FDA Announces Plans to Impose Two-Year Suspension of Pediatric Testing Requirement for Drug Companies
FDA officials yesterday said the agency plans to suspend for two years a rule that requires drug companies to conduct clinical trials on children, the Washington Post reports. The FDA will use the two years to determine whether the regulation "is still needed." The Clinton administration enacted the rule in 1997 to provide doctors and parents with "better information when giving children medications, which mostly have only been tested in adults" (Connolly, Washington Post, 3/19). However, Congress passed legislation in 1997 that awards pharmaceutical companies a six-month patent extension when they test their drugs on children, and as result, the regulation "may have become unnecessary." Last year, three conservative groups -- the Association of American Physicians and Surgeons, the Competitive Enterprise Institute and Consumer Alert -- filed a lawsuit against the FDA to eliminate the pediatric testing requirement (Lueck, Wall Street Journal, 3/19). The regulation "is costing drug companies millions" and "creates new challenges" in finding young test subjects, according to the suit (Attkisson, "CBS Evening News," 3/18). In December, a judge denied an FDA motion to dismiss the lawsuit. The agency yesterday in U.S. District Court in Washington, D.C., asked for an eight-week injunction to delay the lawsuit. The agency plans to announce the suspension of the pediatric testing requirement in the eight-week period (Wall Street Journal, 3/19).
Some consider the pediatric testing requirement a "troubling use of children in medical experiments," and the drug industry has criticized the regulation as "unnecessary," the Post reports (Washington Post, 3/19). In addition, Sam Kazman, general counsel for the Competitive Enterprise Institute, said, "When FDA demands additional testing, even for as sensitive a population as children, it's adding additional hurdles to actually making those therapies available, which means it's denying patients access to new treatments" ("CBS Evening News," 3/18). However, some pediatricians and medical experts said that FDA's plan to suspend the requirement "will leave doctors guessing about which medications are safe to give children." David Kessler, a former FDA commissioner, said, "Unfortunately, there is not good information about what drugs to use, in what dose and when to use them in children. Often, [doctors] are flying blind. The FDA's action today is five steps backward. I don't understand how the agency could have done this." Some Democrats in Congress also criticized the announcement. Rep. Henry Waxman (D-Calif.) said, "The Bush administration has decided to side with the pharmaceutical industry and go along with what they want rather than what's best for kids in this country." Sen. Edward Kennedy (D-Mass.) added that the suspension of the pediatric testing requirement "makes no sense" (Washington Post, 3/19).This is part of the California Healthline Daily Edition, a summary of health policy coverage from major news organizations. Sign up for an email subscription.