Senate OKs Pediatric Drug Testing

Health officials and advocates welcomed the Senate's passage of legislation requiring drug makers to study the safety of their medicines in children. The Food and Drug Administration had required such studies, but a U.S. District Court ruled in October that the agency did not have the authority to do so. The Senate voted late Wednesday to give FDA that authority. Most medicines are tested only in adults. To encourage testing in children, Congress in 1997 created incentives for pharmaceutical companies, awarding them an extra six months without competition from generic competitors for each drug studied in children, a move that prompted more than 400 pediatric clinical trials. "However, it remains important for FDA to have clear authority to require pharmaceutical manufacturers to conduct pediatric clinical trials on appropriate drugs," Health and Human Services Secretary Tommy G. Thompson and FDA Commissioner Mark McClellan said in a statement. The Pharmaceutical Research and Manufacturers of America welcomed passage of the bill as did children's groups, including the Elizabeth Glaser Pediatric AIDS Foundation. Rep. James C. Greenwood (R-Pa.) said he would quickly sponsor a similar bill in the House.

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