Change comes to FDA's reporting structure
FDA Commissioner Margaret Hamburg elevates the Office of Women's Health so that it now reports directly to her, and creates an Office of Special Medical Programs for pediatric, combination and orphan drugs, as well as an Office of Foods.
FDA Commissioner Margaret Hamburg has reshuffled her agency's reporting structure.
On Feb. 19 Hamburg elevated FDA’s Office of Women’s Health so that it now reports directly to the commissioner. Previously that office was a few steps down in the hierarchy, in the chief scientist’s office, according to the notice in the Federal Register.
Hamburg also announced she has created a new Office of Special Medical Programs that includes pediatric therapeutics, combination pharmaceuticals, orphan drugs (pharmaceuticals developed specifically to treat rare medical conditions) and good clinical practice. It also now reports directly to Hamburg.
Hamburg also announced creation of an Office of Foods to provide executive leadership for all food safety, nutrition and labeling programs, reporting directly to the commissioner. The office will be led by a deputy commissioner for foods, and is in harmony with the Obama administration’s drive to elevate food safety in the fiscal 2011 budget.
However, raising the profile of food safety apparently was under way before Hamburg came on board Jan. 4. In an August 2009 notice in the Federal Register, it was stated that the Foods Office, formerly in the FDA’s Office of Operations, would stand alone and report directly to the commissioner.
Hamburg adopted a few other management changes from that earlier notice. But she added a few changes of her own, including the boost to the women’s health office and special medical products.