Yesterday was day one of the 2-day Generic Drug Forum presented virtually by the Agency in conjunction with the CDER Small Business and Industry Assistance program. There were many sessions which are all available here, including presentations on product-specific guidances, OGD labeling review and requirements, new program requirements under FDARA, pre-ANDA interactions with FDA, electronic submissions, an ANDA program performance review, and tips for improving ANDA quality. There were also some case study reviews on ANDA timing, based on action letters and submissions. All of the presentation slides as well as the playback of the video for each presentation is available on the link above.
Today, I just wanted to present a few key pieces from the presentation on the ANDA program performance review presented by Ted Sherwood, Director, Office of Regulatory Operations in OGD.
ANDA approvals and tentative approvals are the true metric that represents the ultimate value of the ANDA review and approval process, because without these final actions, the industry and the public would not have the benefit of high-quality generic drugs at affordable prices.
The chart above demonstrates the success that GDUFA in making generic drugs more readily available to the public. In the chart, you see record-breaking approval performances beginning in FY 2015 and continuing through FY 2019. It is likely that FY 2020 will be substantially lower, as at the current rate of approval for the first 6 months of FY 2020, it is estimated that full approval actions will be about 680 and tentative approval actions will run at around 155 with performance at about the levels seen in FY 2016
The chart on median approval time is a bit confusing and, even after listening to the presentation, it is still hard to grasp. Median approval time has always been a metric of interest. That chart appears to suggest that the median approval times have dropped significantly over the course of GDUFA and continue to go down. As the quality of applications increase, one would expect a drop in the median approval time, but this chart presents the fastest 25% of the cohort year and, because of that, it is thought to be more of a notice to industry that, if you have high quality submissions, you can expect much faster approval times, but what about the median approval times for the entire cohort for each GDUFA year? That was not presented, however, based on a review of the application numbers of ANDAs approved that can be used to predict ANDA submission dates, we know that median times for approvals will significantly higher if we view the approval times for all ANDAs regardless of their cohort year. If we look strictly at cohort year, it will take considerably longer before we have a true number because a fair number of those FY 2018 cohort applications have not yet been approved and thus the number will continue to rise as those applications make it through the system to approval.
After hitting highs in FY 2014 and FY 2017, ANDA receipts are beginning to trend downwards as shown in the above graph. FY 2020 looks like it may be a bit higher than FY 2019 and will likely come in with about 940 submissions at the current observed rate.
The RTR chart can be said to indicate a significant improvement in understanding of industry and an improvement in the quality of ANDA submissions, as the percentage of RTRs has dropped to an all-time low of 5%. GDUFA I focused on attacking the problem of RTRs as it wastes both FDA and industry resources. The issuance of the Dec 2016 RTR guidance has provided industry an excellent road map to improved quality.
While the submission of ANDAs seems to be declining, the number of ANDA supplements is increasing, as shown in the above graph.
As we all know that the approval does not end activity on ANDAs. After approval, applicants may seek a variety of post-approval changes that require supplemental submission. These figures are a bit staggering and represent a shift in the workload from review of original submissions to review supplemental applications.
There are many additional charts and data provided in this presentation. There was a lot of good information provided in the other presentations as well and it is highly recommended that you review the slides of the presenters and, better yet, view the actual recorded virtual presentations.