Senate Committee Expected To Approve Pediatric Drug Testing Bill

The Senate Health, Education, Labor and Pensions Committee today is expected to pass a bill that would require pharmaceutical companies to extend to children the testing of adult medicines "commonly given to kids," including HIV/AIDS medications, the AP/Wall Street Journal reports (AP/Wall Street Journal, 3/19). Sens. Mike DeWine (R-Ohio), Hillary Rodham Clinton (D-N.Y.), Christopher Dodd (D-Conn.), Judd Gregg (R-N.H.) and Edward Kennedy (D-Mass.) yesterday introduced the legislation, which would authorize the FDA to require drug makers to conduct "adequate clinical trials" on the safety and efficacy of drugs in children before the drugs are approved (Davidson, Manchester Union Leader, 3/19). The requirement would cover only those drugs that would be "used widely" for children but are currently only tested in adults. Approximately 75% of medications used by U.S. children have only been tested in adults, USA Today reports (Elias, USA Today, 3/18). The bill is an attempt to "settle a long-simmering" dispute over the FDA's so-called "pediatric rule" instituted in 1998, which was subsequently challenged for overstepping the bounds of the agency's authority (AP/Wall Street Journal, 3/19). U.S. District Judge Henry Kennedy in October ruled that the regulation, which requires pharmaceutical companies to test their products for use in children, "exceeds the FDA's statutory authority and is therefore invalid" (Kaiser Daily HIV/AIDS Report, 12/11/02). Gregg, chair of the Senate committee, said, "A one-size-fits-all approach is never a good idea, especially when it involves giving adult-sized medications to children" (AP/Wall Street Journal, 3/19). Dodd said, "Guesswork may work for cooking, but when it comes to dosages of medicine for children, it is a recipe for disaster."

Reaction
Sam Kazman of the Competitive Enterprise Institute, a not-for-profit public policy organization, said that the legislation would lead to increased prescription drug costs and could prompt pharmaceutical companies to develop fewer new treatments (USA Today, 3/18). However, the Elizabeth Glaser Pediatric AIDS Foundation lauded the bill, saying in a statement that a pediatric drug testing rule is an "essential protection." Mark Isaac, vice president of the foundation, said, "This legislation would finally guarantee children the same access to safe and effective medicines that we demand for ourselves as adults," adding, "This bill will safeguard children by taking the guesswork out of children's medicine. We must act now, before the rule's absence compromises the health of our next generation" (EGPAF release, 3/18).