Health News

Pint-Size Patients Need Pint-Size Prescriptions

Dec. 29, 2000 (Washington) -- As far as research in children goes, we've come a long way. But we've got a ways to go.

Next month, the FDA is expected to submit a report to Congress that -- while detailing a number of notable achievements -- will reveal a gaping black hole: There is no information about how to best treat children with many of the generic drugs currently available.

Because of legislation passed in 1997, the FDA has now managed to collect data from more than 200 proposed drug studies on children. While these studies address almost every ailment that afflicts children, the FDA report is expected to admit that none of those proposed studies are for generic drugs.

Costing about half as much as the brand-name equivalent, generic drugs account for about 40% of the prescription drugs used by Americans. And as a result, experts estimate that hundreds -- if not thousands -- of drugs currently are used to treat children, even though no exact information about using these drugs in children is available.

"It is a significant problem," says Robert Ward, MD, a professor of pediatrics at the University of Utah, who helped draft the 1997 legislation responsible for increasing pediatric clinical trials.

Pediatricians say history proves the desperate need for clinical trials in children. A classic example is the death of several newborns during the 1960s, when they received an adult antibiotic that their infant livers could not break down.

So why don't generic drugmakers also conduct clinical trials in children?

In 1994, the FDA attempted to require the labels of all drugs used in children to list the appropriate doses for the pint-sized patients, but to no avail. By 1997, drugmakers had completed only 11 clinical trials.

While agreeing in principal that prescribing information for children was needed, drug manufacturers questioned whether the FDA had the legal authority to require these studies.

The FDA's charter "does not authorize the FDA to require that manufacturers conduct pediatric studies," argued the drug industry's largest association, Pharmaceutical Manufacturers and Researchers of America.

At the time, former FDA Commissioner David Kessler, MD, in fact, publicly acknowledged the FDA's limitations. "It is our job to review drug applications for the indications suggested by the manufacturer," he said. "We do not have the authority to require manufacturers to seek approval for indications which they have not studied."

Despite these legal questions, in 1998, the FDA ruled that pediatric trials be conducted for yet-to-be-approved drugs that would likely be used in children as a condition of approval starting in January 2001.

Now, according to the latest FDA figures, brand-name drugmakers are about to proceed with about 170 clinical trials in children, and another 27 trials have been completed. But the legislation set to take effect in 2001 does not cover generic drugmakers.