After a two-year search to fill the director position at the FDA's Office of Drug Safety, which monitors approved drugs for new or dangerous side effects, the agency on Wednesday named Gerald Dal Pan, the New York Times reports. Dal Pan previously served as director of the division of surveillance, research and communication support in the FDA's Center for Drug Evaluation and Research since 2003 (Harris, New York Times, 10/20). In addition, the agency announced that it is reorganizing CDER to boost drug safety oversight and drug review efficiency, CQ HealthBeat reports. (CQ HealthBeat, 10/19). Under the arrangement, Dal Pan in his new position will report directly to CDER Director Steven Galson, according to an unnamed agency official. According to the Times, the reorganization "raises the office's stature but does not satisfy critics who say it should be independent of the drug center, which is also responsible for approving new drugs." Sen. Chuck Grassley (R-Iowa) said, "The office needs to be able to make judgments that aren't affected by the conflicts of interest existing within the office of new drugs." Galson said Dal Pan is "eminently qualified to take on the challenge of leading this vitally important office." Galson added that the restructuring will lead to improvements in "how we evaluate and ensure the safety and efficacy of the products we regulate" (New York Times, 10/20). Dal Pan has worked at the agency since 2000, also previously serving as a reviewer of drug marketing applications at FDA. Prior to that, he worked as an adviser on clinical trial designs at Guilford Pharmaceuticals and as a faculty member doing clinical research at Johns Hopkins School of Medicine (CQ HealthBeat, 10/19).
