Makary names Prasad as FDA’s chief medical and scientific officer
Editor’s note: This article was updated on 18 June 2025 to clarify aspects of Prasad’s new role.In an email to US Food and Drug Administration (FDA) staff on Wednesday, FDA Commissioner Martin Makary announced that Vinay Prasad, director of the Center for Biologics Evaluation and Research, will take on a new role as chief medical and scientific officer, in addition to leading the biologics center.
In his new capacity, Prasad will be tasked with advising senior agency officials and representing the agency’s thinking on medical and scientific matters to external stakeholders. Prior to joining the agency, Prasad was a hematologist/oncologist and professor of epidemiology at the University of California, San Francisco, and was a frequent and vocal critic of FDA and certain COVID-19 public health mandates.
In addition to leading the agency’s biologics center, as the new chief medical and scientific officer, he will advise the commissioner and other senior officials on “cross-cutting and emerging medical and scientific issues” that affect the agency’s work.
Previously, the roles of chief medical officer and chief scientist have been separate positions; it is unclear whether the new position of chief medical and scientific officer will replace those roles. Steven Kozlowski is currently listed as the agency’s acting chief scientist, a position he’s held since October 2024, and the role of chief medical officer has gone unfilled since Hilary Marston was pushed out of the role in April 2024 amid mass layoffs across the agency. Kozlowski also serves as the director of the Office of Product Quality Assessment III within the Office of Pharmaceutical Quality at the Center for Drug Evaluation and Research. Focus has reached out to the Department of Health and Human Services for clarification but has not received a response as of publication.
“[Prasad] will provide strategic input and leadership on trans-center working groups and initiatives, ensuring scientific consistency and integration across FDA centers, and build partnerships with academic, governmental, and industry stakeholders,” said Makary in an email reviewed by Focus.
“Dr. Prasad will also provide senior medical and scientific input to me on cross-center medical policy and regulatory decisions, and he will act as a senior medical and scientific representative at national, international, or advisory committee meetings, and forums related to public health, regulatory science, and innovation,” Makary wrote.
Since joining FDA, Prasad has served as a close advisor to Makary and has featured prominently in some of the agency’s major policy actions. Together, Makary and Prasad authored the agency’s revamped policy on COVID-19 vaccinations in the New England Journal of Medicine and laid out the agency’s new priorities in a JAMA Viewpoint article. (RELATED: FDA unveils new COVID-19 framework, restricting shots to elderly and high-risk people, Regulatory Focus 20 May 2025; Makary, Prasad lay out priorities for FDA: Reduced timelines, more AI, faster competition, Regulatory Focus 10 June 2025)
Prasad also led FDA’s recent roundtable meeting with cell and gene therapy (CGT) stakeholders. (RELATED: Stakeholders urge FDA to update CGT regulations to ease path to market for promising therapies, Regulatory Focus 9 June 2025)
“Dr. Prasad’s range of creative ideas and intellect are surpassed only by his energy,” said Makary. “I am delighted he has agreed to take on this dual role and am confident he will continue to provide extraordinary leadership and vision for the FDA."
