Bush Signs Bill Requiring Pediatric Testing of Drugs, Including HIV/AIDS Medications
President Bush on Wednesday signed into law a bill (S 650) that requires pharmaceutical companies to test the safety of their products in children, the AP/Long Island Newsday reports (AP/Long Island Newsday, 12/3). The law codifies a "pediatric rule" issued in 1998 that had allowed the FDA to require pharmaceutical companies to test dosages of their medications for children. 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 law reinstates the authority of the FDA to require pharmaceutical companies to test the safety and efficacy of drugs in children before their products receive approval. The law, which will expire in 2007, allows pharmaceutical companies to obtain waivers on the tests in some cases. The Senate passed the bill in July, and the House passed similar legislation in November (Kaiser Daily HIV/AIDS Report, 11/21). Pharmaceutical companies have tested in children only about 25% of the medications prescribed for children today, the AP/Newsday reports (AP/Long Island Newsday, 12/3). HHS Secretary Tommy Thompson said that the law will "better assure doctors and parents alike that the drugs used to treat our children are safe and will work as expected" (HHS release, 12/3). "Today is an extremely important day for children's health," Kate Carr, president and CEO of the Elizabeth Glaser Pediatric AIDS Foundation, said, adding, "After a tireless battle, we're thrilled that children will be guaranteed the same access to safe and effective medicines that we demand for ourselves as adults" (EGPAF release, 12/3).This is part of the KHN Morning Briefing, a summary of health policy coverage from major news organizations. Sign up for an email subscription.