FDA Reassigns Director of Office of Nonprescription Drugs Amid Strategic Shift

The Food and Drug Administration (FDA) has transitioned Theresa Michele, longtime director of the Office of Nonprescription Drugs, from her role to a leadership position within the FDA’s medical devices center. Michele, who has served at the FDA since at least 2015, was informed of her transfer during an internal meeting on December 3, 2025. This organizational change aims to realign the Office of Nonprescription Drugs with a stronger emphasis on affordability under the leadership of Makary. The FDA’s decision to shift leadership reflects broader regulatory and strategic adjustments within federal health agencies focusing on optimizing policy impact and operational efficiency. This move is significant for market watchers and industry stakeholders as it could influence regulatory approaches to over-the-counter drug approvals and medical device oversight. The reorganization may signal evolving priorities in drug pricing policy, compliance frameworks, and payer/provider relations within the scope of nonprescription and medical device sectors. The FDA’s internal restructuring highlights ongoing efforts to adapt to challenges in drug affordability and medical innovation, affecting insurance coverage considerations and regulatory compliance metrics.