Another GDUFA Goals Letter Surprise – Have you Gotten One of These Missives Yet?

The generic drug industry complained about the GDUFA Goals Letter in the past, when it thought it had negotiated more than goals for Complete Response Letters (CRLs) rather than clear movement towards application approval.  Well, some three years into GDUFA I, there now seems to be a better understanding of what industry thought they got and FDA has adopted, albeit outside of the direct language in the Goals Letter, policies that are driving application towards approval.

Well, hold onto your hats because it looks like industry’s interpretation of another gem in the Goals Letter may not be consistent with FDA’s.  The Goals Letter is replete with language about the electronic submissions and the fact that GDUFA goal dates will not be assigned unless the submission (ANDA or DMF) is in the electronic format specified by FDA at the time of submission.  Exact phrases from the Goals Letter include:

  • Review metric goals (described below) only apply to submissions made electronically, following the eCTD format in effect at the date of submission.
  • Backlog review metric goals (described below) apply to all ANDA applications, amendments, and supplements regardless of current review status in the queue as of October 1, 2012, regardless of whether they were submitted in paper, electronic, or hybrid format.
  • For Abbreviated New Drug Applications (ANDAs) in the year 5 cohort, FDA will review and act on 90 percent of complete electronic ANDAs within 10 months after the date of submission. (emphasis added) Certain amended applications may have differing metrics as discussed below.
  • Electronic– refers to submissions in an all electronic eCTD format in effect at the date of submission.

Apparently FDA’s definition of “all electronic eCTD” and “complete electronic” ANDAs/DMFs may be more stringent than ever envisioned by industry.  It appears that any deviation from the eCTD format, whether it is one page or fifty, whether there is one broken link, or lack of a detailed table of contents for each major section will result in a notice of deficiency, and if you fail to correct the problem within 7 days, then, while your ANDA may be filed (because the requirement for complete electronic ANDAs does not officially kick in until May 5, 2017) FDA will not assign a goal date, because we assume FDA has made a determination that the submission is not “all electronic” or “complete” and does, therefore, not qualify as a “submission made electronically following the eCTD format in effect at the date of submission”.  One firm reported that as there were 2 pages in one report that “did not meet the FDA standards”, their application got filed, but no goal date was assigned.  When the issue was elevated to senior OGD management, the response was that even if there is one data point that cannot be readily read by FDA or if even a single page was not fully legible, that the Filling Review group would refer this to the Policy Group for a decision.  The Policy Group has determined that they need to treat all applicants in the same manner.  Thus, if there are any errors, you can expect the same result.

Standard language we are seeing includes the following:

Reference is made to your original ANDA dated Month/Date/year and our refuse-to-receive correspondence (RTR letter) dated Month/Date/Year. After further consideration, FDA has rescinded its refuse-to-receive (RTR) decision communicated in its Month/Date/Year, RTR letter. FDA previously refused to receive this ANDA on the basis that the ANDA was not submitted in accordance with current eCTD requirements. However, FDA has determined that the GDUFA Commitment Letter contemplates addressing eCTD deficiencies differently for ANDAs eligible for metric goal dates beginning in Year 3 of GDUFA, specifically, by providing that metric goal dates will not apply to such ANDAs. See the Generic Drug User Fee Act Program Performance Goals and Procedures (GDUFA Commitment Letter), at 7, available at see also guidance for industry on ANDA Submissions — Refuse-to-Receive Standards, at 4 (May 2015, Rev. 1) (identical in relevant part to initial version finalized in September 2014). Accordingly, rather than refusing to receive this application for which eCTD deficiencies were not remedied within the 7-day time period provided for addressing deficiencies, FDA will consider your ANDA received for review as of Month, 31, xxxxx, but will not apply a metric goal date.

So what is an electronic submission; what is a paper submission and; what is a hybrid submission?  I think we know the answer to the last two, but is perfection required for the first to get a goal date assigned to the submission?  Is this what industry agreed to?  Did industry’s interpretation of the Goals Letter’s provisions contemplate this latest FDA interpretation?  This “one electronic submission mistake equals no goal date assignment” interpretation by OGD seems a bit draconian.  There has to be a sense of reason here.  This appears to be yet another example of OGD relying on the “plain meaning of the language” in the Goals Letter, but come on, could this be even close to what was envisioned by industry?