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By Marc Kaufman
Washington Post Staff Writer
Friday, October 18, 2002; 1:48 PM
A federal District Court struck down the Food and Drug Administration's Pediatric Rule last night, saying that the agency did not have the authority to require drug makers to test some of their products for childhood use.
The rule, promulgated by the FDA in 1998, has generally been accepted by the pharmaceutical industry, and the number of drugs tested for childhood use has been rising. It has been considered a major achievement by the FDA and public health advocates, who were sharply critical of the court's ruling.
Before the implementation of the rule, most drugs seeking government approval were tested on adults only. Physicians would come to use some of those medicines on children based on medical experience and subsequent studies that might show dosages appropriate for children. Because that use for children was never formally approved by the FDA, it was considered an off-label use, much like some drugs that have been approved for fight a specific disease can later be used on other ailments, even though the government agency has never specifically approved them for that second use.
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. And in his decision, U.S. District Court 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."
Lawrence Bachorik, spokesman for the FDA, said that "the FDA is very disappointed that the court struck down the Pediatric Rule. 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, and so they can be properly labelled for use in children." He said the agency is "weighing its options" on how to proceed.
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. 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."
But Mark Isaac, director of public policy for the Elizabeth Glaser Pediatric Aids Foundation, which has been a proponent of the rule, said the court's decision "deals a very devastating setback to childhood health in America. The pediatric rule has been producing extraordinarily important information about the safety and efficacy of drugs for children, and yesterday's court decision puts the safety of our children at risk."
Isaac said that about 75 percent of prescription drugs have not been tested in children, and so doctors cannot accurately know how youngsters will respond to particular dosages.
When the district court raised some objections to the pediatric rule earlier this year, legislators wrote a bill that would codify the rule and and give it the weight of law. That bill, sponsored by Sens. Hillary Clinton (D-N.Y.), Mike DeWine (R-Ohio) and Christopher Dodd (D-Conn.) passed the Senate health committee unanimously this summer.
© 2002 The Washington Post Company