FDA Lays Out Post-GDUFA Implementation Plans: A Brave New World or A Modern Utopia in the Making?

By Kurt R. Karst –      

The Generic Pharmaceutical Association (“GPhA”) held its annual Fall Technical Conference this week.  There were lots of interesting topics on the conference agenda, such as complex drugs, ANDA filing and refuse-to-receive issues (see the recent FDA guidance here), adverse event reporting, and Center for Drug Evaluation and Research (“CDER”) reorganization plans (see here).  But the big topic on the minds of those attending was FDA’s implementation of the Generic Drug User Fee Amendments of 2012 (“GDUFA”), including how the Office of Generic Drugs (“OGD”) is working to fulfill its GDUFA performance goals, which come into full force beginning in Fiscal Year 2015.

The good news is that FDA seems to be fully on top of GDUFA implementation.  (A rundown of GDUFA year 1 accomplishments was reported on earlier this week by Bob Pollock of Lachman Consultants – see here.)  The bad news, of course, is that in the effort to meet GDUFA goals, the character of the generic drug industry could be forsaken or forgotten, as we've previously opined.  A balance will need to be reached.

It was announced at the conference that the Agency has put together a steering committee to oversee GDUFA implementation – the GDUFA Steering Committee – composed of senior FDA personnel to ensure alignment across CDER components.  As shown below, the GDUFA Steering Committee is itself multifaceted, with various subcommittees.

The Generic Program Subcommittee is taking a cross-functional team approach to manage implementation, as illustrated below, and has developed interim milestones and timeframes for each of the types of submissions to FDA.  

An important aspect of this process is apparently to empower OGD Regulatory Project Managers (“RPMs”) “by delineating process steps and dependencies, associated interim milestones and goal dates, and roles and responsibilities” to ensure “the RPM manages each application appropriately, and [provides] review discipline accountability,” according to a presentation given by Manju Thomas of FDA’s Office of Strategic Programs.  The RPM empowerment initiative also seems to be an idea underlying FDA’s recent 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 stated purpose of the MAPP is to “clarify[y] 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 [RPM] staff in [OGD].”  

Another significant component of the GDUFA Steering Committee is the GDUFA Policy Subcommittee.  This subcommittee, composed primarily of OGD personnel, has been tasked with recommending various policy improvements, according to OGD Regulatory Counsel Keith Flanagan.  The short list of policy improvement items are near and dear to the generic drug industry. 

For starters, there’s OGD’s prioritization policy and how to allocate resources.  The intent is to enable RPMs (and managers) to manage workflow with a balanced attack, keeping 4 goals in mind: (1) public health needs (e.g., drug shortages); (2) meeting GDUFA year 3 (Fiscal Year 2015) cohort goals (e.g., review and act on 60% of original ANDA submissions within 15 months from the date of submission); (3) not losing sight of ANDAs submitted in cohort years 1 and 2 (Fiscal Years 2013 and 2014); and (4) ensuring that the pre-GDUFA backlog of ANDAs is addressed in a balanced manner so that there is not a rush to address these submissions by the end of Fiscal Year 2017.  Under the GDUFA Performance Goals, “FDA will review and act on 90 percent of all ANDAs, ANDA amendments, and ANDA prior approval supplements regardless of current review status (whether electronic, paper, or hybrid) pending on October 1, 2012 by the end of FY 2017.”)

Also before the GDUFA Policy Subcommittee are issues such as “How to avoid multiple cycle reviews?”, “How to address industry’s lackluster response to MAPP 5200.3?” (see our previous post here), “How to provide clarity on the various GDUFA amendment tiers and what constitutes a major, minor, or delaying amendment?” and “How to provide clarity on the review of chemistry supplements?”  One thought being tossed around on ANDA qualify (i.e., “How to avoid multiple cycle reviews?”) is the establishment of a public docket seeking industry comment on best practices (and perhaps a guidance document). 

Each of these policy improvements – and particularly those that are pursued with industry input and involvement – should go a long way to make the transition from a pre- to post-GDUFA world less rocky.  Though there are still some kinks in the system that need to be worked out, and there will certainly be disputes, it is possible that we may be on the road to A Modern Utopia after all.