Report on Activity of the Generic Drug Program Updated for July

While there is not much new or trendy in the updated figures, it is clear that OGD is issuing more Complete Response Letters (CRLs).  July saw the second highest number of CRLs for FY 2016 with 169 (highest was 190 in April).  These numbers are also significantly higher than those in previous years.

This means one of two things, 1) either FDA is stepping up their rate of reviews and CRLs, or 2) generic firms are being overwhelmed by Information Requests (IRs) and Easily Correctible Deficiencies (ECDs) letters and cannot respond within the proscribed time frame, even with an extension which forces FDA to issue a CRL.  Firms may also internally be prioritizing IR and ECD responses for products with the most importance to the company, thus leaving others unanswered and also forcing the FDA to issue a CRL.

Figures released today also show that Office of Generic Drugs Refused to Receive (RTR) 14 ANDAs in July down from a monthly average of 22 for FY 2016 to date.  That is promising, even though these numbers seem to jump around all over the board.  DMF reviews were at 86 for July, a bit below the 2016 monthly average 80 for FY 2016.

Changes Being Effected Supplements hit their second lowest monthly total for FY 2016 at 357, as compared to a monthly average of 447.  There were 33 Prior Approval Supplements submitted in July down a tad from the 2016 monthly average of 37.4.

It is clear that OGD still has a lot of work to do and industry does too.  Balancing IRs and ECDs and responses to CRLs is the need to file new ANDAs.  We are just over a month when the GDUFA goal for original ANDAs submitted on or after October 1, 2016 ramps up to 90% reviews completed within 10 months.  Can OGD get more first-cycle approvals to help the process become more efficient?  Can firms respond in a timelier manner to IRs and ECDs?  That remains to be seen.  In that regard, we will continue to watch the numbers and report what we see.  We are also awaiting an update from FDA on the numbers and percentages of first-cycle approvals for cohort year 3 submissions.  We will see what comes down the pike.