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FDA to consider drug affordability when granting new vouchers to speed up approvals, Makary says

July 11, 2025
01:21 PM
4 min read
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It is unclear how the Trump administration will consider affordability when reviewing a drug, as prices are usually determined after an approval in the U.S.

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financial news

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July 11, 2025

01:21 PM

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CNBC

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

The FDA in June announced a new national priority voucher plan that aims to cut drug review times to one-to-two months for companies it says are supporting "U

National interests," but previous announcements did not explicitly mention making drugs more affordable as a criterion

But it is un how the Trump administration will consider affordability when reviewing a drug, as prices for a duct's launch are usually determined after an apval in the U

Watch now17:3717:37Watch CNBC's full interview with FDA commissioner Dr

Marty MakarySquawk BoxThe Food and Drug Administration will consider drug affordability when granting companies new vouchers that speed up apvals 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

National interests. " But previous announcements on the voucher gram 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

In a bid to reshore drug manufacturing

Commissioner of the Food and Drugs Administration Marty Makary speaks at a news conference on removing synthetic dyes from America's food supply, at the Health and Human Services Headquarters in Washington, DC on April 22, 2025

Nathan Posner | Anadolu | Getty ImagesMakary added that President Donald Trump is "very adamant that he would lower drug prices for Americans, and he doesn't it that Americans are getting ripped off with drugs that are two, five, 10 times higher" in the U

Compared to other developed countries

But it is un how the Trump administration will consider affordability when reviewing a drug, as prices for a duct's launch are usually determined after an apval in the U

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 gram

That includes addressing a health crisis in the U. , dering "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 gram, adding the criteria aren't limited to earlier examples

When asked to vide 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 ducts 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 apvals it gives to companies

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

But questions remain 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.