What Happened at the GDUFA II Meeting and What is Happening at OGD?

Not surprisingly, the FDA said they were doing the best that they could with a new program, and industry said, so far, not good enough.  While these may seem like diametrically opposed views, my understanding is that the apparent positions are not as far apart as they might appear.

The Government Agency representations (other than FDA) touted the importance of generic drugs to the Medicare and Medicaid programs, as well as government purchasing organizations like the Veterans Administration and the Military.  The theme was repeated by multiple presenters from different Government organizations.

Office of Generic Drugs’ (OGD) Keith Flanagan noted that FDA has a strong commitment to meeting its “UFA” goals and OGD has hit all of its GDUFA-negotiated goals to date, with OGD going above and beyond the bounds of the GDUFA goals letter to give industry more of what they have asked for, and they recognize it is the right thing to do.  Flanagan characterized this as a GDUFA 1.5 effort.  David Gaugh, Senior Vice President for Science and Regulatory Affairs at GPhA, noted that approvals need to increase, communication and transparency need to be improved, and questioned how the FDA could have an excess of $277 million in unspent funds given the backlog of applications and inspections, as well as doing Target Action Dates (TADs) instead of just talking about them.

A few of the other big concerns that were mentioned by Industry related to fee reductions or waivers for small business, delay in establishment fees until approval of the ANDA, drug shortages due to slow action by OGD and significant price increases of some generic drugs (presumably artificially created by slow approvals of products when some manufacturers drop out of the market or get into cGMP problems).

Well as noted in a previous post (here), OGD is becoming more sensitive to the transparency and communications concerns raised by the industry and are actively doing something about it.  The delay in assignment of TADs to ANDA has continued to get great industry attention with the complaint of “we hear about it but don’t see it happening.”  The Agency appears to be addressing the TAD issue at a higher level as seen in a memo from Janet Woodcock M.D., Director of the Center for Drug Evaluation and Research (below).  In the past, it has been OGD driving the TAD assignments, but was somewhat slow in acting on assignments of the TADs; now, with the memo from Dr. Woodcock, it has become somewhat of a clear directive to act and act quickly.

So, look for TAD at a fax machine or email account near you.  The full copy of Dr. Woodcock’s June 11th memo is reproduced below:

From: CDER Center Director
Sent: Wednesday, June 10, 2015 5:00 PM
To: CDER-OPQ-ALL; CDER-OGDALL
Subject: GPhA Meeting June 11, 2015 and Target Action Dates

To All Staff Working with ANDAs

We will be meeting with the Generic Pharmaceutical Association (GPhA) on June 11, 2015.  Much of that meeting will be dedicated to updates from the inspection program leads.  We will also announce our final plan for Target Action Dates (TADs).  TADs are aspirational deadlines for Agency action on pre-GDUFA year three Abbreviated New Drug Applications (ANDAs).  All TADs will be both communicated internally and shared with the respective applicant.  The TAD assignments will be announced in phases during the next several weeks.

The benefit of setting a TAD internally is that CDER can synchronize work efforts across OGD, OPQ and other programs.  Externally, the TADs will give applicants a rough idea about when to expect an Agency response.  This will provide industry with increased business certainty for managing products and facilities.

A TAD will be considered met if the if the applicant receives an Approval, Tentative Approval, Complete Response (CR) or a complete set of Informational Requests (IRs) by the action date.  A complete set of IRs means that each pending discipline communicated its comments to the applicant.  In that case, the TAD will be met if the last discipline communicates its IR by the action date.  When the response to a CR and/or key IR is received and the response is determined to be complete (all deficiencies addressed), there will potentially be a new TAD for reviewing the response.   The TADs are aspirational deadlines, but the Center will try its best to meet the TAD for the pre-GDUFA year three applications whenever possible.

We appreciate all of the ANDA discipline reviewers and project managers working together to provide this much needed transparency to your peers and the applicants.  Meeting these TADs will help us achieve a robust generic drug review program.

Thank you,

 

Janet Woodcock, M.D.

Director

Center for Drug Evaluation and Research