FDA Scientist Gerald Dal Pan Will Be Director of FDA Drug-Safety Office
In October 2005 the FDA named staff scientist Gerald Dal Pan its new director of the agency's Office of Drug Safety. This FDA department watches for serious side effects after prescription drugs are approved by the FDA to go on the U.S. market.
Significantly according to the FDA, Dr. Dal Pan will report directly to the head of the FDA's Center for Drug Evaluation and Research -- whereas under the current FDA bureaucracy, the agency's drug-safety office had reported to another division within the FDA.
It is old news by now that the public's perception of the "independence" of the FDA's Office of Drug Safety had started to erode in 2004 with the FDA's handling of safety issues involving the use of antidepressants by children and heart problems associated with the use of Vioxx and other COX-2 drugs.
While the new FDA bureaucratic scheme may raise the drug-safety office's profile within the agency, not all FDA critics are satisfied. Senator Charles E. Grassley, who is chairman of the Senate Finance Committee, said in a statement:
The [Office of Drug Safety] needs to be able to make judgments that aren't affected by the conflicts of interest existing within the office of new drugs.
Dr. Gerald Dal Pan joined the FDA in 2000. Dr. Dal Pan is trained in neurology and internal medicine, and has worked as a drug-safety reviewer.
(Posted by: Tom Lamb)