Court Rejects Testing ‘Adult’ Drugs for Kids
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 the tests.
The ruling, from the U.S. District Court here, means drug companies may continue to sell medicines approved only for adults, but often prescribed for children, without studies showing they are safe and effective for kids or to determine appropriate dosages.
Legislation pending in the Senate would codify the rule into law, and backers said the ruling is likely to bolster their case.
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