Senate Committee Unanimously Approves Pediatric Drug Testing Legislation

The Senate Health, Education, Labor and Pensions Committee yesterday unanimously approved 21-0 a bill that would require pharmaceutical companies to test their products, including HIV/AIDS medications, on children, Reuters Health reports (Rovner, Reuters Health, 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.) on Tuesday introduced the legislation, which would authorize the FDA to require that drug makers conduct clinical trials on the safety and efficacy of drugs in children before the drugs are approved. The requirement would cover only those drugs that would be widely used for children but that are currently only tested in adults. Approximately 75% of medications used by U.S. children have only been tested in adults (Kaiser Daily HIV/AIDS Report, 3/19). The bill would reinstate a Clinton administration regulation, known as the "pediatric rule," which was struck down by a federal court (Reuters Health, 3/19). U.S. District Judge Henry Kennedy in October 2002 ruled that the regulation "exceeds the FDA's statutory authority and is therefore invalid" (Kaiser Daily HIV/AIDS Report, 3/19). "This bill will not only help children, it will remove doubt for doctors," Rodham Clinton said.

'Sunset' Amendment Added
Before approving the bill, the committee added on a straight party-line vote of 11-10 an amendment offered by Gregg that would "sunset," or end, the requirement in 2007, which is the same year that a law giving drug makers voluntary incentive to test their products on children ends. That law allows companies six additional months of market exclusivity for products whose patents have not yet expired. "It's important that [the measures] be tied together," Gregg said. However, Dodd said that the committee would never make temporary a measure to test drugs on adults before they are approved. "Yet we're going to say to one of every four Americans who are children, those rules don't apply to you," he added (Reuters Health, 3/19). Mark Isaac, vice president of the Elizabeth Glaser Pediatric AIDS Foundation, lauded the bill's passage but said that the foundation was "very disappointed" that a time limit was included in the bill. "Children deserve a fundamental and permanent guarantee to safe and effective medicines. ... There is simply no good reason to put a time limit on a basic protection for children's health," he added (EGPAF release, 3/19).