FDA Releases a Proposed Rule on Biologics License Applications and Master Files

FDA Releases a Proposed Rule on Biologics License Applications and Master Files

Today, the Food and Drug Administration (FDA) issued a proposed rule to amend its regulations concerning the use of master files for biological products.  Under the Biologics Price Competition and Innovation Act of 2009 (BPCI Act), an application for a biological product approved under section 505 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) shall be deemed to be a license under section 351 of the Public Health Service Act (PHS Act) on March 23, 2020.  The proposed rule, if finalized, would codify that  if an approved application for a biological product under the FD&C Act references a drug master file (DMF) for drug substance, drug substance intermediate, or drug product (DS/DSI/DP) information, the application can continue to incorporate by reference such information after the approved application is deemed to be license under the PHS Act on March 23, 2020. 

A master file is a submission to the FDA that may be used to provide confidential detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of one or more human drugs. Information contained in a master file can be used to support a submission to FDA by an applicant or sponsor.  DMFs are master files that contain certain information, such as DS/DSI/DP information, that is relevant to applications for drug products regulated under section 505 of the FD&C Act. 

The proposed rule would also codify FDA’s existing practice that an application for a biological product under the PHS Act may rely on a master file, except for information regarding a drug substance, drug substance intermediate, or drug product.  In addition, the proposed rule would codify FDA’s existing practice that information from a master file, including drug substance, drug substance intermediate, or drug product information, may be relied on at the investigational phase of any BLA. 

FDA is working to ensure that there is a seamless transition between regulatory pathways and that there are minimal impacts on manufacturers and patients.  More information on the transition can be found on our “Deemed to be a License” Provision of the BPCI Act website.

For information on the proposed rule, and how to comment, please see the Federal Register Notice.