Snowmageddon, a Government Shutdown, and Other Acts of Nature (Mother or Human) – What are the Effects on FDA Approval Decision Deadlines?

By Kurt R. Karst –      

Midnight, March 4, 2011 – that’s the time and date on which the federal government will close for business if Congress fails to approve a spending bill, or a short-term/stopgap funding measure that would likely just delay a shutdown for a couple of weeks.  If Congress fails to pass a spending bill, agencies like FDA are legally obligated to perform only essential activities necessary to protect life and property during a shutdown.  Although the FDA-regulated industry might be of the opinion that FDA activities related to their pending applications are necessary to protect life and property, that is not the case.  So with a government shutdown looming, it begs the question, what happens to FDA approval decision deadlines that come due during a shutdown or other emergencies, like the extreme weather conditions the Washington, D.C. metro area experienced in February 2010 (a.k.a. Snowmageddon, Snowpocalypse, or Snowzilla)?

Shortly after Snowmageddon, FDA issued a notice addressing the procedures the Agency put in place to manage Prescription Drug User Fee Act (“PDUFA”) and Medical Device User Fee Act (“MDUFA”) goals that came due during, or that were coming due soon after, the closure of the Agency’s offices.  In that case, FDA said the Agency would extend PDUFA and MDUFA goals and that “all submissions that were sent to FDA and would have normally been received during the closure may not be marked as ‘received’, for purposes of calculating any review or regulatory clocks, until the FDA center to which the submission was sent resumes its document receiving services.”  In the face of a government shutdown in the coming weeks, we think FDA could very well follow similar procedures. 

But what about statutory deadlines that, unlike mere goals under PDUFA and MDUFA, cannot be extended?  In particular, we are concerned 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.  That provision states that 180-day exclusivity eligibility is forfeited if “[t]he first applicant fails to obtain tentative approval of the application within 30 months 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).  The “because of” language at FDC Act § 505(q)(1)(G) is important.  FDA recently made a forfeiture decision under FDC Act § 505(j)(5)(D)(i)(IV) notwithstanding the existence of a citizen petition, because “issues unrelated to those raised in the petition were the cause of the delay.”

Although FDC Act § 505(j)(5)(D)(i)(IV) includes an exception where the failure to obtain timely approval will not result in a forfeiture of 180-day exclusivity eligibility if “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,” FDA believes this is the only circumstance supported by the statute - and very narrowly applies the exception at that!  As FDA explained in an October 2008 Letter Decision, “[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).  In other words, if FDA fails to take an approval action by the 30-month date described at FDC Act § 505(j)(5)(D)(i)(IV) because, for example, there was nobody at FDA to issue a tentative approval letter during a shutdown, the failure of Congress to act or Mother Nature’s actions are effectively the ANDA sponsor’s fault.

We understand that this is the position FDA took during Snowmageddon, such that if the 30-month date at FDC Act § 505(j)(5)(D)(i)(IV) 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.  (This “day before approach” is the same approach FDA takes when the 30-month deadline falls on a weekend or a Federal holiday.)  We think FDA could very well take a similar position during a government shutdown, which could last much longer than a couple of days.  To avoid what could become a very messy situation, an ANDA sponsor in a first applicant position with a 30-month tentative approval date that is due in the coming weeks might want to contact FDA now to apprise the Agency of their particular situation.