FDA to think about drug affordability when speeding up approvals: Makary

The Food and Drug Administration will consider drug affordability when granting firms latest 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 goals to chop drug review times to one-to-two months for firms it says are supporting “U.S. national interests.” But previous announcements on the voucher program didn’t explicitly mention making drugs more cost-effective as a criterion. 

“We’re including the affordability of medication as a national priority,” Makary told CNBC.

Lowering drug prices is a key goal of the Trump administration, which is facing a tricky balancing act because it threatens to impose as much as 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 prefer it that Americans are getting ripped off with drugs which might be two, five, 10 times higher” within the U.S. in comparison with other developed countries.

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

The FDA’s website currently outlines 4 examples of “national priorities” that will probably be used to find out which firms will get a voucher under the brand new program. That features addressing a health crisis within the U.S., delivering “more modern cures” to Americans, addressing unmet public health needs and “increasing domestic drug manufacturing as a national security issue.” 

Drug affordability could have been included previously, in response 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 this system, adding the standards aren’t limited to earlier examples.

When asked to offer examples of a health crisis that firms can meet with their drugs, Makary said he desires to see a cure for Type 1 diabetes, more treatments for neurodegenerative diseases and a universal flu shot “so we do not have to attempt to guess which strain is coming.” 

He also said he desires 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’ve got a committee that is arrange that may determine which products and corporations will get these vouchers as a part of a pilot,” Makary said. “But we have to try latest things. We have to ask ourselves, why does it take so long to come back to market? And we would like to see more cures and meaningful treatments for Americans.”

The FDA will give out latest vouchers this 12 months. After a one-year pilot phase, the agency may increase the variety of quick approvals it gives to firms.

Some Wall Street analysts have previously said the voucher program may very well be simpler than tariffs at encouraging drugmakers to bring their manufacturing to the U.S. 

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

One other potential concern is whether or not the FDA will offer vouchers to political allies of the Trump administration, which could include firms that agency staff would normally scrutinize.