WASHINGTON, D.C. — The U.S. Food and Drug Administration has awarded nine companies priority review vouchers under its new Commissioner’s National Priority Voucher (CNPV) pilot program, designed to accelerate approval of drugs and biologics that target major national health priorities.
Announced Thursday, the initiative aims to shorten review times and encourage innovation for products that address unmet medical needs, reduce downstream health care costs, or enhance domestic drug manufacturing. Voucher recipients will receive decisions within one to two months of submitting a complete application, far faster than the FDA’s traditional 10- to 12-month timeline.
Under the pilot, recipients also gain enhanced communication with review staff throughout the development and review process. The FDA retains discretion to extend the review period if applications are incomplete or manufacturing issues arise.
FDA Commissioner Marty Makary said the program represents a shift toward more adaptive, mission-driven regulation. “One of our core goals is to deliver more cures and meaningful treatments—especially ones that have an outsized impact on our most pressing national priorities,” Makary said. “We must modernize the review process and try new approaches to meet the needs of the American people.”
Among the nine products selected are therapies targeting infertility, Type 1 diabetes, pancreatic cancer, deafness, blindness, and nicotine addiction. They include:
- Pergoveris for infertility
- Teplizumab for Type I diabetes
- Cytisinicline for nicotine vaping addiction
- DB-OTO for deafness
- Cenegermin-bkbj for blindness
- RMC-6236 for pancreatic cancer
- Bitopertin for porphyria
- Ketamine for domestic production of a critical anesthesia drug
- Augmentin XR for domestic manufacturing of a common antibiotic
President Trump, speaking at an Oct. 16 news conference on expanding access to in vitro fertilization, highlighted Pergoveris as a potential cost-saving alternative to a leading infertility treatment. “This drug would directly compete against a much more expensive option that currently has a monopoly in the American market, and this will bring down costs very significantly,” he said.
The CNPV pilot uses a team-based review model that brings together physicians and scientists from multiple disciplines. Applications are assessed concurrently, culminating in a one-day “tumor board style” meeting to finalize decisions.
Each FDA drug review division nominated a candidate product for consideration, while sponsors were also invited to apply. The agency expects to name an additional group of CNPV recipients in the coming months.
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