New York Times, USA Today Weigh in on Debate Over Pediatric Testing of Medicines

An FDA plan to suspend for two years a rule that requires drug makers to conduct clinical trials on children is "senseles[s]," and Congress should "press the [Bush] administration to retain the rule it is trying to disown," a New York Times editorial states. Beginning in 1998, the FDA required drug companies to test treatments on children if the drugs "were likely to be used by substantial numbers of pediatric patients." But three groups -- the Association of American Physicians and Surgeons, the Competitive Enterprise Institute and Consumer Alert -- filed a lawsuit saying that the FDA does not have the legal authority to require pediatric tests (New York Times, 4/7). In addition, 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, 4/3). According to the Times, eliminating the mandatory testing rule would leave unstudied many treatments that drug makers "see no profit in testing." The Times also says that "there surely will be circumstances where pediatric tests are needed and will not be conducted unless the FDA can order a company to do them." The Times concludes, "It makes no sense to abandon any weapon in the long uphill fight to obtain safe and effective medicines for the nation's young people" (New York Times, 4/7).

Differing Views
USA Today examines the pediatric testing debate today in a point-counterpoint editorial. USA Today argues in favor of the pediatric testing rule, while Sam Kazman, general counsel for the Competitive Enterprise Institute, argues against it.

• USA Today: If the "ill-conceived" lawsuit against the FDA's mandatory pediatric testing rule is successful, patients would be left with a "voluntary program that uses carrots to encourage the industry to conduct pediatric testing," USA Today writes. The incentive-based testing rule "leaves important gaps that only an FDA mandate can fill." Although there may be a better way to get drugs tested and approved in children, both the FDA and critics of the rule should "be urging that the existing system remain in place" until a new system is identified (USA Today, 4/8).
• Kazman: The FDA's mandatory pediatric testing rule is "far likelier to hurt" children than help them, in part because the rule will make many adult drugs found to be useful in treating children unavailable for pediatric patients, Kazman writes. The mandatory rule "radically alters" the drug-approval process and "adds another hurdle" to a list of "already formidable" government regulations. But Kazman writes that the "most important" reason for opposing the agency's mandate is that "by basing its testing demands on what doctors do in their offices, the FDA is opening the door to regulating the actual practice of medicine" (Kazman, USA Today, 4/8).