FDA announces first-round recipients of national priority voucher program
The US Food and Drug Administration (FDA) has selected nine companies to participate in the recently announced Commissioner’s National Priority Voucher (CNPV) pilot program. As part of the program, the companies will undergo an expedited review process that will last between one to two months.FDA said that the pilot participants have created products “with significant potential to address a major national priority.” The priorities include meeting a significant unmet medical need, reducing downstream healthcare utilization, addressing a public health crisis, boosting domestic manufacturing, and increasing medication affordability through Most Favored Nation pricing.
The program was announced by FDA Commissioner Marty Makary in June.(RELATED: FDA announces new voucher program for drugs tied to national priorities, Regulatory Focus 17 June 2025).
It aims to reduce review times that typically take 10 to 12 months to one to two months, improve communication throughout the review process, provide a multidisciplinary team-based evaluation, and the possibility of accelerated approval if if the product meets requirements. FDA, however, emphasized that the program does not replace existing priority review initiatives.
The products selected for the pilot program include treatments for a wide range of conditions and include:
- EMD Serono’s Pergoveris for infertility
- Sanofi’s Teplizumab for Type I diabetes
- Achieve Life Sciences’ Cytisinicline for nicotine vaping addiction
- Regeneron’s DB-OTO for deafness
- Dompe’s Cenegermin-bkbj for blindness
- Revolution Medicines’ RMC-6236 for pancreatic cancer
- Disc Medicine’s Bitopertin for porphyria
- Phlow Corporation’s Ketamine for domestic manufacturing of a drug for general anesthesia
- USAntiobiotics’ Augmentin XR for domestic manufacturing of a common antibiotic
“We are not taking a passive approach role at FDA,” said Makary. “We are talking to reviewers and going down in the pipeline.
“We’re asking the reviewers on the front line, ‘are you seeing anything that is amazing?’” he added. “If we do, we are calling the companies and we’re moving them to the front of the line.”
On 16 October, the White House announced that EMD's selection of Pergoveris aligns with the Trump administration’s goal to reduce drug prices, as outlined in the President’s MFDN order. Additionally, it coincides with EMS Serono’s objective of manufacturing the drug domestically.
FDA expects to announce another group of CNPV recipients in the coming months.
Legal experts who spoke to Focus in July said there could be legal challenges to the program over how participants were chosen, especially given the limited number of vouchers available, and noted that there are still unanswered questions about how the program works. (RELATED: Questions remain as FDA opens submissions for new priority voucher program, Regulatory Focus 24 July 2025).
FDA announcement on voucher program
