The FDA published a recertification of its Manual of Policy and Procedure (MaPP) titled, “Good Review Practices”, MaPP 6025.1 yesterday.  The first iteration of this document was issued in 2006.  This is its second recertification.  In reviewing the document, I was reminded of several calls and discussions I have recently had with my industry colleagues regarding lack of consistency in the ANDA review process.

While I believe the review process had improved over time, there are still complaints of “new requirements” being included in Complete Response Letters or information requests letters.  Just this week, I was speaking to a client who relayed the following to me.  “We have been trying diligently to provide OGD with everything they want and ask for.  We review past letters and requests and try to incorporate data to support previous OGD requests in all of our new submissions.  However, we frequently get questions on topics we have never been questioned on before or are asked for new information that has never been relayed to us in any of the 100s of applications we have submitted in the past.  We just don’t understand how this can continue to happen?”

This is, unfortunately, not an uncommon refrain and increases the frustration of the industry with the OGD review and approval process. This is not a new problem and I believe that firms have experienced this issue for as long as I can remember; however, we hope that documents like this MaPP that defines what Good Guidance Practice is and what the fundamental values are that make them valuable to be “disseminated and adopted by review staff” are valuable and of use to the industry.   For instance, the MaPP outlines five such values:

  • Quality — Consistent implementation of GRPs by review staff will enhance the quality of reviews, the review process, and the resultant regulatory action.
  • Efficiency — GRPs will improve the efficiency of the review process through standardization.
  • Clarity — GRPs support clarity throughout the review process, including critical review and decision activities that must be completed before a regulatory decision is made.
  • Transparency— Developing and documenting GRPs ensures that our review processes are readily available in one location via the Internet (through CDER’s Web page) to sponsors and the public.
  • Consistency— By offering a consistent approach and only deviating from it when appropriate (after supervisory concurrence), GRPs help reviewers achieve consistency with their reviews and provide standard review processes across divisions and offices.

These values would seem to translate into review expectations that are clear to industry and are well understood.  However, we continue to hear examples where review requirements appear to change based on specific reviewer’s requests at times.  If we want to see first-cycle approvals significantly increase, the Good Review Practice principles articulated in this MaPP must be clearly translated into approval requirements that are consistent and well defined.  Somewhere along the way, there appears to be somewhat of a disconnect that OGD and industry must both work to bridge to improve the consistency in the review process to make evolving review requirements communicated in a timely manner to industry.  OGD must also realize that, when it makes a revision to the approval requirements in general or for a specific product, that applications that are currently submitted and under review clearly will not contain that newly required information in the already submitted application.  Perhaps in such instances, OGD could request such new information in an “information request” type correspondence and permit industry to provide the new information for review in the current review cycle.  Just a thought!