President Bush Signs Bill To Allow FDA To Require Pharmaceutical Companies To Test Products in Children

President Bush on Wednesday signed into law a bill (S 650) that could require pharmaceutical companies to test the safety of their products in children, 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 their products in 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 House passed the bill in November, and the Senate passed similar legislation in July (American Health Line, 11/20). 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).