Congress passed a landmark bill that gives the Food and Drug Administration (FDA) the authority to require drug manufacturers to test new medications in children. The bill also allows FDA to require testing of older drugs widely prescribed to children if the pharmaceutical companies do not do the studies voluntarily. This decision “marks a victory for children all across the country,” believes Rep. Deborah Pryce, R-Ohio, a co-sponsor of the bill.

Over half of medications taken by children only have undergone testing for safety and effectiveness in adults, stated Dianne Murphy, Director of Pediatric Development at the FDA. In fact, drugs are often prescribed “off-label” for youngsters, allowing medicines to be given to children if they’re found to be safe for adults. Yet younger bodies react to drugs differently – “Until you study the drugs they’re taking, every kid is an experiment every time they take a drug,” explained Murphy.

Potential Effects of the New Law
A six-year-old incentive program gave drug manufacturers that already have medications on the market and that do pediatric studies an added six months on their patent before generic drug forms could be sold. The new law will allow the FDA to order studies of older drugs if the agency asks for research under the incentive plan and the pharmaceutical company resists. And the law would apply to all new drugs.

The new law could have a huge effect on drug companies in discouraging the development of new drugs, consequently raising the price of medications, believes Sam Kazman of the Competitive Enterprise Institute (a Washington think tank and plaintiff in the lawsuit that overturned the previous pediatric testing rule). Kazman said the incentive program had already prompted pediatric testing of 91 medicines. That may seem like a lot, but there are over 400 drugs for which the FDA has requested studies in children; less than a fourth of the drugs have actually been tested on this age group.

Furthermore, some of the studies have deepened concern. Pediatric testing of 33 drugs found that over one third of these medications might be unsafe in children or had to be given a specific dose to ensure safety, according to a recent review.

“We think it’s important to have pediatric doses identified, so we’re not opposed to the law. We think the FDA should use this power judiciously, though,” stated Jeff Trewhitt of the Pharmaceutical Research and Manufacturers of America, a trade group for drug companies.

Companies may receive waivers or referrals on children’s drug studies for a variety of reasons, such as when the medications won’t be used by kids or if the studies are highly impractical. Yet William Schultz, attorney for the American Academy of Pediatrics and the Elisabeth Glaser Pediatric AIDS Foundation, does not believe the potential loopholes will weaken the law.