Clearing the Air on Pre-GDUFA Year 3 ANDAs; OGD Issues Revised (and Much Improved) Communications MAPP

By Kurt R. Karst –

Back in September 2013, when FDA’s Office of Generic Drugs (“OGD”) was gearing up for significant implementation of the Generic Drug User Fee Amendments of 2012 (“GDUFA”) (and the associated Performance Goals and Procedures), the Office issued a Manual of Policies and Procedures (“MAPP”) – MAPP 5200.3 – titled “Responding to Industry Inquiries with respect to Abbreviated New Drug Applications in the Office of Generic Drugs.”  The MAPP was intended to clarify “the general principles for handling inquiries with respect to [ANDAs] from the authorized representative for an applicant with an ANDA submission (the authorized inquirer) by Regulatory Project Management (RPM) staff in [OGD].”  At the time, this blogger, channeling concern from some in the generic drug industry, was pretty critical of the MAPP (see our previous post here).  Our friend Bob Pollock (from Lachman Consultants) even turned a nice phrase, calling the document “The MaPP to Nowhere.”  (Bob's post on the revised MAPP, which we discuss below, harkens back to that old post: “MaPP to Nowhere Now has Coordinates to Find the Treasure.”) 

A LOT has happened in the nearly two years since FDA issued MAPP 5200.3.  OGD has undegone a significant transformation, becoming a “Super Office” with a permanent Director and instituting a new organizational structure.  OGD has churned out numerous new and revised policies and guidance documents (see our previous post here).  In early 2014, OGD announced a massive and unprecedented undertaking (presumably to address, in part, an outpouring of concern about MAPP 5200.3) to conduct a complete inventory of all original ANDAs in OGD’s queue, and to provide each applicant with an update regarding the status of their ANDAs (see our previous posts here and here).  Earlier this year, at the Generic Pharmaceutical Association’s (“GPhA’s”) annual meeting, OGD Director Kathleen (“Cook”) Uhl provided an update on the status of GDUFA implementation and included some positive numbers (see our previous post here).  (Recent figures published by FDA show some progress with achieveing the goals of GDUFA, as does the latest GDUFA Performance Report.  Indeed, we understand that OGD recently approved the first GDUFA cohort year 3 ANDA way ahead of the scheduled action date: ANDA 207955 for Tretinoin Gel, 0.05%, approved on August 13, 2015.)  Dr. Uhl also announced at the GPhA meeting that OGD would be assigning Target Action Dates (“TADs”) to pre-year 3 cohort applications (i.e., ANDAs submitted in the year 1 cohort [Fiscal Year 2013] and year 2 cohort [Fiscal Year 2014] – the so-called “GDUFA donut hole”), and indicated that a revision to MAPP 5200.3 was in the works and would address industry concerns.

Earlier today, FDA announced the publication of a revised and renamed MAPP 5200.3.  Titled “Communications with Industry with respect to pre-GDUFA Year Three Abbreviated New Drug Applications,” the revised MAPP, “[d]ue in part to stakeholder feedback,” “substantially expands and sets forth responsibilities and procedures for communications between generic drug program staff and Authorized Representatives concerning the review status of pre-Year 3 submissions.”   Pre-Year 3 submissions include not only the GDUFA donut hole (i.e., applications not approved or withdrawn as of the close of business on September 30, 2014), but pre-GDUFA backlog submissions (i.e., applications not approved or withdrawn as of October 1, 2012).  The Revised MAPP continues OGD’s emphasis on RPM empowerment and responsibility for ANDAs, but also promises a greater depth and improved frequency in communication with ANDA applicants.  

In an email memo “To All Staff Working with ANDAs” (reprinted below),  CDER Director Janet Woodcock, M.D., stated that OGD RPMs “will communicate Target Action Dates, periodically update applicants and/or respond to applicant queries concerning the review status of submissions, communicate when certain major deficiencies may be forthcoming, and provide certain advance notifications of regulatory correspondences.”   These goals are stated in greater detail in the revised MAPP, first in a Background section:

Although GDUFA requires FDA to take action on 90% of the submissions in the pre-GDUFA backlog cohort by September 30, 2017, individual pre-Year 3 submissions lack goal dates. This makes it hard for applicants to plan product launches and conduct other business planning that affects generic drug availability.  To facilitate launch planning – and help ensure public access to affordable, quality generic medicines at the earliest legally available date – we intend to provide information concerning the review status of pre-Year 3 submissions down to the discipline and sub-quality discipline levels. [(Emphasis in original)]

. . .  and then in a Policy section:

Our policy is to provide prompt and accurate responses to any inquiry regarding review status from the Authorized Representative while maintaining appropriate confidentiality related to other stakeholders in the generic review process, including the existence of and information contained in other ANDAs and information contained in a referenced Drug Master File. Generally, inquiries should be responded to within two business days of receipt.

. . . . and then in a Responsibilities section with very specific responsibilities laid out for OGD Division of Project Management Discipline Project Managers, Division of Filing Review Project Managers, and (most importantly) OGD RPMs.  

OGD RPMs bear the greatest responsibilities, being tasked with ensuring application flow, timely responding to applicant (authorized representative) inquiries, and communicating with applicants (including initial TADs and revised TADs, that a newly filed pre-year 3 submission – yes, there are still about 250 ANDAs for which a filing/receipt communication has not yet been sent – has been assigned to that RPM, and advance notice of Complete Response actions).

Of course, the proof is in the pudding.  There will undoubtedly be some initial bumps in the road.  In the long term, however, we’re hopeful that OGD follow-through on the policies and points articulated in revised MAPP 5200.3 will significantly enhance “the user experience” and provide the greater level of clarity the generic drug industry needs and craves.

To All Staff Working with ANDAs

I am pleased to announce the issuance of the revised, joint Office of Generic Drugs-Office of Pharmaceutical Quality MAPP 5200.3, “Communications with Industry with respect to pre-GDUFA Year 3 Abbreviated New Drug Applications” (available on FDA’s Web site []).  It will substantially expand our communications with applicants concerning pre-GDUFA backlog, GDUFA Year 1 and GDUFA Year 2 submissions (collectively, “pre-Year 3 submissions”). 

Although GDUFA requires us to act on 90% of the submissions in the pre-GDUFA backlog cohort by September 30, 2017, individual pre-Year 3 submissions lack GDUFA goal dates.  This makes it hard for industry to plan product launches and conduct other business planning that affects generic drug availability.  To facilitate launch planning, we will provide information concerning the review status of pre-Year 3 submissions down to the discipline and sub-quality discipline levels.  This will help ensure that quality, affordable generic medicines reach the public at the earliest legally available date.  

For example, OGD Regulatory Project Managers will communicate Target Action Dates, periodically update applicants and/or respond to applicant queries concerning the review status of submissions, communicate when certain major deficiencies may be forthcoming, and provide certain advance notifications of regulatory correspondences.

OGD Discipline Project Managers and OPQ Regulatory Business Process Managers will issue Informational Requests for their respective disciplines.  Informational Requests are letters sent to request further information or clarification that is needed or would be helpful to allow completion of the discipline’s review.  The purpose of these communications is to assure that FDA has all the information necessary to evaluate if the application is approvable or must receive a Complete Response Letter.

To facilitate meaningful communications, we are asking review staff members to refer all questions about the overall status of applications to the appropriate OGD Regulatory Project Manager.

We appreciate all of the ANDA discipline reviewers and project managers working together to expand communications with applicants.  Implementing these changes will help us achieve a robust generic drug program.

Thank you,

Janet Woodcock, M.D.