A report released Feb. 29th by the Institute of Medicine (IOM) provided a review of the benefits of current federal laws that offer incentives for or require drug and biologic developers to conduct pediatric studies. The report also highlighted several areas where Congress and FDA could make better use of clinical information gleaned from pediatric studies.
Historically, pediatric studies have been infrequently implemented, due in large part to both the small sample populations available and the relatively low potential economic return for drug developers in those markets. Clinically, many pediatricians prescribe medications approved for use in adults but not tested in children; these medications can often have different risk-benefit profiles between pediatric and adult patients.
Since 2007, Congress has taken a stronger stance on the implementation of pediatric studies, passing the Best Pharmaceuticals for Children Act (BPCA)—which offers drug developers financial incentives to conduct pediatric studies—and the Pediatric Research Equity Act (PREA)—which requires pediatric studies under certain circumstances.
The IOM report noted that these laws have had very positive effects in stimulating the implementation of pediatric studies and generating helpful information about the use of various therapies in pediatric patients. However, the report also suggested that FDA exercise its authority more frequently to require long-term pediatric safety studies as follow-up for approved and currently marketed drugs, and that Congress extend FDA’s authority to impose sanctions and fines for unreasonably delayed pediatric studies.
To read a review of the report on MedicalExpress, click here. To view the full IOM report, click here. If you need help planning or managing clinical trials, contact Pearl.