Heidi Overton is Trump’s pick for next FDA commissioner. Here’s what to know.

President DONALD TRUMP plans to nominate White House policy aide HEIDI OVERTON as his next FDA commissioner. Here, AgencyIQ examines how Overton, a physician who has helped shape this administration’s health policy, might approach running the agency and identifies key questions ahead of her possible confirmation.

By Alexander Gaffney, MS, RAC and Ned Pagliarulo | Aug 19, 2026 4:48 PM EDT

Trump to pick Overton as next FDA commissioner

• President DONALD TRUMP plans to nominate White House policy aide HEIDI OVERTON to lead the FDA. In an Aug. 19 Truth Social post, Trump called Overton a “ROCKSTAR” who would help the FDA “ensure that the U.S. remains the WORLD LEADER for scientific discovery and CURES.” Overton would work with HHS Secretary ROBERT F. KENNEDY JR. and Centers for Medicare and Medicaid Services Administrator MEHMET OZ, Trump added, to deliver on his priorities of “FASTER Cures, INCREASED American Innovation, MAJOR Clinical Trial Reforms, LOWER Drug Prices, and even more MAHA WINS!” News of Trump’s plans was first reported by Bloomberg and several other national media outlets late Aug. 18.
• In choosing Overton, Trump is opting for an administration insider over other reported candidates who would’ve brought outside health system or industry experience. Along with Overton, Trump seriously considered senior Pentagon health official STEPHEN FERRARA and New York Cancer & Blood Specialists CEO JEFF VACIRCA for the FDA role, according to prior reports from Bloomberg, Axios and STAT News. [AgencyIQ previously analyzed the background of all three.]
• Trump’s pick of Overton follows the mid-May resignation of former FDA Commissioner MARTIN MAKARY, which triggered the departure of several other FDA leaders. Makary stepped down after months of rising criticism over his approach on rare disease drugs, vaccines, abortion treatment and e-cigarettes left him with few allies in the administration and Congress. Following him out the door were Center for Drug Evaluation and Research Acting Director TRACY BETH HØEG and Chief AI Officer JEREMY WALSH, while Center for Biologics Evaluation and Research Acting Director KATHERINE SZARAMA and FDA Chief of Staff JIM TRAFICANT were reassigned. [Read AgencyIQ’s analysis of the turnover here.]
• During Makary’s 13-month tenure as FDA commissioner, he set in motion a long list of initiatives but left many incomplete or only partially defined. Acting Commissioner KYLE DIAMANTAS has continued to advance some of those policies, including plans to reform clinical trial regulation, but the future of others remains an open question for the next commissioner. [AgencyIQ tracked Makary’s first year of policies and promises here.]

Who is Heidi Overton?

