The added responsibilities come amid criticism on all sides. Pharma companies complain that an overly cautious approach to potential safety issues generates unreasonable requirements that stymie innovation. Patient and disease groups echo these concerns and want revised risk calculations that incorporate views of the critically ill. Yet, consumer representatives and some members of Congress continue to highlight drug safety problems and demand more extensive testing of new drugs both prior to approval and after coming to market.
To better handle new scientific approaches and today's global regulatory environment, Hamburg has spent the past year orchestrating a top-level reorganization of FDA. The most visible change is the appointment of a cadre of deputy commissioners to coordinate agency operations, which involve some 12,000 employees and more than 20 percent of US consumer products.
A new deputy commissioner for global regulatory operations and policy, Deborah Autor, is in charge of FDA's Office of International Programs and Office of Regulatory Affairs, which operates the agency's far-flung field force. This includes a growing number of foreign offices, established to monitor a surging volume of food and medical products imported into the US. Autor is quite familiar with supply chain vulnerabilities and import issues, as she previously headed the Office of Compliance (OC) in the Center for Drug Evaluation and Research (CDER), which also has undergone a major facelift.
Michael Taylor remains the head of FDA's Office of Foods, overseeing the Center for Food Safety and Applied Nutrition (CFSAN) and the Center for Veterinary Medicine (CVM). An FDA veteran, Taylor has the daunting task of implementing food safety legislation without the resources to inspect more facilities and to expand oversight as required by Congress.
Chief Scientist Jesse Goodman is point man on regulatory science. He also oversees the National Center for Toxicological Research, counter-terrorism, and agency integrity and professional staff development, along with special offices for women's health and for minority health.
Counselor to the commissioner, John Taylor, who served as Hamburg's temporary deputy commissioner for much of this past year, returns to his advisory role, but with added staff responsibilities. He monitors policy and planning functions, legislative relations, and external affairs.