlds". 1 Left · 1The council included Tracy Beth Hoeg and Vinay Prasad, who have both left the FDA. Hoeg repeatedly raised safety objections to Sanofi's Tzield at three council meetings between October 2025 and April and withheld approval; staff granted accelerated approval in June after she and Makary left. Hoeg told Reuters she is concerned about children taking the drug, while Sanofi said the FDA concluded its benefits outweighed the risks. 1

Left · 1Documents show neither of the two newest voucher drugs cleared since Makary left, Merck's cholesterol pill Lipfendra and Revolution Medicines' pancreatic cancer drug Rasonque, was vetted by the council. Merck KGaA's Pergoveris remains unapproved three months after the FDA accepted its final application. For the nine drugs still in the programme, career scientists have resumed overseeing review timelines, two sources said. 1 Mixed · 2The FDA has had no commissioner since May. STAT separately noted that the Senate health committee has scheduled a vote for 18 November on Heidi Overton's nomination as commissioner, with chair Bill Cassidy undecided. 1 2