“The new organizational alignments more accurately reflect the agency’s responsibilities, subject matter expertise and mandates in an ever more complex world, where products and services do not fit into a single category,” Hamburg said in the memo.
A newly created position of deputy commissioner for medical products and tobacco will oversee medical devices, drugs, biologics and tobacco products, as well as special medical programs, Hamburg announced. Dr. Steven Spielberg, director of the Center for Personalized Medicine and Therapeutic Innovation at Children’s Mercy Hospital in Kansas City, will serve as deputy commissioner.
Overseeing food and drug production and supply will be Deborah Autor, in a new role as deputy commissioner for global regulatory operations and policy. Autor is currently director of the Office of Compliance at the FDA’s Center for Drug Evaluation and Research. Dr. Murray Lumpkin will serve as senior adviser and representative for global issues, according to the memo. Lumpkin is currently deputy commissioner for international programs and director of the Office of International Programs.
The third directorate will be the previously established Office of Foods. And the fourth directorate will be an Office of Operations, headed by a chief operating officer, who has not yet been named. This office will oversee human resources, facilities, finance and other agency operations functions, according to the memo.