House Approves Bill Requiring Pediatric Testing of Drugs, Including HIV/AIDS Medications

The House on Wednesday approved by voice vote a bill (HR 2857) that would require pharmaceutical companies to test the safety of their products, including HIV/AIDS medications, in children, the AP/Houston Chronicle reports (Abrams, AP/Houston Chronicle, 11/19). The bill, sponsored by Rep. James Greenwood (R-Pa.), would write into law a "pediatric rule" issued in 1998 that allowed the FDA to require pharmaceutical companies to test their products in children (Rovner, CongressDaily, 11/19). U.S. District Judge Henry Kennedy in October 2002 struck down the rule, which he said "exceeds the FDA's statutory authority and is therefore invalid." The legislation would reinstate the authority of the FDA to require pharmaceutical companies to test the safety and efficacy of drugs in children before their products receive approval (Kaiser Daily HIV/AIDS Report, 7/25). The bill, which would expire in 2007, would allow pharmaceutical companies to obtain exemptions from pediatric tests in some cases, such as when the medications would not be "widely used" by children and when the tests are "highly impractical," USA Today reports (Elias, USA Today, 11/20). The Senate passed a similar bill (S 650) in July. Pharmaceutical companies have conducted pediatric testing of about 25% of the medications used by U.S. children today (Kaiser Daily HIV/AIDS Report, 7/25).

Reaction
Greenwood said that House approval of the bill "marks a nice, full circle of an effort to make sure we do everything humanly possible to make drugs available to kids in dosages that are appropriate for them" (CongressDaily, 11/19). Rep. Deborah Pryce (R-Ohio), a co-sponsor of the legislation, called the bill "a victory for children all across the country" (USA Today, 11/20). Mark Isaac, vice president of the Elizabeth Glaser Pediatric AIDS Foundation, said that the bill would "benefit every child and every family by finally guaranteeing children the same access to safe and effective medicines that we demand for ourselves as adults." In a joint statement, FDA Commissioner Mark McClellan and HHS Secretary Tommy Thompson also praised the legislation (AP/Houston Chronicle, 11/19). Jeff Trewhitt, a spokesperson for the Pharmaceutical Research and Manufacturers of America, said that the group does not oppose the legislation, but he added, "We think the FDA should use this power judiciously." Sam Kazman, general counsel at the Competitive Enterprise Institute, criticized the bill, which he said would "have a chilling effect on ... the development of new drugs." The Bush administration called for the legislation after the October 2002 court ruling, and President Bush is expected to sign the bill (USA Today, 11/20).

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