Pediatric Drug-Testing Bill Gets White House Boost

Secretary of Health and Human Services (HHS) Tommy Thompson announced last month that HHS will pursue rapid passage of legislation giving the Food and Drug Administration authority to require pharmaceutical manufacturers to conduct appropriate pediatric clinical trials on drugs and biologics.

Citing the overwhelming lack of safety and efficacy information on psychotropic medications prescribed to those under age 18, officials of both APA and the American Academy of Child and Adolescent Psychiatry (AACAP) immediately gave strong support to the proposed legislation.

That announcement came as the government decided not to appeal a federal district court finding in October that the FDA lacks the legal authority to impose certain requirements for pediatric testing in children. The court’s action was a result of a legal challenge to regulations put in place in 1998, known as the “pediatric rule,” which APA, AACAP, and the AMA supported (Psychiatric News, January 19, 2001).

“The fastest and most decisive route for establishing clear authority in this area is to work with Congress for new legislation,” Thompson said at a press briefing last month. “Children are a special population that need to have access to drugs that can benefit them, and these drugs need to be properly tested for pediatric use, not prescribed and sold without testing. Congress alone can speak clearly on the authority that FDA needs and the provisions that may be appropriate for drug manufacturers when they are required to carry out these tests.”

While the FDA had strongly defended the pediatric rule, FDA Commissioner Mark B. McClellan, M.D., noted that “continued litigation is likely to take years, and its outcome is uncertain. The better course now is to work with the committees in Congress and enact new, specific legislation rapidly.”