The Office of Generic Drugs (OGD) is evolving as the GDUFA process is gaining steam, and the pieces are coming together regarding coordination of reviews, and as efficiency in the review and approval process improves. Here are some interesting facts that have come out of OGD recently that may prove the above states are an accurate assessment of OGD’s current state.
One FDA official recently stated: “At the very beginning of GDUFA I, the ratio of submissions pending FDA vs. submissions pending industry was roughly 5:1 or 4:1. Now it’s about 2.3:1 and accelerating. Because we truly have built the machine and truly are cranking it up, the volume of CRs and IRs may be starting to press industry.” This observation is unique in that we have not had access to the number of CRs (Complete Responses) or IRs (Information Requests) that have been issued over the last few months, even though we have seen the number of approvals increase. But the comment about the number of CRs and IRs “pressing industry” does not surprise me. Firms have been waiting for many CRs for 3 to up to 5 years, then-poof! – they appear out of thin air and the firms just are not quite prepared to begin work on them. Now with the issuance of Target Action Dates (TADs), firms should know better about when they would be receiving communications from FDA and may be better prepared to deal with responding to those communications in a timelier manner. So now a “backlog” of FDA CRs and IRs may be building in industry’s court, while industry works through formulating their responses. This may be good for FDA on a temporary basis, but those responses will be coming back in to OGD and will go back on the Agency’s clock upon receipt. Hopefully, the new process will perform well in turning those responses around, in accordance with the GDUFA goals associated with the classification of the response.
Another interesting tidbit is that OGD has stated that it intends to take action on all pre-year 3 submissions by the end of GDUFA 1. That also includes the pre-GDUFA backlog, and OGD notes that they are ahead of schedule and will definitely meet or exceed the 90% GDUFA backlog review goal. In addition, OGD indicates that they are striving to move ANDA towards approval, rather than just to issue a CRL action.
For Year 3 cohort submission, the filing review is at an average of 31 days. For the pre-year 3 submissions, there are still about 100 left to address from the huge backlog of ANDAs that came in in FY 2014.
One very interesting question that has previously not been addressed by OGD and is of great interest to the industry is, how will additional cycles be timed for review for pre-year 3 submissions? That question has been answered, as OGD notes that it will issue TADs for pre-year 3 responses as follows – major amendment responses will receive a 10-month TAD (7 months for an expedited review application), minor amendment responses will be on a 5-month TAD (3 months for an expedited review ANDA), and ECDs (Easily Correctable Deficiencies) and IRs will receive a TAD of 3 months. These revelations make it clear to me that OGD is confident enough in the review process to make these TAD goals public. (Remember that a TAD is not a mandated GDUFA goal and is something extra that OGD is doing to promote better communication.)
We will likely hear more at the GPhA Fall Technical meeting in early November and we will keep you posted on the latest developments.