U.S. News: FDA Under New Chief to Fast-Track Some Drugs, Tap AI

 

“WASHINGTON -- Embracing artificial intelligence. Taking on companies that make ultra-processed foods. And offering a fast track to approve drugs the Trump administration views as a priority.

 

Welcome to the new Food and Drug Administration as envisioned by Dr. Marty Makary, who is leading the agency under Health Secretary Robert F. Kennedy Jr. Both men have said they want to overhaul the agency, citing what they see as the FDA's reputation for coziness with pharmaceutical companies.

 

Makary's goal is "to deliver more transparency, unleash innovation, eliminate conflicts and lower drug pricing," said Calley Means, a White House adviser and ally of Makary's.

 

The changes are coming so swiftly, and often without input from career scientists, that Makary faces declining staff morale threatening to stymie his efforts. He must also contend with the administration's staff cuts at the FDA, which have been partly undone but shrank the workforce nonetheless. And critics say Makary is playing fast and loose with the FDA's commitment to world-class science.

 

"Instead of gold-standard science, what I'm seeing is an effort to create a scientific record that supports a particular conclusion," said Susan Mayne, a former head of a food safety division at the FDA.

 

The FDA regulates products that account for one-fifth of American consumer spending -- from lettuce to vapes to pet vaccines. The former Johns Hopkins surgeon's stewardship of the agency will be key to whether the Make America Healthy Again movement -- championed by Kennedy and adopted by President Trump -- can secure policy wins at the federal level. From his perch at the FDA, he will also influence the number of new treatments, the safety of the nation's food supply and the country's response to outbreaks such as bird flu or screwworm.

 

One of Makary's new ideas is dubbed the "Commissioner's National Priority Review Voucher," which will allow him to promise frequent feedback and sped-up drug application reviews to specially selected companies, according to a document viewed by The Wall Street Journal that outlines the proposed program.

 

The document outlined approval within 30 days of a firm's sending final data, compared with the typical 10 months now. After this article was published, a Health Department spokesman said the document was a draft, and the FDA released a press release that said the sped-up review would be one to two months, rather than 30 days.

 

Makary's push for a nimbler agency that closely communicates with certain companies is at odds with past criticism from Kennedy and his supporters, who have lambasted the agency for its rapid approval of Covid-19 vaccines.

 

The FDA will give the vouchers to firms that "are aligned with the national health priorities" of addressing unmet public-health needs, making drugs domestically to boost national security or making drugs more affordable in the U.S., according to the document, though it didn't offer further detail. The agency could give the vouchers for specific products, or to companies to speed up the product approval of their choosing. The vouchers would be valid for two years and couldn't be sold.

 

Congress has created past FDA voucher programs, but the FDA could create this program on its own, lawyers with expertise in drug law said. Still, rewarding companies that have lowered drug costs would be new territory for the agency, which has had little to do with drug prices.

 

"If this is able to incentivize research or work in certain significant priorities that otherwise would not be affordable or interest to manufacturers, that would be a significant win," said Lowell Schiller, a former acting chief counsel at the FDA. "It would need to be a thorough review that doesn't cut corners."

 

Some employees remain hopeful that a new artificial-intelligence tool named Elsa, unveiled by Makary, will help product reviewers spot fake data. Currently the tool is clunky and gets basic facts wrong, people who have used it said.

 

"The errors were the result of users' learning a new system and were not inherent to Elsa," the FDA spokesman said.

 

An FDA official said about 6,000 people are using the tool weekly. AI can "modernize the FDA and radically increase efficiency in the review process," Makary wrote in the medical journal JAMA.

 

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New Leadership at a Tumultuous Time

 

Dr. Marty Makary took the helm at the FDA just as Robert F. Kennedy Jr. carried out sweeping job cuts in the nation's health agencies, including 3,500 at the FDA, though some of those have been walked back.

 

Last week employees were able to access scientific journals that had been cut off during the Department of Government Efficiency's cost-cutting.

 

But agency morale remains low, according to people inside and outside the agency. So many employees have recused themselves on industry matters -- indicating that they are looking elsewhere for jobs -- that it has been difficult to staff certain projects at the agency, according to people familiar with the matter. Former FDA Commissioner Scott Gottlieb said on CNBC in April that as many as 600 reviewers, or about a quarter of the review staff, had recused themselves.

 

"Recusals also occur to ensure staff not participate in engagements that have even the perception of a conflict of interest," an FDA spokesman said.” [1]

 

1. U.S. News: FDA Under New Chief to Fast-Track Some Drugs, Tap AI. Whyte, Liz Essley.  Wall Street Journal, Eastern edition; New York, N.Y.. 18 June 2025: A3.