Federal court overturns FDA pediatric drug testing rule

Bills before the House and Senate would require drug testing in children, but passage is uncertain.

By Tanya Albert, AMNews staff. Nov. 18, 2002.

In light of an October court decision, pediatricians are renewing their push for legislation requiring drug companies to test products in children to ensure that medications are safe and effective for them.

The U.S. District Court for the District of Columbia ruled that the Food and Drug Administration had exceeded its authority when it created the 1998 Pediatric Rule, which allows the agency to require companies to conduct clinical trials in children.

The opinion agreed with the arguments made by the Arizona-based Assn. of American Physicians and Surgeons and two conservative public interest groups -- Consumer Alert and the Competitive Enterprise Institute. The organizations sued the FDA in December 2000.

The court said that only Congress could grant the FDA the authority over pharmaceutical firms that is found in the Pediatric Rule.

"This court does not pass judgment on the merits of the FDA's regulatory scheme," U.S. District Court Judge Henry H. Kennedy Jr. wrote for the court. "The Pediatric Rule may well be a better policy tool than the one enacted by Congress; it might reflect the most thoughtful, reasoned, balanced solution to a vexing public health problem. ... The issue is the rule's statutory authority, and it is this that the court finds lacking."

The 57,000-member American Academy of Pediatrics and other groups this spring already had started to lobby Congress to codify the Pediatric Rule. Efforts began when the FDA in March announced that it would suspend the rule. Government officials quickly changed their minds, and in April the Dept. of Health and Human Services announced that it would continue to enforce the rule. [...]