A number of presenters from Office of Generic Drugs (OGD) at the GPhA Fall Technical Workshop noted that “We have listened to what you have said and we hear you” and have indicated that MaPP 5200.3 that addressed communication with industry (see previous post here) will be revised. That MaPP basically cut off lines of communication relative to ANDA status, and the uproar from industry continues till today. Industry representatives have indicated that the transparency in the communication with OGD is something that is essential to being able to make reasonable business decisions in a timely manner and are needed to appropriately run their business organization.
With OGD indicating that MaPP 5200.3 is in the process of being revised, questions as to how far the revisions will go towards normalizing communication practices are clearly on the minds of the industry attendees. You could almost hear a cheer from the audience when the announcement was made. When questioned as to when industry might see the revised MaPP, Keith Flanagan indicated that they are actively working on it, but that changing the document is actually more challenging than industry can imagine but hoped the revision could be issued by the end of the year – but that was only a best guess.
The generics industry has been taking issue with the OGD interpretation of the FDA GDUFA Goals Letter especially where there appears to be a lack of linking the goals of GDUFA to approvals of ANDAs. The industry believes that that link needs to be as important as meeting the metrics cited in the Goals Letter for the simple reason that the tenants of the Hatch-Waxman Act is to get high quality, low cost generics into the hands of patients at the earliest time that all scientific requirements have been met and legal impediments to approval have been resolved.
Marcie McClintic Coates, J.D., Vice President and Head of Global Regulatory Affairs, Mylan, Inc. made this point in her remarks in the industry overview of GDUFA section of the workshop. Marcie noted that “yes, there are metrics that the FDA must meet and those are important, but don’t forget the underlying requirements and tenents of Hatch-Waxman – getting drugs available to patients the first day that legal barriers are gone.”
With the constant FDA mantra of “read the Goals Letter”, Keith Flanagan, J.D., Regulatory Counsel, OGD, FDA responded to Marcie’s comments by saying “we wish you would hold us accountable for the metrics that were negotiated rather than the goals you may want us to hit.” He further noted that, “FDA-wide effort regarding how to deal with goal dates and managing reviews to goal dates will pay off big time”. Keith acknowledged that there are two top priority issues after meeting the GDUFA goals and they are: moving the freight for pre-GDUFA and pre-year three submissions, and providing information to applicants regarding pending approvals so the industry can perform the necessary activities to launch their products in a timely manner.
This difference in interpretation of the Goals Letter is likely to continue until the negotiations for GDUFA II are completed, but if you read between the lines, it appears that OGD is saying that, if we continue to do what we are doing and drive the review process by applying the GDUFA goals and metrics, then the approvals will come. The generics industry has notoriously been impatient but Dr. Uhl believes that OGD has turned the corner and is past the tipping point. While the industry may be a bit more skeptical, the proof will be in the pudding as the year three metrics are applied and OGD is working very hard to deal with the backlog ANDAs, supplements and cohort year 1 and 2 ANDA submission. Let’s hope that Cook’s view is the correct view.