The two major human drug laws relating to pediatric populations are the Pediatric Research Equity Act (PREA) and the Best Pharmaceuticals for Children Act (BPCA). The Pediatric Research Equity Act originally was passed in 2003. PREA requires pharmaceutical companies to assess the safety and effectiveness of new drug and biologic products in pediatric patients. BPCA was passed in 2002. BPCA provides a financial incentive to pharmaceutical companies to test drugs with remaining patent life in pediatric patients. In addition, this Act creates a process by which FDA and the National Institutes of Health (NIH) can partner to obtain studies of off-patent drugs in pediatric patients.
A key difference between the laws is that PREA is a mandatory law and BPCA is voluntary.