FDA Proposes Faster Drug Reviews for Companies That Equalize US Prices with Foreign Countries.

The FDA is considering a proposal to offer faster drug reviews to pharmaceutical companies that "equalize" the cost of their medicines between the US and other countries. This is a new approach for the agency, which typically avoids pricing debates. The FDA would issue national priority review vouchers to companies that promise to match foreign prices, potentially reducing review times from 10 months to one to two months. However, the impact of this program is unclear and drugmakers have limited control over US prices.

The U.S. Food and Drug Administration (FDA) is exploring a new initiative that could significantly accelerate the drug review process for pharmaceutical companies. The agency is considering offering faster reviews to companies that commit to equalizing the cost of their medicines between the U.S. and other countries. This move, which is part of a broader effort to address drug pricing, is a departure from the FDA's typical stance on pricing debates.

Under the proposed program, the FDA would issue national priority review vouchers to companies that agree to match the prices of their drugs with those in other countries. These vouchers could reduce the typical review time from 10 months to one to two months. The FDA's Commissioner, Marty Makary, has stated that this program aims to incentivize companies to lower drug prices in the U.S. to levels comparable to those in other countries [3].

The new program, which will commence in 2025, is part of a broader initiative to address health crises and unmet public health needs. Companies must submit the chemistry, manufacturing, and controls (CMC) portion of their application at least 60 days before the final application to qualify for a voucher [2]. The FDA's team-based review process for these applications is designed to maintain the agency's rigorous standards for safety, efficacy, and quality.

The impact of this program remains uncertain. While drugmakers may have limited control over what patients ultimately pay in the U.S., the financial incentive to lower prices could be substantial. The value of these vouchers is significant, with some previous vouchers selling for over $100 million in the secondary market [3]. However, the new national priority vouchers cannot be sold.

The FDA's proposal to fast-track drug reviews for price parity is a novel approach that could potentially reduce the time and cost of bringing new drugs to market. However, it remains to be seen how effective this program will be in achieving its goals and whether it will be adopted by drugmakers.

References:
[1] https://www.marketscreener.com/quote/stock/MERCK-CO-INC-13611/news/U-S-FDA-Accepts-New-Drug-Application-for-Merck-s-Doravirine-Islatravir-an-Investigational-Once-Da-50479466/
[2] https://www.aol.com/news/us-fda-issue-vouchers-drug-152106231.html
[3] https://www.bloomberg.com/news/articles/2025-07-11/fda-offers-to-trade-faster-drug-reviews-for-lower-us-prices