While it is no surprise, the prepublication notice in the Federal Register today (here) announces the withdrawal of the FDA guidance Exocrine Pancreatic Insufficiency Drug Products–Submitting New Drug Applications. The announcement comes just 19 days prior to the date when these products can no longer be submitted as an NDA. Remember, FDA had noted in that guidance that ANDAs were likely not appropriate for exocrine pancreatic products due to the complexity of the protein product and (for reasons described below) will no longer be acceptable for submission as NDA products.
This action comes as FDA is transitioning many protein / biologic products previously approved under NDAs to requiring licensing as biologics. Products that are approved and identified on FDA transition list (here) will be “deemed” as Biologic License Applications (BLAs) on the transition date. This change was brought about by passage of the Biologics Price Competition and Innovation Act of 2009 (BPCI Act) and was enacted as part of the Patient Protection and Affordable Care Act (Pub. L. 111-148), which redefined the definition of a “biologic product”.
“FDA intends to issue guidance regarding how the concepts described in the withdrawn guidance would apply to proposed pancreatic enzyme products submitted under the PHS Act, including the extent of integration of various types of data and information about the use of PEPs into BLAs. In the interim, the Agency encourages sponsors interested in submitting a BLA for a PEP to contact the relevant review division in the Office of New Drugs in FDA’s Center for Drug Evaluation and Research with any questions.”