Implementation of the “Deemed to be a License” Provision of the Biologics Price Competition and Innovation Act of 2009

PDA appreciates the FDA developing such a short and straightforward guidance document on this subject and has the following comments and recommendations to enhance the clarity and content. PDA recommends that FDA explicitly state in this or future guidance its intent to consider the transition as an administrative process (as opposed to one that requires data or a substantive review). An FDA mandate for sponsors to address differences in technical requirements as part of the transition is an unnecessary utilization of both FDA and authorization holder resources. Biological products approved under section 505 of the FD&C Act are demonstrated to be safe and effective and have a long history of quality. FDA's current interpretation creates, as a practical matter, the potential for at least a 6 month black out period for the submission of post-approval supplements for approved 505 biological products. This black out period may, for example, delay the implementation of critical manufacturing changes needed to meet the increasing demand for life savings medicines. This is especially problematic for Changes Being Effected supplements that are effective but not yet approved as of the 23 March 2020 transition date. PDA recommends that FDA develop a mechanism whereby a pending NDA supplement would not have to be withdrawn and resubmitted as a BLA supplement.