FDA to take into account the affordability of drugs when the permits are accelerated: Makary
The Food and Drug Administration will take into account the affordability of drugs if it grants companies new vouchers that accelerate the approval of some treatments, the Commissioner of the agency Marty Makary told CNBC on Friday.
In June, the FDA announced a national priority voucher plan that aims to reduce the time to check drugs to one to two months for companies that they say, which they say, support “US national interests”. In previous announcements on the voucher program, however, it was not expressly mentioned that drugs became more affordable as a criterion.
“We enter the affordability of drugs as a national priority,” Makary told CNBC.
The reduction in drug prices is an important goal of the Trump administration, which is exposed to a difficult total amount, since it threatens to raise up to 200% tariffs for pharmaceuticals imported in the USA in order to form the production of medicinal products.
The commissioner of the Food and Drugs Administration, Marty Makary, speaks at a press conference on the removal of synthetic dyes from American food supply on April 22, 2025 in Washington, DC.
Nathan Posner | Anadolu | Getty pictures
Makary added that President Donald Trump is “very relentless that he would lower drug prices for Americans, and he does not like the Americans in the United States to be torn down with two or five or ten times.
However, it is unclear how the Trump management takes affordable when checking a drug
On the FDA website, four examples of “national priorities” are currently being described, with which it is determined which companies receive a voucher as part of the new program. This includes combating a health crisis in the United States, providing “more innovative healing” for Americans, fighting public health and increasing domestic purposes as a national security problem “.
According to a report by the Wall Street Journal in June, a medicine may already have been affected.
A spokesman for the Department of Health and Human Services confirmed that the FDA will consider the affordability of the drugs for the program and that the criteria are not limited to previous examples.
When Makary was asked that it was examples of a health crisis that companies can affect with their medication, he would like to see a remedy for type -1 diabetes, more treatments for neurodegenerative diseases and a universal flu so that we do not have to try to guess which tribe comes. ”
He also said that he wanted to see more treatments for cancer in stage 4 or if the disease spreads from its original location to distant parts of the body.
“We have a committee that is set up, which determines which products and companies receive these vouchers as part of a pilot,” said Makary. “But we have to try new things. We have to ask ourselves why it takes so long to come to the market? And we want to see more remedies and sensible treatments for Americans.”
The FDA will issue new vouchers this year. After a one -year pilot phase, the agency can increase the number of fast permits that companies grant.
Some Wall Street analysts have previously announced that the voucher program could be more effective than tariffs to encourage drug manufacturers to bring their production to the USA
However, there are questions about the risks of accelerating drug reviews to 30 days, which the fastest of the FDA has ever carried out.
Another potential concern is whether the FDA will offer political allies of the Trump administration vouchers that could include companies that would normally examine the agency's employees.
