While we had underestimated approvals and slightly overestimated Tentative Approvals in our November 1 post (here) on this topic, nevertheless, OGD beat the old record of 126 for total approval actions in a month by 2. OGD fully approved 110 ANDAs and tentatively approved 18 ANDAs for a total of 128 ANDA approval actions starting off FY 2019 with a bang! The official numbers were posted today on the Activities Report of the Generic Drugs Program (FY 2019) Monthly Performance (here).
The number of complete response letters (CRLs) for October 2018 stood at 175, significantly below the 220.6 monthly average of CRLs for FY 2018 (the first full year under GDUFA II). OGD received 83 ANDAs in October 2018, compared to 65 in the same month in 2017, 35 ANDAs in 2016, and 50 in 2015. Since October is usually a month with below average ANDA receipts because of the September end of FY rush to get ANDAs into the Agency, this unusually high number of submissions in October 2018 may be a harbinger of a big year for ANDA submissions.
While approving more ANDAs would appear to be a good thing, the Association for Accessible Medicines said in an October press release “It is important however to recognize that in the current U.S. health care system more generic approvals does not automatically translate into more competition. Not all new generic approvals make their way to market – by some estimates less than half do – which means the full benefit of generic competition to help counter increasing brand drug prices is not being realized.” Issues like this can occur when prices sink so low that it is no longer profitable for some companies to stay in the product. When multiple players drop out, the price tends to creep up. Also, when 8-10 applications are approved on a patent expiration date or NCE-1 date, not all applicants will be able to effectively enter the market; some may decide to stay on the sidelines until they see an opportunity. While this certainly translates into good news for consumers in the short run, if players start to exit the market when prices fall significantly, then the trend can be reversed.
Thus, there are a lot of factors that go into the generic-generic and generic-brand competition buckets and increasing ANDA approvals is only a part of the mix. However, generic manufacturers and the FDA can only do what they can do. Realistically, I don’t believe that any manufacturer would really object to record numbers of approvals as an outcome of GDUFA, after all that is where most of the criticism of OGD has come with industry asking OGD – where are all of the approvals with all the money we are spending on GDUFA?
Are the numbers of approvals going to become a new Catch-22? I would hope not, but you never know in this business.