More FDA leaders are departing. Here’s what the turmoil may mean for agency policies and priorities
Several of former FDA Commissioner MARTIN MAKARY’s top deputies are following their boss out the door or moving out of agency leadership. The shake-up signals HHS interest in a clean break from Makary and could carry consequences for some of the policies and projects he had touted.
By Laura DiAngelo, MPH, Alexander Gaffney, MS, RAC and Ned Pagliarulo | May 19, 2026 1:57 PM EDT
A busy weekend at White Oak
- Leadership turnover: Late last Friday and into the weekend, news broke that several higher-ups at the FDA were leaving their positions. While some are leaving the agency altogether, others are moving to other positions within the FDA.
- A list of leadership moves at the drug centers: Acting Center for Drug Evaluation and Research Director TRACY BETH HØEG has left the agency entirely, with an exit interview with a blogger indicating it was an unexpected and unwilling departure. MICHAEL DAVIS, previously deputy CDER director, will now serve as acting director. Davis has been with the agency for about seven years, working previously as a team lead in CDER’s psychiatry division. Acting Center for Biologics Evaluation and Research Director KATHERINE SZARAMA will be moving to a role in medical product regulation at the agency, according to POLITICO’s reporting, while KARIM MIKHAIL will take over as acting CBER director. Mikhail joined the FDA in 2025 as a senior advisor after previous roles in leadership at biotech startups and 22 years at Merck & Co. in a variety of global roles, according to his LinkedIn profile.
- FDA Chief of Staff JIM TRAFICANT is leaving that role to become a senior adviser. Deputy Commissioner for Strategic Initiatives LOWELL ZETA is now also acting as chief of staff. Zeta, an attorney who is also special counsel for the FDA, had been at FDA between 2020 and 2021 and rejoined in April 2025. Chief AI Officer JEREMY WALSH appears to have departed the agency altogether, according to POLITICO reporting. In 2025, Walsh became the first, and thus far only, chief AI officer for the FDA. Agencies were directed to identify a hief AI officer under a White House memo implementing the president’s executive order on AI, but there’s no word yet on who would succeed Walsh, or even if it will remain a standalone position at the agency.
- Once and future turnover: The news of higher-up turnover at the FDA came just days after the resignation of Commissioner MARTIN MAKARY, which as AgencyIQ previously noted was not altogether unexpected. KYLE DIAMANTAS, formerly the Deputy Commissioner for Human Foods, is now acting commissioner. DONALD PRATER is currently serving as acting head of the Human Foods Program while Diamantis holds the top job. Makary’s departure followed some other recent top-level changes, including the ouster of CBER Director VINAY PRASAD in April, which elevated Szarama to her acting CBER chief role. Ordinarily, the FDA’s principal deputy commissioner would serve as acting commissioner during a leadership turnover, but that role is currently vacant since SARA BRENNER was elevated to senior adviser to HHS Secretary ROBERT F. KENNEDY JR. CHRIS KLOMP, an HHS chief counselor overseeing the FDA, last week indicated that more changes could be coming for the agency, POLITICO reported. Klomp said that the personnel moves were made “for good reasons,” according to that report The lack of permanent leadership at the highest levels of the agency raises significant questions about next steps for the ambitious policymaking agenda put forward by Makary and his team.
Policy from the podium unplugged: What happens now?
- Makary made full use of the bully pulpit that his position as FDA commissioner afforded him, launching a panoply of projects that varied widely in impact and implementation. Some, such as the Commissioner’s National Priority Voucher pilot program, have been up and running for months. Others, such as a recently launched real-time clinical trials initiatives, are still nascent. Many remain more proclamation than fully fleshed-out policy, as AgencyIQ has detailed in depth here. While the broad goals Makary’s projects supported appear generally popular – faster reviews, streamlined testing requirements and agency adoption of AI, for example – his “policy from the podium” style could mean some initiatives lose momentum with his exit. In general, these projects and initiatives were announced by press releases or at events, rather than through the FDA’s traditional routes of formal notice in the Federal Register or guidance development. These initiatives tend to operate within existing authorities or programs, and without the dedicated funding or discrete work groups that new regulatory programs would ordinarily receive. The durability of initiatives that rely on people tends to be more uncertain than those based in rulemaking and guidance. Below, we highlight as examples four policies closely associated with Makary and discuss the implications of his departure on their future.
