Makary talks FDA priorities, says recent cuts addressed redundancies

Editor's note: This article was updated on 16 May 2025 to clarify FDA Commissioner Martin Makary's statements about vaccines.

Leveraging artificial intelligence in product reviews and postmarketing surveillance is a top policy priority for the US Food and Drug Administration (FDA), FDA Commissioner Martin Makary said at the Food and Drug Law Institute (FDLI) Annual Conference on Thursday. He also said the agency will roll out a new framework for vaccines and again confirmed that the agency is not planning a major reorganization of its product centers.
 
Makary made these remarks during an interview with FDLI President and CEO Christine Simmon, in which he defended the recent staff cuts at the agency, stating that some redundancies had to be eliminated and noting that the cuts brought the agency back to pre-COVID staffing levels.
 
When asked to describe his vision for the agency, Makary stated that he envisions “a strong partnership between industry and the FDA.” He emphasized the importance of maintaining "impeccable independence" in scientific evaluation. He acknowledged that achieving this balance is crucial because the agency cannot simply adopt a passive stance toward industry; doing so would hinder its effectiveness. Makary expressed a desire for more effective treatments for Americans and healthier food for children and said the agency would rebuild trust by combining gold-standard science with common sense.
 
Makary also stated that, despite rumors, “there will be no major reorganization" of the FDA and that “we have to focus on cures and medical treatments, on healthy food for children, and on completing the core work of operating a great agency.”
 
Yet he said that the new administration is also taking a hard look at how the agency operates. “There’s a bit of territorialism with the centers, and there was a bit of empire building. We want to see more teamwork, [less] tribalism, and fewer duplicate services not only at FDA but also at HHS.”
 
For example, Makary said there are nine offices at FDA focused on women’s health. “Do we need all nine?” While these are “important offices,” he said there is no reason why these offices cannot be consolidated.
 
Makary said the recent layoffs have brought the agency back to its 2018-2019 staffing levels. “Since 2007, FDA has doubled the number of employees, from 9,000 plus to 19,000 just a couple of months ago. There was a 100% increase in staff.”
 
Makary emphasized that one of his priorities is to enhance the use of AI in product reviews to expedite the review process. Last week, FDA announced plans to implement AI tools through the agency to assist in conducting scientific reviews following the completion of a pilot program that incorporated generative AI into reviews. (RELATED: FDA plans to roll out AI agency-wide for reviews in June, Regulatory Focus May 2025)
 
“I am very excited about AI; it is one of our big priorities. On day one, we pulled together some really talented AI minds from inside the agency and outside, and we asked them, ‘What can we do to have an open and frank conversation about some of the work they would like to see addressed with AI?’” he said.
 
He stated that submission packages can sometimes consist of thousands of pages, containing duplicate information that reviewers must filter out. Makary mentioned that AI can summarize a vast amount of content.
 
Another one of his goals is to enhance the FDA's postmarketing surveillance of drugs by creating a comprehensive database linked to electronic health records. This database aims to quickly identify safety signals as soon as a drug is approved. Additionally, it will allow for real-time querying of drug safety information.
 
“We should not be learning five years from now that Vioxx killed 38,000 Americans or ten years later that Oxycontin killed perhaps one million Americans … we are going to have eyes that we have never had before to make sure that things are right.” Makary said the same team that is working on the agency’s AI tools will be developing this database.
 
According to Makary, with Vinay Prasad now serving as the director of the Center for Biologics Evaluation and Research (CBER), the agency is “planning to unleash a massive framework” in the coming days for vaccines to clarify they agency's expectations for manufacturers. 

“We want to be very transparent, and we want to create a framework for vaccine makers that they can use so they have a predictable FDA, where they don’t have to worry ‘how is this going to be received?’" Makary said, adding that Prasad has been holding meetings with CBER staff to develop this framework.