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FDA News

FOR IMMEDIATE RELEASE
P06-59
April 18, 2006

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FDA Names First Associate Center Director for Safety Policy and Communication in the Center for Drug Evaluation and Research
FDA Centralizes Drug Safety Policy and Communication

The Food and Drug Administration today announced the appointment of CAPT Paul Seligman, M.D., as the Associate Center Director for Safety Policy and Communication in the Center for Drug Evaluation and Research (CDER). In this newly created position, Dr. Seligman will provide oversight of drug safety issues and policies and manage the staff who disseminate safety information to healthcare professionals and patients through FDA's website.

"This new position signifies FDA's commitment to drug safety," said Steven Galson, M.D, FDA's Director of CDER. "The appointment of Dr. Seligman represents our efforts to consolidate responsibility for developing Center-wide drug safety policy as well as coordinating our efforts in the area of risk communication. We anticipate that this step will help to provide a more standardized and predictable approach to ensuring drug safety and enhance the effectiveness and timeliness of the information we provide to the healthcare community and the public."

As Associate Center Director, Dr. Seligman will provide oversight of the development of Center-wide drug safety policies and will oversee the Center's communication initiatives related to the safety and appropriate use of medicines. As part of his responsibilities he will have immediate oversight of the Drug Safety Board staff and the MedWatch program and will play a significant role in implementing recommendations from external organizations, such as the Institute of Medicine and the Government Accountability Office, which have conducted in depth examinations of drug safety processes at FDA.

Dr. Seligman joined FDA in 2001 as the Director of the CDER Office of Pharmacoepidemiology and Statistical Science (OPaSS).

"During his tenure as head of OPaSS, Dr. Seligman led the organization through a period of challenge, change, and growth," said Dr. Galson. "His steady leadership during this time has been a critical attribute for the center and agency."

As part of CDER's reorganization announcement on October 2005, the position of Associate Center Director for Safety Policy and Communication was announced to bring greater focus, attention and energy to important Center-wide drug safety and risk communication initiatives, as well as efforts that require close coordination with the Commissioner's Office and external stakeholders.

Dr. Seligman, a Captain in the Commissioned Corps of the U.S. Public Health Service, is board-certified in internal medicine, public health, general preventive medicine and occupational medicine. Before joining FDA, Dr. Seligman was the Deputy Assistant Secretary for Health Studies at the Department of Energy, where he headed the national and international program for radiation research, environmental, and occupational health studies.

His career also has included an assignment to the U.S. Senate as a fellow of the American Political Science Association; service with the Centers for Disease Control and Prevention as an epidemic intelligence officer, chief of the medical section of the Surveillance Branch at the National Institute for Occupational Safety and Health; and, before entering medical school, a tour as a Peace Corps volunteer in Kenya.

Dr. Seligman is the author of numerous scientific articles, reviews, and book chapters on topics related to occupational medicine and radiation health.

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