FDA Office Of Drug Safety Acting Director Is Ralph Lillie
This article was originally published in The Pink Sheet Daily
Executive Summary
The agency continues its national recruiting effort for a permanent director of the office as Congress introduces bills which would reorganize FDA's oversight structure. Lillie has served as CDER's emergency preparedness officer as well as deputy director of the former Office of Postmarketing Drug Risk Assessment.
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FDA Emergency Preparedness Officer Ralph Lillie is serving as acting director for the Office of Drug Safety in the Center for Drug Evaluation & Research. Lillie will helm the drug safety office while FDA continues its national search for a permanent director. Lillie has worked directly on drug safety issues previously, serving as the deputy director in the former Office of Postmarketing Drug Risk Assessment. Lillie left OPDRA in 1999 to become CDER's Office of Information Technology director and was named CDER emergency preparedness officer in May 2002. FDA announced Nov. 5 that it was widening its search for a director of the Office of Drug Safety as part of an expanded drug safety initiative (1 (Also see "FDA Widens Search For Drug Safety Director" - Pink Sheet, 5 Nov, 2004.)). The position has been vacant since the departure of former ODS Director Victor Raczkowski in October 2003. Office of Pharmacoepidemiology & Statistical Science Director Paul Seligman had served as ODS acting director following Raczkowski's departure. The role of the Office of Drug Safety in FDA has been the subject of much debate on the heels of the Vioxx withdrawal, and legislation has been introduced in Congress suggesting the office be separated from the agency's review functions (2 (Also see "FDA Drug Safety Office Would Have $100 Mil. Budget Under Dodd Bill" - Pink Sheet, 21 Jan, 2005.)). [Editors' note: Senate HELP Committee Health Policy Staff Director Stephen Northrup and House Energy & Commerce Committee Deputy Chief Counsel for Oversight Alan Slobodin will discuss healthcare priorities for the 109 Congress during a Feb. 9 Drug & Device Dialogue interactive audio conference. Get answers to your most pressing legislative questions. Register today at 3 www.drugdevicedialogue.com/ ]. - Adam Eckstein |