New MaPP – Shuts Door on ANDA Review Status Requests from Other than Authorized Representative

The Office of Generic Drugs (OGD) has long taken the position that calls from multiple industry representatives about the same application to different OGD review staff or senior staff do nothing but waste the time of OGD.  This is definitely accurate; however, those multiple calls in the past were made because information was difficult (if not impossible) to get, and oftentimes inaccurate or outdated.  OGD has issued numerous guidances and directives alerting industry to identify a single point of contact at their organization, and for that individual to only contact the appropriately assigned project manager for the specific application for status requests.

This action (I believe) has cut down on numerous industry calls and has made the process of responding to legitimate status requests much more efficient for OGD.  A new Manual of Policy and Procedures (MaPP) 5200.12 directs OGD reviewers and senior management to direct any ANDA status to the appropriate Project Manager (PM) in either OGD or the Office of Product Quality (OPQ).

In addition, the MaPP discusses that:

FDA will provide prompt and accurate responses to any inquiry regarding review status from the Authorized Representative while maintaining appropriate confidentiality related to (1) other stakeholders in the generic review process, (2) the existence of and information contained in other ANDAs, and (3) information contained in a referenced Drug Master File. Generally, FDA should respond to inquiries within 2 business days of receipt.

While the issue of protecting confidential information has always been the stance of FDA, recent events may have caused this reminder to be included in the MaPP, which as you know, is an internal FDA document that describes how the FDA does its business.  It also points out that PMs should be diligent in informing authorized representatives to keep their contact information up to date.

Don’t get caught with your pants down as OGD is certainly serious about this policy and process.  I have told firms that I will no longer be able to contact FDA on their behalf unless I am included on the telcon with the authorized industry representative.  The world is changing because the review process is changing, and GDUFA I and II have had significant impact on the way OGD does business.  Please read the new MaPP so you don’t get caught in the crosshairs!  A full copy of the document can be found here.