FDA names permanent director for Center for Drug Evaluation and Research

March 17, 2008 — /FDA/ — Commissioner of Food and Drugs Dr. Andrew C. von Eschenbach announced March 10, after a national search, the appointment of Janet Woodcock, M.D., as director of the agency’s Center for Drug Evaluation and Research.

This appointment is of significance because CDER is charged with assuring that safe and effective drugs, including prescription, over-the-counter, and generics, are available to Americans.

“Dr. Woodcock’s outstanding scientific credentials and historical knowledge of the complexities involved in drug safety and regulation make her uniquely qualified to oversee, as well as modernize, the techniques, tools, and methods used for evaluating the safety and effectiveness of drugs throughout the product life-cycle,” says Dr. von Eschenbach.

A prominent FDA scientist and executive, Dr. Woodcock has received numerous awards, including a Presidential Rank Meritorious Executive Award, the American Medical Association’s Nathan Davis Award, the American Association for Cancer Research Public Service Award, the National Organization for Rare Disorders Public Health Leadership Award, the Personalized Medicine Coalition’s Award for Leadership in Personalized Medicine, the National Alliance for Hispanic Health’s VIDA Award, and six special citations from FDA commissioners.

Dr. Woodcock received her doctorate from Northwestern Medical School and completed further training and held teaching appointments at the Pennsylvania State University and the University of California in San Francisco.

Throughout her career at the FDA, Dr. Woodcock has played an integral role in advancing the health of the American public. Under her strong leadership, FDA launched the Critical Path Initiative designed to bridge the gap between basic scientific research and the medical product development process. This initiative called for a collaborative cross-sector effort to modernize the drug development process and has resulted in several prominent partnerships looking at a wide variety of scientific issues. Dr. Woodcock will continue to be involved in this initiative, as well as the emerging post-market surveillance collaborations with the private sector.

While serving as the agency’s deputy commissioner and chief medical officer, where she oversaw scientific and regulatory operations, Dr. Woodcock agreed to assume the role of acting director of CDER in October 2007. The recently announced Safety First program is one of the initiatives she has led since assuming the center director role in an acting capacity.

“Dr. Woodcock’s exemplary service since October was confirmation of her being ideally suited to lead the center during this crucial period following the passage of the Food and Drug Administration Amendments Act of 2007,” notes Dr. von Eschenbach. “The agency is fully committed to implementing the drug safety programs laid out by this act and meeting the goals set under the Prescription Drug User Fee program, which will help ensure that CDER has the additional resources that are needed to conduct these very complex and comprehensive reviews.”

An internist and rheumatologist, Dr. Woodcock has previously held several other leadership positions in the agency, including director, Office of Therapeutics Research and Review, and acting deputy director, Center for Biologics Evaluation and Research, as well as director of CDER.

“The FDA is truly blessed to have extraordinary public servants like Janet who are willing to use their skills and talents to guide the centers in achieving the agency’s mission of protecting and promoting the public health,” notes Dr. von Eschenbach.

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