A new prescription for FDA leadership: Dr. Heidi Overton tapped as commissioner

On August 19, 2026, US President Donald Trump announced that he will nominate Dr. Heidi Overton to serve as the next commissioner of the US Food and Drug Administration (FDA). The announcement came three months after former Commissioner Martin A. Makary resigned in May 2026. Kyle Diamantas, FDA’s deputy commissioner for food, has served as acting commissioner since Makary’s departure.

Overton currently serves as deputy assistant to the president for domestic policy. She earned her medical degree from the University of New Mexico School of Medicine and a PhD in clinical investigation from the Johns Hopkins Bloomberg School of Public Health. She completed general surgery residency training at Johns Hopkins and is board certified in public health and general preventive medicine. During the first Trump administration, Overton served as a White House fellow in the Office of American Innovation and on the Domestic Policy Council. She then joined the America First Policy Institute (AFPI), where she ultimately served as chief policy officer and vice chair of its Center for a Healthy America before returning to the White House in January 2025.

In announcing the nomination, President Trump identified several priorities that he expects Overton to pursue at FDA, stating that she would work with US Department of Health and Human Services Secretary Robert F. Kennedy Jr. and Centers for Medicare & Medicaid Services Administrator Mehmet Oz to “rapidly deliver on [President Trump’s] priorities of faster cures, increased American Innovation, major clinical trial reforms, lower drug prices, and even more MAHA wins!” The announcement did not detail plans for implementing these priorities.

Although Overton has not published a comprehensive platform, her prior positions and her work in the White House offer insight into several issues likely to intersect with the agency’s work.

Cannabis and CBD. Overton has been involved in the administration’s work concerning medical marijuana and cannabidiol (CBD). A December 2025 executive order directed the federal government to expand medical marijuana and CBD research and called for expedited completion of the process of rescheduling marijuana to Schedule III of the Controlled Substances Act. In April 2026, following the US Department of Justice’s order placing certain medical marijuana products in Schedule III, Overton publicly discussed implementation of the initiative, characterizing the action as a significant step toward increasing research and indicating that further action on broader marijuana rescheduling was expected.

Vaccines. Overton has played a public role in the administration’s recent changes to federal childhood vaccine recommendations. She spoke at the August 10, 2026, signing of an executive order establishing revised childhood vaccine recommendations. She emphasized that states ultimately implement school vaccination requirements and pointed to public education, parental information, and trust as mechanisms for maintaining vaccination rates. The executive order recommends immunization against 11 diseases and places certain other immunizations into risk-based or shared clinical decision-making categories. It also calls for separate measles, mumps, and rubella vaccines once such products are domestically available.

Mifepristone. Overton’s earlier policy writing provides an indication of her views on FDA’s regulation of medication abortion. In a 2023 AFPI issue brief, Overton criticized FDA actions that eliminated the in-person dispensing requirement for mifepristone and subsequently permitted dispensing through retail pharmacies. The brief advocated for additional safeguards, including in-person evaluation to determine clinical appropriateness, as well as restoring and strengthening Risk Evaluation and Mitigation Strategy (REMS) safeguards governing mifepristone dispensing. Given the Supreme Court of the United States’ May 2026 order preserving FDA’s current mifepristone REMS framework while litigation over the 2023 REMS modifications continues, Overton’s prior writing on this issue may draw attention during the confirmation process. The FDA safety review on mifepristone also may take greater priority under her leadership.

Drug access and public health. While at AFPI, Overton supported expanding access to certain drugs and vaccines. In a 2023 report addressing fentanyl, she supported FDA’s decision to permit over-the-counter sale of Narcan and recommended expanding nonprescription availability to additional branded and generic naloxone formulations. Earlier at AFPI, she coauthored a 2021 analysis of Operation Warp Speed, highlighting how parallel development activities and substantial upfront investment accelerated vaccine development. Together, these writings suggest an interest in supporting mechanisms that reduce barriers to certain medical product access.

What comes next

The FDA commissioner is appointed by the president with the advice and consent of the US Senate. As of September 10, 2026, Overton’s nomination does not yet appear on the White House’s published list of nominations formally transmitted to the Senate. Once transmitted, the nomination is expected to be referred to the Senate Committee on Health, Education, Labor, and Pensions (HELP), whose jurisdiction includes FDA. Republicans hold a one-member majority on the HELP Committee, which must advance the nomination before a full Senate vote. Early reactions suggest that the nomination may face a contested path: HELP Chair Bill Cassidy has expressed strong concerns, while Democratic members, including Senator Patty Murray, have announced opposition. The confirmation process should give stakeholders additional insight into Overton’s priorities for FDA and how her prior health policy work may translate into agency policy.

The McDermott difference

McDermott Will & Schulte will continue to monitor developments involving FDA leadership and the potential implications for FDA-regulated industries. If you have questions regarding the nomination or its potential impact on your business, please contact a member of McDermott’s Life Sciences FDA, Global Regulatory & Market Access Practice Group.