Senate HELP Committee Approves Bill That Would Require Pediatric Testing for Certain Drugs

The Senate Health, Education, Labor and Pensions Committee on Aug. 1 passed a bill (S 2394) by voice vote that would require pharmaceutical companies to test the safety of certain treatments in children, Reuters reports (Richwine, Reuters, 8/1). The legislation, sponsored by Sens. Hillary Clinton (D-N.Y.), Mike DeWine (R-Ohio) and Christopher Dodd (D-Conn.), also would require drug companies, based on the results of the tests, to place labels on the treatments that provide instructions on use in children or warnings against pediatric use (CongressDaily/AM, 8/2). Although the FDA has a regulation that requires drug companies to test the safety of certain treatments in children, the agency has considered a suspension of the rule (Reuters, 8/1). The Clinton administration enacted the rule in 1997 to provide doctors and parents with more information about the safety of treatments in children. However, Congress passed legislation in 1997 that awards pharmaceutical companies a six-month patent extension when they test their treatments on children, and as a result, some conservative groups said that the FDA should suspend the rule. The FDA in March considered a proposal to suspend the rule for two years after the Association of American Physicians and Surgeons, the Competitive Enterprise Institute and Consumer Alert last year filed a lawsuit against the agency to eliminate the regulation (Kaiser Daily Health Policy Report, 3/20). Public health groups and some lawmakers criticized the plan to suspend the regulation, and the FDA dropped the proposal in April (Kaiser Daily Health Policy Report, 4/22).

Force of Law
Although HHS Secretary Tommy Thompson said that the FDA would defend the regulation in court, sponsors of the legislation said that the rule should have the force of law. "We need to make sure that when it comes to medicine, children receive the same protections as adults," Clinton said. Clinton added that she expects the bill to pass the Senate this year. Rep. Henry Waxman (D-Calif.) has introduced a similar bill (HR 4730) in the House. Jeff Trewhitt, a spokesperson for the Pharmaceutical Research and Manufacturers of America, criticized the legislation as "unnecessary" (Reuters, 8/1).