Hamburg reorganizes FDA

FDA Commissioner Margaret Hamburg announced on Wednesday a major reorganization of the agency that includes the recruitment of Stephen Spielberg, a pediatrician with deep ties to academia and the drug industry, to a new senior position. Hamburg has created four "directorates:" the offices of medical products and tobacco; global regulatory operations and policy; foods; and operations. The reorganization creates a new level of management with authority that cuts across the agency's centers. Leadership of the centers is not affected by the new structure.

Spielberg is leaving his position as director of the Center for Personalized Medicine and Therapeutic Innovation at Children's Mercy Hospital in Kansas City to head the medical products directorate. In addition to academic posts, Spielberg served as VP for pediatric drug development at Johnson & Johnson (NYSE:JNJ) and executive director of exploratory biochemical toxicology, and clinical and regulatory development at Merck & Co. Inc. (NYSE:MRK). He will "provide high-level coordination and leadership across [FDA's] Centers for drug, biologics, medical devices, and tobacco products," according to Hamburg's announcement. ...