• Overton is deputy assistant to the president for domestic policy and a senior member of the White House’s Domestic Policy Council, where she has helped coordinate health policy and work related to the Make America Healthy Again Commission. She previously was chief policy officer and vice chair of the Center for a Healthy America at the America First Policy Institute, a Washington-based think tank aligned with Trump. While there, she wrote about abortion and gender transition policy, Covid-19 vaccine mandates and hospital price transparency, among other topics. She received a medical degree from the University of New Mexico School of Medicine and completed a general surgery residency at Johns Hopkins Hospital. She also received a Ph.D. in clinical investigation from the Johns Hopkins Bloomberg School of Public Health. At Johns Hopkins, she conducted research and wrote papers with Makary on opioid overprescribing, opioid guidelines for surgical procedures, health insurance plan commissions, polypharmacy among Medicare patients and multiple myeloma treatment.
• A regular presence at White House press conferences and announcements related to health policy, Overton’s joined Trump at events on fertility treatment, psychedelic research, drug pricing and vaccines, among others. At the event on psychedelics, which was held to promote an executive order on research, Kennedy credited Overton for her work behind the scenes. “Thank you, Heidi, for your leadership and for your attention to detail. It was often frustrating but always right,” Kennedy said. (Trump referenced this comment in his Truth Social post.) She also spoke at length during an Oval Office event to announce Trump’s executive order on the U.S. childhood vaccine schedule, suggesting at least public alignment with Kennedy on a divisive political issue. Kennedy, in an Aug. 19 post on the social platform X, called Overton “the best person for the job.”
• Overton’s role translating political priorities into policy has put her at the center of several high-profile fights within the administration. According to a recent profile in The Atlantic, Overton played a significant role in shaping – and trimming – Trump’s executive order on psychedelic research, so much so that advocates for the order threatened to withdraw from the signing ceremony. She also earned the ire of some Make America Healthy Again proponents for allegedly “slow-walking” the recent rescheduling or marijuana, according to the profile, which also revealed that she’s currently working to draft new policies on unapproved peptides.
• Overton also has a close working relationship with Department of Agriculture Secretary BROOKE ROLLINS, her former boss at the Domestic Policy Council. According to The Atlantic’s profile, Overton was at the center of mediating between HHS and USDA on the development of the 2025-2030 Dietary Guidelines for Americans, and “chafed at Kennedy’s idea of throwing out all of the Biden administration’s work” on the DGAs, preferring to retain more of the guideline’s original scientific underpinnings. Her collaboration with USDA in that work reportedly drew the concern of HHS officials, who believed she was undermining their policy objectives in favor of USDA, according to The Atlantic. Overton was also closely involved in the drafting of the first MAHA executive order in February 2025, which established the commission responsible for studying childhood chronic diseases and potential causes.
• HHS Chief Counselor CHRIS KLOMP defended Overton in The Atlantic’s profile. Klomp told the publication that Overton had aligned disparate priorities in assembling the psychedelic order, helping ensure it was “done the right way.” Klomp is highly influential within the department and helps run much of its day-to-day work. POLITICO previously reported that Klomp was involved in Makary’s ouster and the elevation of former FDA Principal Deputy Commissioner SARA BRENNER to become Kennedy’s senior counselor for public health. Trump recently nominated Klomp to be HHS deputy secretary; Congress has not yet held confirmation hearings.

What is Overton’s regulatory philosophy?

• As AgencyIQ has noted in the past, FDA commissioners typically make decisions based on an underlying regulatory philosophy. For some, this fundamental approach is entrenched prior to their selection. This was the case with Makary, who had made a reputation criticizing what he saw as medical dogma and, while in office, sought to course-correct the agency’s acceptance of these tenets. For others, the circumstances of their tenure may shape their operating philosophy, as with former Commissioner STEPHEN HAHN, who assumed the role as the Covid-19 pandemic was just beginning.
• Overton does not have a long track record of public comments on the FDA, outside of a few select topics. But, as a White House aide, she is intimately familiar with the Trump administration’s political priorities and appears closely aligned ideologically. As with other health leaders in the administration, she’s criticized past Covid vaccine policies and the public health agencies that developed them during the pandemic. The Centers for Disease Control and Prevention, she and Hoover Institute fellow BRIAN MILLER wrote in 2024, is “overdue for both a holistic reevaluation and strategic refocusing.” She has also criticized the FDA’s regulation of abortion treatment, calling for an end to agency policies that permit the abortion medicine mifepristone to be dispensed by mail and at retail pharmacies. And she’s called for conservatives to develop their own academic journals and funding strategies to advance research that federal health agencies don’t typically pursue. “We need research funding that is willing to say, ‘No, let’s fund these type of studies.’ That’s not happening at the NIH. The FDA isn’t prioritizing those kinds of decisions. The CDC certainly is not,” she said on a 2023 episode of a podcast hosted by the America First Policy Institute. “So all of those agencies have to be reformed in how they fund and prioritize.”
• The White House’s choice of Overton could be seen in part as a response to the chaotic ending of Makary’s tenure, when the former commissioner seemed out of sync with the president and Republican lawmakers on tobacco and abortion policy. Yet if confirmed, Overton would have to bridge the deregulatory impulses of Make America Great Again politics and the industry-skeptical views of the MAHA movement in a much more public role than her current seat on the Domestic Policy Council. She would also face pressure from industry and patient groups that grew frustrated with the FDA’s erratic decision-making and rare disease drug reversals under Makary.

