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By Marc Kaufman
Washington Post Staff Writer
Saturday, October 19, 2002; Page A09

A federal judge has struck down the Food and Drug Administration's requirement that drug companies test some of their products among children, saying the agency had overstepped its authority.

The rule, promulgated by the FDA in 1998, has been generally accepted by the pharmaceutical industry, and the number of drugs tested for childhood use has been rising. The rule has been considered a major success by the FDA and public health advocates in helping improve medical care for children.

FDA officials said yesterday the agency was "very disappointed" by the decision. "We still think it is vitally important that drugs be studied in children so that their safety and efficacy can be determined on the basis of sound data," said spokesman Lawrence Bachorik. He said the agency is "weighing its options" on how to proceed.

Before the FDA rule was implemented, most drugs were approved after being tested only in adults. Physicians would prescribe medicines for children based on medical experience and subsequent studies that might show dosages appropriate for children -- but the use was generally "off label," or beyond what was approved by the FDA. Congress passed legislation in 1997 that encouraged drug companies to test their drugs in children. The FDA's Pediatric Rule served to force testing if the companies balked.

But several groups, including the Competitive Enterprise Institute and the Association of American Physicians and Surgeons, sued the FDA to overturn the Pediatric Rule, arguing that it improperly expanded the agency's authority because it opened the door to greater oversight of off-label uses of drugs, which is widespread in medicine. And in his decision, U.S. District Judge Henry H. Kennedy Jr., of the federal court for the District of Columbia, agreed.

"The Pediatric Rule may well be a better policy tool than the one enacted by Congress (which encourages testing for pediatric use, but does not require it)," Kennedy wrote. "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 wanting."

Kennedy relied in part on a 2000 Supreme Court decision that also rejected an assertion of FDA authority, in that case to regulate tobacco. Kennedy said that Congress had spoken on the subject of pediatric testing when it created incentives for companies to comply. He said the Pediatric Rule, which requires the testing, was at odds with the legislation.

Sam Kazman, CEI's general counsel, welcomed the decision.

"In our view, the Pediatric Rule constituted a drastic change in the drug approval process," he said. "The FDA essentially claimed it could force new uses, or new patient populations -- in this case, children -- on a label. While the rule was limited to pediatric uses, it opened the door for testing requirements for other off-label special patient populations and for other off-label uses. The end result could be a far riskier and costly approval process, and ultimately, fewer drugs."

The Bush administration announced earlier this year that it intended to suspend the Pediatric Rule, citing new legislation that made it less necessary and the pending lawsuit. Many legislators responded angrily, and the administration relented. Nonetheless, Sens. Hillary Rodham Clinton (D-N.Y.), Mike DeWine (R-Ohio) and Christopher J. Dodd (D-Conn.) introduced a bill that would codify the rule into law, and it passed the Senate health committee unanimously this summer.

Clinton said yesterday that she considered the court decision was a "major step backwards for children's health." She said the drug industry needed both incentives to test for children, and a stick to require testing when companies resisted. She said Kennedy's conclusion that the Pediatric Rule is at odds with laws passed by Congress is "ill-informed about how the legislation was intended to work, and how it does work."

Louis Z. Cooper, president of the American Academy of Pediatrics, also called the decision "a terrible blow."

"This court decision returns children to the status of a 'therapeutic afterthought' by the pharmaceutical industry," he said. "While adults will be ensured that drugs on the market are safe and effective for their use, children will not be afforded the same assurances."

A spokesman for the Pharmaceutical Research and Manufacturers of America (PhRMA), Mark Grayson, said yesterday that his group was not a party to the lawsuit and did not have problems with the Pediatric Rule. He also said, however, that the drug industry considered incentives to be the best way to encourage drug testing for children.

In the past, drug companies generally had not conducted tests with children because they were expensive and because of concerns about the ethics of using children in medical research. The FDA's rule had raised concerns that children could not give proper consent.