OFFICE OF NEW DRUGS MODULE

PREA vs. BPCA

There are differences and similarities between the Pediatric Research Equity Act (PREA) and the Best Pharmaceuticals for Children Act (BPCA), including:

• PREA studies are mandatory; BPCA studies are voluntary.
• PREA requires studies only on indication(s) under review; BPCA studies relate to an entire moiety and may include unapproved and different indications.
• Studies for orphan indications are exempt from PREA; however, written requests may be issued for orphan indications under BPCA.
• PREA and BPCA cover drugs and biologics.
• PREA/BPCA pediatric studies must be labeled.

In essence, BPCA is a carrot, an incentive to do something that may be beneficial. PREA is the stick of the legislator. Ultimately, PREA and BPCA have a shared goal of providing new pediatric information and drug labeling, and encouraging the appropriate use of medication to treat these patients. FDA is responsible for carrying out the intent of both laws simultaneously and effectively.