FDA’s Office of Generic Drugs Says “We Hear You, and We’re Willing to Bite the Bullet” in a Massive Effort to Address Post-GDUFA Stakeholder Transparency Concerns

By Kurt R. Karst –     

FDA’s implementation of the Generic Drug User Fee Amendments of 2012 (“GDUFA”) and adherence to the triad of key aims laid out in the accompanying Performance Goals and Procedures – Safety, Access, and Transparency – have been a bit of a roller coaster ride for the generic drug industry, the Office of Generic Drugs (“OGD”), and even us. 

It wasn’t too long ago that we were griping on this blog (see here) about 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” that FDA published in September 2013 as part of the preparatory efforts in the lead-up to full GDUFA implementation beginning on October 1, 2014.  Although the stated intent of the MAPP is to “clarif[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 Regulatory Project Management (RPM) staff in [OGD]” we were concerned it represented what we called the “UFAization” of OGD (i.e., the process by which an FDA component, after the enactment of a User Fee Act, becomes focused on so-called process enhancements to meet goals and commitments at the expense – both literally and figuratively – of those who are subject to such user fees.) 

We were a little more upbeat about news shared by FDA at the Generic Pharmaceutical Association’s (“GPhA’s”) 2013 Fall Technical Conference about GDUFA implementation, including year 1 accomplishments and the announcement that a  committee – the GDUFA Steering Committee – had been put together to oversee GDUFA implementation (see our previous post here).  We were even more encouraged when the news came out that the Department of Health and Human Services approved the reorganization of OGD into a “Super Office” and that a new reporting structure would be created, including the creation of a new Office of Generic Drug Policy to handle, among other things, Hatch-Waxman disputes (see our previous post here). 

On the downside, we have heard some complaints about FDA’s enhanced ANDA refuse-to-receive standards reflected in recent guidance and less-than-helpful responses to Controlled Correspondence, though we have not focused on either topic in a blog post.  And then there’s the issue of how OGD will handle the recent explosion in ANDA submissions, as reported by Bob Pollock at the Lachman Blog (see here).  

But what we’re here today to announce is what can only be described as a massive and unprecedented undertaking on the part of OGD to address what seems to be an outpouring of concern about the perceived effects of MAPP 5200.3.  In other words, OGD has heard industry’s concerns and wants to do something about it – at least to the extent the Office can do so. 

In a recent memorandum to the Commissioned Corps (“CC”) Officers serving in OGD, OGD’s Acting Director, Kathleen Uhl, M.D., says that OGD’s “recent process changes, while critical to improving review efficiency, have made it harder for industry to assess the status of their submissions, and to plan the market launch of generic medicines that are important to industry and consumers alike.”  As such, writes Dr. Uhl, CC Officers “will be placed in mission critical status until completion of a one-time, special initiative related to GDUFA implementation.”  And what is this “special initiative”?  “Beginning February 1,” writes Dr. Uhl, “OGD’s CC officers will conduct a complete inventory of all the original ANDAs in our queue, and provide each applicant with an update regarding the status of its ANDAs.”  

That’s right, ANDA sponsors will be receiving, on a rolling basis, information on all of their respective original ANDAs (and amendments to them) – but not supplements – pending at the Agency.  This covers ANDAs submitted to FDA pre-GDUFA and pending on October 1, 2012 (i.e., the backlog), and that are subject to the GDUFA goal of 90% action by the end of FY 2017.  It also includes ANDAs submitted to FDA in the full year 1 (Fiscal Year 2013) and partial year 2 (Fiscal Year 2014) GDUFA cohorts.  These two GDUFA cohort years have been referred to as the “GDUFA donut hole” because, other than first Paragraph IV submissions, there are no FDA performance goals associated with review and action on them.  Performance goals take effect on October 1, 2014 (Fiscal Year 2015), when OGD has agreed to review and act on 60% of original ANDA submissions within 15 months from the date of submission, among other goals.  Note, however, that action on an ANDA within 15 months does not necessarily mean approval of that application.  More likely, OGD will be issuing Complete Response Letters reflecting full division-level review of deficiencies from all relevant review disciplines, including inspections.  Certainly, that seems to be the trend – see here and here.  This also means that once OGD issues a Complete Response Letter, and a sponsor responds, there may be another call from industry to gain some transparency into ANDA status. 

Although ANDA sponsors will not be able to request prioritization of the ANDAs on their respective lists, FDA’s action goes a long way to give greater transparency to application status, and could help as companies plan for the future.  As Dr. Uhl notes, “[t]he inventory and update goes above and beyond our negotiated GDUFA commitments.  It represents an extra effort to improve transparency, and help stakeholders cope with some of the uncertainty and disruption created by GDUFA implementation.”

Thank you OGD for listening to your stakeholders and providing a greater level of transparency; and thank you CC Officers for dedicating your time to this special initiative!