Washington: Judge Voids Rules on Pharmaceutical Tests

Judge Henry H. Kennedy Jr. of the Federal District Court in Washington has struck down rules that required drug companies to test their products in children. The rules were intended to give doctors and parents more information about the drugs' safety and the proper dosage. "The pediatric rule exceeds the Food and Drug Administration's statutory authority and is therefore invalid," said Kennedy. In the ruling, issued on Thursday, Kennedy said that the FDA was overreaching, just as when it tried to regulate tobacco products. In both cases, he said, the agency's rules were inconsistent with the statutory framework established by Congress.

Kennedy said the rules were incompatible with two laws that encourage, but do not mandate, the study of prescription drugs in children: the FDA Modernization Act of 1997 and the Best Pharmaceuticals for Children Act, signed in January by President Bush. The basic problem, Kennedy said, is that the rules required drug companies to study the effects of their products in children, even when the companies did not label or market the drugs for use by children. After a drug is approved for one purpose, doctors often prescribe it for other purposes.

Under the rules, the government could have ordered drug companies to develop pediatric formulations of some adult medicines. Young children often have difficulty swallowing pills, tablets and capsules, so companies could have been required to devise liquid, chewable or injectable forms. The government could have obtained court injunctions to enforce the rules. Violators could have been held in contempt and fined. The FDA has not decided whether to appeal, a spokesperson said.

Mark Isaac, vice president of the Elizabeth Glaser Pediatric AIDS Foundation, said, "If the court decision is allowed to stand, it will be a devastating blow to children's health."

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