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Nancy L. Buc, Madhusha Dissanayake, and Buc & Beardsley, Llp v. Food and Drug Administration

February 1, 2011

NANCY L. BUC, MADHUSHA DISSANAYAKE, AND BUC & BEARDSLEY, LLP, PLAINTIFFS,
v.
FOOD AND DRUG ADMINISTRATION, DEFENDANT.



The opinion of the court was delivered by: Colleen Kollar-kotelly United States District Judge

MEMORANDUM OPINION

This action arises out of a series of requests made by the law firm Buc & Beardsley, LLP ("Buc & Beardsley") and two of its attorneys, Nancy L. Buc and Madhusha Dissanayake (collectively, "Plaintiffs"), pursuant to the Freedom of Information Act ("FOIA"), 5 U.S.C. § 552 et seq., seeking the disclosure of documents and records relating to Zicam cold remedy nasal products from the Food and Drug Administration (the "FDA"), an operating division of the United States Department of Health and Human Services. After the FDA failed to fully respond to several separate FOIA requests within the statutorily prescribed time period, Plaintiffs commenced this action seeking declaratory and injunctive relief, including an order requiring the FDA to promptly produce the records and documents requested. Presently before the Court is the FDA's [7] Motion for a Stay pursuant to Open America v. Watergate Special Prosecution Force, 547 F.2d 605 (D.C. Cir. 1976). Specifically, the FDA seeks a stay of the proceedings in this action until early September 2011-seventeen months and two weeks from the filing of its moving papers*fn1 -in order to complete its review and release the records responsive to Plaintiffs' various requests. For the reasons set forth below, the Court concludes that the FDA has failed to carry its burden of establishing the "exceptional circumstances" required to justify the stay it seeks and shall therefore DENY the FDA's [7] Motion for a Stay. While mindful of the substantial backlog of pending FOIA requests that the FDA presently faces, in light of the FDA's failure to establish its right to the relief sought and the fact that the FDA has already taken for itself a period of time far in excess of the statutory default to discharge of its obligations, the Court shall require the FDA to (a) begin processing Plaintiffs' outstanding requests immediately, (b) promptly produce any responsive documents on a rolling basis, and (c) complete its production on or before March 1, 2011.

I. BACKGROUND

Plaintiff Buc & Beardsley, LLP represents Matrixx Initiatives, Inc. ("Matrixx") in FDA-related matters and submitted the FOIA requests at issue in this action on Matrixx's behalf. Compl., Docket No. [1], ¶ 4. Each of the five FOIA requests at issue was signed either by Plaintiff Nancy L. Buc, a partner at Buc & Beardsley, or by Plaintiff Madhusha Dissanayake, an associate at the firm. Id. ¶¶ 12, 20, 28, 34, 42. The five requests, in chronological order of their submission date, are as follows:

* Request 2009-5323: On June 29, 2009, Plaintiffs submitted their first FOIA request to the FDA ("Request 2009-5323"), requesting the FDA's health hazard evaluations of Zicam cold remedy nasal products. Id. ¶¶ 11-17.

* Request 2009-6862: On August 18, 2009, Plaintiffs submitted their second FOIA request to the FDA ("Request 2009-6862"), requesting documents and records relating to Compliance Policy Guide 7132.15. Id. ¶¶ 19-25.

* Request 2009-8794: On October 22, 2009, Plaintiffs submitted their third FOIA request to the FDA ("Request 2009-8794"), requesting documents and records relating to a Drug Safety Oversight Board Meeting discussing Zicam cold remedy nasal products. Id. ¶¶ 27-31.

* Request 2009-9403: On November 16, 2009, Plaintiffs submitted their fourth FOIA request to the FDA ("Request 2009-9403"), requesting "all documents or records . . . relating to a press conference FDA held regarding Zicam cold remedy nasal products, a Warning Letter issued by FDA to Matrixx, regarding these products, and a News Release, Public Health Advisory, Fact Sheet, Consumer Article, and Drug Safety Podcast that FDA posted on its website." Id. ¶¶ 33-39.

* Request 2009-9424: Also on November 16, 2009, Plaintiffs submitted their fifth and final FOIA request to the FDA ("Request 2009-9424"), requesting "documents and records relating to the statements of Douglas

C. Throckmorton, M.D. that were made during a telephone call with counsel for Matrixx from Buc & Beardsley." Id. ¶¶ 41-47.

The timeliness of the FDA's response to two of these five requests is no longer at issue in this action. First, the FDA responded in full to Request 2009-8794 four months after its receipt and prior to the commencement of this action. Id. ¶ 31. Second, in the time since this action was commenced, the FDA has apparently responded in full to Request 2009-5323-albeit over eight months after its receipt. Decl. of Frederick J. Sadler in Supp. of Def.'s Mot. for a Stay ("Sadler Decl."), Docket No. [7-1], ¶ 16; Decl. of Nancy B. Sager in Supp. of Def.'s Mot. for a Stay ("Sager Decl."), Docket No. [7-15], ¶ 34.*fn2 As a result, the only requests that remain outstanding in full or in part are Request 2009-6862, Request 2009-9403, and Request 2009-9424 (collectively, the "Outstanding Requests"). As of today, two of these requests have been pending for approximately one year and two months, while the remaining request has been pending for approximately one year and five months.

Each of the Outstanding Requests was forwarded to the FDA's Center for Drug Evaluation and Research (the "CDER") and thereafter routed to the CDER's Division of Information Disclosure Policy (the "DIDP") for further processing. Sager Decl. ¶¶ 36, 40, 44.*fn3

In processing FOIA requests, the DIDP employs a multi-track system: (1) requests are assigned to the "Simple Track" when they (a) "can be answered quickly with readily available documents" and "require no further searching or redacting," or (b) are "reasonably expected by DIDP to require no more than one hour of search time and two hours of review time;" and (2) requests that do not qualify for the "Simple Track," because they will require more extensive searches or significant review time, are generally assigned to the slower "Complex Track." Id. ¶ 8. The pending searches pertaining to the Outstanding Requests have all been assigned to the DIDP's Complex Track. Id. ¶¶ 37, 41, 46.*fn4

Regardless of whether they are on the Simple or Complex Track, the DIDP generally processes requests on a "first-in, first-out" basis. Id. ¶ 8. An exception to this policy is made when a request that is low in the Complex Track queue seeks identical or very similar records to another request that has reached the top of the queue. Id. ¶ 10. In that situation, in the course of processing the request at the top of the queue, the DIDP may, in the interest of efficiency, release the overlapping records to parties who are further back in the queue. Id. In this case, the DIDP has determined that there is substantial overlap between Request 2009-9403 and Request 2009-9424 and an earlier, third-party request for Zicam-related documents in the Complex Track. Id. ...


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