By Kurt R. Karst –
In a move that brings to mind Scene 2 of Monty Python and the Holy Grail, in which a mortician roams the streets ringing a bell and calling out “Bring out your dead!” (a close second being the Monty Python “Dead Parrot” sketch), FDA is announcing, in a notice to be published in the Federal Register on June 14th, that 364 inactive ANDAs will be deemed voluntarily withdrawn unless the Agency is informed otherwise. The announcement likely kicks off a broader FDA initiative to get a handle on pending ANDAs as the Agency prepares for implementation of the Generic Drug User Fee Amendments of 2012 (“GDUFA”) (here and here). GDUFA is pending in Congress as part of broader FDA legislation.
Under GDUFA, there is, among other fees, a one-time (Fiscal Year 2013) ANDA backlog user fee that will be calculated by dividing $50 million by the number of ANDAs in the backlog as of October 1, 2012. Under the proposed GDUFA text, “[e]ach person that owns an [ANDA] that is pending on October 1, 2012, and that has not received a tentative approval prior to that date, shall be subject to a fee for each such application.” Provided GDUFA becomes law this year, FDA must publish a notice in the Federal Register by October 31, 2012 announcing the amount of the ANDA backlog fee. That fee must be paid no later than 30 calendar days from FDA’s publication of the Federal Register notice.
As a result of how a backlog ANDA is defined in GDUFA, the true ANDA backlog consists of more than just those applications pending in the Office of Generic Drugs (“OGD”) on October 1, 2012 that have not been acted on (i.e., awaiting an approval, tentative approval, or not approvable/complete response action). (Today, that number stands at almost 2,900 applications – see the table below). Instead, the true ANDA backlog consists of all ANDAs not yet acted on, as well as all ANDAs submitted to OGD over the past few decades that are the subject of a not approvable or complete response letter and that have not been withdrawn.
FDA’s June 14th notice addresses a portion of those ANDAs that will be part of the backlog for GDUFA user fee purposes. Specifically, the notice addresses so-called “Inactive ANDAs,” which are applications “that have been determined to be incomplete and as to which the ANDA applicant has not communicated with FDA since July 8, 1991.” Why July 8, 1991? We understand that the 364 ANDAs listed by FDA are identified in DARRTS (FDA’s Document Archiving, Reporting, and Regulatory Tracking System) as “incomplete” and that the last date on which FDA received correspondence on any of those 364 ANDAs was July 8, 1991. The date also seems to correspond to a timeframe in which FDA issued a couple of industry letters – in June 1990 and November 1991 – concerning the completeness of applications.
The Inactive ANDAs predate and are, therefore, not subject to FDA’s regulation at 21 C.F.R. § 314.110(c). That regulation, which became effective on June 29, 1992, was last amended in July 2008 (73 Fed. Reg. 39,588), and states:
(c) Failure to take action. (1) An applicant agrees to extend the review period under section 505(c)(1) or (j)(5)(A) of the act until it takes any of the actions listed in paragraph (b) of this section [(i.e., resubmission, withdrawal, or request opportunity for hearing)]. For an application or abbreviated application, FDA may consider an applicant’s failure to take any of such actions within 1 year after issuance of a complete response letter to be a request by the applicant to withdraw the application, unless the applicant has requested an extension of time in which to resubmit the application. FDA will grant any reasonable request for such an extension. FDA may consider an applicant’s failure to resubmit the application within the extended time period or to request an additional extension to be a request by the applicant to withdraw the application.
(2) If FDA considers an applicant’s failure to take action in accordance with paragraph (c)(1) of this section to be a request to withdraw the application, the agency will notify the applicant in writing. The applicant will have 30 days from the date of the notification to explain why the application should not be withdrawn and to request an extension of time in which to resubmit the application. FDA will grant any reasonable request for an extension. If the applicant does not respond to the notification within 30 days, the application will be deemed to be withdrawn.
For the 364 Inactive ANDAs identified by FDA in the June 2012 notice, the Agency will deem them to have been voluntarily withdrawn unless the the sponsor (which includes any successor in interest, because many of the companies identified no longer exist) timely notifies FDA in writing of its intent to actively pursue approval. To protect confidentiality, FDA delinks the sponsor names and ANDA information.
FDA’s notice on Inactive ANDAs appears to be Phase 1 in the Agency’s efforts to do some house cleaning in anticipation of the enactment and implementation of GDUFA and to develop a master list of backlog ANDAs. We suspect that Phase 2 will concern pending ANDAs that are the subject of a not approvable/complete response action and that have not been withdrawn. That cohort of ANDAs is likely to be much larger larger than the 364 Inactive ANDAs. Phase 3 will likely concern what is typically considered the ANDA backlog (i.e., those ANDAs pending and not yet acted on by FDA) and may not be implemented until GDUFA is enacted.