Makary says FDA is ‘strong’ despite recent leadership turmoil

WASHINGTON – The US Food and Drug Administration (FDA) remains strong, despite recent turmoil in its leadership ranks, FDA Commissioner Marty Makary said at the Milken Institute’s 2025 Future of Health Summit, in part due to a teamwork mentality at the agency that did not exist before.

Over the past year, several top FDA officials have left the agency, including George Tidmarsh, former director of the Center for Drug Evaluation and Research (CDER), who resigned last week. The departures have raised concerns about what to expect from the agency.

Makary said that the agency will continue to fulfill its mission. He said he has been working to change the culture at the FDA to be more collaborative, moving the agency away from the “fiefdom culture” that he claimed had led the six major product centers to operate independently.

“We have 16,000 employees. We regulate 20% of the US economy. We've got offices in 50 countries,” said Makary. “It's a large organization, and the centers were running their own secret governments.

“The commissioners were sort of put out to pasture, you know, kind of like, ‘Well, we do what we want. We'll fill you in, and you can take some credit,’” he added. “So, we broke that up.”

Makary said that there is now a teamwork culture at the FDA, and a “giant team” at the agency is working on reforms, including “a bunch of drug reforms” that the agency will announce over the next three months.

“The FDA is strong,” said Makary. “I want everybody to know the FDA is going to meet all of its targets with the user fee deadlines. We're going to meet all of our funding goals.

“The trains are running on time,” he added. “They're running, hopefully faster now that we are going to cut the idle time, not cutting corners on safety, we're cutting the idle time in the review.”

Makary said the agency is challenging its deeply held assumptions, such as the need for animal testing and the fact that it takes more than a decade to get new drugs to market. He said that computational modeling can serve as an alternative to animal testing, reducing the years required for drug development and lowering research and development costs. He added that the US needs to be more attractive for Phase I trials, which are disproportionately going to China and Australia.

“Why do we have [clinical trial] phases done in separate, giant applications?” said Makary. “You don't go to college after you apply and then apply again for your sophomore year with a 100,000-page application… and then apply again for your junior year.

“We can use new technology to run continuous trials and have the regulators look at endpoints in the cloud,” he added. “We've got to try new things.”

Makary also said in some instances, the FDA should be able to review products and provide decisions within weeks.

“I will go directly to the reviewers and ask them, ‘Are you seeing anything in the pipeline, in animal studies, in Phase 2 trials, that look amazing, game-changers?'” said Makary. “And if so, we're going to partner with that company, and yet keep our review impeccably independent.”

Makary also promoted the Commissioner’s National Priority Voucher (CNPV) pilot program, which is intended to accelerate reviews of drugs considered critical to national security, among other criteria. Following his talk, FDA announced six new products under the program, which include potential treatments for cancer, sickle cell disease, obesity, and drug-resistant tuberculosis in children.

“In this administration, we are interested in talking about, ‘How do we fix our nation's health care system,’ and that means addressing the health of the population in health care utilization, and that's part of the worth of pricing,” said Makary. “We're not interested in 1% or 2% reductions in drug prices. We're interested in massive reductions.”

Makary says FDA is ‘strong’ despite recent leadership turmoil

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