Trump says Makary is out as FDA commissioner, following industry and White House backlash

• Staff morale plummeted at the FDA following layoffs and departures of career scientists, including longtime cancer regulator Dr. Richard Pazdur who cited Makary as his reason for leaving
• Makary's controversial appointee Vinay Prasad oversaw polarizing decisions including initially refusing to review Moderna's flu shot and rejecting uniQure's Huntington's disease gene therapy, drawing industry criticism before leaving in April
• High-profile drug rejections included Replimune's melanoma treatment (rejected twice) and other rare disease therapies, prompting Sen. Ron Johnson to launch an investigation in March

Summary: FDA Commissioner Marty Makary Ousted Amid Controversy

President Donald Trump announced Tuesday that Dr. Marty Makary is out as FDA Commissioner after more than a year leading the agency. The surgical oncologist, previously known for criticizing government Covid-19 pandemic responses, faced mounting criticism from multiple fronts during his tenure.

Key Issues:

Makary's leadership was characterized by internal dysfunction, staff departures, and widespread industry backlash. Career scientists, including prominent cancer regulator Dr. Richard Pazdur, left the agency citing leadership concerns. Staff morale plummeted following layoffs and organizational turmoil.

The White House grew frustrated with Makary's perceived slow progress on Trump administration priorities, including legalizing flavored vapes. Simultaneously, the pharmaceutical and biotech industries criticized controversial regulatory decisions, particularly high-profile rejections of rare disease treatments.

Controversial Appointees:

Vinay Prasad, Makary's polarizing appointee overseeing vaccines and biotech treatments, left in late April after mounting criticism. Prasad's decisions included initially refusing to review Moderna's flu shot—a move the company called inconsistent with agency guidance—though the FDA later reversed course.

Notable Rejections:

• UniQure's Huntington's disease gene therapy faced rejection amid controversy over trial requirements
• Replimune's melanoma drug candidate was rejected twice (July and April), with the FDA citing insufficient effectiveness evidence and trial design concerns

In a May CNBC interview, Makary defended the agency's decisions, stating he works "for the American people" and stood by FDA scientists, denying any improper industry influence.

Senator Ron Johnson (R-Wisc.) launched an investigation in March into the FDA's rare disease treatment rejections. Despite touting accomplishments like a priority voucher program for accelerated drug reviews, Makary's tenure ultimately proved unsustainable amid escalating criticism.