The FDA announced the first round of pharmaceuticals that will receive expedited reviews under the Commissioner’s National Priority Voucher (CNPV) pilot program.
The program accelerates the 10-12 month timeline of review by “convening a multidisciplinary team of physicians and scientists for a team-based review, interacting frequently with the sponsor to clarify questions, and completing review of the application concurrently,” the FDA explained. The team will meet for a one-day meeting upon completing review steps.
Recipients of the voucher program are products with “significant potential to address a major national priority, such as meeting a large unmet medical need, reducing downstream health care utilization, addressing a public health crisis, boosting domestic manufacturing, or increasing medication affordability with Most Favored Nation pricing.”
“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,” said FDA Commissioner Marty Makary. “We must modernize the review process and try new approaches to meet the needs of the American people.”
Products selected for the program include:
- infertility drug Pergoveris
- Type I diabetes drug Teplizumab
- Cytisinicline for combatting nicotine vaping addiction
- DB-OTO for deafness
- Cenegermin-bkbj for blindness
- RMC-6236 for treating pancreatic cancer
- Bitopertin for porphyria
- Ketamine for domestic manufacturing of a critical drug for general anesthesia
- Augmentin XR for domestic manufacturing of a common antibiotic
The voucher program comes as President Trump hailed Pergoveris for in vitro fertilization (IVF) treatments. “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,” Trump said during a news conference.
