FDA seeks legislation, not court fight, to push for child drug research

Posted: Sunday, February 09, 2003

WASHINGTON -- The Bush administration won't appeal a court decision that threw out rules that required drug companies to test in children adult medicines commonly given to kids.

Instead, federal health officials announced Monday they will work to get Congress to write those child-testing rules into law this year. Congress could settle the long-simmering dispute much faster than a court fight, said Food and Drug Administration Commissioner Mark McClellan.

The move does not mean the FDA is backing away from the so-called ''pediatric rule,'' he stressed.

''We want legislation that gives us the authority to require pediatric testing,'' McClellan said. ''This is an important public health issue.''

Adult medications commonly are prescribed for children despite a lack of studies proving if the drugs work in youngsters, are safe for them -- and if so, what dose to use. Researching medications in children can be difficult because of ethical issues and because it's difficult to find enough sick children to test. Drug companies often have little incentive to do the work if they expect desperate doctors will use the medications anyway because they have no other option.

In 1998, the FDA issued a regulation, known as the ''pediatric rule,'' allowing the agency to require tests for those adult drugs used most often in children.

A conservative think tank and a private doctors' group challenged the rule, arguing the FDA cannot force drug makers to conduct tests of kids if they are not seeking FDA approval for use in children.

In October, a federal judge agreed, ruling that Congress had specifically refused to require drug testing in children but instead passed legislation giving drug companies financial incentives to conduct such research.

Monday was the deadline for the FDA to appeal that ruling, and it decided not to, instead pursuing Congress.

Conversations with committees in the House and Senate that oversee medications give McClellan ''some confidence'' that legislation specifically authorizing the pediatric rule will move fairly quickly, he said.

Rep. Billy Tauzin, R-La., and Sen. Judd Gregg, R-N.H., who head those committees, could not be immediately reached for comment.

Two child health groups that support the pediatric rule -- the American Academy of Pediatrics and Elizabeth Glaser Pediatric AIDS Foundation -- did file a motion Monday to appeal in U.S. District Court in Washington, pledging to continue the legal battle.

The groups expressed disappointment that the FDA didn't pursue a pediatric rule in the courts as well as in Congress.

''But we are encouraged by the strong statement of support'' from the FDA, said AIDS Foundation public policy director Mark Isaac. He urged McClellan to ensure the legislation's details back ''the strongest possible protection for children.''

The suit challenging the rule was filed by the Association of American Physicians and Surgeons and the Competitive Enterprise Institute.

The law generally allows the FDA to require testing only for medication uses for which a drug maker is seeking formal approval, even though doctors can later prescribe the drugs ''off label'' for different uses. The groups argued that the pediatric rule could set a precedent for FDA to require testing of other off-label drugs.

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