FDA Gets a New Look

Dec 01, 2011

Jill Wechsler
The FDA is under pressure to encourage medical product development, monitor an increasingly global supply chain, and accomplish everything with ever-tighter resources. In the last few years, Congress added tobacco oversight to FDA's plate and expanded oversight of food safety. And that's on top of mandates to speed new therapies to market while ensuring they are safe and risk-free.

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.

Parallel Reviews
Commissioner Margaret Hamburg's response is to promote new approaches to drug development, including streamlined clinical research methods and development of biomarkers and other new tools for product evaluation. Hamburg outlined these strategies in an October 2010 white paper on FDA's Regulatory Science Initiative, followed by a "Strategic Plan for Regulatory Science" in August. A "blueprint" on "Driving Biomedical Innovation" issued this October outlines how FDA will revise burdensome and obsolete regulations, provide more help to small biomedical companies, and create a "rapid drug development pathway" for critical therapies. Hamburg also is collaborating more with other federal agencies on research, enforcement, and product evaluation initiatives (see sidebar).

New Structure

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.

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