Through its recently unveiled Priority Voucher program, the FDA seeks to accelerate the review process for companies that promise to keep prices down.
The FDA is exploring the possibility of offering faster product reviews to pharmaceutical companies that will commit to setting lower prices for their drugs, opening up a new and unusual avenue of controlling the costs of medicines in the U.S.
According to reporting from Bloomberg News on Friday, this pricing initiative will leverage the FDA’s recently announced Priority Voucher program, which aims to shorten the review period for products and companies that are “aligned with U.S. national priorities,” as per a June 17 announcement. Under this program, regulatory decisions could be delivered within 1–2 months, down from the usual 10–12 months.
“We can issue a national priority review voucher for companies that are promising to equalize the price” of their products between the U.S. and other similarly developed countries, FDA Commissioner Marty Makary said, as per Bloomberg. “We want to incentivize good behavior in the marketplace.”
In a separate interview for CNBC on Friday, Makary added that “the president is very adamant that he would like to see lower drug prices for Americans.”
“We are including the affordability of drugs as a national priority,” the commissioner added, with this voucher program being one component of that effort. The FDA has currently set up a committee to evaluate which products and companies will be awarded this priority voucher as part of a “pilot,”Makary said.
Indeed, the Trump administration has made lowering drug prices a cornerstone of its domestic policy. In May, President Donald Trump unwrapped what is arguably the largest piece of this platform: the Most Favored Nations rule, which seeks to bring down drug costs in the U.S. to the same level as in other similarly developed countries.
The order is far-reaching in that it covers all corners of the government’s insurance program and the public markets. The directive will initially focus on drugs that have the biggest pricing gap between the U.S. and other countries, but officials at the time warned that no product or drug class will be exempted.
Trump has also been hanging the threat of tariffs over the biopharma industry, announcing last week that he is mulling a 200% levy on pharma imports but that he could give companies at least a one-year grace period to adjust their supply chains. It remains unclear when exactly these tariffs will kick in.
