GAO Report on FDA Tracking of Pediatric Research
The Government Accountability Office (GAO) has issued a report entitled "Pediatric Research: Products Studied under Two Related Laws, but Improved Tracking Needed by FDA." The report examines the extent to which the Pediatric Research Equity Act (PREA) and the Best Pharmaceuticals for Children Act (BPCA) have impacted the conduct of pediatric studies since Congress reauthorized the laws in 2007. The GAO reports that at least 130 products (80 products under PREA and 50 under BPCA) have been studied for use in children since the 2007 reauthorization, all of which had labeling changes that included important pediatric information. The FDA’s data may be incomplete due to shortcomings in tracking practices. The GAO also found that stakeholders, including sponsors, pediatricians, and health advocacy organizations, described challenges that could limit the success of PREA and BPCA, including confusion about compliance requirement due to a lack of FDA guidance and a lack of economic incentives to study products with no remaining market exclusivity. The GAO recommends that FDA improve its information tracking and data maintenance processes.