What’s Overton’s path to confirmation?

• The Senate Committee on Health, Education, Labor and Pensions is tasked with vetting nominees to lead the FDA. Currently, the committee is chaired by BILL CASSIDY (R-La.), who lost his primary election after Trump backed his opponent. A doctor and proponent of vaccines, Cassidy reluctantly supported Kennedy’s nomination as HHS secretary but appeared to resist backing other nominees for senior health positions. More recently, Cassidy has sparred directly with the president over the war in Iran. Put more simply, Cassidy’s support for Trump’s next FDA nominee may not be a given. Whoever goes before HELP will also have to navigate competing crosscurrents on abortion policy, an issue both Cassidy and HELP member JOSH HAWLEY (R-Mo.) have made clear is a priority to them. Hawley, in particular, had repeatedly raised concerns that Makary was not moving quickly enough to limit access to mifepristone. Yet HELP’s Republican roster also includes SUSAN COLLINS (Maine) and LISA MURKOWSKI (Alaska), who in the past have taken relatively more moderate positions on abortion access. Republicans outnumber Democrats on HELP by only one seat, so the loss of any Republican support would mean a candidate needs to secure votes from Democrats. Senators may also be conscious of how their votes may play in the November midterms, causing the confirmation vote to be delayed until after the elections.
• While Trump commands immense influence over Senate Republicans, several of his health nominees have either stalled out or struggled to gain lawmakers’ support. Trump was forced to withdraw his first nominee to run the CDC, DAVID WELDON, after failing to secure sufficient support. More recently, Trump withdrew his nomination of CASEY MEANS for surgeon general for similar reasons, while his pick of ERICA SCHWARTZ to run the CDC barely secured enough votes for confirmation. In each case, the nominees’ existing views on vaccines, or answers to questions put to them on vaccines in hearings, sparked pushback from both Republican and Democratic lawmakers. A confirmatory hearing would put Overton – and her role in shaping the administration’s vaccine policies – under the microscope.
• Once Overton is formally nominated, Diamantas can continue serving as acting commissioner past the December deadline that would have applied under the Vacancies Act. There is precedent for a long period of acting leadership. JANET WOODCOCK, for example, was acting commissioner for 13 months while the Biden administration tried to get her confirmed as commissioner. Diamantas has earned positive reviews for steadying the FDA after the turbulent ending to Makary’s tenure and has successfully managed the rollout of major initiatives such as Operation TrialBlazer.

What are the key questions facing Overton?