- The CNPV program is arguably Makary’s signature initiative. And at least by measure of practical effect, it is among the furthest along. Launched in June 2025, the program offers significantly expedited approval reviews to selected participants, along with enhanced communication with the agency. The FDA has awarded 22 vouchers to date and approved seven of the designated products. (One was rejected and the developer of another reportedly withdrew from the program.) From the start, however, the program has faced criticism for a decision-making structure that risks the politicization of product reviews. Former CDER heads RICHARD PAZDUR and GEORGE TIDMARSH both cited concerns with the program and, since departing, Pazdur has pointed to it as evidence that the firewall between political leaders and scientific reviewers has been “breached.” There have been legal questions over FDA’s authority to create the program without congressional authorization and pushback over the program’s lack of documented process. The agency took steps to address both issues late last year, releasing a staff manual guide that more narrowly circumscribed the role of a “tumor board”-style review council. While the council is still closely involved, the final call on approval of designated products is made by the office or division director of the relevant review team. Though Makary’s exit means the program loses its most visible champion, the process now in place should be able to continue, especially since the program’s focus has shifted to assessing already-nominated candidates. However, almost every seat in the review council is now either vacant or held by an acting official. The FDA is planning a public hearing on June 4 that could provide further clarity.
- Makary spent much of his tenure at the FDA outlining his vision to move large numbers of prescription drug products to over-the-counter availability. “We want to see a mass transition to more nonprescription drugs,” he said in a Jan. 15, 2026, interview. As Makary talked up his plans, the FDA took steps seemingly in preparation for future agency action, including issuing a request for information that drew extensive industry input. And at a public meeting held April 23, Office of Nonprescription Drugs Director KAREN MURRY said the agency will launch a pilot program this year to work with certain over-the-counter drug programs. “New and updated guidances” are also in the works, said Murry, who Makary named to lead ONPD after ousting longtime leader THERESA MICHELE. [Read AgencyIQ’s analysis of the April meeting here.] While policy-making processes now appear in motion, they appear likely to be smaller in scope than the wholesale overhaul Makary envisioned. The planned pilot, for instance, aims to focus on a “limited number of candidate drugs,” according to Murry. Both it and the agency’s broader plans also rely on the participation of industry, which has indicated in comments and at the April meeting that it’s seeking more explicit guidance from the agency. These plans will take time to develop, especially if Diamantas or whoever President DONALD TRUMP nominates to replace Makary doesn’t similarly prioritize a mass OTC transition. Still, the underlying rationale for making more drugs nonprescription – increasing affordability and access – could resonate with an administration that’s seeking to show voters it can deliver lower-cost medicines.
- Makary announced a new inspection pilot during what turned out to be his final public appearance, at the Food & Drug Law Institute’s annual conference on May 6. Through the pilot, the FDA plans to conduct abbreviated, one-day “screening inspections” at manufacturing facilities identified as low-risk. Multiple inspectorates across food, medical products and clinical research are involved in the pilot, according to an agency statement. Makary had touted the agency’s plans on this front several times prior to FDLI, framing it as an opportunity for FDA to stretch its limited inspection resources further. Like many initiatives of his tenure, however, industry currently has limited information to go on. In its statement, the FDA said that, as of April 2026, it had already carried out 46 one-day assessments and planned to continue the pilot through fiscal year 2026. But “evaluation metrics to assess effectiveness” remain in development, according to the statement, which was also light on information about how the FDA assesses the risk of a manufacturing facility. Whether or not the pilot endures, the underlying rationale behind it looks likely to endure as the Trump administration remains focused on boosting domestic drug production. Speaking at the same FDLI conference, Deputy Commissioner GRACE GRAHAM told attendees to expect the FDA to continue prioritizing “America First” policies.
