Dec 3 (Reuters) – The U.S. Food and Drug Administration is moving Theresa Michele, longtime director of the office of non-prescription drugs, to a new role, a federal official said on Wednesday. The move comes a day after FDA’s drug evaluation chief, Richard Pazdur, announced his decision to retire, marking another high-profile departure in a […]
Health
US FDA removes longtime director of over-the-counter drugs office
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Dec 3 (Reuters) – The U.S. Food and Drug Administration is moving Theresa Michele, longtime director of the office of non-prescription drugs, to a new role, a federal official said on Wednesday.
The move comes a day after FDA’s drug evaluation chief, Richard Pazdur, announced his decision to retire, marking another high-profile departure in a long list of changes in the agency under U.S. Health Secretary Robert F. Kennedy Jr.
Michele has been leading the over-the-counter drugs division since 2015, overseeing the development, review and regulation of products such as pain relievers and flu medications.
The federal health official said the agency is reimagining Michele’s previous office to focus more on affordability.
STAT News, which reported the development earlier in the day citing sources, said Michele told staff in an internal meeting that the human resources office was transferring her to a leadership position in the FDA’s medical devices center, effective Thursday.
According to the report, FDA Commissioner Marty Makary blamed Michele for the regulator not approving enough non-prescription drugs.
The U.S. health regulator has been in a state of upheaval with shifts in key management, job cuts and programs to expedite drug development. Analysts have noted that these changes feed perceptions of internal turmoil at the FDA, which adds uncertainty for the biotech sector.
(Reporting by Christy Santhosh in Bengaluru; Editing by Krishna Chandra Eluri)