Draft Guide on Reconsiderations at the Division Level Provide Process for Certain GDUFA Disagreements

I disagree with FDA – how many times have you said that, but did not act because, 1) you did not know who to call, or 2) you just did not know the process?  Under the GDUFA II program, there is actually a provision for reconsideration outlined in the GDUFA II Goal Letter (and if you have not heard this a thousand times – READ THE GOAL LETTER).  Well, now there is a draft guide to help you understand not only what issues are appropriate for reconsideration at the Division level (remember, this is not formal dispute resolution – which comes after all else fails) but how and where to send in your reconsideration requests.

According to the draft guidance, the following are examples of appropriate issues for reconsideration:

  • Refuse to receive decision
  • Tentative approval letter
  • Complete response letter
  • FDA determination that a Supplement-Changes Being Effected or a Supplement-Changes Being Effected in 30 days is a PAS
  • Classification of a major amendment to an ANDA or PAS
  • Classification of the standard review status of an ANDA, ANDA amendment, PAS, or PAS amendment
  • Denial of a pre-ANDA meeting

The guidance also discusses what is not appropriate for such reconsideration (including advice at meetings or in minutes of meeting or in teleconferences because such advice represents current Agency thinking, but since applicants are free to take another scientifically valid approach, these are not regulatory decisions and thus not appropriate for reconsideration.  FDA also advises that, if the reconsideration approach is taken, the sponsor “should not actively engage with other entities within FDA or pursue other regulatory or legal pathways on the same matter at the same time because this may waste Agency resources and/or impede FDA’s consideration of a request for reconsideration.”)

The guidance goes on to note that new information should not be submitted in a request for reconsideration, and explains how FDA will handle reconsiderations requests for products submitted under GDUFA I.

Requests for reconsideration will be handled as expeditiously as possible, with a GDUFA II goal of 90% within 30 days, if the request is made within 7 days from the date of the regulatory action taken by FDA.  If the firm fails to submit the reconsideration within this timeframe, then FDA will respond as soon as possible.  The guidance also describes:

  • How to submit the reconsideration request
  • The contents and format of the request
  • FDA‘s procedure for reviewing and responding to requests

To view a complete copy of the draft guidance, click here.