The FDA will consider drug affairs by accelerating approvals: Makary


The food and medication administration will consider the affordability of medicines by granting new coupons that accelerate the approvals of some treatments, the Commissioner of the Marty Makary agency on Friday said Friday.

The FDA in June announced a national priority coupons plan that aims to reduce drug review times to two months for companies that say they are supporting “national interests of the United States.” But the previous ads in the coupons program did not explicitly mention that drugs are more affordable as a criterion.

“We include drug affairs as national priority,” Makary told CNBC.

Reducing medications prices is a key objective of the Trump administration, which faces a difficult equilibrium act, since it threatens to impose up to 200% of tariffs on pharmaceutical products imported to the US. UU. In an attempt to forward the manufacture of medicines.

The Commissioner of the Food and Drug Administration, Marty Makary, speaks at a press conference on the elimination of synthetic dyes of the United States Food Supply, at the Health Headquarters and Human Services in Washington, DC, on April 22, 2025.

Nathan Posner | Anadolu | Getty images

Makary added that President Donald Trump is “very inflexible in which he would reduce drug prices for Americans, and do not like Americans to be cheated with drugs that are two, five, 10 times higher” in the US. UU. Compared to other developed countries.

But it is not clear how the Trump administration will consider the affordability when reviewing a medication, since the prices of launching a product are generally determined after an approval in the United States.

The FDA website currently describes four examples of “national priorities” that will be used to determine which companies will get a coupon under the new program. That includes addressing a health crisis in the United States, delivering “more innovative priests” to Americans, addressing not satisfied public health and “increasing the manufacture of national medicines as a national security problem.”

The affordability of drugs may have been included above, according to a report by the Wall Street Journal in June.

A spokesman for the Department of Health and Human Services confirmed that the FDA will consider the affordability of medicines for the program, adding that the criteria are not limited to previous 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 vaccine against universal flu “so we don't have to try to guess what tension is coming.”

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

“We have a committee that is configured that will determine which products and companies will get these coupons as part of a pilot,” Makary said. “But we have to try new things. We have to ask ourselves, why does it have been coming to the market for so long? And we want to see more cures and significant treatments for Americans.”

The FDA will deliver new coupons this year. After a one -year pilot phase, the agency can increase the number of rapid approvals it gives to companies.

Some Wall Street analysts have said that the coupon program could be more effective than tariffs to encourage drug manufacturers to take their manufacture to the United States.

But there are questions about the risks of accelerating drug reviews at just 30 days, which is the fastest that FDA has done.

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

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