FDA issues a draft guidance for industry on Implementation of the ‘Deemed to be a License’ Provision of the BPCI Act of 2009

The draft guidance explains that FDA will not approve any pending or tentatively approved application for a biological product under the FD&C Act after 23 March 2020.

Although the majority of therapeutic biological products have been licensed under the PHS Act, some protein products (e.g., insulin and insulin analogs, human growth hormone, pancreatic enzymes, follitropin products) historically have been approved under the FD&C Act. The BPCI Act changed the statutory authority under which these protein products will be regulated by amending the statutory definition of a “biological product” in the PHS Act to include a “protein (except any chemically synthesized polypeptide).”

The BPCI Act describes requirements for submission of an application for a “biological product” during a 10-year transition period ending on 23 March 2020 (10 years after the date of enactment). On 23 March 2020, an approved marketing application for a biological product under section 505 of the FD&C Act will be deemed to be a license for the biological product under section 351 of the PHS Act. The draft guidance describes FDA’s interpretation of this statutory provision, and explains that FDA will not approve any pending or tentatively approved application for a biological product under the FD&C Act after 23 March 2020. The draft guidance also provides recommendations to sponsors of proposed biological products intended for submission in a new drug application (NDA) (including a 505(b)(2) application) that may not receive final approval under the FD&C Act by 23 March 2020, to facilitate alignment of product development plans with FDA’s interpretation of the transition provisions of the BPCI Act.

Sponsors with product-specific questions should contact the relevant review division within the Office of New Drugs in FDA’s CDER regarding the development of a biological product intended for submission in a marketing application under the FD&C Act (during the transition period ending on 23 March 2020) or under section 351(a) or 351(k) of the PHS Act, as appropriate.