FDA Prioritizes Nine Drugs Under New Fast-Track Initiative

The U.S. Food and Drug Administration (FDA) has announced the selection of nine companies to receive priority review vouchers through its newly established Commissioner’s National Priority Voucher (CNPV) pilot program. This initiative, revealed on October 19, 2023, aims to expedite the review process for drugs and biologics that address significant national health priorities.

This new program intends to shorten the typical review timeline from 10 to 12 months to just one to two months for those who submit complete applications. The FDA will also facilitate enhanced communication between developers and review staff throughout the process. While the expedited timeline is a significant improvement, the FDA retains the right to extend the review period if applications are incomplete or if there are manufacturing challenges.

Innovative Approaches to Drug Approval

FDA Commissioner Marty Makary emphasized that the CNPV program signifies a shift towards more flexible and mission-driven regulatory practices. “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 stated. He highlighted the need to modernize the review process to better serve the public’s health needs.

The selected therapies target a range of conditions, including infertility, Type 1 diabetes, pancreatic cancer, deafness, blindness, and nicotine addiction. Notable products include:

• Pergoveris for infertility
• Teplizumab for Type 1 diabetes
• Cytisinicline for nicotine addiction related to vaping
• 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 aimed at domestic manufacturing of a common antibiotic

During an October 16 press conference focused on expanding access to in vitro fertilization, former President Donald Trump highlighted Pergoveris as a potentially cost-effective alternative to an existing, more expensive infertility treatment. He noted, “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.”

Collaborative Review Model Enhances Efficiency

The CNPV pilot program employs a team-based review system, bringing together physicians and scientists from various disciplines to evaluate applications concurrently. This collaborative approach culminates in a one-day, “tumor board style” meeting to finalize decisions. Each division within the FDA’s drug review sector nominated a candidate product for consideration, while sponsors were encouraged to submit their own applications.

The FDA anticipates announcing further groups of CNPV recipients in the coming months, as the program seeks to address unmet medical needs and foster innovation in drug development. By prioritizing these critical therapies, the FDA aims to positively impact public health outcomes and reduce overall healthcare costs.