Big Decisions Loom in 2014 for Generic Applicants

Betwixt and between, there are a number of dilemmas looming over generic drug firms in 2014 – some with no easy answers, but hopefully firms are considering their choices sooner rather than later.  Two of these issues relate to the all-important question “Exactly when should the ANDA be submitted?”.  Any generic drug firm knows that that answer is never easy and is dependent on many factors, such as biostudy success, completion of stability testing, facilities being ready for inspection and first-to-file opportunities, just to name a few.  And of course, such practical scientific or regulatory deadlines are further complicated by the directed business goal of “the sooner the better”.

Two major milestones in 2014 will significantly affect ANDA submission and review times in this year and brings yet another wrinkle to the generic drug project planning mix.  Effective June 20, 2014, the new OGD Stability Guidance applies. The big change outlined in the guidance which impacts ANDA submission is the requirement for inclusion of 6 months accelerated and room temperature stability data on 3 drug product exhibit batches at the time of filing of the application. While the basis for the new requirement is understandable from FDA’s perspective (aligns more with ICH, the more data the better), still, reality sets in – 3 additional months of stability data?  And 2 more batches?  You can be guaranteed the bean counters are telling R&D and Regulatory to get that product in before more money has to be spent.  …so the push to get the submission in before June 20th is on.  Be certain to remember that, for those trying to beat the clock with the current 1 batch and 3-month stability requirement, your application must be otherwise complete for filing purposes, because, if your ANDA is refused for filing, and if you resubmit your ANDA on or after June 20, you must meet the new stability requirements in the resubmission.

But wait, there is also that other 2014 milestone to think about.  October 1, 2014 brings the start of GDUFA year 3; the year when the review metrics outlined in the GDUFA Goals letter finally kicks in.  The FY 2015 GDUFA goal for original ANDAs is that 60% of those ANDAs submitted must be acted upon (reviewed, but not necessarily approved) in 15 months (progressing to 90% in 10 months by GDUFA year 5 (FY 2017)). Submitting an application and knowing when it will be picked up for review or when your action date will be at least 60% of the time? Sweet!

So what is a firm to do?  Push to submit a one stability batch ANDA before June 2014 and have it languish (possibly for years) in the forlorn queue of applications with no review goal dates?  Or bite the bullet, spend the money for additional testing and 2 more exhibit batches and submit the ANDA after on or after October 1 with the knowledge it will be subject to GDUFA goal review metrics at least 60% of the time in FY2014?  Will more money be lost waiting for an approval than spent complying with new requirements?  Who’s to know and who makes the final call?  Time to start crunching those numbers, and quickly.