FDA Announces First Recipients of Makary’s National Priority Voucher Program, Expanding Scope for Accelerated Drug Reviews

The FDA, under Commissioner Martin Makary, has launched a new Commissioner's National Priority Voucher (CNPV) pilot program to dramatically accelerate drug and biologic approval review times from the standard 10–12 months down to just 1–2 months for selected products5 1.

On October 16, 2025, the FDA announced the first batch of nine companies as recipients of the CNPV vouchers, each developing medicines or biologics with significant potential to address key national priorities such as unmet medical need, public health crises, affordability, and supply chain resilience5 10 3 11.

Recipients of the vouchers include Regeneron Pharmaceuticals, Revolution Medicines, Disc Medicine, EMD Serono, and others. One highlighted example is EMD Serono’s infertility treatment, Pergoveris, which agreed to significant drug pricing reductions to improve U.S. market access10 9 3.

The CNPV program specifically favors products that address U.S. health crises, fill large unmet needs, encourage innovative cures, support domestic manufacturing, and/or increase accessibility via price controls (such as Most-Favored Nation pricing)5 7 10.

Unlike previous FDA voucher programs limited to rare diseases or pediatric indications, the CNPV pilot explicitly prioritizes drugs aligned with broader national interests and does not require congressional authorization2 3 5.

The vouchers enable enhanced communications with FDA and allow portions of applications—such as manufacturing and labeling data—to be submitted early for pre-review, further facilitating a rapid final review once pivotal clinical data are submitted7 2.

Vouchers in this program are non-transferable and must be used by the original recipient within two years7.

FDA reserves the right to extend the accelerated review period in cases of incomplete data, ambiguous clinical results, or complex manufacturing issues5 3.

Future expansion of the program is possible, with the number of vouchers potentially increasing in subsequent years if the pilot is considered successful2 3.