As the Affordable Care Act approaches the 10-year anniversary of its being signed into law, one aspect of the ACA is poised to finally take effect this month. When the Biologics Price Competition and Innovation Act of 2009 (BPCIA) was enacted as part of the ACA, Congress left much of the details up to the FDA to determine. In addition to creating the 351(k) biosimilar approval pathway, Congress via the BPCIA intended to bring all biologics together under the same law, which it planned to do through the “deemed to be a license” provision.
While most biologics are licensed under the Public Health Service (PHS) Act and approved through a biologics license application (BLA), some protein products have gained FDA approval under the Federal Food, Drug, and Cosmetic (FD&C) Act through a new drug application (NDA). The BPCIA did two things to impact this: First, it modified the definition of a “biological product” to include a “protein (except any chemically synthesized polypeptide).” Second, it said that biologics approved under the FD&C Act on or before March 23, 2020 — 10 years after the BPCIA was enacted — would transition over to the PHS Act. Thus, an approved marketing application for one of these drugs under section 505 of the FD&C Act would be deemed to be a license for the product under section 351 of the PHS Act.