FDA Office Of Drug Safety Director Is Surveillance Division Head Gerald Dal Pan
This article was originally published in The Pink Sheet Daily
Executive Summary
Appointment of the Division of Surveillance, Research & Communication Support director as permanent director of the Office of Drug Safety ends a two-year vacancy.
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FDA is turning to five-year agency veteran Gerald Dal Pan to permanently fill the high-profile role of Office of Drug Safety director. Dal Pan has served as the director of the Office of Drug Safety's Division of Surveillance, Research & Communication Support since the end of 2003. He will officially begin as ODS director Nov. 13. The agency's Oct. 19 announcement of a permanent ODS director comes two years after the departure of former ODS Director Victor Raczkowski in October 2003. Since that time, the position has been filled on an acting basis, first by Office of Pharmacoepidemiology & Statistical Sciences Director Paul Seligman and then by FDA Emergency Preparedness Officer Ralph Lillie (1 (Also see "FDA Office Of Drug Safety Acting Director Is Ralph Lillie" - Pink Sheet, 26 Jan, 2005.)). FDA renewed and expanded its search for an ODS director in November 2004 and posted a position description on the federal government's job site in June (2 (Also see "Help Wanted: FDA Seeks Drug Safety Office Director" - Pink Sheet, 29 Jun, 2005.)). Dal Pan joined FDA in 2000 from Guilford Pharmaceuticals, where he directed clinical research. Prior to becoming director of DSRCS in 2003, Dal Pan was a medical reviewer in the Division of Anesthetic Critical Care & Addiction Drug Products. Dal Pan is also a part-time assistant professor in the neurology department of Johns Hopkins University School of Medicine. FDA said the ODS director's responsibilities will include working with patient groups, the healthcare community and Congress; maintaining contacts with regulators; and implementing drug safety initiatives, such as FDA's Drug Safety Oversight Board. "Dr. Dal Pan's extensive academic training and his practical experience in clinical medicine, drug development, and public health and risk management, coupled with his strong and vocal leadership within FDA, makes him eminently qualified to take on the challenge of leading this vitally important office," Center for Drug Evaluation & Research Director Steven Galson said in a statement. Anne Trontell will continue to serve as ODS deputy director; a successor to Dal Pan as head of DSRCS has not yet been appointed. In conjunction with the announcement of Dal Pan's new position, Galson also outlined plans for a reorganization of CDER. One goal of the proposed reorganization is increased visibility of the agency's drug safety efforts. FDA said it intends to announce specific CDER changes by early November. - Elizabeth Walker |