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# No Broad FDA Reorganization Coming: Makary
- URL: https://www.fdaweb.com/no-broad-fda-reorganization-coming-makary/
- Published: 2025-04-29T12:00:00.000Z
- Updated: 2026-09-14T15:10:35.000Z
- Author: David McFarland
- Tags: Biologics, FDA Policy/General, Drugs, Devices, #legacy-id-D5159083

FDA commissioner **Martin Makary** says there will be no agency-wide reorganization. Interviewed by **Jeremy Faust** for an *Inside Medicine* Substack [post](https://insidemedicine.substack.com/p/exclusive-in-conversation-with-fda), Makary said some staff asked for a reorganization and he rejected the proposal. “We are consolidating travel office, information technology, and some other things that make sense for efficiency,” he said, “but nothing else is planned…. We are going to focus on making FDA a great place to work. Reviewing applications is hard work. Our staff deserves a great place to work.”

In the interview, Makary said it is necessary to ask big questions such as why it takes over 10 years for a new drug to come to market, why medical artificial intelligence is held in old regulatory processes, why there is a lower inspection standard for foreign drug manufacturers and why the U.S. has ignored ultra-processed food and thousands of chemicals in the U.S. food supply that are banned in Europe.

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

Asked about his “agenda,” Makary said he is focused on cures and meaningful treatments, healthier food for children, facilitating innovation, and 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 FDA to help accomplish these goals and am excited to work with them.”

When Faust referenced widespread low morale at FDA, Makary replied that morale has been bad for years. “Over many years,” he said, “the different Centers at FDA became siloed fiefdoms that sparred with each other and duplicated resources. What also killed morale three years ago was when FDA’s two most respected vaccine scientists, Drs. Gruber and Krause, left the agency over disagreements with leadership over vaccine policy. We are now rebuilding the culture to create more teamwork, collegiality, and shared services across the agency.”

When told that agency scientists are saying they don’t have the resources they need as a result of the reductions in force that took away support staff and the reductions could lead to missing user fee targets and declining meetings, Makary replied that FDA had 9,500 employees in 2007 and 19,000 in 2024, without a commensurate improvement in approval times, innovation, artificial intelligence, food safety, and agency morale. He said the increased staffing has led to “regulatory creep. The agency has become bloated with duplicate services because of the siloed culture…. To be clear, no scientists or inspectors were laid off.”

Makary said he has been assured by Center leaders that user fee target dates can and will be met and he trusts their assurances.

Faust raised the possibility that a pending [Novavax BLA](https://www.fdaweb.com/novavax-hhs-clarify-on-post-approval-covid-study/) that would convert its protein-based Covid vaccine from an emergency use authorization to full approval would be a test for how much independence Makary will have in running the agency.

“I am responsible for 100% of the decisions made at FDA,” Makary declared. “No one above me has been or will be making decisions on products. Secretary Kennedy may have strong recommendations, which he has a right to, but 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.”

Makary acknowledged that FDA is asking Novavax to do a clinical study for a vaccine product that could cost tens of millions of dollars. “But my job is upholding gold standard science and rebuilding public trust,” he said, “not to save pharma companies tens of millions of dollars.”