Last week, President Trump announced the nomination of Dr. Heidi Overton, the current Deputy Director of the White House Domestic Policy Council, to be FDA Commissioner. He made the announcement in a post on social media, in which he praised Dr. Overton’s credentials and her work in the White House on the President’s health agenda. Dr. Overton is a physician, specializing in “public health and general preventive medicine,” and she also holds a Ph.D. in clinical investigations. Prior to joining the Administration, Dr. Overton was the Chief Policy Officer of the America First Policy Institute, which is closely aligned with the Trump Administration, and Vice Chair of the Institute’s Center for a Healthy America. 
 
FDA has been without a permanent agency head since the departure of Commissioner Marty Makary in May 2026, whose tenure at the agency has been characterized by many as a time of turmoil, during which both agency staff and industry leaders were dissatisfied with his leadership. Notably, Dr. Overton has worked closely with Dr. Makary, who served as her thesis advisor and collaborator on several publications prior to their work in the Trump Administration. 
 
In addition to the extent to which she is aligned with former Commissioner Makary, and her planned approach to agency leadership, Dr. Overton’s perspective on vaccine policy will be under scrutiny, after she was credited for having a key role in President Trump’s August 10 Executive Order (EO 14420), which called for a revised childhood vaccine schedule. During the signing of the EO, she described the Administration’s concerns as being focused on government mandates, rather than vaccines themselves, and emphasized the role of “shared clinical decision-making.” 
 
Dr. Overton’s nomination has not yet been sent to the Senate for review, a procedural requirement to initiate formal Senate consideration of her nomination, including a review by the Senate HELP Committee. Chair of the Senate HELP Committee, Bill Cassidy (R-LA) stated in a post on social media that he has concerns about both Dr. Overton’s stance on vaccines, as well as her ability to effectively lead the agency. In addition, a number of Democrats, including Senator Patty Murray (D-WA), have expressed opposition and concerns with the choice of Dr. Overton as the nominee for FDA Commissioner, noting concerns with her position on vaccines and other science-related issues among others. 
 
Given the concerns expressed by policymakers thus far, Dr. Overton’s path to confirmation may prove to be difficult, with issues related to timing and Senate procedure creating additional complications. Senators Collins (R-ME) and Murkowski (R-AK), who could also have a significant impact on whether her nomination advances, have not yet publicly shared their views on her nomination. The Senate is in recess through September 14, and will be out again from October 1 through November 9, after the midterm elections. With uncertainty regarding her path through the Senate HELP Committee under Chair Cassidy’s leadership, there is a chance that Dr. Overton’s nomination is delayed until January, after his departure from the Senate, should Republicans maintain the Senate majority in November. Once Dr. Overton is formally nominated, current Acting Commissioner Kyle Diamantas may remain in the role past the December date that would have prevented him from doing so had there not been a nominee under the Vacancies Act. 
 
Ultimately, the next confirmed FDA Commissioner will take on leadership of an agency that has experienced significant change, as well as several ongoing initiatives, including Operation Trialblazer and the recently announced FDA reorganization. While Dr. Overton’s nomination itself may unlock appointments of other senior agency leaders, unlike many of her predecessors, Dr. Overton will not inherit a seasoned cadre of long-serving center directors, deputy commissioners, and senior career executives with decades of institutional knowledge. This will certainly increase the management challenges facing her as a first-time commissioner. 

On August 21, HHS, through the Office of the Secretary, released a request for information (RFI) seeking public input on the categories used in federal vaccine recommendations and the role of “shared clinical decision-making” in the recommendation and administration of childhood vaccines. The Administration has recently renewed its effort to revise the childhood vaccine schedule through an Executive Order (EO 14420) that directed HHS agencies to take “any appropriate steps” to advance the revised schedule, which reduces the number of vaccines recommended in total and shifts multiple vaccines from being recommended as routine for all children to being recommended based on “shared clinical decision-making” (SCDM). In the RFI, HHS seeks input on the three categories of routine, risk-based, and SCDM, as well as category assignments and whether additional categories should be adopted, including “recommended, but not during infancy,” and “recommended with qualification.” In the RFI, HHS also acknowledges certain challenges related to the SCDM category that have been observed over time, including additional time to implement SCDM recommendations and confusion regarding insurance coverage of SCDM vaccines. The RFI requests responses to several questions related to SCDM recommendations including how to ensure that patients understand the coverage requirements that apply to SCDM vaccines. It also asks whether the categories convey differences in the strength of the evidence for individual and population benefits.  

HHS states in the RFI that responses will be reviewed by the Task Force on Safer Childhood Vaccines, which was reinstated by HHS in August 2025 and is tasked in the EO with advancing the new schedule. The RFI does not discuss the role of the CDC or the CDC Director in adopting potential changes to recommendation categories and it is unclear what level of input, if any, the new CDC Director had in the RFI. The RFI is open for public comment until September 20. 

On August 20, CDC Director Dr. Erica Schwartz gave her first “all-hands” address to agency staff. As noted in her nomination hearing, Dr. Schwartz reportedly shared with staff her three initial priorities: “earning trust through transparency and scientific rigor, strengthening CDC’s ability to detect and respond to health threats, and deepening partnerships with states and communities.”  

She also reportedly sought to assure staff that she is comfortable disagreeing with Administration leadership when needed, and that they should feel safe doing the same with her. Dr. Schwartz’s confirmation as CDC Director coincides with the renewed push from the Administration to revise the childhood vaccine schedule, which is recommended by CDC’s Advisory Committee on Immunization Practices and ultimately requires the signoff of the CDC Director. Disputes over this process ultimately led to the departure of the last CDC Director, Dr. Susan Monarez.

On August 18, FDA issued a discussion paper on considerations for the regulation of generative AI-enabled medical devices, in which it proposes to take a risk-proportionate approach based on the device’s intended use. In evaluating risk, FDA is considering drawing distinctions between patient-facing, informational functions versus healthcare provider-facing information functions, as well as distinctions between healthcare generalists versus specialists. The paper seeks public feedback on topics such as risk assessment, premarket evaluation, post–market monitoring, and other issues relevant to the regulation of these devices. FDA’s Digital Health Center of Excellence (DHCoE) is leading the effort as part of the agency’s broader work to advance regulatory frameworks for AI and digital health technologies. Throughout the document, FDA states it is committed to working collaboratively with stakeholders, including clinicians, “to develop efficient, scientifically sound, and least burdensome approaches” to regulating AI devices. The discussion paper is open for public comment until October 19.