Warning Letter? What Warning Letter? . . . Latest Developments in Pacira and a Look at FDA’s History of Withdrawing Warning Letters

October 30, 2015

By David C. Gibbons & Anne K. Walsh


In a previous post we described the recent challenge by Pacira Pharmaceuticals, Inc. (“Pacira”) to FDA’s authority to restrict a manufacturer’s promotional activities.  See Pacira Pharms., Inc. v. FDA, No. 15-7055 (S.D.N.Y. Sept. 8, 2015).  Pacira’s allegations are based on FDA’s threatened enforcement as communicated in a September 22, 2014 Warning Letter issued to Pacira.  In the latest twist of events, FDA “unpublished,” or withdrew, the underlying Warning Letter.  As of the date of this post, there has been neither official word from FDA nor any indication from Pacira as to FDA’s reasoning behind the withdrawal of the Warning Letter.  But we note that this action is extremely rare and that its occurrence is most likely related to FDA’s litigation position.

A (Very) Brief History of Warning Letter Withdrawals

We were able to confirm only three instances where FDA truly withdrew a previously-issued Warning Letter.  The first instance involved a Warning Letter directed at Van Den Bergh Food Company.  Apparently FDA prepared a Warning Letter but never issued it because the company had corrected the labeling issues FDA cited.  FDA’s Chicago District Office, however, inadvertently sent the Warning Letter to FDA Freedom of Information staff for public “display” (FDA did not begin posting Warning Letters on the internet until 1997).  As a result, FDA had to officially withdraw the Warning Letter in 1995.  Barbara J. Shulman, Consumer Safety Officer, FDA, Letter to FOI Requestors (Apr. 26, 1995).  A year later, FDA withdrew a Warning Letter issued to Laerdal Manufacturing Corporation that cited the manufacturer for GMP violations; these violations had been subject to earlier litigation by the parties, which FDA had lost.  James G. Dickinson, FDA Withdraws Laerdal Warning Letter, Medical Device and Diagnostic Industry Magazine, 1 (Jan. 1, 1996).  Finally, FDA withdrew a Warning Letter issued to device manufacturer, Ophtec, because, according to Ophtec, the alleged violations cited by FDA therein were “factually inaccurate.”  FDA Retracts Warning Letter to Devicemaker, FDAnews Device Daily Bulletin (Jul. 24, 2007). 

There have been other instances where Warning Letters were temporarily withdrawn or withdrawn and subsequently reissued.  For example, a Warning Letter issued to Proctor & Gamble on October 14, 2009 concerning its marketing of Vicks cold and flu over-the-counter medications was withdrawn but reissued approximately two weeks later.  FDA, Press Release, FDA: Proctor & Gamble Unlawfully Marketing Two Vicks Cold and Flu Medicines Containing Vitamin C, (Oct. 30, 2009).  FDA’s press release concerning this incident noted that the October 14 Warning Letter was mistakenly posted on FDA’s website due to a “computer error.”  Id.; see also our previous blog post here

Settlement of the Pacira Case May be on the Horizon

Although FDA’s response to Pacira’s Motion for Preliminary Injunction was due on October 26, the court issued a revised Scheduling Order on October 22.  The Order indicated that the parties are in settlement negotiations:  the parties “wish to continue their efforts to reach a consensual resolution” and defer the litigation proceedings by not making mandatory court filings.  To that end, the court agreed to extend to mid-November the due date for FDA’s Opposition to Plaintiff’s Motion for Preliminary Injunction and its Answer to the Complaint.

In light of these settlement negotiations, there are at least two plausible theories as to why FDA withdrew the Pacira’s Warning Letter.  First, should FDA and Pacira settle the matter, withdrawal of the Warning Letter would almost certainly be a condition of settlement.  FDA taking this step now may demonstrate its good faith efforts to negotiate settlement in the matter.  Second, should the case proceed, FDA may challenge the justiciability of Pacira’s equitable relief claims, given that the withdrawal of the Warning Letter suggests the Company faces no immediate threat of harm – an approach FDA attempted in the Amarin case when it tried to moot the litigation via a letter indicating FDA would not object to most of Amarin’s promotional claims at issue (for further information, see our post on Amarin here.)  It is difficult to understand how withdrawal of this Warning Letter would similarly moot this matter, however, given Pacira has already stopped its conduct to the satisfaction of FDA such that it closed out the Warning Letter.

Stay tuned for our next update, which will either report on a settlement, FDA’s response to Pacira, or another extension of the deadline to continue settlement discussions.