Bush Administration Will Support New Pediatric Drug Testing Legislation

The Bush administration yesterday said it will not appeal a court decision against an FDA pediatric drug testing rule, but the administration plans to "throw its weight" behind legislation that would require drug companies to test certain medications on children before they can go to market, the Wall Street Journal reports. A federal judge in October struck down the rule, which required pharmaceutical companies to test new drugs in pediatric patients (Adams, Wall Street Journal, 12/17). U.S. District Judge Henry Kennedy ruled that the regulation "exceed[ed] the FDA's statutory authority and is therefore invalid." In 1997, Congress passed legislation to encourage pharmaceutical companies to test their products in children, and in 1998 the FDA implemented the Pediatric Rule to enforce the law. Although the number of treatments tested in children has increased and pharmaceutical companies have "generally accepted" the rule, the Competitive Enterprise Institute, the Association of American Physicians and Surgeons and Consumer Alert filed suit against the FDA, arguing that the regulation "improperly expanded" the agency's authority (American Health Line, 10/21). According to the AP/Nando Times, the FDA had until this week to appeal the ruling, but instead decided to pursue legislation (Neergaard, AP/Nando Times, 12/16). HHS Secretary Tommy Thompson said, "The fastest and most decisive route for establishing clear authority in this area is to work with Congress for new legislation" (HHS release, 12/16).

The Elizabeth Glaser Pediatric AIDS Foundation and the American Academy of Pediatrics filed a motion in federal court last week requesting the right to defend the pediatric testing rule by appealing the October decision (AAP/EGPAF release, 12/6). On Monday, the groups filed a motion in U.S. District Court in Washington, D.C., to appeal the earlier ruling and vowed to continue the legal battle, the AP/Nando Times reports (AP/Nando Times, 12/16). However, the decision to support legislation requiring pediatric testing by the Bush administration could render the legal case brought by the Glaser Foundation and the AAP "moot," the Journal reports. A bill attempting to make the pediatric testing regulations law has already cleared the Senate Health, Education, Labor and Pensions Committee, and Senate staffers were attempting to get the bill to the floor as Congress ended its session this year. Sen. Judd Gregg (R-N.H.), who will chair the health committee in the upcoming Congress, is expected to bring the bill to the Senate floor early next year. According to Mark Isaac of the Glaser Foundation, the administration's "help" with the legislation should make pushing the legislation through Congress easier. Sam Kazman, general counsel for CEI, expressed disappointment over the administration's decision to support legislation. "This policy is aimed at protecting our kids, but in the long run it may do the exact opposite" by slowing drug development, Kazman said (Wall Street Journal, 12/17).