AIDS Alert

In response to the finding that only five of 14 approved AIDS drugs have been tested in children and no protease inhibitors have been approved for pediatric patients under age two, the White House has proposed a rule to require pharmaceutical companies to test more drugs in children and report data to the Food and Drug Administration at the same time, or shortly after, the drug is okayed for adults. The Better Pharmaceuticals for Children Act, part of recent FDA reform legislation, supports that rule by setting up marketing incentives for pharmaceutical companies to encourage the testing of drugs in children. However, the AIDS Policy Center and other children's groups fear the rule has too many waivers, giving manufacturers numerous loopholes. To address many of the concerns about pediatric HIV drugs, the International Association for Physicians in AIDS Care has launched "Children First," a demonstration project in several states that will work to create resources and structures to provide all HIV-positive children with access to all HIV drugs within three years. The group has organized a 1998 meeting of drug companies, clinicians, and government health officials to set an agenda for pediatric HIV treatment research and make plans to develop a pediatric HIV mentor program. IAPAC will also develop a pediatric HIV resource center and suggests appointing a national pediatric HIV drug coordinator.

The CDC National Center for HIV, STD, and TB Prevention makes this information available as a public service only. Providing this information does not constitute endorsement by the CDC. Reproduction of this text is encouraged; however, copies may not be sold, and the CDC National AIDS Clearinghouse should be cited as the source. Copyright 1996, Information, Inc., Bethesda, MD