Dr. Marty Makary has resigned from his position as Commissioner of the U.S. Food and Drug Administration (FDA), concluding a contentious tenure marked by internal strife and widespread criticism. President Donald Trump announced the departure, stating that Kyle Diamantas, formerly the FDA’s top food official, would assume the role of acting commissioner. Makary’s resignation comes after more than a year at the helm of the agency responsible for regulating food, drugs, and medical devices.

Makary’s time at the FDA was characterized by significant internal dysfunction and leadership turmoil, drawing considerable backlash from various stakeholders including drugmakers, physicians, and patient advocacy groups over a series of regulatory decisions. The White House reportedly grew increasingly impatient with what it perceived as slow progress on key policy initiatives, such as the legalization of flavored vapes. Additionally, his handling of the abortion pill mifepristone, including an alleged delay in its safety review, drew condemnation from organizations like Susan B. Anthony Pro-Life America. Health and Human Services Secretary Robert F. Kennedy Jr. ultimately made the decision to replace Makary, with the administration hoping to name a permanent nominee in the coming weeks.

The outgoing commissioner also faced scrutiny over the agency’s high-profile rejections of several rare disease treatments. The pharmaceutical industry, currently engaged in negotiations for the reauthorization of the Prescription Drug User Act Fee, expressed unease over the leadership shake-up. Staff morale within the FDA reportedly suffered due to layoffs and the departure of experienced scientists, with some citing Makary’s leadership as a direct cause. Controversial appointments, such as Vinay Prasad, who oversaw vaccines and biotech treatments, further fueled criticism within the biotech and pharmaceutical sectors, notably with the FDA’s initial refusal to review Moderna’s flu shot and the rejection of uniQure’s Huntington’s disease gene therapy.

Makary defended the agency’s decisions, asserting his commitment to the American public and the integrity of FDA scientists, particularly regarding the rejections of drugs like Replimune’s melanoma candidate. However, the controversies prompted Senator Ron Johnson to launch an investigation into the FDA’s handling of rare disease treatments. The incoming commissioner will inherit these complex issues, including the ongoing review of mifepristone and the challenge of securing Senate confirmation, which could be complicated by political dynamics.