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FDA to suspend pediatric drug rule

Updated:
(WASHINGTON) - The Food and Drug Administration plans to suspend for two years a regulation requiring drug companies to conduct studies of pediatric drugs, CNN has learned. The agency wants to assess whether the new rule "remains necessary" in light of other legislation.

Democratic lawmakers, in a letter to President Bush, urged him to direct the FDA to "reverse course and preserve this important safety measure."

At issue is what is known as the "pediatric rule," which since 1998 has required manufacturers to evaluate the "safety and effectiveness" of their pediatric drugs in "certain circumstances," such as in cases where the drugs will be used by a substantial number of children.

After the rule was issued, three groups -- the Association of American Physicians and Surgeons, the Competitive Enterprise Institute and Consumer Alert -- sued the FDA, charging it did not have the legal authority to require pharmaceutical companies to conduct studies on pediatric drugs.

In documents filed in federal court Monday, the FDA asked the court for a stay in the litigation so that the agency can put the rule on hold for two years.

The FDA wants to determine how the provisions of the "pediatric rule" and the Best Pharmaceuticals for Children Act, signed into law by the president in January, relate to each other and whether the pediatric regulation "remains necessary."

The Best Pharmaceuticals for Children Act gives manufacturers an economic incentive -- six months of exclusive marketing after the patent expires -- if the company decides to conduct a study on the safety and effectiveness of the drug.

The law also includes other programs to carry out pediatric studies if manufacturers don't decide to conduct them.

Democratic lawmakers argue that under the voluntary plan, there is no guarantee that tests will be carried out and no guarantee that the information gained from the study will be included on the product's label.

"This rule assures that new medications vital for children's health are studied so that essential safety and dosing information is available to clinicians," wrote Democratic lawmakers Rep. Henry Waxman, D-Calif., Rep. John Dingell, D-Mich., and Rep. Sherrod Brown, D-Ohio, the ranking Democrats of the Government Reform Committee, the Energy and Commerce Committee and the Energy and Commerce Subcommittee on Health.

Dr. Ralph Kauffman of the American Academy of Pediatrics told CNN that the rule was a "major step forward" in health care for children, and removing it permanently would be "detrimental for children's health."

But Dr. Jane Orient, executive director of the Association of American Physicians and Surgeons, one of the groups that filed the lawsuit against the FDA, said the pediatric rule adds a "huge" amount to the cost of drugs, delays the entry of new drugs into the marketplace and uses children as "guinea pigs."

The White House, so far, has not commented. A spokesman said the administration is still looking into the matter.

The groups suing the FDA want the lawsuit to continue and believe the rule should be permanently removed, not suspended.

"Because even though the rule is suspended, it is still on the books," said Sam Kazman, general counsel of the Competitive Enterprise Institute. "The fact that the FDA wants all the time to study it indicates that they themselves are having second thoughts" about the regulation.

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