Today is April 7, 2015, and the FDA Monthly Approvals list for March shows only 14 approvals and 4 ANDA Tentative Approvals. Granted that the number of ANDA is declining, with the whopping backlog, it is hard for this former FDAer to understand the focus of the Office of Generic Drugs (OGD) relative to the goals of Hatch-Waxman. I totally recognize that the GDUFA goals are mandated for OGD’s performance, but if the ANDAs are not driven to final approval, the Complete Response Letter and OGD’s success in meeting all of its GDUFA goals may be rather hollow for the generic industry.
Now, maybe the FDA Monthly Approval report is not as reliable or accurate, or as up to date as it should be, and perhaps there were actually more approvals in March (albeit the last approvals listed are for March 30th), but that is the only data we have out here in industry to work with. If that is indeed the case, then there is a real continued concern. Without accurate reporting of OGD productivity data, how can the industry have a view into the progress that OGD is making in implementing the new review paradigm and to see if it is indeed working?
Here we are 6 months into year three and to see the fewest number of approvals in any month since GDUFA was implemented is certainly making some CEOs a bit nervous.