Depending on the context, a year can either seem like an eternity or a rather short period of time; the details and context will always matter.  In the draft Guidance for Industry issued on July 22nd  (here ), the Office of Generic Drugs (OGD) laid out its expectations for complying with the regulatory requirement for the timely response by an applicant to a Complete Response Letter(CRL). As stated in the Guidance, extensive delays in responding to a CRL represent several challenges for the Agency, with those challenges potentially compounding over time for both the Agency and for the ANDA sponsor.

Enforcement of the regulation at 21 CFR 314.110(c) by FDA is an event that ANDA applicants will need to monitor closely in the future. As I’m sure many of you are aware, OGD’s past practice has been to (more or less) summarily grant extension requests. From now on, these will now be a historical artifact and ANDA holders will need to provide rationale to support the request for extension. Providing a reasoned explanation for any delay in response isn’t necessarily a negative, as this provides the ANDA sponsor with an opportunity to inform OGD of any challenges they are experiencing in providing the complete response. This can be useful to get into the ANDA record and may even assist the Agency when making certain decisions.

In all honesty, this is something that OGD has really needed to do for some time but is potentially fraught with challenges. Only a short time ago, when I was with OGD, it wasn’t uncommon to see applications with two or three extensions, and I believe I recall seeing one application with six extensions – certainly an anomaly but seven years for a response…C’MON, MAN.  From OGD’s perspective, these ANDA outliers skew certain statistics through no fault of the Agency and really add to the review burden of FDA. From a personal perspective, I will be interested to see how uniformly OGD intends to apply this regulation now that this Guidance has been issued.

Perhaps the most controversial application of this regulation will be to an applicant that is potentially eligible for 180-day exclusivity. Application of this regulation could result in outright forfeiture when a single applicant holds the exclusivity seat. Forfeiture of exclusivity via withdrawal of an application encompasses both a voluntary withdrawal by the applicant and when the Secretary considers the application to have been withdrawn – (see the FD&C Act at 505(j)(5)(D)(II)- here). The oddity here being the regulation at 314.110(c) considers this to be a “request by the applicant to withdraw the application.” Firms that potentially hold 180-day exclusivity seats should pay special attention to the second bullet in section III.C, in particular the example given language below.

Evidence of progress being made toward the completion of work needed to respond to the deficiencies in the CRL (e.g., information demonstrating that the ANDA applicant is working to address the deficiencies).

There are many potential complexities in administering this regulation, and there is plenty of hedging language in the guidance to afford OGD discretion in making their decisions. The underlying tone suggests that OGD will give firms the benefit of the doubt, as long as a reasonable explanation has been offered. Hopefully, OGD can track metrics and update Industry at regular intervals on the frequency and general circumstances where OGD administered such withdrawal actions.

If you have any questions about the impact of the new Guidance on your firm’s applications, please reach out to me at