An effort to force companies to test new medications in children has suffered a setback. A federal court in Washington, D.C., last week struck down a 1998 Food and Drug Administration (FDA) rule aimed at developing safe dosing regimens for children. But supporters of the pediatric rule are urging Congress to override the court's order.
The pediatric rule required companies to include children in drug trials before FDA would approve any product likely to be prescribed for children. Prior to the rule, doctors complained that without tests, they had to guess how their small charges would respond to a particular drug. But FDA's move sparked a lawsuit 2 years ago from the Association of American Physicians and Surgeons and two other groups. They argued that Congress hadn't given the agency the power to mandate pediatric testing, and a federal judge agreed. Now, the American Academy of Pediatrics and other organizations are pushing Congress to formally give FDA that power. A vote on the issue could come as early as next month.
