Implications of California v. Texas for the BPCIA
Mark Perry, Wayne Barsky, Betty Yang & Michael Showalter
The Biologics Price Competition and Innovation Act (BPCIA), which stimulates price competition and facilitates access to biological therapies by establishing a regulatory framework and patent resolution mechanism for the launch of biosimilars, was enacted as part of the same legislation that produced the Affordable Care Act (ACA). In California v. Texas, the petitioners have asked the Supreme Court to hold the ACA’s individual mandate unconstitutional and rule that the remainder of the ACA— including the BPCIA— is inseverable from the individual mandate and must fall as well. The case thus threatens the BPCIA’s existence.
But if the Court holds the individual mandate unconstitutional, and even if it concludes that certain health insurance provisions in the ACA are inseverable, the Court should not additionally rule that the BPCIA is inseverable. Statutory text and legislative history make clear that the BPCIA was conceived of and operates as an independent, standalone legislative scheme–and unlike much of the ACA, it held broad bipartisan support. The BPCIA was enacted with the ACA only for reasons of convenience. Under settled principles of severability, the BPCIA should survive.
Food and Drug Law Journal
Volume 75, Number 4