Marty Makary has resigned as commissioner of the FDA, ending a turbulent 13-month tenure that brought rapid regulatory experimentation, political controversy and new uncertainty for the drug, biologics, vaccine and medical device industries.
US President Donald Trump confirmed Makary’s departure this week and named Kyle Diamantas, the FDA’s deputy commissioner for food, as acting commissioner. Diamantas, a lawyer by training, had been leading the agency’s Human Foods Program, overseeing nutrition, food safety, resource allocation and food-related policy initiatives.
His appointment places a non-physician, food-policy-focused official at the helm of an agency whose remit spans prescription drugs, biologics, medical devices, diagnostics, vaccines, tobacco products and the US food supply.
Makary, a surgeon and health policy researcher, was confirmed by the Senate in March 2025 and sworn in as the FDA’s 27th commissioner on April 1, 2025. His time at the agency was short but marked by efforts to accelerate reviews, incorporate AI into regulatory workflows, reduce reliance on animal testing and reshape the FDA’s approach to food additives and nutrition policy.
Get industry leading pharma and biotech news, events and expert insights delivered to your inbox.
Makary rose to prominence in conservative Republican circles as a vocal critic of certain COVID-19 public health measures, often appearing on Fox News.
But his time at the FDA was marked by internal turmoil, including mass layoffs, leadership turnover and controversies that raised concerns among staff and observers about whether political priorities were taking precedence over the agency’s scientific standards.
His exit comes at a sensitive moment for the US health regulatory system. According to reporting by The Associated Press, the FDA commissioner’s resignation widens a broader leadership gap across the Department of Health and Human Services (HHS), with the CDC lacking a permanent director, no Senate-confirmed US surgeon general and vacancies or acting leadership in other key public health roles. This raises questions not only about who will lead the FDA next, but how consistently the agency will apply review standards during a politically charged period.
For biopharma companies, the change may be met with a mix of relief and caution. Reuters reported that biotech sentiment improved modestly following news of Makary’s departure, with the Nasdaq Biotechnology Index rising about 1% and shares of some companies that had faced FDA disputes under Makary also climbing.
However, analysts also warned that a leadership vacuum could create longer-term volatility if it slows decision-making, disrupts regulatory guidance or leads to ideologically or politically driven agendas.
Related: FDA Launches Real-Time Clinical Trials Pilot to Cut Drug Development Timelines
Makary’s tenure was defined by an aggressive reform agenda. In May 2025, the FDA announced the completion of its first AI-assisted scientific review pilot and set a timeline to scale AI tools across FDA centers. The agency framed the rollout as a way to support scientific reviewers and improve efficiency as part of a push to modernize regulatory operations, especially as the FDA faces increasingly complex submissions in areas such as cell and gene therapy, oncology, rare disease and combination products.
The FDA also moved forward with efforts to phase out animal testing in drug development, beginning with monoclonal antibodies (mAbs) and similar biologic therapies before expanding to other drug classes. In April 2026, the agency said it had achieved first-year goals tied to its roadmap for reducing animal testing in preclinical safety studies, positioning the effort as part of a transition toward more human-relevant models and alternative testing methods, such as AI-based computational models of toxicity and cell lines and organoid toxicity testing in a laboratory setting (referred to as New Approach Methodologies or NAMs data).
Makary also oversaw high-profile efforts to accelerate certain reviews. In April 2026, the FDA approved a first-ever gene therapy for genetic hearing loss under the Commissioner’s National Priority Voucher (CNPV) pilot program. Makary said the program showed the agency could review complex products, including dual-vector gene therapies and combination products, on shortened timelines.
While accelerated pathways are attractive to companies developing therapies for rare and serious diseases, critics say they must ensure consistent, robust scientific standards to maintain confidence among regulators, physicians, payers and patients. As such, the CNPV program has come under scrutiny regarding its “unclear” nomination process, potential to strain manufacturing capabilities and legal risks. The program has especially come under fire for lacking transparent criteria on how the 18+ vouchers (as of March 2026) were awarded.
The FDA is seeking feedback on eligibility criteria, selection processes and program implementation on the pilot program, with a meeting scheduled on June 4, 2026, for public input.
At the same time, Makary’s leadership drew criticism across several fronts. His tenure included conflicts involving companies such as Replimune, Sarepta, Moderna and uniQure over drug and vaccine-related decisions.
There were also heightened political tensions around abortion policy, vaccines, tobacco and vaping products, as well as food policy priorities linked to the Trump administration’s “Make America Healthy Again” agenda.
It remains to be seen whether Diamantas will maintain Makary-era initiatives or pause major reforms until a permanent commissioner is selected. As deputy commissioner for food, Diamantas has been closely associated with the agency’s nutrition and food safety portfolio, including efforts around food dyes and broader food policy. His background may support continuity on the food side of the FDA’s mandate, but the drug, biologic, vaccine and device sectors will be watching for signals from CDER, CBER and CDRH leadership.
Makary’s successor will inherit an agency that has been focused on moving faster and adopting new technologies, lined with concerns of maintaining standards and public trust in an increasingly politicized and volatile health policy landscape.
<script src=”https://platform.linkedin.com/in.js” type=”text/javascript”> lang: en_US</script>
<script type=”IN/FollowCompany” data-id=”1845094″ data-counter=”bottom”></script>
Join or login to leave a comment
JOIN LOGIN