Law on Drug Testing Is Cause for Debate

A law encouraging drug companies to test their products in children is set to expire at the end of this year. If it does, experts say, the clinical trials involving children could stop as quickly as they boomed.

The so-called pediatric exclusivity law offered drug manufacturers an extra six months of patent protection if they tested drugs in children. The law has been a financial bonanza for some companies--even those whose products are not crucial to the care of pediatrics.

Between 1991 and 1996, before the law went into effect, only 11 studies of drugs already on the market were completed in pediatric patients, according to the Food and Drug Administration. But between July 1998 and September of last year, after the law was passed, almost 200 drug manufacturers submitted proposed study plans.

Makers of generic drugs have criticized the law, but both the drug industry and many health officials are urging Congress to renew it.

“We think the exclusivity legislation has done more to improve our knowledge about how to use drugs than anything we’ve tried over the last two decades,” says Dianne Murphy, associate pediatrics director at the FDA. “So if it expires, we think there would be a real slowing down of research.”

*

Under another FDA regulation, the agency can still require testing in pediatric patients, but only for new drugs coming onto the market.

Murphy acknowledges that the exclusivity legislation is controversial because, by extending patent protection, it keeps lower-cost generic drugs off the market for six months longer. Under patent protection, manufacturers typically have about 11 to 13 years after a drug reaches the marketplace during which other companies are barred from selling copycat versions.

But she says: “We think the impact of exclusivity on the cost of drugs is very small.”

Others have criticized drug companies for testing drugs that will have only a minor impact in pediatrics, such as medications for rheumatoid arthritis and high cholesterol.

Christopher Milne, assistant director of the Tufts University Center for the Study of Drug Development, says even these drugs can be useful to children. “There are problems that may seem like adult problems, but there is still a significant population of children who have them,” he says.

Offering drug companies a financial incentive to do testing that they otherwise wouldn’t do “is a carrot approach,” says Sam Kazman, general counsel for the Competitive Enterprise Institute, which has opposed any extensions of the FDA’s regulatory authority. “But whether companies are doing this at the expense of public health is less likely.”