On August 4, 2025, the U.S. Food and Drug Administration (FDA) appointed Sean Keveney as its new chief counsel, a pivotal leadership role within the agency tasked with overseeing all legal affairs. The announcement comes during a period of internal restructuring and heightened political scrutiny for the FDA. Keveney replaces Robert Foster, who had been serving in the role temporarily and has now returned to the Department of Health and Human Services (HHS) to resume a position as acting general counsel.
Keveney brings a strong background in health law and public service to the FDA. Prior to this appointment, he served as acting general counsel at HHS, where he helped shape and implement regulatory strategies under the current administration’s “Make America Healthy Again” initiative. His legal career spans nearly two decades, with sixteen years dedicated to the Civil Rights Division at the Department of Justice. There, he worked on a wide range of federal enforcement issues, building a reputation for legal rigor and cross-agency coordination.
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Keveney steps into the FDA at a crucial juncture. His predecessor, Hilary Perkins, resigned abruptly just two days after being appointed, triggering a wave of controversy. Perkins faced immediate political backlash due to her prior public stances supporting access to abortion medication and advocating for vaccine mandates. These positions sparked sharp criticism from several lawmakers, including Senator Josh Hawley, who labeled her views as out of alignment with public health policy under the current administration. Her swift resignation left the FDA in a delicate position, both legally and politically.
The departure of Perkins and the return of Foster to HHS opened the door for Keveney’s appointment, which many in the agency hope will bring stability and continuity. His legal leadership comes at a time when the FDA is under pressure to navigate an increasingly complex regulatory landscape. From drug and vaccine approvals to food safety and medical device oversight, the agency faces mounting legal challenges, particularly around areas where science, public health, and policy intersect. The legal counsel’s office plays a central role in interpreting, defending, and implementing the agency’s mandates.
While at HHS, Keveney led a comprehensive restructuring of the agency’s Office of General Counsel, which included consolidating its ten regional offices into four strategic hubs located in Philadelphia, Atlanta, Kansas City, and Denver. This restructuring was aimed at improving operational efficiency and reducing administrative costs. Keveney also introduced a new senior counsel position dedicated to food, drug, and biomedical issues—a position that has now become a key liaison role between HHS and FDA legal operations. His organizational skills and emphasis on legal clarity are expected to shape the FDA’s approach to internal governance and external enforcement.
Keveney’s new role is expected to extend beyond routine legal review. He will likely play a major part in policy decisions that impact drug pricing reforms, the regulation of artificial intelligence in medical diagnostics, and ongoing litigation tied to opioid approvals and distribution practices. Additionally, he is expected to help steer the agency through questions related to public trust, transparency, and scientific integrity—especially as legal interpretations of emergency use authorizations and vaccine policy continue to evolve in the post-pandemic landscape.
He is also co-leading a newly formed working group between HHS and the Department of Justice, tasked with increasing enforcement under the False Claims Act in cases involving healthcare fraud. The group is developing new frameworks to crack down on illegal billing and deceptive practices in both government and private-sector healthcare programs. His experience in civil rights enforcement and inter-agency collaboration is expected to serve him well in these efforts.
The leadership of FDA Commissioner Dr. Marty Makary, appointed earlier in 2025, has set a tone of cautious reform and scientific accountability. Makary has committed to streamlining approval pathways without compromising safety and efficacy standards. He has also signaled his support for evidence-based regulatory frameworks that prioritize transparency in drug and device approvals. Keveney’s legal acumen and administrative background appear to align with Makary’s approach, raising expectations for a coordinated leadership style within the agency’s upper ranks.
Despite these qualifications, Keveney’s appointment comes with significant challenges. The FDA is facing increasing legislative oversight, with several congressional inquiries already underway related to its handling of recent food safety incidents and ongoing litigation over opioid medications. The agency must also confront rapidly emerging technologies, including AI-driven diagnostics and gene-editing treatments, all of which raise new legal and ethical questions. The chief counsel’s office is expected to play a central role in addressing these developments and providing legal guardrails as policy continues to evolve.
Sean Keveney assumes his new responsibilities at a time when the FDA’s legal authority, independence, and scientific mission are all under intense scrutiny. As the chief counsel, he will be tasked with defending the agency’s actions, advising leadership on legal risks, and ensuring that the FDA remains both legally sound and policy-relevant in a rapidly changing healthcare landscape. His tenure could significantly shape how the agency interprets and enforces its mandates in the years to come.
