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Diana L. Courson

Legislation Enacted Requiring Pediatric Drugs To Be Studied in Children

January 1, 2004

Zuckerman Spaeder successfully represented the Elizabeth Glazer Pediatric AIDS Foundation (Pediatric AIDS Foundation) and the American Academy of Pediatrics (AAP) to obtain legislation that will require drug companies to undertake pediatric studies in drugs likely to be used for children. The Pediatric Research Equity Act (PL108-155) addresses a serious medical problem. Today approximately 75 percent of the drugs used by pediatricians have not been studied in children to determine the dose that is safe and effective.

The law will codify a regulation issued by the Food and Drug Administration in 1998, which a U.S. district court invalidated in October 2002. After the government refused to appeal that decision, the Pediatric AIDS Foundation and the AAP intervened and appealed to the U.S. Court of Appeals for the DC Circuit. The case was scheduled for oral argument in January 2004, but pursuing the case is no longer necessary because of the new law.

Zuckerman Spaeder attorneys William B. Schultz and Logan Smith represented the two organizations in Congress and in the courts. Our representation in the judicial case was part of Zuckerman Spaeder's pro bono program.