The FDA will select at most five companies that align with national priorities, including lower drug prices and increased domestic investment.
The FDA’s Commissioner’s National Priority Voucher program will favor drugmakers who commit to lowering their drug prices and to moving their manufacturing and development operations into the U.S., among other national priorities, the agency revealed on Tuesday.
First announced last month, the National Priority Voucher program seeks to accelerate drug decisions, shaving review periods from 10–12 months down to 1–2 months, but only for companies that align with certain national priorities. The FDA opened a pilot run of the program on Tuesday and named five such priorities. The priorities are similar those laid out when the program was announced, with the addition of increasing affordability:
- Addressing a U.S. public health crisis.
- Delivering more innovative cures for the American people.
- Addressing a large unmet medical need.
- Onshoring drug development and manufacturing to advance the health interests of Americans and strengthen U.S. supply chain resiliency.
- Increasing affordability.
The latter two of these priorities are particularly timely given the Trump administration’s recent policies. Tariffs, for instance, have become a centerpiece of President Donald Trump’s trade policy, used as leverage to incentivize companies to increase their domestic investments and shift their operations stateside.
In May, Trump also unveiled his Most Favored Nations (MFN) rule, meant to lower drug prices in the U.S. to the same level as in other similarly developed countries. The National Priority Voucher program specifically cites the MFN. The award “could include a company that lowers the U.S. price of a drug or drugs consistent with Most Favored Nation pricing,” according to the regulator’s website, “or reduces other downstream medical utilization to lower overall healthcare costs.”
For the first year of its implementation, the Commissioner’s National Priority Voucher program will select no more than five awardees. Applications—which should include a statement of interest 350 words or fewer—will be assessed by a “senior, multi-disciplinary review committee” headed by the agency’s Office of the Chief Medical and Scientific Officer. The FDA did not indicate when it expects to name the selectees for the pilot run of the program.
In an email to BioSpace in June, the FDA explained that the Commissioner’s Voucher will not be transferable but will remain valid through changes in company leadership.
Since assuming leadership of the agency, FDA Commissioner Marty Makary has eyed various changes to the regulator’s approval pathways. For instance, in an April interview on The Megyn Kelly Show, Makary said that he was considering a new pathway for approving rare disease drugs based on a “plausible mechanism.” If a drug “makes sense physiologically,” he explained, then it may qualify for approval even without a randomized controlled trial. Then, in May, Makary and new Center for Biologics Evaluation and Research director Vinay Prasad unveiled a new risk-based framework for approving COVID-19 vaccines, focusing on adults over 65 and at-risk individuals six months to 64 years old.
