FDA Cements “It’s Our Party and We’ll Punt if We Want to” Stance on 180-Day Exclusivity Failure to Obtain Tentative Approval Forfeiture Decisions

By Kurt R. Karst –      

Ever since FDA came up with the idea of a so-called “180-day exclusivity punt,” the Agency has taken a shine to using it with impunity, as a quick perusal of our 180-Day Exclusivity Tracker shows.  FDA’s recent approval of ANDAs for generic versions of Pfizer, Inc.’s GEODON (ziprasidone HCl) Capsules approved under NDA No. 020825 is one good case on point. 

Under FDC Act § 505(j)(5)(D)(i)(IV), one of the six 180-day exclusivity provisions added to the FDC Act by Title XI of the Medicare Modernization Act, 180-day exclusivity eligibility is forfeited if:

The first applicant fails to obtain tentative approval of the application within 30 months after the date on which the application is filed, unless the failure is caused by a change in or a review of the requirements for approval of the application imposed after the date on which the application is filed.

The 2007 FDA Amendments Act clarified FDC Act § 505(j)(5)(D)(i)(IV), such that if “approval of the [ANDA] was delayed because of a [citizen] petition, the 30-month period under such subsection is deemed to be extended by a period of time equal to the period beginning on the date on which the Secretary received the petition and ending on the date of final agency action on the petition (inclusive of such beginning and ending dates) . . . .” (FDC Act § 505(q)(1)(G)).  FDA has applied and discussed this provision on many occasions, including in recent Citizen Petition responses – see, e.g., Docket No.  FDA-2011-P-0486 and Docket No. FDA-2010-P-0632.

FDA’s “punt” when a first applicant is eligible for 180-day exclusivity but does not obtain a timely tentative approval goes something like this:

[Generic Applicant] was one of the first applicants to submit a substantially complete ANDA with paragraph IV certifications to the [‘XXX] patents.  As a first applicant, therefore, [Generic Applicant] may be eligible for 180 days of generic drug exclusivity for [Drug].  This exclusivity, which is provided for under section 505(j)(5)(B)(iv) of the Act, would begin to run from the date of the commercial marketing by any first applicant. The agency notes that [Generic Applicant] failed to obtain tentative approval of this ANDA within 30 months after the date on which the ANDA was filed.  See section 505(j)(5)(D)(i)(IV) (forfeiture of exclusivity for failure to obtain tentative approval).  The agency is not, however, making a formal determination at this time of [Generic Applicant’s] eligibility for 180-day generic drug exclusivity.

FDA’s punt language has gone through some refinements and changes throughout the years since the Agency first introduced the concept when approving ANDA No. 076969 for Metoprolol Succinate Extended-Release Tablets on July 31, 2006 (see our previous post here).  FDA has also applied the punt concept to the failure-to-market forfeiture provisions at FDC Act § 505(j)(5)(D)(i)(I) in at least one case (see our previous post here).  FDA has never, to our knowledge, issued a written decision that that there was a “punt return” – i.e., a formal decision after a punt decision that although a first applicant failed to obtain timely tentative approval, FDA has determined that there was “a change in or a review of the requirements for approval of the application imposed after the date on which the application is filed” and that 180-day exclusivity is saved.

In the case of generic GEODON, FDA punted on 180-day exclusivity for several ANDAs – seemingly unnecessarily.  According to FDA’s Paragraph IV Certification List, the first ANDAs for Ziprasidone HCl Capsules, 20 mg (base), 40 mg (base), 60 mg (base), and 80 mg (base), were submitted to FDA on February 7, 2005.  Only one ANDA was tentatively approved within 30 months of ANDA submission (i.e., on or about August 7, 2007): ANDA No. 077560 (approved on March 2, 2012) was tentatively approved on May 16, 2007).  Three other ANDAs (two of which have also received final approval) were not tentatively approved within 30 months of ANDA submission: ANDA No. 077561 (approved on March 2, 2012), ANDA No. 077565 (tentatively approved on December 29, 2008 and approved on March 2, 2012), and ANDA No. 077562 (tentatively approved on September 17, 2008).  

Thus, for generic GEODON, FDA was faced with a situation similar to that the Agency faced with generic STARLIX (nateglinide) Tablets in 2009.  There, FDA addressed for the first time the following question: “What is the effect of a forfeiture of 180-day exclusivity eligibility due to the failure of a first applicant to obtain tentative ANDA approval pursuant to FDC Act § 505(j)(5)(D)(i)(IV) when at least one other first applicant remains eligible for 180-day exclusivity?”  FDA ruled in a Letter Decision that a forfeited first applicant that “lawfully maintains” a Paragraph IV Certification to an Orange Book-listed patent is nevertheless a first applicant whose ANDA can be approved, who can trigger 180-day exclusivity for an eligible first applicant, and who can therefore enjoy the benefits of such exclusivity (see our previous post here).  FDA’s approval decision for a forfeited first applicant of generic STARLIX clearly states that 180-day exclusivity was forfeited because of a failure to obtain timely tentative approval. 

Fast forward 2.5 years later to generic GEODON and FDA, instead of ruling that a first applicant forfeited 180-day exclusivity eligibility because of a failure to obtain timely tentative approval, takes a more conservative approach and says that the Agency is punting on exclusivity for those ANDAs not tentatively approved within 30 months of application submission.  Perhaps there are particular facts surrounding generic GEODON that swayed FDA one way over the other.  Or perhaps (and we think more likely) FDA, as a general policy, has chosen to make as few final decisions on 180-day exclusivity as possible to avoid or otherwise stave off possible litigation.  Indeed, such avoidance pops up elsewhere.  Just last week, FDA issued a non-response denial to two citizen petitions concerning labeling carve-out issues for generic versions of SEROQUEL (quetiapine fumarate) and SEROQUEL XR (quetiapine fumarate).  The petitions, which FDA determined to be subject to the 180-day response timeframe under FDC Act § 505(q), were submitted a little more than six months before generic SEROQUEL might be approved.  Had FDA outright denied the petitions with a substantive response, that could open the door to a lawsuit and potentially delay or prevent the generic genie from coming out of its bottle.  Delaying a final, substantive response until ANDAs might be approved makes it more difficult to put the genie back in its bottle.