PRESCRIBING UNTESTED DRUGS TO CHILDREN

By Nicholas Regush

The FDA has decided to suspend a 1997 federal rule that requires drug companies to conduct tests on children to establish whether drugs are safe and effective for them. The agency says it plans to study whether the rule is still necessary.

This move has angered pediatric and consumer groups because it is now expected that many more drugs will be prescribed to children without knowledge of any potential harmful effects. This will force physicians to often guess which drugs tested in adults will also be suitable for use in children.

Companies already have an incentive to do research in children because they receive — courtesy of Congress — a six-month patent extension on a particular drug. So the drug industry believes that this will keep companies motivated to test new drugs in children.

Critics of the FDA move counter that such an incentive alone does not bring about sufficient testing and that doctors will often remain in the dark about how a particular drug may work in children and how much dosage is required for it to be beneficial or harmful. According to some politicians, including Sen. Edward M. Kennedy, the FDA decision makes no sense.

But there is much more to this issue than is being reported. According to Vera Hassner Sharav of the Alliance for Human Research Protection, the 1997 federal rule should have required the FDA or the Department of Health and Human Services to conduct an impact study "to determine whether, and how, children would be affected adversely" by entering clinical drug tests. Hassner says that, "It is most disturbing that neither the administration nor Congress has seen fit to request an annual report detailing information about pediatric research in order to ensure that children are not being harmed or exploited. Congress does mandate detailed annual reports about the conduct of animal research. Animals are protected under the Animal Welfare Act of 1966; children who are recruited into clinical trials — with cash payments to parents — are unprotected."

The rule suspension by the FDA should obviously not be the only concern voiced about drug testing in children.