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FDA Places Hold on all ANDA PAS & CBE Reviews

In a blog posting earlier this year, we discussed the then median 26 month ANDA approval time and how it was getting longer. We now know that the Office of Generic Drugs (OGD) currently has over 3000 ANDA post-approval supplements (PAS) waiting for action, of which 1500 have been pending for over 6 months. In order to manage the workload the OGD Division Director has placed a hold on all ANDA supplements until next year. At this time, OGD is only reviewing original ANDAs. OGD has hired staff to address this issue and training is in progress with a goal of reinstating review of ANDA supplements by the end of 2010. This hold includes post approval supplements and CBE/CBE30s (Changes Being Effected).

Understanding the current backlog and the fact that at year end a major number of filings reach the FDA, once the review begins in 2011, it is hard to predict how long it will take to begin reviewing pending supplements. CBE30s that were submitted in 2010 may get reviewed in 2011 and sponsors could receive comments after a change has already been implemented.

The FDA will give special consideration/review to PAS submissions in the cases of drug shortages or disasters, but if there are other drugs on the market that meet the need, the FDA would not give the PAS priority.

As always, you must follow-up with your Project Manager at the FDA to understand what is occurring in the division that you are working with so that you can manage changes to your commercial product submission. Another consideration for an ANDA holder is to convert to a 505(b)(2) submission, balancing the filing fees with PDUFA driven review times.