• Issue Brief
  • March 14, 2012

Laws on Safe and Effective Drugs for Children

The Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act (PREA) are two laws that encourage and require the study of drugs in children. Data resulting from BPCA and PREA studies are added to drug labels to give parents and providers essential information on the safety and efficacy of drugs used in children.

PREA requires drug companies to study adult drug indications in children when the product is likely to be used in a significant number of children or represents a meaningful therapeutic benefit over existing therapies. While PREA is a requirement, it cannot delay access to the adult version of the product.

BPCA is an incentive for drug companies to conduct FDA-requested pediatric studies—especially for off-label drug uses—in return for an additional six months of marketing exclusivity.

More information on PREA and BPCA can be found in this issue brief, compiled by the American Academy of Pediatrics and Elizabeth Glaser Pediatric AIDS Foundation, with the support of the Children’s Hospital Association and other allied health organizations.

An Institute of Medicine (IOM) report brief can also be accessed to provide more evidence that BPCA and PREA have helped provide better information about the efficacy, safety and appropriate prescribing of drugs.

Association contact: Jenny Rudisill (202) 753-5340