FDA Unveils Second Round of National Priority Voucher Recipients, Including Obesity Drug Leaders

The U.S. Food and Drug Administration (FDA) has announced the second batch of recipients for its new "national priority voucher" program, highlighting a continued focus on expediting the development and approval of drugs addressing critical health needs. The latest round of vouchers includes notable entries in the obesity treatment space, as well as therapies for cancer, tuberculosis, and sickle cell disease.

Obesity Giants and Cancer Treatments Lead the Pack

Eli Lilly's oral GLP-1 candidate orforglipron and Novo Nordisk's Wegovy (semaglutide) were among the high-profile recipients named in the FDA's November 6 release. Executives from both companies appeared alongside President Donald Trump in the Oval Office, underscoring the White House's involvement in new pricing agreements for these treatments.

Other voucher recipients include Boehringer Ingelheim's zongertinib for HER2 lung cancer, recently approved as Hernexeos; Johnson & Johnson's tuberculosis medication bedaquiline (Sirturo); GSK's monoclonal antibody Jemperli (dostarlimab) for rectal cancer; and the sickle cell disease gene therapy Casgevy (exagamglogene autotemcel), developed jointly by Vertex Pharmaceuticals and CRISPR Therapeutics.

Program Aims and Controversy

FDA Commissioner Marty Makary, M.D., explained the program's objectives: "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. We are pioneering new ways of bringing these cures and meaningful treatments to the market faster."

The program, launched in June with applications accepted starting in July, aims to reduce the typical 10-to-12-month review timeline to just one or two months for medicines aligning with U.S. national priorities. This accelerated process will be facilitated by a one-day meeting of multidisciplinary experts, mimicking a tumor board approach used in cancer treatment discussions.

However, the program has not been without its critics. Robert Steinbrook, M.D., health research group director at Public Citizen, voiced concerns about the potential risks of expedited reviews: "Research has shown that when the FDA rushes to review and approve new drugs, there is a higher likelihood that these drugs will have safety problems after approval. The voucher program will only be a boon for Big Pharma at the expense of the American public and will likely bypass the agency's advisory committee process that allows for outside independent input."

Legal Implications and Future Outlook

The selection process for voucher recipients has raised questions about potential legal challenges. Komal Karnik Nigam, a lawyer with global firm Hogan Lovells, suggested that litigation could arise "to the extent that it is not clear why certain applicants were chosen." The high level of interest in the program may lead to disputes over the allocation of these valuable vouchers.

As the pharmaceutical industry adapts to this new fast-track system, the impact on drug development timelines, pricing strategies, and patient access to innovative therapies remains to be seen. The FDA's national priority voucher program represents a significant shift in the regulatory landscape, with far-reaching implications for drug manufacturers, healthcare providers, and patients alike.