Makary Removed as FDA Chief Amid Industry and White House Pressure, Says Trump

• Staff morale plummeted following layoffs and the departure of career scientists, including longtime cancer regulator Dr. Richard Pazdur, amid growing distrust of leadership
• 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 widespread industry criticism
• The White House was frustrated with Makary's slow progress on Trump priorities like legalizing flavored vapes, while drugmakers and patient groups opposed high-profile rejections of rare disease treatments

FDA Commissioner Marty Makary Removed Following Industry Backlash and White House Pressure

Key Development:

President Donald Trump announced Tuesday that Dr. Marty Makary has been removed as FDA Commissioner after serving more than a year in the role. The surgical oncologist, previously known for criticizing government COVID-19 pandemic responses, faced mounting pressure from multiple fronts.

Reasons for Departure:

Makary's tenure was plagued by internal dysfunction, leadership turmoil, and significant backlash from drugmakers, physicians, and patient advocacy groups. The White House reportedly grew frustrated with his slow implementation of Trump's key policy initiatives, including the legalization of flavored vapes. Simultaneously, staff morale plummeted following layoffs and the departure of career scientists, including prominent cancer regulator Dr. Richard Pazdur, who cited distrust of leadership.

Controversial Decisions:

The FDA under Makary faced criticism for high-profile drug rejections, particularly affecting rare disease treatments:

• Initially refused to review Moderna's flu shot (later reversed)
• Rejected uniQure's Huntington's disease gene therapy
• Twice rejected Replimune's melanoma drug candidate (April and July rejections)

Key Appointee:

Dr. Vinay Prasad, an outspoken academic serving as a key official overseeing vaccines and biotech treatments, left in late April following intense criticism from the pharmaceutical and biotech industries. His decisions, including the Moderna flu shot rejection, drew particular scrutiny.

Defense:

Makary defended his record in a May CNBC interview, citing his priority voucher program for accelerating drug reviews and maintaining that FDA decisions were based on independent scientific teams, not industry pressure.

Senator Ron Johnson (R-Wisc.) launched an investigation in March into the FDA's rejection of rare disease treatments.