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Many biologics tested in children, but more work to be done
Pediatricians have long lamented the shortage of pediatric drug studies, but many biologics include at least some pediatric information in their labeling, according to results of an Institute of Medicine review published online.
Marilyn J. Field, PhD, of the Institute of Medicine (IOM), and colleagues reported an analysis of biologics approved by the FDA between 1997 and 2010. The analysis of biologics was initiated as part of a recently published IOM study (Safe and Effective Medicines for Children, 2012) that examined public policies to require or encourage pediatric studies of medications.
Field and colleagues reported that nearly 90% of the 96 biologics had been approved for pediatric use, had some pediatric information in the labeling, or had been studied or were planned for study in children (eg, were registered at ClinicalTrials.gov). For 55 separately analyzed vaccines, the rate was slightly higher, around 95%.
“Most of the products with neither pediatric labeling nor registered pediatric studies are approved for indications that are rare or not diagnosed in children,” the researchers said.
Field and colleagues said initiatives such as the Best Pharmaceuticals for Children Act, which was recently extended to biologics, should continue to encourage testing of these products in children.
“Although pediatric studies have expanded in recent decades, studies of drug safety and effectiveness often exclude some age groups, especially infants and neonates,” Field told Infectious Diseases in Children.
Disclosure: Field reports that funding for this study was from the FDA through the National Academy of Sciences.
Marilyn J. Field, PhD, can be reached at mfield@nas.edu.
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