We Noticed Something, the Potential Elemental Impact of Documentation!

Here it is, 11 days into January 2018, and so far this month (at least at the last check this morning) OGD had approved only two ANDAs.  Could it be that they pushed so many out in the first quarter of FY 2018 that there were none left to cross the finish line in early January, or was there something else at play here?  We got a hint when a couple of firms noted to us that they thought they were ready to receive an approval, but after January 1st instead got a Complete Response Letter stating that they did not have the actual documentation that they met the new conditions of the draft Guidance document “Control of Elemental Impurities in Drug Products”.  This document provides guidance in light of the issuance of three publications: ICH Q3D Elemental Impurities, USP<232> Elemental Impurities – Limits and USP<233> Elemental Impurities – Procedures.

With this hint, we looked back at the USP and draft guidance and at the implementation date of the new USP requirements and guess what – it is January 1, 2018.  We previously reported here on this issue and warned firms that:

“The scope of the Guidance provides a footprint for additional work that all marketed drug products must meet.  Firms that have not undertaken a process to assure that their products meet the requirements should begin to seriously assess that they have the resources necessary to meet the compliance dates and have a plan in place to be certain that they do not get caught short.  Remember, 2018 is right around the corner!”

Whether or not this is the reason for the low number of early January approvals is not known, but the link to the January 1, 2018 implementation date make us suspicious.   Apparently, just saying you comply is not the same as providing the data that demonstrated that your manufactured product complies, as was eluded to in our post referenced above.  If this looks like it may be correct, we would appreciate feedback from our readers who might have experienced this issue with FDA.  You can provide that directly to me at r.pollock@lachmanconsultants.com.

While I may be way off base, the dots certainly seem to connect.