Speaking at the GPhA Fall Technical Workshop on October 30, 2013, Dr. Kathleen Uhl, Acting Director of the Office of Generic Drugs (OGD) provided a first look at the structure of the new OGD Super Office. There are a number of new organizational blocks that signal to this old former OGDer that not only more changes are on the way, but that emphasis on certain pre- and post-approval issues are going to be beefed up considerably.
First, and perhaps most notably, in the Office of the Director, there will now be a Clinical Safety Surveillance staff and a Communications staff. The former will likely be looking at pre- and post-marketing issues as they relate to safety. We hear that perhaps Carol Holquist from Division of Medication Error Prevention and Analysis (DMEPA) may be interested in returning to her OGD roots and she would be a good candidate to aid in not only naming issues, but also assist in “functional” and safety evaluation of generic products relating to potential medication or prescribing errors. This may also be a prelude to a potential change in labeling for generic drug sponsors to permit them to make unilateral safety changes. You all know how I feel about that (see previous posts here and here).
Now a Communication staff would be great if it results in the Industry getting more communication with OGD. Not sure what the charge of this group will be, but any additional communication will certainly be welcome, especially after MaPP 5200.3 published in September 2013 (see previous post here).
Some previous branches will be elevated to Division level; for example, the Current Regulatory Support Branch will morph into the Division of Filing Review. Also, a new Office of Research and Standards will be added and it looks like this is where some of the Science teams might be based. The big new office addition of the Office of Generic Drug Policy will be the on the hot seat right off the bat trying to produce guidance and make policy decision on a whole host of issues regarding GDUFA implementation and ANDA review and approval, as well as clarifications of existing policy that have been impacted by GDUFA, as well as developing new policy that will be mandated by the transformational change in the ANDA review and approval process.
Of course, conspicuously missing from the new OGD organization structure are the Chemistry Divisions and the Microbiology Division that will move to the new super Office of Product Quality next year. Maybe the Communication Staff will coordinate the communication between OGD and those two critical review functions that will not reside outside of OGD.
We wish OGD good luck in executing this organizational change and hope they can find great folks to fill some of those critical positions.