FDA Draft Guidance for Industry: Implementation of the ‘Deemed to be a License’ Provision of the Biologics Price Competition and Innovation Act of 2009 (BPCI Act)

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Implementation of the `Deemed to be a License’ Provision of the Biologics Price Competition and Innovation Act of 2009.” This draft guidance describes FDA’s approach to implementation of the statutory provision under which an application for a biological product approved under the Federal Food, Drug, and Cosmetic Act (FD&C Act) on or before March 23, 2020, will be deemed to be a license for the biological product under the Public Health Service Act (PHS Act) on March 23, 2020. Specifically, this draft guidance describes FDA’s interpretation of the “deemed to be a license” provision of the Biologics Price Competition and Innovation Act of 2009 (BPCI Act) for biological products that have been or will be approved under the FD&C Act on or before March 23, 2020. This draft guidance also provides recommendations to sponsors of proposed protein products intended for submission in an application that may not receive final approval under the FD&C Act on or before March 23, 2020, to facilitate alignment of product development plans with FDA’s interpretation the transition provisions of the BPCI Act.