In today’s SBIA Generic Drug Forum, there were a number of presentations related to generic drug statistical reporting. As someone who tracks OGD activities somewhat obsessively, these presentations validated many of the observations that I’ve been making in my blog posts on the OGD’s public statistical reporting.
The presenters reviewed the types of required and routine reports (such as those required by FDARA, including the quarterly Activities Report of the Generic Drug Program FDARA Title VIII Sections 807 and 805, which provides data on the number of ANDA applications pending at the FDA and those pending with industry mean and median approval statistics), the status of ANDAs subject to Priority Review under Section 505(j)(11)(A) of the FDC&A, and ANDAs with a Competitive Generic Therapy designation under Section 506H of the Act, among other metrics.
In addition, Agency representatives discussed other monthly reports like the Activities Report of the Generic Drug Program, Competitive Generic Therapy approvals, and the yearly mandated Performance Report to Congress for the Generic Drug User Fee Amendments.
The presentations provided the uses of (and the limitations of) the public data; for instance, in the quarterly Activities Report of the Generic Drug Program FDARA Title VIII Sections 807 and 805, the data reported on mean and median approval times is generally not reflective of the time anticipated for approval of a quality application submitted today as the numbers reported still do factor in a significant number of older applications, which can impact the approval times. The OGD does not have cohort mean and median approval times for applications by year. The OGD also mentions that there are significant fluctuations due to the ebb and flow of monthly workload output, which makes conclusions about current output progress difficult at times, a point I refer to frequently in my blog posts. One additional thing I have often pointed out in this forum is that the data presented in one report may not always match the data in other reports for a variety of reasons.
Other presentations covered the FDA’s internal KASA program and data integrity issues in the manufacturing of APIs and drug products, clinical and bioequivalence areas, analytical work, and the cGMP arena. Case studies were presented that illustrated the continuing Agency concern about data integrity issues, illustrated by the significant numbers of FDA 483 observations and Warning Letters citing data integrity concerns. The ultimate impact on product quality and patient safety from DI issues is a continuing concern for the Agency, industry, and of course, public health.
If you haven’t registered for the Generic Forum, I suggest you do so today, before the second day’s sessions begin tomorrow morning. That way you’ll have access to all of the slides from both days. You can do so here.
