The BPCA became law in 2002. It was reauthorized in 2007 under the Food and Drug Administration (FDA) Amendments Act, and again in 2012 under the FDA Safety and Innovation 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 the NIH to prioritize therapeutic areas and sponsor clinical trials and other research about on- and off-patent drug products that need further study in children