The Biologics Price Competition and Innovation Act (BPCIA) was enacted in March 2010 as part of the Affordable Care Act (ACA). The objective of the BPCIA, like the Hatch-Waxman Amendments of 1984 for generic copies of non-biological drugs, was to increase price competition and generate cost...

FDA review times have significantly declined since the passage of PDUFA in 1992, while agency resources have expanded through user fees. After the recent withdrawal of Vioxx and other high-profile products, there have been increasing concerns that PDUFA has adversely affected drug safety....