Another month and another report of the approval actions of the Office of Generic Drugs (OGD) for our reader’s review. For the month of February 2015, OGD approved 21 ANDAs. While that may seem a bit low, to be fair, OGD also tentatively approved (TA) 10 ANDAs for a total of 31 approval actions. The number of tentative approvals is the highest seen since December 2013 when there were 12 TAs, and in April 2013 when there were 18 TAs. Remember, a TA is issued where the applicant has met all scientific and regulatory requirements, but the application cannot be approved because of patent or exclusivity issues.
Many of the TA-ed products are for products associated with the President’s Emergency Program for AIDS Relief (PEPFAR), but there are a number that cannot yet be marketed due to patent or exclusivity issues . A PEPFAR product that reaches TA status may be sold outside of the United States to underdeveloped countries to treat AIDS patients at a reduced cost. PEPFAR products also receive the highest priority in the review process.
So far this fiscal year, the best month for combined approval actions (TAs and full approvals) was October, where reported approval actions totaled 55 (45 full approvals and 10 TAs). With the organizational changes, policy changes, new IT system, and the progress made in training new reviewers advancing, perhaps the efficiency improvements hoped for in the review and approval process are about to be realized. We will keep a close eye on this situation for all of our readers.
One other interesting note is that, on the FY 2015 Activities Report of the Generic Drug Program, there are some additional categories of amendments not seen on the previous FY activities reports. They include amendments submitted to OGD based on Easily Correctable Deficiency (ECD) and Information Request (IR) letters. For February FY 2015, OGD reports 45 being received. This means that ECD and IR requests are being issued in greater numbers, possibly indicating that earlier communication with ANDA applicants is occurring. In addition, pre- and post-2015 amendments to original ANDAs and supplements are being broken down with greater granularity. While the OGD report provides the number of complete response letters (CRL) issued per month, it does not outline the number of ECD/IR letters issued by OGD, which makes it difficult to realize the volume of those requests that are currently being issued.
The expansion of the report clearly indicated OGD’s move towards greater transparency of its workload and actions on applications and supplements, which is a good thing for industry to know.
