FDA APPOINTS NEW ODS DIRECTOR
Following a "broad" four-month nationwide search, the FDA has selected an internal candidate to fill the long-vacated director position in its Office of Drug Safety (ODS), the agency announced recently.
Gerald Dal Pan, currently director of the FDA's Division of Surveillance, Research, and Communication Support (DSRCS), will take the reins of ODS, where he will be charged with running the agency's high-profile postmarketing drug safety program. Dal Pan joined the FDA in 2000 as a medical reviewer in the Division of Anesthetic Critical Care and Addiction Drug Products, before becoming director of DSRCS in 2003.
"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," said Steven Galson, director of the FDA's Center for Drug Evaluation of Research (CDER).
Dal Pan's duties will include leading of the agency's drug postmarketing risk assessment operations; working closely with stakeholders inside and outside the federal government, including the Drug Safety Oversight Board and Congress; developing and maintaining international and national contacts with regulators; implementing policies and initiatives related to adverse drug events and the MedWatch program; and representing the FDA and CDER in scientific and regulatory matters related to drug safety.
The FDA launched a formal search for an ODS director in June -- a move that came more than 18 months after former director Victor Raczkowski left the agency for the private sector. Prior to Dal Pan's appointment, ODS was run on an interim basis by Ralph Lillie, formerly deputy director of the FDA's Office of Postmarketing Drug Risk Assessment.
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