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• Posted May 1, 2025

FDA Commissioner: No Major Reorganization, Just Smart Reforms

THURSDAY, May 1, 2025 (HealthDay News) — Dr. Marty Makary had just finished his last surgery at Johns Hopkins when he stepped into one of the most powerful roles in American public health. 

Now, as the new commissioner of the U.S. Food and Drug Administration (FDA), he's wasting no time charting a new course for the agency.

In an exclusive interview with physician and writer Dr. Jeremy Faust on Substack, Makary opened up about his first weeks on the job, his vision for the future, and why he believes the FDA doesn’t need a full overhaul to deliver faster and more trustworthy guidance and oversight.

"There will not be a reorganization," Makary said in the interview. Instead, he wants to focus on simple reforms, like removing synthetic dyes from the food supply, using more modern technology and keeping science independent from industry.

Makary also shared concerns about how long it takes new medications to come to market. 

He questioned outdated systems that slow the approval of medical artificial intelligence (AI) and allow for lower inspection standards for foreign drug makers.

"My belief is that the FDA can modernize if we challenge deeply held assumptions and traditional ways of doing things," Makary explained. "To do so, we have to uphold two fundamental guiding principles — gold standard science and common sense."

The new commissioner also said, "To be clear, no scientists or inspectors were laid off," during recent staffing cuts, despite reports from some employees who feel resources are running very low.

He said he is assessing staffing needs and trying to address unforeseen consequences.

Makary did say, however, that duplication is an issue. 

"The agency has also become bloated with duplicate services because of the siloed culture," he said. "We had hundreds of employees with 'strategy' or 'strategic' in their job title, many CIO’s, and several travel offices. Some of the biggest areas of waste were in the duplicative IT systems. There were also hundreds of communications staff." 

A few of Makary's other priorities include:

• Promoting faster and more efficient drug approvals

• Reducing animal testing

• Creating healthier food for children

• Supporting the use of AI in medicine

• Promoting public safety 

"There is literally nothing political about any of these priorities," he said. "I have tremendous confidence in the many scientists, inspectors, and staff at the FDA to help accomplish these goals and am excited to work with them. My goal is to get to know as many of them as I can."

Makary noted that the agency acted last week to remove eight petroleum-based food dyes from the U.S. food supply. He expects more announcements in coming weeks. 

He brushed off allegations of political pressure at the agency.

"I am responsible for 100% of decisions made at the FDA. No one above me has been or will be making decisions on products," Makary said, adding Health and Human Services Secretary [Robert F.] Kennedy [Jr.] has a right to offer recommendations.

"But," he added, "I make my decisions based on the two guiding principles of gold standard science and common sense. When Secretary Kennedy offers a suggestion to me, he always adds, 'You decide for yourself.' So, yes, there is independence."

On COVID vaccines, Makary emphasized the need for newer data, especially now that most people have some immunity.

"Today, there is broad population immunity, and the big question is does it provide a benefit? Without a study on the new formulation and product, we can’t give an honest evidence-based answer to that question," he said. 

"These are new vaccine products, not the tried-and-true flu shot that has been around for 80 years," Makary added. "If we had a study showing that COVID boosters help keep people out of the hospital today, it could significantly increase the low COVID vaccine uptake rate that we have today."

As for concerns about low morale at the agency, Makary acknowledged past issues. 

"There are many past and present narratives, some with political spin. The only narrative that is definitely not true is that morale was great before," he explained.

"We are now rebuilding the culture to create more teamwork, collegiality, and shared services across the agency."

More information

Read more about the U.S. Food and Drug Administration's current initiatives.

SOURCE: Dr. Jeremy Faust, Q&A, Substack, April 29, 2025