It is clear that the Office of Generic Drugs (OGD) wants to assure that first-time generic submissions also translate into first-time generic approvals. In FY 2013, OGD approved a total of 440 ANDAs. Of that total, there were 108 ANDAs reported on the OGD First-Time Generic Drug Approval lists for the year. So it appears that OGD’s goal of getting first time approvals to the American public as quickly as possible at least translates into the percentage of first-time generic approvals (e.g., 1 in 4 ANDA approvals in FY 2013 was for a first-time generic approval of the product or 25%).
With the higher cost of brand name products, there is clearly a Hatch-Waxman mandate to get generic versions of product approved at the earliest possible date. There is also a new focus related to cost consciousness lately being raised by the public, Congress and third-party payors. Many articles and blog posts bear this out (albeit for only a certain segment of the generic market). We have addressed this issue in one previous blog post (here) but it deserves another mention here. Yes, it is true that the OGD MaPPs and the GDUFA goals letter address prioritizing and/or concentrating on bringing first-time generics to the market, but should the Agency also look to expediting approvals for ANDA products where the price of currently marketed products is skyrocketing? After all, it is the patient and the government that must bear the burden for most drug costs (either directly or indirectly). And if patient cannot afford the generic drugs they are prescribed it certainly may be the same as not having them available.
So far, in October and November of FY 2014, OGD has approved 14 first-time ANDA submissions and approved a total of 57 ANDAs during that same period. So, we start out FY 2014 with the same 25% approval rate of first-time generics. We will have to see how Congress addresses the cost hikes seen for a number (albeit limited) of generic products. One legislative proposal was to charge the brand name Centers for Medicare and Medicaid (CMS) rebate for a generic product that raises its price by more than 100%. I am skeptical that this would ultimately be passed by the Congress, but my guess is that we will see something happen once the new Congress is seated. We will keep our eyes peeled and let you know where this is all going.
I believe that a 25% first generic monthly approval rate is really pretty good and the situation will even be better if the number of monthly approvals increase in the near future and that percentage stays the same.
