FDA Criticized for Suggesting Suspension of Pediatric Clinical Trials Requirement

An FDA proposal that may suspend for two years a rule that requires drug companies to conduct clinical trials on children has drawn a "firestorm of protest," USA Today reports. On March 18, the FDA told a U.S. District Court in Washington, D.C., that it would suspend the pediatric testing requirement for two years, but on March 28, the agency issued a "clarification" and said it "may or may not stay all or part" of the requirement (Elias, USA Today, 4/3). Last year, three groups -- the Association of American Physicians and Surgeons, the Competitive Enterprise Institute and Consumer Alert -- filed suit against the FDA to eliminate the pediatric testing requirement, which was enacted by the Clinton administration in 1997 to provide doctors and parents with better information when giving children medications. Critics of the rule say that it is redundant because Congress passed legislation in 1997 that awards pharmaceutical companies a six-month patent extension when they test their drugs on children (Kaiser Daily Health Policy Report, 3/20). They also say that the FDA "goes beyond its legal authority" by ordering drug makers to conduct tests on children.

The Debate
Philip Walson, a pediatric pharmacology expert at the University of Cincinnati Medical School, warned against suspending the requirement in part because the patent incentive passed by Congress makes pediatric testing "all voluntary." He added that under the congressional measure, drug companies' initial pediatric trials often test only "down to a certain age," and there is no incentive for further testing if a drug is later used to treat younger children. The American Academy of Pediatrics also favors keeping the mandatory testing requirement. But according to Sam Kazman of the Competitive Enterprise Institute, the FDA "has no business telling private companies to add pediatric tests and label claims." Kazman added that the agency is "starting down the road to regulating physician practice, which is far beyond what [it is] authorized by Congress to do" (USA Today, 4/3).