Saturday, April 20, 2002

Rules on drug tests for children unchanged

By Derrick DePledge
Gannett News Service

        WASHINGTON — The Bush administration reversed plans Friday to suspend for two years a federal rule requiring drug companies to test certain drugs for children.

        Instead, the Food and Drug Administration will continue to enforce the rule and ask for advice on how best to encourage new drug studies in conjunction with a federal law that provides market incentives for drug companies that test drugs for children.

        Medical experts estimate that only 25 percent of drugs on the market are tested and labeled for children.

        Several lawmakers strongly opposed the Bush administration's decision to suspend the policy — known as the pediatric rule. The administration had argued that it needed time to study whether the federal market incentive made the rule unnecessary.

        Three senators — including Mike DeWine, R-Ohio — said Wednesday that they would propose a bill to add the pediatric rule to federal law. Mr. DeWine, a sponsor of the market incentive, said it was designed to enhance, not replace, the pediatric rule.

        The incentive provides drug companies with an additional six months of market exclusivity for testing drugs for children. Brand-name drug companies can earn millions by extending an exclusive patent and keeping lower-cost generic versions off the market.


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