FDA Issues “One-Stop Shop” Draft Guidance Document on Post-MMA 180-Day Exclusivity

January 13, 2017By Sara W. Koblitz & Kurt R. Karst

Last January, when FDA issued the Agency’s Calendar Year 2016 Guidance Agenda, we were pretty stoked to seek guidance was planned on various ANDA and Hatch-Waxman issues, including “Three-Year Exclusivity Determinations for Drug Products;” “Submission of ANDAs for Certain Highly Purified Synthetic Peptide Drug Products;” and “Determining Whether to Submit an Application Under 505(b)(2) or 505(j).” But we were especially excited about a guidance tentatively titled “180 Day Exclusivity: Guidance for Industry.”  After all, it’s not very often that we see FDA issue guidance on that topic.  In fact, we’re not aware of any guidance document issued by FDA on the topic since the December 2003 enactment of the Medicare Modernization Act (“MMA”).  Instead, FDA has issued numerous citizen petition decisions, 180-day exclusivity forfeiture letter decisions, and precedent-setting approval decisions.  And then there are all of the court decisions over the past decade.  (While we’re on the topic of FDA guidance documents, earlier this week, FDA issued the Calendar Year 2017 Guidance Agenda for the Center for Drug Evaluation and Research.)

So we waited, and then we waited some more . . . but nothing was released by FDA. Of course, we had lots to keep us busy in the interim.  In particular, there was FDA’s October 6, 2016 publication of a Final Rule implementing portions of the MMA (see our previous post here, as well as a recent webinar we presented on the rule – here and here).  The final rule largely deals with the non-180-day exclusivity provisions of the MMA, though it does include some discussion about 180-day exclusivity (e.g., commercial marketing to trigger exclusivity).

Finally, and with little fanfare, FDA released earlier this week a draft guidance titled “180-Day Exclusivity: Questions and Answers.” The draft guidance, which is also identified on FDA’s Calendar Year 2017 Guidance Agenda, is one of many guidance documents FDA has issued in a recent pre-Trump Administration blitz of guidance documents.  While the draft guidance on 180-day exclusivity itself does not reveal anything revolutionary, the guidance provides a one-stop shop reference on post-MMA 180-day exclusivity insofar as it consolidates court cases and documents released in litigation, letter decisions, citizen petition responses, and other correspondences to provide answers to commonly asked questions about 180-day exclusivity.  It’s a must-read guidance document for anyone involved in Hatch-Waxman issues, and a guidance that we appreciate FDA publishing.

Although the guidance document mentions pre-MMA 180-day exclusivity, FDA doesn’t rehash history. That being said, folks should keep in mind that, like a bad penny, pre-MMA 180-day exclusivity can – and does – continue to show up, and could theoretically do so in perpetuity (see our previous post here).  We were recently reminded of that fact when FDA approved ANDA 206726 for Methylphenidate Hydrochloride Extended-Release Tablets, 18 mg, 27 mg, 36 mg, and 54 mg.

FDA’s guidance document on 180-day exclusivity addresses a wide range of questions and concerns that arise when 180-day exclusivity is contemplated. As with all FDA guidance documents, FDA details the applicable statutory scheme and the legal authority for 180-day exclusivity.  FDA also details the approval pathway for ANDAs, including patent certifications, patent infringement actions, tentative approval, and conditions under which 180-day exclusivity may be forfeited.  The guidance then transitions to a Question and Answer format and divides the document into several topics of note to ANDA applicants:

  • First applicant status;
  • The relationship of 180-day exclusivity to patents;
  • The trigger for and the scope of 180-day exclusivity;
  • Relinquishment and waiver of 180-day exclusivity;
  • Forfeiture of 180-day exclusivity; and
  • Procedural questions.

The guidance addresses both basic questions and more nuanced questions. Notably, in spite of judicial objection (see our paper on FDA’s Broken System), FDA adheres to the Agency’s position outlined in Hi-Tech Pharmacal Co., Inc., v. United States Food and Drug Administration and AstraZeneca Pharmaceuticals LP v. Burwell, that FDA will make decisions about eligibility for 180-day exclusivity when an ANDA is ready for approval.

As always, FDA intends that the guidance will “enhance transparency” and facilitate the development, approval, and marketing of generic drugs. FDA will update the guidance with additional questions and answers as appropriate. After all, there are still a lot of unanswered questions pending – see, e.g., here – and there will certainly be more to come.

Given FDA’s decision to issue draft guidance on 180-day exclusivity, we’re unlikely to see a proposed rule any time soon to implement the 180-day exclusivity forfeiture provisions of the MMA. But if the new draft guidance doesn’t whet your appetite for 180-day exclusivity, and you still need to “geek out” on the topic, then you can give Erika Lietzan’s recent paper on “The Law of 180-Day Exclusivity” a read. Or, for fun, match up the FDA interpretation discussed in the draft guidance with the appropriate letter decision or citizen petition decision.