New drug safety officer for FDA will have more clout

Oct 19 2005

The U.S. Food and Drug Administration has a new director to its Office of Drug Safety.

Apparently FDA staff scientist Gerald Dal Pan is being appointed to the long-vacant post.

According to an FDA official it is hoped the appointment will boost the "clout and stature" of the unit that watches for side effects after medicines reach the market.

It seems Dal Pan will report directly to the head of the FDA's Center for Drug Evaluation and Research, a move that is expected to improve the image of the safety office so it will be "on par" with the Office of New Drugs, which approves new medicines for sale.

Previously, under the old structure, the safety office reported to another division within the drugs center.

Last year complaints about the standing of the drug safety office emerged after two scientists said their concerns had been downplayed or dismissed in the handling of antidepressants used by children and Merck withdrew the arthritis pill Vioxx.

Dal Pan, is a medical doctor with training in neurology and internal medicine; he joined the FDA in 2000 and worked as a drug reviewer for more than three years.

Since 2003, he has served as director of surveillance, research and communication support, one of three divisions within the drug safety office.