FDA, Ahead of GDUFA II Enactment, Starts the Ball Rolling with Pre-Submission Facility Correspondence Guidance

Although both the U.S. House of Representatives and U.S. Senate are still in the midst of considering legislation – the FDA Reauthorization Act of 2017 (“FDARA”) (H.R. 2430 and S. 934) – to, among other things, reauthorize an alphabet soup of user fee programs, including the second iteration of the Generic Drug User Fee Amendments (“GDUFA II”), and as the Congressional Budget Office analyzes the cost of FDARA (see here), FDA has apparently decided that it’s pretty certain that GDUFA will ultimately be enacted into law. Earlier this week, FDA issued a draft guidance document, titled “ANDAs: Pre-Submission Facility Correspondence Associated with Priority Submissions,” that is intended to implement a new Pre-Submission Facility Correspondence (“PFC”) process for certain ANDA sponsors.

As part of GDUFA II, FDA and the generic drug industry hammered out a Commitment Letter under which FDA agreed to review and act on certain “priority ANDAs” (including original ANDAs, ANDA amendments, and ANDA Prior Approval Supplements) within timeframes shorter than those established for “standard ANDAs.” For example, while FDA agreed to review and act on 90% of standard original ANDAs within 10 months of the date of ANDA submission, 90% of priority original ANDAs will be reviewed and acted on “within 8 months of the date of ANDA submission, if the applicant submits a Pre-Submission Facility Correspondence 2 months prior to the date of ANDA submission and the Pre-Submission Facility Correspondence is found to be complete and accurate and remains unchanged.” If, however, “the applicant does not submit a Pre-Submission Facility Correspondence 2 months prior to the date of ANDA submission or facility information Changes or is found to be incomplete or inaccurate,” then FDA will review and act on 90% of priority original ANDAs within 10 months of the date of ANDA submission.  Whether a particular ANDA submission qualifies for “priority” status will depend on the sponsor meeting the criteria laid out in FDA’s “Prioritization MAPP” (i.e., Manual of Policies and 35 Procedures (MAPP) 5240.3, Rev. 2, “Prioritization of the Review of Original ANDAs, Amendments, and Supplements”).

As described above, the PFC process is the linchpin to obtaining an 8-month priority review goal date. And as we approach the beginning of Fiscal Year 2018 when GDUFA II is expected to go into effect, FDA wants to make the PFC process as clear as possible now so that ANDA sponsors can begin putting together the necessary paperwork to submit requests in anticipation of the GDUFA II goals becoming reality.  To that end, the draft guidance “establishes FDA’s expectations for the content, timing, and assessment of the PFC,” and, specifically defines:

• The content and format of the information that should be submitted in the PFC to enable FDA’s assessment of facilities listed in the PFC.
• PFC timeframes and their intersection with the subsequent ANDA submissions.
• The possible outcomes of the Agency’s assessment of the PFC.
• When and how the PFC submitter is notified by the Agency about the status of the PFC.

The draft guidance lays out a detailed set of instructions for ANDA sponsors to follow when making a PFC submission. And knowing FDA’s (the Office of Generic Drug’s) penchant for kicking out or refusing submissions that don’t meet even the smallest detail, ANDA sponsors would be wise to ensure that every “i” is dotted and every “t” is crossed in a PFC submission.

Timing is also a critical component of the new PFC process, because PFCs have a short expiry date. The GDUFA II Commitment Letter provides that a PFC should be submitted to FDA two months ahead of the planned ANDA submission date in order for an application to be eligible to receive the shorter 8-month goal date.  According to FDA:

[I]f the time elapsed between submission of the PFC and submission of the planned ANDA is too long, it is less likely that facility information will remain unchanged, as defined by the GDUFA II Commitment Letter. Thus, FDA’s PFC facility assessment may become out-of-date and need to be repeated after the planned ANDA is submitted, eliminating the benefit of the PFC submission to both FDA and the applicant.  Therefore, this guidance establishes a window of time between 2 and 3 months after PFC submission during which applicants should submit their planned ANDA.

This is referred to in the draft guidance as the “ANDA Submission Window.” For example, if a PFC is submitted to FDA on December 1st, then the planned ANDA should be submitted to FDA between February 1st and March 1st.  Similarly, if the PFC is submitted to FDA on December 31st, then the planned ANDA should be submitted to FDA between February 28th (in a non-leap year) and March 31st.