FDA suspends child-drug testing rule

Move draws criticism from some Democrats

ASSOCIATED PRESS WASHINGTON, March 18 — In a major victory for the drug industry, the Food and Drug Administration is suspending a rule that allows the government to require safety testing of adult medicines commonly given to children — from asthma treatments to Prozac.

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Until recently, studying medicines in children was a neglected area of medical research. Adult medications are commonly given to children without studies of their safety or proper dosing because doctors have no alternative. Parents and pediatricians were elated when the pediatric rule was put in place in 1998, mandating that drug companies study how new medicines affect children, except when the FDA grants waivers.

The rule was challenged in a December 2000 lawsuit by a conservative think tank and the Association of American Physicians and Surgeons, represented by an attorney recently appointed to be the FDA’s chief counsel. He reportedly has recused himself from the government’s debate of the issue.

In a filing Monday in U.S. District Court for the District of Columbia, the FDA requested a two-month stay in the lawsuit so it can publish a notice suspending the rule for two years.

Shortly after the pediatric rule’s adoption, Congress passed the financial incentives, so it’s unclear to what extent the FDA ever forced manufacturers into child drug studies.

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