WASHINGTON, Oct. 18 — A federal judge 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 Judge Henry H. Kennedy Jr. of the Federal District Court here.
In the ruling, issued on Thursday, Judge Kennedy said that the food and drug agency 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.
The Clinton administration proposed the drug rules in 1997 and issued them in final form in 1998. The Bush administration said in March that it planned to suspend the rules, but reversed itself a month later after an outcry from pediatricians and some members of Congress.
Hillary Rodham Clinton, who championed the rules during the Clinton White House years, is now the chief Senate sponsor of a bill to write the testing requirements into law. The bill, approved in August by a Senate committee, has not reached the Senate floor.
Most drugs prescribed for children have been tested only in adults, with an assumption that the drugs' effects in children would be very similar. But, the F.D.A. argued in issuing the rules, "correct pediatric dosing cannot necessarily be extrapolated from adult dosing information."
Thus, the agency said, children often receive inappropriate doses, or they get older, less effective medicines.
Lawrence Bachorik, a spokesman for the drug agency, said, "We are very disappointed that the court struck down the pediatric rule, which we have vigorously enforced throughout the litigation." The agency has not decided whether to appeal the decision, he said.
The plaintiffs who challenged the rule are conservative or libertarian organizations: the Association of American Physicians and Surgeons, the Competitive Enterprise Institute and Consumer Alert.
Dr. Jane M. Orient, executive director of the association, said it was inappropriate to "use kids as guinea pigs." Sam Kazman, general counsel of the institute, said, "The regulations would have made drugs scarcer and more expensive in the long run, by adding to the risk and the expense of drug development."
The drug industry was not a plaintiff. Drug companies initially objected to the rules, but learned to live with them.
Judge Kennedy said the rules were incompatible with two laws that encourage, but do not mandate, the study of prescription drugs in children: the F.D.A. Modernization Act of 1997 and the Best Pharmaceuticals for Children Act, signed in January by President Bush.
In those laws, Congress created financial incentives for drug companies to test their products in children. By contrast, Judge Kennedy said, "the F.D.A. adopted a command-and-control approach."
Under the statutes, if a company voluntarily does pediatric studies of a new drug, the product may be shielded from competition for six additional months. Such market exclusivity can produce hundreds of millions of dollars in revenue for the manufacturer.
The basic problem, Judge 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.
Mrs. Clinton said the court's rejection of the rules "underscores the need for immediate Congressional action" to impose similar requirements. One of the Republican co-sponsors of the bill, Senator Susan Collins of Maine, said, "It's even more important now that we pass this legislation to give F.D.A. statutory authority to mandate that drug companies do research on pediatric drugs."
Dr. Philip D. Walson, a spokesman for the American Academy of Pediatrics, said that in the absence of clinical data, a doctor had to make "an educated guess" about how much of a drug to prescribe for children. Youngsters generally need smaller doses, he said, but for some drugs, they require adult doses, or even more.
"A child of 6 can metabolize some drugs more rapidly than a person age 36 or 60," Dr. Walson said. "Some organs like the liver work better in young children than in middle-age or elderly patients."
The court did not assess the merits of the rules as health policy.
"The pediatric rule may well be a better policy tool than the one enacted by Congress," Judge Kennedy said. "It might reflect the most thoughtful, reasoned, balanced solution to a vexing public health problem. The issue here is not the rule's wisdom. The issue is the rule's statutory authority, and it is this that the court finds lacking."
But 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."
New York Times
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