Although Office of Generic Drugs (OGD) total activity numbers (including issuance of Complete Response Letters (CRLs), etc.) will not be posted until about 2 weeks after the close of the month, it is disappointing that the number of approvals this late in the month appears only in the teens.
While there are many things going on at OGD (training of new staff, Guidance and Policy development, the reorganization to a Super Office, among other important things) the bottom line for industry is the number of approvals that OGD issues and the number and timeliness of OGD deficiency responses it receives. But approvals rule the roost in terms of industry importance because, after all, you cannot sell products that receive CRLs.
It has been 20 years since I left OGD but, when I was there, we used the term “moving the freight” to describe the importance of getting actions to sponsors. When numbers were low, we pushed the reviewers. We tracked applications that were getting close to approval to assure that important issues were addressed quickly so the approval could be issued. We watched the review queue like a hawk and, if an ANDA was getting close to the statutory 180 day review clock, we showed up at the reviewer’s door to assure they knew the deadline was coming. I must admit we did have a more manageable workload at the time, but we had far fewer people as well. When I left OGD at the very end of 1994, we had 155 staff handling the workload. Prior to GDUFA, OGD has about 350 and, now with GDUFA hires, that will soon be in the neighborhood of 600+. I will also concede that the reviews have become much more complex and detailed and that requirements for applicants are increasing all of the time, but I am not always certain that the additional requirements bring value to the process. For instance, one of the goals of implementing the Quality Overall Summary (the 45-60 page summary of the ANDA) was to provide reviewers with a written narrative that was supposed to speed the decision on the ANDA by providing the reviewer with a road map as to what was contained in the application and further explain up from the what, how and why they made their product which was to be supported by the data in the rest of the ANDA. But this just became another time-consuming effort for industry with little apparent difference in the amount of time actions took on ANDAs. Now OGD is requiring three times as much stability data, asking firms to validate USP methods (I hope this was a one-time mistake but something we have recently seen at LCS) and placing other additional requirements on sponsors. So the cost of doing business continues to rise, not only from the need to generate additional data, but the time it takes to get an application approved.
I wish I better understood the new “behind-the-scenes” OGD operating system, better understood the interplay between the Office of Pharmaceutical Quality and OGD now that the two are separate Super Offices, better understood why the freight is not moving down the tracks at a faster pace, better understood how the new transparency is really transparency. But I have been gone from the FDA for a long time and perhaps the ramp up is much more difficult that even I can imagine. But my guess is that the generic drug industry will measure OGD’s success by only three things: 1) the quality and quantity of information it receives on the status of its pending applications; 2) the number and speed of the CRLs it receives (that is one of the GDUFA goals) and; 3) the number and speed of the approvals it receives (which as we all know is not one of the goals found in the GDUFA goals letter). All else will likely be noise to the generic industry.
With year 3 of GDUFA around the corner, the new order in OGD will certainly come under even greater scrutiny, as the honeymoon afforded by this new law begins to fade. It is only a matter of time that the industry as whole will wonder “where’s the freight?” and their voices will become even louder on this issue.