Phew! Pre-June 20, 2014, ANDA Applicants Can Rest Easy, Regarding Stability!
Written by Bob Pollock • July 24, 2014
In previous post earlier this week (here), we were hoping to discover the Agency position on this particularly important issue. But now sources within the Agency have confirmed that the date of an ANDA original submission determines the stability requirements. That is, even if the application receives a Refuse-to-Receive (RTR) letter after June 20, 2014, the application will be held only to the stability requirements at the time of the original submission. Thus, the Agency has decided to make a bright line of June 20, 2014 as the start date for the requirement for 3 batches with 6 months room temperature and 6 months of accelerated stability at time of original submission.
This is good news for any of the approximately 700-800 ANDAs still in the completeness and acceptability review process that were originally submitted to the Office of Generic Drugs (OGD) prior to June 20, 2014. We understand that there was quite a bit of discussion on this issue, but the reasons for making a bright line determination appeared to be the most reasonable and easiest to enforce. The one thing OGD does not need is a complicated, contentious decision-making process that could lead to either protracted debates with applicants or even court challenges. In the end, OGD has decided that this straightforward approach was in the best interest of both OGD and industry.
So with this information, one more chapter on OGD policy is now closed. A happy day for all!
Garth Boehm • July 25, 2014
As a side issue, while I understand the OGD decision, this will be a "reward" for companies that filed failing studies in order to get the ANDA in by June 19. The problem for OGD is that their RTR decisions are somewhat arbitrary and they might very well lose a Federal Court Challenge, so better to just give in and keep their flexibility rather than risk a court-ordered, rigid system for RTR.
