FDA names former pharmaceutical company executive to oversee US drug program

Key Points

• FDA Commissioner Marty Makary named Dr. George Tidmarsh to permanently direct the agency’s Center for Drug Evaluation and Research, replacing acting director Dr. Jacqueline Corrigan-Curay.
• Tidmarsh is a longtime pharmaceutical executive who founded Horizon Pharmaceuticals and has served as an adjunct professor at Stanford University.
• He will oversee key priorities set by Makary and Health Secretary RFK Jr., including a safety review of the abortion pill mifepristone and scrutiny of other established drugs like antidepressants and hormone therapies.
• The FDA’s drug center, its largest unit with nearly 6,000 staffers, has been hit by about 2,000 layoffs and over 1,000 buyouts under recent workforce cuts, raising concerns about the timeliness of new drug reviews.

WASHINGTON (AP) — The Food and Drug Administration on Monday named a longtime pharmaceutical executive to run the agency’s drug program, the latest in a string of leadership changes at the agency.

FDA Commissioner Marty Makary announced that Dr. George Tidmarsh, a cancer and pediatric specialist, will direct the agency’s Center for Drug Evaluation and Research, which regulates the safety and effectiveness of all U.S. drugs.

His appointment comes a month after the center’s acting director, Dr. Jacqueline Corrigan-Curay, announced her retirement.

As the agency's top drug regulator, Tidmarsh will be charged with following through on a number of commitments made by Makary and his boss, Health Secretary Robert F. Kennedy Jr., including reviewing the safety of the abortion pill mifepristone. The FDA is also scrutinizing certain uses of other long-established drugs, including antidepressants and hormone-replacement drugs for menopause.

Tidmarsh founded and led several pharmaceutical companies, including Horizon Pharmaceuticals, maker of an anti-inflammatory medication for arthritis. He has also served as an adjunct professor at Stanford University.

The FDA's drug center is the agency's largest unit, with nearly 6,000 staffers responsible for reviewing the safety and effectiveness of new drugs and monitoring the use and marketing of older drugs.

About 2,000 FDA staffers have been laid off as part of widescale cuts to the federal health workforce overseen by Kennedy. More than 1,000 others have taken buyouts or early retirement, while many others are reportedly searching for new jobs. The departures have threatened basic FDA operations, including the timely review of new drugs.

FDA's drug center hasn’t had a permanent director since January, when Dr. Patrizia Cavazzoni stepped down days before President Donald Trump took office.

Nearly all of the FDA’s senior leadership positions have turned over in recent months, either due to retirements, resignations or actions by administration officials placing them on administrative leave.

FDA center directors typically hold their positions for years or even decades, serving across multiple administrations, whether Republican or Democrat.

In May, Makary named Dr. Vinay Prasad, a prominent critic of the FDA’s COVID response, to run the agency’s vaccine center. He was also named to the post of FDA chief medical officer. Prasad joined the agency after his predecessor, longtime vaccine chief Dr. Peter Marks, was forced out in March.

The head of FDA’s tobacco center was also forced to step down in April. A permanent replacement has not yet been named.

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