Angry old couple in quarrel

Are elemental Impurity issues causing the Dip in ANDA Approvals Again?

This morning after reading an article in the Pink Sheet entitled US FDA Urged To Stop Slowing Approvals By Seeking Metals Data From Suppliers written by Joanne S. Eglovitch, my mind harkened back to the early 2018 slowdown (and almost stop) in ANDA approvals based on the elemental impurities issue (see earlier post (here).

The article discussed the fact that FDA was asking inactive ingredient makers and suppliers to provide additional information on elemental impurities.  They cite one industry individual as saying that basically the FDA is overreaching as “[T]he International Council on Harmonisation’s Q3D guideline on elemental impurities only specifies that the drug product manufacturer submit this information” on elemental impurities and claims that this is holding up generic drug approvals.  To read the article, I refer you to the Pink Sheet news of August 26, 2019.

Hmm!  The last three months have seen a slowdown in ANDA approvals (compared to the record-breaking pace of previous months this FY, and although the slowdown is nothing like we saw in the first few months of 2018 when the USP requirements kicked in, it got me to thinking – could this be part of the sudden slowdown in approvals?  Could this be one of those times when the Agency appears to be making a new requirement based on its interpretation of ICH Q3D or is the industry overreacting to additional requests from the Agency?  Obviously, there is some major disagreement between FDA and industry and the issue needs to be settled one way or another.