Happy New Year to all and welcome back to the Lachman blog! The first reporting of the year addresses what is on every generic company’s mind – how is OGD doing since GDUFA’s implementation?
The Office of Generic Drugs reports the following activity relative to its workload in FY 2013 and 2014 (so far).
During FY 2013, OGD issued 150 refuse-to-receive (RTR) actions to applicants. Remember, each ANDA that receives an RTR action incurs a 25% filing fee penalty. The year also saw firms withdraw 107 ANDAs.
OGD approved 440 ANDAs as compared to 517 in FY 2012, which represents a decrease of about 15%. There were 95 Tentatively Approved ANDAs (remember, these are applications that have met scientific and regulatory approval requirements, but OGD is precluded from final approval due to a period of patent or exclusivity protection) in FY 2013 compared to 102 in FY 2012, or a reduction of a little over 9% this year.
OGD received 968 original ANDAs in FY 2013 compared to 1103 in FY 2012, or a reduction in original ANDA submissions of about 13% in 2013. During the year, OGD issued 1251 Complete Response letters. In 2012, OGD was issuing review-specific deficiency letters, so no real comparison can be made to the previous year’s activity for this category.
OGD also performed 1699 DMF complete assessments. The new reporting also provides for statistics on submissions of amendments for backlog ANDAs and cohort year applications, but OGD has yet to release backlog figures for the numbers of application pending, CMC supplements pending or labeling supplements. Perhaps we will see those numbers if OGD expands its reporting.
OGD recently reported the first two months activity for FY 2014, and notable among those statistics are that, for October and November, OGD issued 40 RTR actions, which is significant for a two-month period and may reflect the revised RTR provisions announced at the end September 2013 (see previous post here). OGD approved 60 ANDAs and issued 14 Tentative Approvals during the first two months of FY 2014, but received 99 originals during that same time period. The December numbers are not in yet, but we will report on them as soon as they are available. OGD has reported that they have met all GDUFA goals so far; tracking the activity numbers may help us understand better where OGD stands, but it still is going to take time before any real improvement is realized. With the newly reported finalization of OGD’s elevation to Super Office status and the reorganization efforts required, as well as the projected move of OGD staff to the White Oak campus this spring, all will likely have a negative impact on OGD output, at least in the short term. Stay tuned to this blog for coverage of the developments!