US FDA dismisses director of over-the-counter drugs office

On December 3, a federal official confirmed that the U.S. Food and Drug Administration (FDA) is reassigning Theresa Michele, who has led the agencys office for non-prescription drugs for several years, to a new leadership role. This change follows closely on the heels of FDAs drug evaluation head, Richard Pazdur, announcing his retirement, highlighting another significant leadership shift under U.S. Health Secretary Robert F. Kennedy Jr.

Michele has directed the over-the-counter (OTC) drugs division since 2015, overseeing the review, approval, and regulation of products including pain relievers and flu remedies. According to the federal official, the FDA plans to restructure her former office with a greater emphasis on making medications more affordable.

Earlier reports from STAT News, citing internal sources, indicated that Michele informed her team during a staff meeting that she will be moving to a senior role at the FDAs Center for Medical Devices, effective Thursday. FDA Commissioner Marty Makary reportedly attributed Micheles reassignment to dissatisfaction with the pace of non-prescription drug approvals.

The FDA has been experiencing notable organizational changes, including leadership shifts, staff reductions, and initiatives to accelerate drug development. Analysts suggest these developments contribute to a perception of internal instability, which may affect confidence in the biotech sector.

Author: Lucas Grant