WASHINGTON -- A federal court threw out rules requiring drug companies to test adult medicines commonly given to children, saying Congress never intended to give the Food and Drug Administration power to require these tests.
The ruling, issued late Thursday by the U.S. District Court in Washington, means drug companies may continue to sell medicines that are approved only for adults, but often are prescribed for children, without studies showing they are safe and effective for kids or to determine appropriate dosages.
Adult medications commonly are prescribed for children without these studies, because studies in children are rare and doctors have no alternative.
In 1998, the FDA issued a regulation known as the "pediatric rule" allowing the agency to require tests for medicines that are commonly given to children.
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