The Food and Drug Administration Safety and Innovation Act (FDASIA), enacted in 2012, requires the Secretary of Health and Human Services to report on the implementation of sections 505A and 505B of the Federal Food, Drug, and Cosmetic Act, which are commonly known as the Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act (PREA), respectively. This report was first required to be submitted to Congress by July 9, 2016, and then every five years thereafter.
These reports (1) provide an assessment of the implementation of BPCA and PREA, as well as the impact of those statutes, (2) highlight additional successes stemming from these two statutes, and (3) offer suggestions for advancing pediatric drug development by ensuring that the objectives underlying BPCA and PREA are effectively and efficiently implemented.
- BPCA and PREA Status Report to Congress July 1, 2015 – June 30, 2020
- BPCA and PREA Status Report to Congress July 9, 2012 – June 30, 2016