Usually I concentrate on ANDAs received and the numbers approved as a measure of the Office of Generic Drugs’ (OGD) progress, but this month, let’s just mention that there were 41 full approvals and 7 tentative Approvals and, as the table below reveals, OGD received 74 ANDAs in April 2014. By the way, OGD reported issuing 100 Complete Response Letters in April 2014.
|Submissions This Month||Oct||Nov||Dec||Jan||Feb||Mar||Apr|
|Abbreviated New Drug Applications (ANDA)||41||58||225||85||76||112||74|
|Amendments – Originals||176||156||143||139||131||160||155|
|To Backlog ANDAs||152||123||114||117||109||128||122|
|To Cohort Yr 1 ANDAs||22||27||25||18||15||26||22|
|To Cohort Yr 2 ANDAs||2||6||4||4||7||6||11|
I would like to look more closely at the Amendments received this month and point out some interesting facts regarding them. Amendments or responses to Complete Response letters (CRL) represent the ongoing process of updating ANDAs by applicants based on either changes the firm deems necessary to make to the ANDA or in response to a CRL. Of interest is that most of the activity associated with amendments still focuses on the backlog of ANDAs that were before the Agency prior to October 1, 2012. In April, there were 122 such amendments out of a total of 155 received by OGD for the month. As you can see, amendments to Cohort Year 1 and Cohort Year 2 are dwarfed by the number of Backlog ANDA amendments. This obviously reflects the long lead time for Cohort Years 1 and 2 ANDA to be picked up and reviewed. Most of the Cohort Year 2 amendments are presumed to be gratuitous amendments of some sort, as the actual review of Cohort Year 2 ANDA is likely just beginning, thus not many Cohort Year 2 CRL have likely been issued. We cannot tell by the numbers provided if the amendments are in response to CRL or are just gratuitous amendments, so it is a bit hard to really put our finger on the nature of the activity.
Needless to say, if there was a bit more granularity in the numbers reported, and if the actual backlog figures were presented for ANDA and Supplements, it might be easier to gauge OGD’s progress. However, from the look of things, OGD is just really getting to CRLs for Cohort Year 1 applications with possibly the exception of expedited ANDA in that Cohort year. With metrics set to kick in for Cohort Year 3 ANDAs in a mere 4 months, something has got to give!
One other interesting observation is in relation to the Post-CRL Meeting requests. It appears that applicants are really not availing themselves of the opportunity to clarify deficiencies or issues in the CRL as there have only been a total 20 such requests so far in the first 7 months of FY year 2014. This tracks somewhat closely with a total of only 23 such request for post-CRL meeting in all of FY 2013. Either OGD is getting better at writing clear CRL or industry is just not availing themselves of this important opportunity to obtain clarification from FDA on issues they find confusing.
|Post CR Meeting Requests This month||Oct||Nov||Dec||Jan||Feb||Mar||Apr|
When I review the statistics for next month, I will try to concentrate on another aspect of the OGD statistical reports in an effort to keep you up to date with issues that I see as important relative to understanding how OGD is doing and how the industry will fare in the coming year.