Generics

Well, just a few days ago I posted a blog on OGD activity for the first two months of FY 2014. Today, the December numbers came out and holy cow! While December is notoriously a month of heavy submissions due primarily to the end of year rush, this December beat all records at an astonishing 225 ANDAs.

Happy New Year to all and welcome back to the Lachman blog! The first reporting of the year addresses what is on every generic company’s mind – how is OGD doing since GDUFA’s implementation?

Having previously written about the need for Generic companies to step up the quality of their submissions to avoid refuse-to-receive (RTR) letters as well as avoiding time review penalties for major amendments or multiple minor or unsolicited amendments, I must take a moment to perform a reality check on what happens when the Generic Drug User Fee Act’s (GDUFA) metric kick in on applications submitted after October 1, 2014. As we know, there are no metrics for ANDAs submitted in years one and two of GDUFA; however, years three through five must be looked at with intense scrutiny in light of the good, the bad and the (potentially) ugly aspects of the metrics themselves.

Ever since the implementation of the Generic Drug User Fee Act (GDUFA), Guidance documents are flying out of FDA and landing faster than the planes at Atlanta’s busy Hartsfield airport. One such Draft Guidance was posted yesterday on the FDA web site (here) entitled Size, Shape, and Other Physical Attributes of Generic Tablets and Capsules. While the specific issue addressed in this Guidance is clear, the general issue of something I like to call “functionality” is now being formally addressed through Guidance documents, as opposed to deficiency letters.

Appearing on the FDA’s Paragraph IV database listing on December 3, 2013 is an ANDA filing for Ethinyl Estradiol and Etonogestrel drug-emitting polymeric ring that is used as a contraceptive to prevent pregnancy. What caught my eye and what it interesting about this product is that it is the first of a kind ANDA for an intravaginal contraceptive product of this nature. In addition, its posting date (December 3, 2013) and the ANDA submission date listed as June 17, 2013 (see chart below) suggests that either OGD has a very extensive backlog of ANDAs to process, or that this application presented some unique issues of either bioequivalence or chemistry manufacturing and controls that had to be resolved prior to a decision to receive (file) the application. My guess is that it might be the latter, since OGD has said it was expediting initial completeness and acceptability reviews of ANDAs with Paragraph IV certifications (indicating a challenge to the patent listed for the reference listed drug).