The Senate late Wednesday approved by unanimous consent a bill (S 650) that would require pharmaceutical companies to test the safety of their products, including HIV/AIDS medications, in children, Reuters/Philadelphia Inquirer reports (Reuters/Philadelphia Inquirer, 7/25). The bill, introduced by 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.) in March, would reinstate a Clinton administration regulation, known as the "pediatric rule," which was struck down by a federal court. U.S. District Judge Henry Kennedy in October 2002 ruled that the regulation "exceeds the FDA's statutory authority and is therefore invalid." The bill would reinstate the FDA's authority 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 only have been tested in adults (Kaiser Daily HIV/AIDS Report, 3/20). Pediatricians said that because many medications have never been tested in children, they often have to "guess the proper doses" when prescribing to children, according to the New York Times (Pear, New York Times, 7/25). The bill now moves to the House, where Rep. James Greenwood (R-Pa.) has said he will "quickly sponsor a similar bill," according to Reuters/Inquirer (Reuters/Philadelphia Inquirer, 7/25). A spokesperson for Rep. Billy Tauzin (R-La.) said a vote on the House version would likely come in September.

Reaction
American Academy of Pediatrics President Stephen Edwards said he hoped the House would quickly pass the legislation (Heil, CongressDaily/AM, 7/25). Mark Isaac, vice president for governmental and public affairs at 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" (Reuters/Philadelphia Inquirer, 7/25). CongressDaily/AM reports that the Bush administration supports the legislation (CongressDaily/AM, 7/25). In a joint statement, FDA Commissioner Dr. Mark McClellan and HHS Secretary Tommy Thompson said, "[M]edicines to be used by children should undergo specific pediatric testing and not simply rely on adult tests. This testing is needed both for new drugs and also for already-approved drugs that may be prescribed for children but still lack pediatric testing (HHS release, 7/24).

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