Weekend and Holiday ANDA Tentative (or Final) Approvals and 180-Day Exclusivity: We Won’t Know if Anyone is Swimming Naked Until the Tide Goes Out!

By Kurt R. Karst –

So much of what we do and think about each day inevitably leads us back to one topic: Hatch-Waxman.  Take, for example, Polar Vortex 2014.  That recent event got us thinking about two things: Snowmageddon 2011, and how warm we hope it will be on the beach in Summer 2014.  Snowmageddon 2011 brough us back to thinking about a March 2011 blog post we wrote on the storm’s effects on FDA approval decisions, including ANDAs for drug products eligible for a period of 180-day exclusivity.  And thoughts about the beach in Summer 2014 brought to mind (for some reason) a quote from Warren Buffett: “You never know who’s swimming naked until the tide goes out.”  That saying applies well to ANDA 180-day exclusivity, because you don’t necessarily know whether or not a first applicant has forfeited eligibility for exclusivity – even though a statutory deadline has been missed – until FDA acts like the tide and reveals which ANDA applicant has (or does not have) exclusivity.  (Clearly, the mind works in strange and indescribable ways.)

Going back to our March 2011 post, we expressed concern about how FDA might handle 180-day exclusivity forfeiture decisions under FDC Act § 505(j)(5)(D)(i)(IV) during a government or other emergency shutdown (which happened during Snowmageddon).  That provision, added by the 2003 Medicare Modernization Act, states that 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 [FDA] 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). 

The 2012 FDA Safety and Innovation Act (“FDASIA”) made further changes with respect to the application of FDC Act § 505(j)(5)(D)(i)(IV) to certain ANDAs.  For example, for an ANDA submitted to FDA between January 9, 2010 and July 9, 2012 initially containing a Paragraph IV certification (or that is amended during that time to first contain a Paragraph IV certification), the time to obtain timely tentative approval (or final approval if tentative approval is not warranted) is 40 months during the period of July 9, 2012 and September 30, 2015, and not 30 months (see our previous post here).

FDA’s initial interpretation of the exception provision at FDC Act § 505(j)(5)(D)(i)(IV) – i.e., “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” – was very narrow.  For example, FDA explained in an October 2008 decision that “[t]his express description of the circumstances in which exclusivity will not be forfeited for failure to obtain tentative approval makes it clear that, under other circumstances in which an applicant has failed to obtain tentative approval, regardless of what party might be responsible for that failure, the first applicant will forfeit exclusivity” (emphasis added).  (Many of the instances in which FDA has applied the exception provision are detailed here.)  More recently, however, FDA has shown some willingness to allow some wiggle room.  For example, as we previously noted, FDA has considered and rejected as too draconian “but for” causation in its application of FDC Act § 505(j)(5)(D)(i)(IV).

In any case, it was our belief back in 2011 that if the 30-month date at FDC Act § 505(j)(5)(D)(i)(IV) fell on a date that was during a government or other emergency shutdown, FDA would decide that an ANDA sponsor forfeited 180-day exclusivity eligibility if action was not taken on the application the day before the shutdown.  We commented that “this is the position FDA took during Snowmageddon, such that if the 30-month date . . . fell on February 8-11, 2010, and FDA failed to act on an application by February 7, 2010, then an ANDA sponsor would have forfeited 180-day exclusivity.”  It turns out that no approval action was taken for any of the at-risk ANDAs when the government reopened on February 12, 2010, so no Snowmageddon-related forfeiture decisions had to be made. 

We took this unofficial position one step further and commented that “[t]his ‘day before approach’ is the same approach FDA takes when the 30-month deadline falls on a weekend or a Federal holiday.”  And, in fact, that’s what we believe FDA’s thinking on the topic was initially.  But FDA has never actually had to decide – through a reasoned decision-making process – whether or not an approval action on the day after a weekend or holiday results in a grant or forfeiture of 180-day exclusivity eligibility when the 30-month (or 40-month) deadline pursuant to FDC Act § 505(j)(5)(D)(i)(IV) fell on that previous weekend or holiday. 

Way back in March 2009, FDA did approve one “weekend application” – ANDA No. 078515 for Drospirenone and Ethinyl Estradiol Tablets, 3.0 mg/0.02 mg (28-Day Regimen) – and affirmed in the approval letter that applicant’s eligibility for 180-day exclusivity.  That exclusivity-bearing ANDA was received by FDA as of September 29, 2006, and was approved (without the need for tentative approval) on Monday, March 30, 2009.  That’s one day outside of the 30-month window.  We highly doubt, however, that FDA thought through the exclusivity issue when the Agency approved the ANDA and affirmed exclusivity eligibility.

How to handle 180-day exclusivity for “weekend applications” and “holiday applications” is likely to come up again, however.  In fact, we combed through ANDA records, looked over FDA’s ANDA Paragraph IV Certifications List, and identified at least two instances that may someday ripen into an official FDA decision on the issue.  The first concerns a generic version of EPZICOM (abacavir sulfate, 600 mg and lamivudine, 300 mg) Tablets.  FDA is believed to have received ANDA No. 079246 as of September 27, 2007.  Thirty months later was Saturday, March 27, 2010; however, FDA tentatively approved the ANDA on Monday, March 29, 2010.  The second instance is quite recent and concerns a generic version of DEXILANT (dexlansoprazole) delayed-release capsules, 60 mg.  FDA is believed to have received ANDA No. 202294 as of August 25, 2010.  Forty months later (because this ANDA is subject to the FDASIA provision noted above) was Wednesday, December 25, 2013 (Christmas); however, FDA tentatively approved the ANDA on Thursday, December 26, 2013. 

How will FDA ultimately resolve 180-day exclusivity for “weekend applications” and “holiday applications,” allowing the tide to go out and reveal who has (or does not have) exclusivity eligibility?  We don’t know for sure, but we note that there are myriad instances in which statutory deadlines that fall on a weekend or holiday are moved to the next day – even in the Hatch-Waxman context.  Consider, for example, FDA’s regulation at 21 C.F.R. § 314.107(f) on computation of the 45-day clock for purposes of filing a patent infringement lawsuit in response to notice of a Paragraph IV certification.  That regulation states that “[t]he 45-day clock . . . begins on the day after the date of receipt of the applicant’s notice of certification by the patent owner or its representative, and by the approved application holder.  When the 45th day falls on Saturday, Sunday, or a Federal holiday, the 45th day will be the next day that is not a Saturday, Sunday, or a Federal holiday.”