The FDA has released the second batch of recipients for the new "national priority voucher" program, with executives for two of the beneficiaries appearing in the Oval Office with President Donald Trump earlier today.
Eli Lilly’s star oral GLP-1 candidate orforglipron and Novo Nordisk’s Wegovy (semaglutide) were named voucher winners in a Nov. 6 release from the FDA. Executives from both companies stood alongside Trump at a press conference today highlighting their new pricing deals with the White House.
The other recipients are Boehringer Ingelheim’s zongertinib for HER2 lung cancer, which was recently approved as Hernexeos in August; Johnson & Johnson’s tuberculosis med bedaquiline, sold as Sirturo; GSK’s monoclonal antibody Jemperli (dostarlimab) for rectal cancer; and sickle cell disease gene therapy Casgevy (exagamglogene autotemcel), developed by Vertex Pharmaceuticals and CRISPR Therapeutics.
“National priority vouchers are granted to a select group of products where the company has agreed to increase affordability, domesticate manufacturing as a national security issue, or address an unmet public health need,” FDA Commissioner Marty Makary, M.D., said in the release. “We are pioneering new ways of bringing these cures and meaningful treatments to the market faster.”
Makary launched the priority program in June, and the agency began accepting applications in July. The program is designed to cut the typical 10- to 12-month review timeline down to just one or two months for medicines that align with U.S. national priorities.
The accelerated reviews will be enabled by a one-day meeting of multidisciplinary experts, the FDA said in the release, mimicking a tumor board where medical experts get together to discuss a patient’s cancer.
The first group of recipients was announced less than a month ago, on Oct. 17. That batch included a hearing loss gene therapy from Regeneron; Merck’s fertility drug pergoveris, which is already approved in 74 countries but not yet in the U.S.; and Sanofi’s Tzield (teplizumab), a drug for Type 1 diabetes.
The vouchers are nontransferable but can be retained if a company changes ownership. They can be tied to a specific investigational drug or can also carry an “undesignated” status and be used for a biopharma’s novel drug of choice. The FDA hasn't specified the classification of any national priority voucher winners.
Even in its short life, the FDA’s priority voucher program has attracted its fair share of criticism.
“The priority voucher program is not a ‘common sense’ approach as the FDA Commissioner claims, but a dangerous one,” Robert Steinbrook, M.D., health research group director at advocacy group Public Citizen, said in a June 18 statement. “Research has shown that when the FDA rushes to review and approve new drugs, there is a higher likelihood that these drugs will have safety problems after approval. The voucher program will only be a boon for Big Pharma at the expense of the American public and will likely bypass the agency’s advisory committee process that allows for outside independent input.”
And at least one expert has suggested the program could land the FDA in legal hot water.
“I think it is possible that it can end up in litigation to the extent that it is not clear why certain applicants were chosen,” Komal Karnik Nigam, a lawyer with global firm Hogan Lovells, told Regulatory Focus on July 24. “Given the amount of interest that we have seen for this program it seems possible there may be some kind of litigation in the future in terms of who did and who did not receive one of these vouchers.”