FDA releases a proposed rule on biologics license applications and master files

The FDA issued a proposed rule to amend its regulations relating to the use of master files for biological products. As per the requirements of the Biologics Price Competition and Innovation Act of 2009 (BPCI Act), marketing applications for biological products that previously could have been submitted under section 505 of the FD&C Act must be submitted under section 351 of the Public Health Service Act (PHS Act) as of March 23, 2020. On March 23, 2020, the BPCI Act would require that approved applications for a biological product under section 505 of the FD&C Act will be subject to licensure under section 351 of the PHS Act. If finalized, this proposed rule would allow for certain biological products approved under the FD&C Act to continue to incorporate by way of reference to information about drug substances, drug substance intermediates, or drug products (DS/DSI/DP) found in drug master files after the application for a biological product is approved and deemed to be licensed under the PHS act.

A drug master file is a confidential detailed document voluntarily submitted to the FDA that consists of information such as DS/DSI/DP information. This is relevant as it can be used to support a submission to FDA for drug products regulated under section 505 of the FD&C Act.

The proposed rule would also codify FDA’s practice of allowing applications for a biological product submitted under the PHS Act to incorporate by reference information other than DS/DSI/DP information that can be found in a master file. Furthermore, the proposed rule codifies FDA’s practice of permitting investigational new drug applications to incorporate by reference information from a master file for products subject to licensure under the PHS Act.

The FDA is working hard to ensure that there is a seamless transition between regulatory pathways. More information regarding the proposed rule can be found on the “Deemed to be a License” Provision of the BPCI Act page of the FDA’s website.

We will continue to monitor any future changes moving forward. If you have any questions about the proposed rule and the FDA, how this will affect your company, or for any of your regulatory requirements feel free to contact us at [email protected] or use our contact form.