Sean Keveney Named FDA’s Next Chief Counsel
This latest FDA leadership appointment comes as the agency focuses on balancing regulatory challenges with opportunities for accelerated patient access.
The U.S. Food and Drug Administration (FDA) and the Department of Health and Human Services (HHS) have announced the appointment of Sean Keveney as Chief Counsel of the FDA as the agency continues to navigate ongoing legal and regulatory complexities (1). Keveney assumes the position following a period of leadership transition, succeeding Robert Foster, who served as acting Chief Counsel after the abrupt resignation of Hilary Perkins just two days into her appointment (2).
Seasoned government attorney, Keveney, arrives in the role with an extensive background that includes serving as Acting General Counsel at the HHS. Throughout his career, he has played a pivotal role in leading policy reforms and enforcement initiatives and has held senior roles in the Department of Justice’s Civil Rights Division as well as clerking for Judge William Garwood of the U.S. Court of Appeals for the Fifth Circuit (1).
Dr. Marty Makary, the FDA Commissioner, praised Keveney’s selection, citing the appointment as part of a broader effort to attract top talent to the FDA and modernize the agency in line with current scientific and regulatory demands.
“America is in a golden age of food and drug regulation,” said Makary, in an agency press release (1). “From modernizing the agency to address national priorities to phasing out the petroleum-based food dyes linked to behavior disorders in children, the FDA is accomplishing things under the Trump Administration that few previously thought possible. Sean Keveney’s appointment as our Chief Counsel reflects the talent and experience we have brought to FDA for the mission to Make America Healthy Again.”
With Keveney now leading as FDA Chief Counsel, Robert Foster becomes Acting General Counsel at HHS, while also retaining his responsibilities as FDA Chief Counsel for Food, Research, and Drugs across both the FDA and HHS, amid ongoing public health and policy debates. President Trump recently put forward Michael Stuart, a former U.S. Attorney and current West Virginia state senator, for the position of General Counsel at HHS where his nomination underwent review by the Senate Committee on Finance in late July 2025.
The rapid turnover in senior leadership at the FDA, coupled with shifting regulatory priorities, has generated considerable uncertainty for biopharma companies this year. Continuous regulatory unpredictability has impacted investment decisions and complicated long-term innovation strategies across the industry, while persistent fluctuations in federal research funding continue to jeopardize vital early-stage discovery projects.
Nevertheless, the most recent leadership transition may also signal a shift toward new strategic priorities and fresh opportunities. With the FDA placing greater emphasis on deregulation and accelerating drug approvals through initiatives like the Breakthrough Therapy and Fast Track programs (3), which are aimed at streamlining the review process and bringing innovative treatments to market more rapidly.
Ultimately, the latest leadership changes have the potential to deliver long-term advantages for all stakeholders in drug development, particularly for U.S.-based firms. Most within the biopharma sector are likely to welcome an innovation-friendly environment, aiming for quicker patient access to new therapies as well as greater stability and predictability in the near future.
References
FDA. FDA Names Top HHS Lawyer as Chief Counsel. Press Release, Aug. 04, 2025.
Reuters. US FDA's top lawyer Hilary Perkins resigns two days into role. News, March 14, 2025.
FDA. Fast Track, Breakthrough Therapy, Accelerated Approval, Priority Review.
For Patients, June 12, 2023.