FDA ADDS ETHICIST TO STRENGTHEN PROTECTION OF CHILDREN IN TRIALS

In response to a rising number of pediatric clinical trials, the FDA is adding an ethicist to the staff of its Office of Pediatric Therapeutics in an effort to ensure protections for children.

Robert Nelson, the chair of the FDA's Pediatric Advisory Committee, will be the agency's pediatric ethicist beginning Oct. 16. This position is mandated by the "Best Pharmaceuticals for Children Act," which became law in early 2002.

This position is important given the rising number of clinical trials involving children, Dianne Murphy, the FDA's director of the Office of Pediatric Therapeutics, said in a Sept. 14 release. Nelson will "help us assure these trials, and all of FDA's interactions with the pediatric community, clearly meet the highest ethical standards," she added.