FDA to consider drug affordability when speeding up approvals: Makary

The Food and Drug Administration will consider drug affordability when granting companies new vouchers that speed up approvals of some treatments, the agency’s Commissioner Marty Makary told CNBC on Friday. 

The FDA in June announced a national priority voucher plan that aims to cut drug review times to one-to-two months for companies it says are supporting “U.S. national interests.” But previous announcements on the voucher program did not explicitly mention making drugs more affordable as a criterion. 

“We are including the affordability of drugs as a national priority,” Makary told CNBC.

Lowering drug prices is a key goal of the Trump administration, which is facing a tough balancing act as it threatens to impose up to 200% tariffs on pharmaceuticals imported into the U.S. in a bid to reshore drug manufacturing.

Makary added that President Donald Trump is “very adamant that he would lower drug prices for Americans, and he doesn’t like it that Americans are getting ripped off with drugs that are two, five, 10 times higher” in the U.S. compared to other developed countries.

But it is unclear how the Trump administration will consider affordability when reviewing a drug, as prices for a product’s launch are usually determined after an approval in the U.S.

The FDA’s website currently outlines four examples of “national priorities” that will be used to determine which companies will get a voucher under the new program. That includes addressing a health crisis in the U.S., delivering “more innovative cures” to Americans, addressing unmet public health needs and “increasing domestic drug manufacturing as a national security issue.” 

Drug affordability may have been included previously, according to a Wall Street Journal report in June. 

A spokesperson for the Department of Health and Human Services confirmed that the FDA will consider drug affordability for the program, adding the criteria aren’t limited to earlier examples.

When asked to provide examples of a health crisis that companies can meet with their drugs, Makary said he wants to see a cure for Type 1 diabetes, more treatments for neurodegenerative diseases and a universal flu shot “so we don’t have to try to guess which strain is coming.” 

He also said he wants to see more treatments for stage 4 cancer, or when the disease has spread from its original site to distant parts of the body. 

“We have a committee that’s set up that will determine which products and companies will get these vouchers as part of a pilot,” Makary said. “But we’ve got to try new things. We’ve got to ask ourselves, why does it take so long to come to market? And we want to see more cures and meaningful treatments for Americans.”

The FDA will give out new vouchers this year. After a one-year pilot phase, the agency may increase the number of quick approvals it gives to companies.

Some Wall Street analysts have previously said the voucher program could be more effective than tariffs at encouraging drugmakers to bring their manufacturing to the U.S. 

But questions remain about the risks of speeding up drug reviews to as little as 30 days, which is the fastest the FDA has ever done.

Another potential concern is whether the FDA will offer vouchers to political allies of the Trump administration, which could include companies that agency staff would normally scrutinize.