FDA mulls faster drug reviews in exchange for lower prices in U.S.- Bloomberg

FDA Commissioner Marty Makary said during an interview with Bloomberg Television that his agency may expedite reviews of marketing applications of pharmaceutical manufacturers that seek to “equalize” the cost of their medicines to those charged in foreign nations.

During the interview, scheduled to be aired Friday at 6 p.m. EDT, Makary suggested that the FDA’s newly launched national priority voucher program might be leveraged for this purpose.

“We can issue a national priority review voucher for companies that are promising to equalize the price,” he said, adding, “We want to incentivize good behavior in the marketplace, and these priority vouchers are worth a lot of money.”

In June, the FDA announced its national priority voucher program, which aims to cut the regulator’s review time from about 10–12 months to 1–2 months following the submission of a final drug application. At the time, the FDA said it would issue a limited number of those vouchers to “companies aligned with U.S. national priorities.”

Makary’s remarks come as the U.S. government pushes drugmakers to lower U.S. drug prices to those charged elsewhere.

In May, President Donald Trump signed an executive order directing the Department of Health and Human Services to implement his most-favored-nation policy, under which drugmakers are required to lower prices of branded therapeutics to the level of those in OECD countries.