Senate approves bill requiring pediatric testing of drugs
BY Advocate.com Editors
July 26 2003 12:00 AM ET
The Senate on Wednesday unanimously approved a bill that would require pharmaceutical companies to test the safety of their drugs, including anti-HIV medications, in children. The bill, sponsored by senators Mike DeWine (R-Ohio), Hillary Rodham Clinton (D-N.Y.), Christopher Dodd (D-Conn.), Judd Gregg (R-N.H.), and Edward Kennedy (D-Mass.), would reinstate a rule implemented by former president Bill Clinton that was struck down by a U.S. district court judge in 2002. The rule will allow the Food and Drug Administration to require that drugmakers conduct clinical trials on the safety and efficacy of their medications in children before the drugs receive marketing approval.
The requirement would apply to only those drugs that would be widely used by children but are only tested in adults. About 75% of medications used by children in the United States are tested only on adults, including some anti-HIV drugs. The Elizabeth Glaser Pediatric AIDS Foundation said, "This vote was a major victory for children and a critical next step towards a guarantee that children have the same access to safe and effective medicines that we demand for ourselves as adults." The measure now moves to the House where Rep. James Greenwood (R-Pa.) says he will sponsor a House version of the bill.