Thursday, December 18, 2008

FDA Drug Safety Official Seligman Set to Depart

FDA's top drug safety communication official--Center for Drug Evaluation & Research Associate Director of Safety Policy and Communication Paul Seligman--will apparently be moving to a new position focusing on food supply integrity issues.

Seligman is understood to be departing CDER to focus on food quality being imported from Latin America.

Seligman’s departure will leave a void in the safety communication area at FDA’s Center for Drug Evaluation & Research at a critical time for the agency.

FDA is just beginning to get its arms around implementing the many postmarket surveillance provisions of the FDA Amendments Act, including the Risk Evaluation & Mitigation Strategies (REMS), a new requirement for quarterly web postings of emerging drug safety signals and the evolving Sentinel active surveillance system (See “Communication Conundrum,” The RPM Report, October 2008).

Seligman was named associate director of safety policy and communication in April 2006, a newly created position at the time that reported directly to the CDER director. He was previously director of the Office of Pharmacoepidemiology & Surveillance, which was eliminated.

The associate director position was an important organizational change for CDER when first announced because it demonstrated the center’s focus on safety.

eligman’s primary role was to develop drug safety policies across CDER and oversee the MedWatch voluntary adverse event reporting system, the Drug Safety Oversight Board, the “early communication” program, the drug safety newsletter, and the quarterly safety signal web postings mandated by FDAAA.

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