Jill Wechsler

To make FDA more efficient and competent, Commissioner Margaret Hamburg is taking action on several fronts. She has reorganized her immediate office to emphasize food safety and scientific integrity and to quickly inaugurate agency involvement in regulating tobacco. FDA is announcing new rules and policies almost daily and broadcasting its intent to enforce manufacturing and marketing requirements aggressively. Hamburg is highly visible in all these initiatives, outlining new policies at press briefings and public meetings and emphasizing that she is calling the shots at the agency.

Changes at the top

Other changes include establishing an office of external affairs to better communicate FDA decisions and proposals to the media, health professionals, and interest groups. A new Office of Special Medical Programs will oversee several interrelated activities such as bioresearch monitoring, combination products, orphan drugs, and pediatrics. Budget development will be the responsibility of the policy office, which will explain to Congress how FDA will spend its resources and justify requests for additional funding. Hamburg is benefiting from a record $3-billion FDA budget for the coming year (including roughly $600 million in user fees), but will face a tough fight to keep the increases coming.

A prominent addition to FDA is the Center for Tobacco Products, which was authorized by Congress in June 2009 and established by the agency in record time. Hamburg announced in August that the Center would be headed by Lawrence Deyton, a physician with experience in academia, public health, and Congress. Deyton successfully revitalized smoking-cessation programs as a top health official at the Department of Veterans Affairs.

The tobacco legislation charges FDA with enforcing marketing restrictions on tobacco products, regulating product ingredients, and taking action to reduce youth smoking. FDA also has leeway to promote smoking cessation, which could stimulate the development and approval of more nicotine-replacement therapies such as patches, gums, and lozenges. The new tobacco center will start operations with $5 million from FDA and the expectation that industry user fees will provide sufficient resources to support research on tobacco use and regulatory and enforcement programs.