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FDA Pediatric Rule

Medical Drugs Not Adequately Tested for Child Safety

WASHINGTON, D.C. -- November 27, 2002 -- Doctors today do not have enough information about the safety of the drugs that they prescribe to children. The Federal Food and Drug Administration (FDA) had created the Pediatric Rule to solve this problem. The rule required drug manufacturers to test medications in children, and properly label pediatric dosages. Without such labeling, children can receive ineffective or harmful drugs, or suffer from unexpected drug side-effects.

Last month, a federal district court struck down the FDA's Pediatric Rule, stating that the agency had overstepped its statutory authority (Association of American Physicians and Surgeons, Inc. v. FDA, U.S. District Court for the District of Columbia, Civil Action 00-02898). The demise of the rule has upset various medical and consumer groups.

"This decision is a terrible blow to guaranteeing that the drugs pediatricians prescribe to children with asthma or cancer, for example, are safe to use," said Louis Z. Cooper, MD, American Academy of Pediatrics President (Press Release, October 18, 2002). "Families deserve to know that when their pediatrician prescribes a drug, it has been subjected to the same rigorous scientific studies that are required for the use of that drug in adults," Joe Sanders, M.D., the group's Executive Director, had previously commented in support of the Pediatric Rule. (Press Release, July 9, 2002).

Restoring the Pediatric Rule

The court decision comes on the heels of a recent study showing that adverse reactions to drug treatments are a significant cause of death and injury in infants under two years of age. The data makes a case for more scrutiny of medical drugs used for children, not less.

Recent legislation would reinstate some of the Pediatric Rule's protections. S.B. 2394, introduced by Senator Hillary Clinton (D-NY) requires applicants for new drugs to include pediatric dosage information and assess the product's safety and effectiveness for children. A similar bill, H.R. 5594, was introduced into the House of Representatives by Reps. Deborah Pryce (R-OH) and Connie Morella (R-MD). It is uncertain whether either of these bills will pass in this year's legislative session.

The full text of S.B. 2394 and H.R. 5594 may be found at Thomas Legislative Information, 107th Congress. Search on each bill in the Bill Number box.

At Brayton Purcell, we are concerned with injuries from unsafe drugs. If you have a question about your drug exposure or that of your child, please feel free to contact us to learn about your legal options.

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