FDA Commissioner Makary Proposes Fast-Track Drug Review Vouchers Tied to Lower US Prices, Without Detailing Criteria

FDA Commissioner Marty Makary has proposed awarding 'national priority review vouchers' to pharmaceutical companies that agree to 'equalize' drug prices between the US and foreign markets, aiming to incentivize lower prices in the US2.

Makary has publicly advocated for this strategy but has not provided details on how companies would need to adjust prices to qualify for a voucher2.

These vouchers would allow for much faster application reviews—potentially one to two months instead of the standard 10-12 months—if companies pledge price parity23.

The program is a pilot and will, in its first year, grant a limited number of non-transferable vouchers to companies aligned with defined US national priorities, such as addressing health crises or unmet needs3.

To qualify, companies must submit specific parts of their application early and be available for ongoing, prompt communication with the FDA13.

The real-world effectiveness of the program and whether it will be adopted by industry remain uncertain; some questions about safeguards, criteria, and implementation have gone unanswered124.

Sources:

1. https://www.ainvest.com/news/fda-proposes-faster-drug-reviews-companies-equalize-prices-foreign-countries-2507/

2. https://stocktwits.com/news-articles/markets/equity/fda-may-fast-track-new-drug-reviews-in-return-for-companies-lowering-drug-prices-report/ch8cizDR5ZU

3. https://www.biopharmadive.com/news/FDA-national-priority-review-voucher-program-drugs-national-interests/750991/

4. https://www.statnews.com/2025/06/18/fda-new-priority-review-voucher-program-analysis-of-risks-questions/