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FDA Shakes Up Drug Office Amid Departures
4 Dec, 2025
Summary
- FDA director of non-prescription drugs moves to new role.
- The move follows the drug evaluation chief's retirement announcement.
- The office is being reshuffled to focus more on affordability.
Theresa Michele, who has directed the FDA's office of non-prescription drugs since 2015, is transitioning to a new leadership position within the agency's medical devices center. This personnel change was announced by a federal official and follows closely on the heels of drug evaluation chief Richard Pazdur's decision to retire. These moves contribute to a period of notable management shifts and personnel changes within the FDA.
The agency plans to re-envision Michele's former office, with a stated aim to increase its focus on the affordability of non-prescription medications. This strategic recalibration could signal a new direction for the regulation and development of over-the-counter drugs. The development was first reported by STAT News, citing internal sources.
This series of changes at the FDA has fueled perceptions of internal flux, potentially creating uncertainty for the biotechnology sector. Analysts are observing these shifts closely as they occur under the broader administration's initiatives.