- The Real Time Clinical Trials program was announced jointly by Makary and Walsh. On Friday, a few hours before news of his departure, Walsh hosted a two-hour “industry information session” call to answer questions about the signature initiative, joined by the agency’s then-Deputy Chief Medical Officer MALLIKA MUNDKUR and the Oncology Center of Excellence’s SUNDEEP AGRAWAL. The RTCT initiative was a key priority for Makary, and appears to have been driven largely by Walsh, who took point on the design and development of the pilot program. In April, Walsh and Makary announced the RTCT pilot by saying that the agency was already working with the sponsors of two real-time clinical studies to pressure-test the concept. The announcement also included a request for information about how a pilot version of the project should be designed, indicating that the project was still in its nascency. So far, the ambitious pilot project for real-time clinical trial reporting only exists in a press release and an RFI, raising questions about the team that would lead and operate it, especially without Walsh or Makary’s leadership.
New leadership at FDA: A longer-term look
- The ouster of Høeg, Szarama, Traficant and Walsh makes it look like HHS and FDA leadership are taking steps to make a clean break from Makary’s leadership. These departures, paired with the recent resignation of Prasad and Brenner’s move to HHS, leave the FDA without most of the leaders who were most closely associated with Makary and his marquee policies. The departures are notable since some acting leaders – Høeg and Szarama – were swapped for other acting leaders, and just days after Diamantas was named acting commissioner. This indicates to us two things: That FDA and HHS leaders wanted this to be a clean break, and that they weren’t willing to wait for a new commissioner to be named for initial changes to happen.
- The next FDA commissioner has a path to making extraordinarily rapid staffing changes at the agency. The new commissioner will have the opportunity to select a new principal deputy commissioner, chief of staff, CDER director, CBER director and deputy directors, chief AI officer, and more. That’s a remarkably broad opportunity for reform that most commissioners have not historically been afforded. Most come into office and inherit their predecessors’ leadership teams, and often keep them in place temporarily. The current absence of established FDA leaders could now allow the next commissioner to make rapid changes to the agency, heralding a new approach in regulatory policy and approvals in short order.
- The lack of a stable leadership roster also heightens risks for FDA and industry. Significant turnover means the FDA will soon be led by a team who are likely new and inexperienced at running the FDA. That could, in turn, result in risks, including significant changes to existing policies, new philosophies for product approvals, and varying levels of familiarity with how the FDA has been historically run. As noted above, Klomp has previewed that additional personnel changes could be coming, meaning that the departure of Makary-allied staff could continue over the near-term.
- One thing to watch: For how long will this interim leadership team be in place? We think there are two likely scenarios. In a best-case scenario for the White House, a nominee for commissioner will be named in the next few weeks and the Senate, eager to set the FDA on the right path before the August recess and election recess, will move expeditiously to confirm the commissioner. But as we have previously explained, it is just as likely that things do not move expeditiously. Senate Health, Education, Labor and Pensions Committee Chairman BILL CASSIDY (R-La.) just lost his primary for reelection after the President actively campaigned against him, giving him little incentive to expedite hearings to confirm a new FDA commissioner. Whoever becomes the next nominee will need to balance the political demands of anti-abortion groups, the Make America Healthy Again movement, tough questions from Democrats about Makary’s record, and more. In addition, the extensive election-year recesses from Congressional business will significantly limit the time available to push the confirmation process forward. In this scenario, it seems probable that the confirmation process would wrap up after the midterm elections.
- Even after a commissioner is confirmed, it’s worth starting to think about the extent to which current acting leaders might be kept in place. It wouldn’t surprise us if HHS is treating the confirmation period as a sort of active trial period for some positions, such as Mikhail as CBER Director.
To contact the author of this item, please email Laura DiAngelo ( ldiangelo@agencyiq.com), Alexander Gaffney ( agaffney@agencyiq.com) or Ned Pagliarulo ( npagliarulo@agencyiq.com).
To contact the editor of this item, please email Kari Oakes ( koakes@agencyiq.com).