More Guidance on the Way from Office of Generic Drugs, and Other Nuggets

At today’s Science and Regulatory Advisory Committee meeting at the GPhA Annual Meeting in Orlando, Florida (apologies to those in the mid-West and Northeast), Keith Flanagan, the Office of Generic Drugs’ (OGD) Regulatory Counsel provided a look into some guidance documents the industry can expect to see in short order.

The roll out is designed to clarify how GDUFA is going to work, regarding submissions and work flow.

The five documents to expect are:

1)      A Prioritization MaPP, which will outline OGD’s internal procedures for how Regulatory project managers and their supervisors will assign priorities across the workload.  The document will describe issues, such as public health priority review, how OGD will treat First-to-File applications, Paragraph IV and III applications, etc.

2)      Guidance on the Quality of 505(j) Applications-but we were warned not to expect anything novel or new.  Hopefully, the document will provide some useful tips on improving quality of applications.

3)      An ANDA Amendment Tier Guidance to help clarify the relatively confusing portion of the statute and GDUFA goals metrics as they apply to amendments to pending applications.  Keith asked that the industry remember that, upon issuance of the second major amendment, there are no goal dates associated with the application, and thus, told the meeting attendees to assure the quality of their submissions.

4)      Supplemental Guidance to describe how Prior Approval Supplements will be treated under GDUFA

5)      Controlled Correspondence Guidance that will define what a controlled correspondence is and what it isn’t.

There was a hint that, in an unusual move, there may be a revision of MaPP 5200.3, “Responding to Industry Inquiries with respect to Abbreviated New Drug Applications in the Office of Generic Drugs”.  If this does occur, a revision based on some industry and GPhA comments will be very unusual since MaPPs typically explain the way FDA does things internally.

Also, in responding to questions about the status project that was undertaken, OGD acknowledged that the process they went through to provide a snapshot of where each company’s application was in the queue may not have provided as much granularity as firms had hoped, and that it was an effort for which the industry should give credit for OGD initiating this project, as it was over and above the requirements of GDUFA.  OGD will likely also begin assigning target goal dates to many applications as a practice exercise to see how they do in meeting those dates.  If this occurs, the firm will receive a letter stating the target goal date, so firms may have a heads up that either a Complete Response Letter, Tentative Approval, or Approval may be coming. 

OGD has heard the industry, and there are certain things they can and certain things they cannot do.  They will attempt the feasible, but will not attempt to implement wants that are not feasible.  Keith said that OGD likes the FedEx tracking concept for application that may get them out of the status update business, but based on the current IT structure, this may be something for GDUFA II that can be negotiated.