FDA Heard You, But Did They Really Hear You?

The FDA today posted a revised draft guidance (here)  on the Pre-submission Facility Correspondence (PFC) required to gain a priority review under GDUFA II.  We previously reported on the initial draft guidance here and did not think it could get worse — but apparently we were wrong.

Many in the industry have complained that with the stated purpose of the PFC to identify all facilities used in the proposed application the Agency could determine whether a facility inspection was needed.  If so, then FDA could get a jump on scheduling the inspection, so they would be able to meet the tight 8-month goal date for a priority review.  However, with the amount of information requested in the PFC, it turned into a mini-ANDA.  While the FDA, in the revised guidance, has tried to make it easier for firms by requesting that they only need to submit certain eCTD sections of the proposed ANDA at least two months in advance of the actual ANDA submission, they have actually made it much harder and potentially almost impossible for ANDA applicants!  Why?  Because many times the firms are waiting for the bioequivalence data (which is required in the PFC) to drop into the ANDA just days before it can be submitted.  In addition, the last two months before a submission is scheduled to be submitted, firms are working feverishly to get the submission in the appropriate format for submission.

The revised guidance (15 pages) is now requested that 28 eCTD sections of the ANDA must be submitted in the PFC. With the current restraints on applicants, and the data coming in many times just before the ANDA submission is scheduled to be submitted, this may have a chilling impact on either delaying a submission to the FDA to meet the 60-day pre-submission requirement or cause the applicant to miss out on the ability to obtain priority review.

In either case, this, in my opinion, places the priority review program into the “is it worth it” category, or even worse into “does it make a difference” category since you may have to delay your submission by 2 months anyway.  Is it possible that the FDA does not know what happens at the preparation of the ANDAs and the sequence of events that cause the firm to work up to the last minute to get a timely-filed application into the gateway? I don’t know but we will have to see how all this plays out over the next few months.