Congress gives FDA authority to require drug testing in children

Some physicians call the legislation "misguided" and question the ethics of recruiting pediatric patients.

By Tanya Albert, AMNews staff. Dec. 8, 2003.

Pediatricians say a newly passed bill ensures that they will finally get the information they need to make the best possible decisions when they prescribe medications to children.

The Pediatric Research Equity Act, which President Bush is expected to sign, gives the Food and Drug Administration the authority to require pharmaceutical companies to test specific medications for use in children. The House passed the American Academy of Pediatrics-backed bill last month, after unanimous Senate approval in July.

Drug companies were not required to test prescription medications on children until the FDA adopted the Pediatric Rule in 1998. Many physicians were happy to finally see scientific data on the appropriate dosages for medications used in children, rather than relying on educated guesses derived from studies done in adults. In the vast majority of cases, the initial phases of a study of a new medication were done in adults to ensure it was relatively safe before testing was done in children, according to the AAP.

But in October 2002, a federal court struck down the rule on the grounds that the FDA didn't have the authority to require companies to test medications in children. Since then, more than 110 new medications and biologics have gone on the market without testing in children, the AAP said.

The Pediatric Research Equity Act would give the FDA the authority it needs to require testing in children and would thus allow the agency to restore the Pediatric Rule. For pediatricians, that would bring a sense of relief by eliminating much of the guess work when prescribing medication to children.