Today, the FDA released its second revision to its “Guidance for Industry – Formal Dispute Resolution: Appeals Above the Division Level”.  The revised draft Guidance expands the previous Guidance (released in March 2013) to include applications covered under the Biosimilars User Fee Act of 2012 (BsUFA) and provides additional clarification as to what matters are not appropriate for Formal Dispute Resolution Requests (FDRRs).  The document also describes the FDA’s decision to manage all “formal requests for appeals of scientific/medical disputes related to an application for a user fee product through the FDR process.”

FDA makes it clear in the draft Guidance that they expect that sponsors seeking an appeal only use one mechanism at a time.  As they had done in the past, no longer is it okay to request a meeting and then initiating a FDRR prior to the meeting; no more requesting FDR prior to receiving a Cmplete Response Letter.  There are a number of other examples of when FDA will not grant a FDRR.  So, if you are going to use the process, make certain that you don’t go shopping for another means to air your issue at the same time.

The Guidance document also provides a list of examples of issues that may be appropriate for FDRR:

  • Complete response (CR) letter
  • IND clinical hold (partial or full)
  • Request for breakthrough therapy designation denied
  • Request for proprietary name review denied
  • Refuse to receive for an ANDA

FDA notes that, in most cases, the goal for response to a FDRR will be 30 days from receipt of the request; however, there are a number of examples where that goal may be extended.  For instance, where FDA asks for additional clarifying information from the sponsor or where they may want to confer with outside experts etc.  In such cases, FDA will try to respond within 30 days of receiving the clarifying information.

FDA also reminds sponsors that FDRR may not contain new data and the appeal of the decision must be based from a review of the information existing in the application at the time the original decision was made.

All FDRR must be sent to the respective applications, but FDA requests that sponsors notify the Division of the dispute request so that it can be handled in an expeditious manner.  The Guidance directs sponsors to the appropriate contacts for each type of application.

While not without precedent, the fact that this is a second revision to a draft Guidance seems to indicate that the Agency felt that significant changes were made to the first draft such that before finalization another comment period may be necessary.  Given that draft 1 issued 2.5 years ago, it could be a while before this document is finalized.  The complete Guidance document can be viewed here.