The Best Pharmaceuticals for Children Act (BPCA) became law in 2002. It was reauthorized in 2007 under the Food and Drug Administration (FDA) Amendments Act, in 2012 under the FDA Safety and Innovation Act, and again in 2017 under the FDA Reauthorization Act.
The overarching goals of the BPCA are:
- To encourage the pharmaceutical industry to perform pediatric studies to improve labeling for patented drug products used in children, by granting an additional 6 months patent exclusivity
- For NIH to prioritize therapeutic areas and sponsor clinical trials and other research for off-patent drug products that need further study in children