If the first half of October is any indication of the approval performance of OGD, then we are off to a good start of FY 2019. The first eleven business days of October 2018 yielded forty-three full approvals and fourteen tentative approvals (TAs), and there are still ten business days left in October. Two big days so far this month were October 12th, which saw eleven full approvals and seven TAs, and October 16th, which again saw eleven full ANDA approvals and one TA. The most significant thing about these two big approvals days is that there were no large group approvals for NCE-1 or when there were patent expiration days for a single drug product.
Remembering my days at the Agency, I know how labor-intensive it is to get approval packages through the review process. The process of review and rereview by so many different disciplines to make sure all the boxes have been checked takes a lot of coordination and is very time-consuming. By the looks of the first half-month of the new fiscal year, could OGD be chasing yet another year of record numbers of approvals? Has the review machine hit its full stride? We shall see, but early indications are certainly positive.
Data on approvals can be reviewed here on the FDA’s All Approvals list. Again, remember that additional approvals and TAs may pop up after a few days. I want to also mention a view expressed by the Association for Accessible Medicines (AAM) relative to the record number of approvals coming out of the OGD. While AAM notes that “by some estimates less than half” of all ANDA approvals never come to market for various reasons (see AAM statement here), approvals do drive the positive statistics and, especially since there are still a fairly large number of first generic approvals in the mix, it certainly can’t hurt. I do agree that the number of ANDA approvals does not always directly impact drug costs as one might think, but they certainly set the market up for multiple options, should a drug shortage develop.
