FDA to evaluate drug affordability in the allocation of new vouchers for expedited approvals, according to Makary.

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The Food and Drug Administration (FDA) will consider drug affordability when granting companies new vouchers that expedite the approval of certain treatments, as stated by the agency’s Commissioner Marty Makary during an interview on Friday. In June, the FDA announced a national priority voucher plan aimed at reducing drug review times to one to two months for companies that support “U.S. national interests.” However, prior announcements regarding the voucher program did not explicitly include drug affordability as a criterion.

“We are including the affordability of drugs as a national priority,” Makary remarked. Lowering drug prices is a significant aim of the current administration, which faces challenges in balancing potential tariffs of up to 200% on pharmaceuticals imported into the U.S. in an effort to reshore drug manufacturing.

During a press conference at the Department of Health and Human Services in Washington, D.C., Makary held up a study from The Lancet while announcing the FDA’s intention to phase out petroleum-based synthetic dyes in the nation’s food supply. He stated that President Trump is “very adamant” about lowering drug prices for Americans, expressing concern over the high costs of medications in the U.S. compared to other developed nations.

It remains unclear how affordability will factor into drug reviews, especially since launch prices are typically set after approval in the U.S. The FDA’s website currently lists four examples of “national priorities” that will guide the issuance of vouchers under the new program. These include addressing a health crisis in the U.S., delivering “more innovative cures” to Americans, responding to unmet public health needs, and increasing domestic drug manufacturing as a national security concern.

According to a Wall Street Journal report from June, drug affordability may have been addressed previously. A spokesperson for the Department of Health and Human Services confirmed that the FDA will indeed take affordability into account for the program, emphasizing that the criteria are not restricted to earlier examples.

When asked for examples of health crises that companies could address with their drugs, Makary mentioned a desire for a cure for Type 1 diabetes, advancements in treatments for neurodegenerative diseases, and a universal flu shot “so we don’t have to try to guess which strain is coming.” He also expressed a need for more treatments for stage 4 cancer, indicating that a committee will decide which products and companies will receive these vouchers as part of a pilot program.

“We have to try new things,” Makary said. “We need to ask ourselves why it takes so long to reach the market, and we want to see more cures and meaningful treatments for Americans.” The FDA plans to distribute new vouchers this year. Following a one-year pilot phase, the agency may increase the number of expedited approvals for companies.

Some analysts have argued that the voucher program could be a more effective incentive than tariffs for encouraging drug manufacturers to establish production within the U.S. However, questions remain regarding the risks associated with accelerating drug reviews to as little as 30 days, which would be the fastest timeline the FDA has ever implemented. There are also concerns about whether the FDA will grant vouchers to political allies of the administration, potentially including companies that typically undergo rigorous scrutiny by agency staff.