FDA Awards Second Round of Commissioner's National Priority Vouchers to Major Biopharma Companies

The U.S. Food and Drug Administration (FDA) has announced the recipients of its second batch of Commissioner's National Priority (CNP) vouchers, awarding six to larger biopharma companies for drugs that are mostly already on the market. This move marks a shift from the first round of recipients, which included a mix of large and small pharmas at various stages of drug development.

Voucher Recipients and Their Products

The latest CNP vouchers were awarded to:

• Novo Nordisk for Wegovy (semaglutide), approved in 2021 for obesity and related health conditions
• Vertex and CRISPR Therapeutics for Casgevy, approved in December 2023 for sickle cell disease
• Eli Lilly for orforglipron, an investigational drug for obesity and related health conditions
• Boehringer Ingelheim for zongertinib (Hernexeos), approved in August for HER2 lung cancer
• Johnson & Johnson for bedaquiline (Sirturo), approved in 2024 for drug-resistant tuberculosis in young children
• GSK for dostarlimab (Jemperli), approved in 2023 for endometrial cancer

FDA Commissioner Marty Makary stated, "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."

Implications and Industry Response

The CNP vouchers, introduced in June, are designed to expedite the drug review process for programs aligned with U.S. national priorities. With a CNP voucher, the review timeline could be reduced from 10-12 months to just 1-2 months.

Steven Grossman, a policy and regulatory consultant, noted that the first round of vouchers "embodied a new definition of 'unmet medical need,' one not tied to the traditional standard of serious and life-threatening diseases." He highlighted the inclusion of vouchers for investigational drugs addressing deafness, blindness, infertility, and onshoring to reduce ongoing drug shortages.

Pricing Agreements and White House Discussions

Coinciding with the voucher announcements, executives from Novo Nordisk and Eli Lilly met with the Trump administration to discuss an agreement to sell their GLP-1 medicines—semaglutide (including Wegovy) and tirzepatide, respectively—at approximately $350 per month through the administration's direct-to-consumer platform TrumpRx.

While the FDA's announcement did not clarify why vouchers were awarded to already-approved drugs, this development, along with the pricing discussions, suggests a potential shift in focus towards increasing affordability and access to existing treatments that address significant public health concerns.