For years, doctors assumed that children, biochemically speaking, are little adults. So anytime they had to give a child a grownup medication, such as Prozac, they just lowered the dose on the basis of his or her weight. But in 1998 the FDA ruled that companies had to conduct pediatric tests of adult drugs. That rule followed a 1997 law offering drugmakers a six-month extension on their patents if they did so voluntarily.
Good thing. Turns out kids aren't little adults, after all. New studies show that young children need to take the epilepsy drug Neurontin in higher doses than adults because they excrete it faster. And Prozac, the drug that carried bewildered Gen X-ers through the '90s, can retard growth in kids and adolescents.
Still, two conservative groups sued the FDA, arguing that Congress hadn't given the agency the authority to require such tests, and in October 2002 a federal judge agreed. Last week the Senate, in a unanimous voice vote, moved to reverse that decision, passing a bill allowing the FDA once again to require the tests. The rare show of bipartisan unity on a health-care issue bodes well for the nation's children: the measure now moves to the House carrying emphatic FDA support.