DURHAM, NC -- The Food and Drug Administration Modernization Act (FDAMA, 1997), designed to stimulate more drug safety studies in children, has resulted in more than 130 label changes since its inception nearly six years ago, according to researchers at Duke Children's Hospital.
Their analysis appears in the September issue of Pediatrics.
Under this and subsequent renewal of this legislation, pharmaceutical companies were given a six-month extension of their exclusive marketing rights on a drug if they performed clinical trials requested by the FDA to determine the drugs' safety, dosing, and efficacy in children.
According to P. Brian Smith, MD, an assistant professor in Duke's department of pediatrics, many safety concerns cannot be detected until after the introduction of a product to a larger and more diverse population. The Best Pharmaceuticals for Children Act (2002) required the FDA to review and report to a public expert panel the adverse events occurring after granting pediatric exclusivity. That effort was needed because pediatric clinical trials are notoriously small, making it more likely that some safety concerns would not be detected until after the drug is used in a larger pediatric population.
Using MedWatch, the FDA's computerized information database for collecting reports of adverse events, the FDA's Pediatric Advisory Committee reviewed 67 drugs granted the extension. "This is a voluntary, cost-effective reporting system that can identify adverse events that may never have been seen in a clinical trial," Smith said.
"Just because a drug goes through testing and clinical trials does not mean its entire safety profile is known," says Danny Benjamin, MD, a co-author of the study and pediatrician at Duke Children's Hospital. "Before this incentive, there was no systematic, focused pediatric review of the data provided to the FDA's adverse event reporting system. Now, field experts in pediatr
|Contact: Debbe Geiger|
Duke University Medical Center