FDA names former pharmaceutical company executive to oversee US drug program
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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The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute's Department of Science Education and the Robert Wood Johnson Foundation. The AP is solely responsible for all content.
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Any statements that are not statements of historical fact may be deemed to be forward-looking statements. Words such as 'believe,' 'anticipate,' 'plan,' 'expect,' 'will,' 'may,' 'intend,' 'prepare,' 'look,' 'potential,' 'possible' and similar expressions are intended to identify forward-looking statements. These forward-looking statements include, without limitation, statements relating to our future operations, research and development programs, clinical trials and ELEVIDYS. Actual results could materially differ from those stated or implied by these forward-looking statements as a result of such risks and uncertainties. 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We caution investors not to place considerable reliance on the forward-looking statements contained herein. Sarepta does not undertake any obligation to publicly update its forward-looking statements based on events or circumstances after the date hereof, except as required by law. Source: Sarepta Therapeutics, Inc.
