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Last month, a federal judge struck down the Food and Drug Administration's (FDA) Pediatric Rule, which required drug companies to test new products in children so that adequate information about safety and dosage in children could be included on drug labels. Judge Henry H. Kennedy, Jr., of the Federal District Court for the District of Columbia concluded that, "the Pediatric Rule exceeds FDA's statutory authority and is therefore invalid."
The FDA's efforts to promote pediatric testing of new products began with a voluntary measure in 1994. At the time, there was growing concern that product labeling for many drugs used in children failed to provide sufficient directions for safe pediatric use. The 1994 rule required manufacturers to survey data on new and existing drugs and determine whether it would support pediatric labeling, and if it did, to file a supplemental new drug application (NDA).