The Institute of Medicine releases report on pediatric studies conducted under BPCA and PREA

The Institute of Medicine (IOM) released a report today that finds that federal laws motivating or requiring drugmakers to conduct pediatric studies have yielded important information to guide the use of medications in children.

Titled “Safe and Effective Medicines for Children: Pediatric Studies Conducted Under the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act,” the report also notes that studies involving children continue to be limited and suggests avenues to improvement, such as strengthening the design and execution of pediatric studies requested under BPCA or required by PREA, as well as expanding the research scope to include more long-term safety studies and studies in neonates.

The report’s release precedes the 2012 Congressional vote on reauthorization of both BPCA and PREA, which occurs every five years. As directed by Congress, the Food and Drug Administration (FDA) asked the IOM to convene a committee to review aspects of pediatric studies and changes in product labeling that resulted from these legislative acts. Of note, since the two policies were adopted, the FDA has approved 400 labeling changes for drugs used in children.

More information about the IOM report may be found at:


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