FDA Releases Revised Draft Guidance for “Formal Dispute Resolution: Appeals Above the Division Level”

March 15, 2013

By Alexander Varond

On March 12, 2013, FDA released a draft version of a revision to the February 2000 final guidance entitled “Formal Dispute Resolution: Appeals Above the Division Level.”  We refer to the draft version as “Revision 1.”  Revision 1 retains the original title and many of the recommendations first published in the February 2000 guidance.
The most significant update in Revision 1 is the extent to which FDA emphasizes that new information or analyses should not be submitted as part of a formal dispute resolution request (“FDRR”).  Note, however, that this concept is not a major departure from FDA’s February 2000 guidance; in fact, the key language from that version remains in Revision 1:

Because all FDA decisions on any dispute must be based on information already in the relevant administrative file (§ 10.75(d)), no new information should be submitted as part of a request for reconsideration or appeal.

FDA added considerable language regarding the necessity for sponsors to present any new data or new analyses of data at the division level before incorporating those data or analyses into an FDRR.  The new language includes the following key points:

  • “New analyses of data previously reviewed should be considered new information, and therefore should be submitted to the division for review before being submitted as support for an appeal.”
  • “In addition, the FDA will not consider an appeal if information that has not been previously reviewed by the division has been submitted in support of the appeal.”
  • “[W]hen the FDA [requests] additional clarifying information from the sponsor [as part of an FDRR], this does not mean new information that has not been reviewed by the division . . . .”

In addition, FDA explained that FDRRs will not be reviewed if the appealed issues are also currently under review at the division level.

Less substantive issues addressed by Revision 1 include an explanation of the review timelines for drugs subject to the Generic Drug User Fee Act and CBER-regulated products, updates to the FDRR submission procedure, and a clarification of the review timelines for responding to human drug application FDRRs related to PDUFA products.