October 21, 2002
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."
New York Times
10.19.02; Robert Pear
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