FDA to consider drug affordability when speeding up approvals: Makary
The post FDA to consider drug affordability when speeding up approvals: Makary appeared on BitcoinEthereumNews.com. 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. 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 Images 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…
The post FDA to consider drug affordability when speeding up approvals: Makary appeared on BitcoinEthereumNews.com.
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. 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 Images 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…
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