• Overton’s lack of organizational leadership expertise is something to emphasize given the extraordinary challenges faced by Makary, who also lacked experience and surrounded himself with similarly inexperienced aides. Overton would be charged with leading roughly 15,000 FDA employees through many challenges, including the reauthorization of the agency’s user fee programs in Congress, the midterm elections, efforts to reform the FDA in Congress, and the need to rebuild the agency’s expertise following significant staff cuts and attrition. However, Overton, like Makary, does not have experience leading large organizations like the FDA. While she has significant policy experience from her time as a White House fellow, at the America First Policy Institute and on the Domestic Policy Council, none of those positions in government and the nonprofit sector involve leading large bureaucracies. A key thing to watch is whether she selects leaders with significant FDA or government experience to help make up for these deficiencies.
• How would FDA employees perceive Overton? A big problem Makary faced as FDA commissioner was that he generally failed to win the trust or admiration of the agency’s career staff, who frequently told AgencyIQ that Makary didn’t seem to fully grasp the complexity and importance of their work. Regaining this trust will be important for Overton to retain and recruit FDA staff – which she’ll need to do if the agency is to accomplish its stated lofty policy goals, including advancing the MAHA agenda and reforming the country’s clinical trials ecosystem. But Overton may face significant headwinds from staff concerned about bias or inexperience. While she has a medical degree, her only post-training experience has been as a political operative working in the White House or for the America First Policy Institute. She appears never to have practiced medicine after residency, moving directly from being a general surgery resident at Johns Hopkins to a White House fellowship under the first Trump administration and then to her other political and policy advocacy roles. Staff may further worry that the FDA, historically a (mostly) politically neutral regulatory body, will lean into politics and take actions based on the whims of the administration leaders instead of good science.
• By selecting Overton, the White House seems to be indicating that some of Makary’s key policies will continue. It’s worth noting that Overton is as close to an “insider” hire as one can make without hiring from the FDA itself. Because Overton ran the health portfolio of the Domestic Policy Council, she was already in position to oversee and shape the FDA’s policy proposals under Makary, whom she knew as a trainee in Baltimore and with whom she was reportedly close.
• To the extent that Overton’s policy preferences hew to Makary’s, industry can expect a predictable sense of either relief or frustration. Pharmaceutical executives are likely to benefit from a continued focus on “America First” policies intended to bolster U.S. clinical trials and manufacturing, though vaccine manufacturers will likely be frustrated by continued lack of vaccine regulatory certainty under the Trump administration. The key thing to watch during Overton’s confirmation hearings will be any signs that she is either looking to upend existing policies or simply continue the status quo. Trump’s Overton announcement indicates it’s likely to be business as usual, however, given his recitation of ongoing administration priorities.
• Who would Overton select for the FDA’s senior leadership team? Overton’s dearth of prior bureaucratic or private sector experience should prompt her to make strong choices for her first-line reports; she and her chosen lieutenants will have plenty of opportunities to shape the agency in significant ways. The principal deputy commissioner slot, last held by SARA BRENNER, remains open and serves as the effective second-in-command position at the FDA. MIKE DAVIS and KARIM MIKHAIL are acting heads of CDER and CBER, respectively, and Overton would need to decide whether to keep them or select new leaders. Another important hiring decision will be whether to retain or replace Acting Chief of Staff LOWELL ZETA. Many commissioners have traditionally filled this role with longtime FDA insiders, to help them navigate institutional complexities.
• The White House has also reportedly been reviewing options for permanent CDER and CBER leadership, according to a June 27 Bloomberg story. The Pink Sheet, meanwhile, reported on July 8 that HHS is weighing reinstituting an FDA leadership position similar to the deputy commissioner for medical products and tobacco role that was eliminated in 2018 under then-Commissioner SCOTT GOTTLIEB. Taken together, these reports suggest that Overton’s selection could be accompanied by a broader shake-up that could meaningfully reshape the agency’s leadership.
• Overton would also need to implement recently announced FDA staffing reforms that would overhaul the agency’s leadership structure in some critical ways, including a new Office of Health Advancement and Office of National Health Security. However, it’s not clear whether Overton herself would make all the selections. Klomp, as HHS chief counselor, has taken an active role in steadying the FDA in recent months, and we expect that he will work closely with the next commissioner to vet leadership nominees, and perhaps even make specific recommendations or selections.
• Overton seems better equipped than Makary to handle complex stakeholder demands. This was a notable weak spot for Makary, who frequently seemed to walk into problems before realizing their extent or importance. In contrast, the job of the White House Domestic Policy Council is almost exclusively stakeholder management, problem-solving and taking on fights between principals. Overton has also already worked closely with Trump – a stark departure from Makary, who was a neophyte to politics and largely unknown to the president. She also is familiar with all HHS, White House and political stakeholders already, which would likely serve her well as she pushes for FDA policy advancement.

To contact the authors of this item, please email Alexander Gaffney ( agaffney@agencyiq.com) or Ned Pagliarulo ( npagliarulo@agencyiq.com).

To contact the editors of this item, please email Kari Oakes ( koakes@agencyiq.com) or Jason Wermers ( jwermers@agencyiq.com).