The Petrie-Flom Center is pleased to announce the availability of a new resource on its website: the legislative history of the Biologics Price Competition and Innovation Act (BPCIA). The BPCIA, passed as part of the Affordable Care Act (ACA), created a pathway for the approval of biosimilar products and awarded innovator biologic companies twelve years of exclusivity for their products. Modeled after the Hatch-Waxman Act of 1984, which established our system of generic small-molecule drug approvals while simultaneously creating a five-year period of exclusivity for new drugs, consideration of the BPCIA’s history is often lost in the discussion over the ACA’s history as a whole. This resource selects only those documents relating to the BPCIA and may thus prove particularly useful for scholars of FDA law.
This new resource comes at an opportune time, as the courts and Congress have both turned their focus to the provisions of the BPCIA. In 2015, the Federal Circuit issued a divided opinion interpreting the BPCIA’s instructions to biosimilar and innovator drug sponsors, and that opinion has now been appealed to the Supreme Court. Just last month, the Justices called for the views of the Solicitor General on this question, a step which may significantly increase the likelihood of an eventual cert grant. At the same time, several members of Congress have introduced a bill that would decrease the BPCIA’s grant of exclusivity from twelve years to seven years, bringing it more in line with the five-year period in the Hatch-Waxman Act or seven-year period in the Orphan Drug Act. The twelve-year period of exclusivity may have been the most contentious aspect of the BPCIA as passed, with even the FTC arguing strongly against such a lengthy period at the time.
Members of the public may also be interested in an article written by Professor Erika Lietzan and colleagues providing an excellent analysis of the BPCIA’s legislative history.