New Leadership Seeks to Transform FDA - Pharmaceutical Technology

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New Leadership Seeks to Transform FDA
Strict enforcement, new rules, and organizational changes signal an activist tone.


Pharmaceutical Technology
Volume 33, Issue 10, pp. 32-40


Jill Wechsler
US Food and Drug Administration officials are moving aggressively to address the charges of incompetence and ineffectiveness that have roiled the agency in recent years. In January 2009, the Government Accountability Office (GAO) added FDA to its list of high-risk government programs that should be reorganized to better ensure drug safety. GAO and other critics acknowledged a lack of government funding as a prime factor, along with the rising complexity of medical technology and the increased globalization of biomedical production.

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

In August, Hamburg formally unveiled a modest reorganization of the Office of the Commissioner (OC). A new food czar—a deputy commissioner of food—will oversee FDA's Center for Food Safety and Nutrition and the Center for Veterinary Medicine. Former FDA official and food regulatory expert Michael Taylor recently returned to the agency as Hamburg's special advisor on foods and is a likely candidate to fill the new position. However, Hamburg is not appointing a comparable official in charge of drugs, biologics, and medical devices as observers had speculated that she would.

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.


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