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Treatment Action Group v. Food and Drug Administration

United States District Court, D. Connecticut

September 20, 2016

TREATMENT ACTION GROUP and GLOBAL HEALTH JUSTICE PARTNERSHIP, Plaintiff,
v.
FOOD AND DRUG ADMINISTRATION and DEPARTMENT OF HEALTH AND HUMAN SERVICES, Defendant.

          RULING ON MOTION TO STAY, PARTIAL MOTION FOR SUMMARY JUDGMENT, AND CROSS-MOTION FOR PARTIAL SUMMARY JUDGMENT

          Victor A. Bolden United States District Judge

         Plaintiffs Treatment Action Group (“TAG”) and the Global Health Justice Partnership (“GHJP”) bring this action against The Food and Drug Administration (“FDA”) and its parent agency, the Department of Health and Human Services (“HHS”) under the Freedom of Information Act (“FOIA”) 5 U.S.C. § 552 et seq., seeking the production of clinical trial data and communications regarding clinical trial design and the FDA approval process relating to two Hepatitis C virus (“HCV”) drugs, Sovaldi and Harvoni. ECF No. 1.

         Defendants filed a motion to stay this action to allow Defendants 14 months to process Plaintiff's FOIA request in accordance with the FDA's typical first-in, first-out multi-track processing system. ECF No. 16. TAG and GHJP move for partial summary judgment regarding their entitlement to expedited processing under 5 U.S.C. § 552(a)(6)(E) and for the denial of the Defendants' motion to stay. ECF No. 19. Defendants have filed a cross-motion for summary judgment, arguing that the Plaintiffs are not entitled to expedited processing. ECF No. 37.

         For the reasons stated herein, Defendants' motion to stay this action is DENIED. Plaintiffs' motion for summary judgment regarding their entitlement to expedited processing is also DENIED and Defendants' cross-motion for summary judgment on the expedited processing issue is GRANTED.

         Nevertheless, given that Defendants have stated that the FDA is currently processing the Plaintiffs' FOIA request, consistent with the applicable law, the Court orders the FDA to immediately produce all responsive records that have been gathered so far and to report back to the Court by October 21, 2016 regarding responsive records that have yet to be produced and when the Plaintiffs could expect to receive any documents outstanding as of October 21.

         I. STATEMENT OF FACTS

         TAG is an independent AIDS research and policy think tank seeking better treatment options for HIV-related diseases. FOIA Request at 5, ECF No. 19-2. GHJP is a nonprofit initiative of Yale Law School and Yale School of Public Health dedicated to facilitating open science, community engagement, and public health. Id. The FDA is responsible for ensuring that drugs marketed to the public are safe and effective. Pl.'s Local Rule 56(a)(1) Statement ¶ 38, ECF No. 19-30.

         The FDA approved Sovaldi and Harvoni after the drugs received Priority Review under the Breakthrough Therapy Designation Program. Pl.'s Local Rule 56(a)(1) Statement ¶ 55. Solvadi (sofosbuvir) and Harvoni (sofosburvir/ledipasvir) are drugs used in the treatment of HCV. FOIA Request at 1, ECF No. 19-2. The FDA approved Sovaldi in December 2013. Id. Harvoni was approved more recently, in October 2014. FDA, FDA Approves First Combination Pill to Treat Hepatitis C, (Oct. 10, 2014), http://www.fdagov/NewsEvents/Newsroom/Press Announcements/ucm418365.htm.

         The FDA subsequently revised the warning labels for both drugs based on previously unknown interactions with the antiarrhythmia medication amiodarone. Pl.'s Local Rule 56(a)(1) Statement ¶ 58. An estimated 3.2 million people in the USA are infected with HCV. FOIA Request at 1, ECF No. 19-2. Both Sovaldi and Harvoni are expensive, with a typical 12-week course of Sovaldi costing $84, 000 and a 12-week course of Harvoni costing $94, 500. Id.

         A. Plaintiff's FOIA Request

         On December 17, 2015, TAG and GHJP submitted a FOIA request by letter to the FDA and HHS seeking records related to the FDA's approval of Sovaldi and Harvoni. Pl.'s Local Rule 56(a)(1) Statement ¶ 18. The eight categories of information requested included: all data submitted to the FDA as part of the New Drug Application (“NDA”) for Sovaldi and Harvoni including but not limited to patient-level safety and efficacy data, all correspondence between the Defendants and the companies developing the drugs relating to any aspect of the FDA approval process, and any other raw clinical trial data regarding the drugs. Id. ¶¶ 19-20. Plaintiffs requested expedited processing under 5 U.S.C. § 552(a)(6)(E), a public interest fee waiver for duplication fees under 5 U.S.C. § 552(a)(4)(A)(iii), and a fee limitation under 5 U.S.C. § 552(a)(4)(A)(ii)(II). Id. ¶¶ 22-24.

         On December 22, 2014, Sara Kotler, the Acting Director of the FDA's Division of Freedom of Information, denied Plaintiffs' request for expedited processing. Kotler Letter, ECF No. 19-4. Ms. Kotler's letter indicated that the Plaintiffs had “not demonstrated a compelling need that involves an imminent threat to the life or physical safety of an individual “ or “an urgency to inform the public concerning actual or alleged Federal Government Activity.” Id. The letter did not inform Plaintiffs of when they could expect a response to their request, instead it stated that the FDA would “process [the] request in the order in which it was received.” Id.

         On January 26, 2015, Plaintiffs filed an administrative appeal of the denial of their request for expedited processing and what they allege to be the constructive denial of their request for the eight categories of records by letter to the Deputy Agency Chief Freedom of Information Officer in HHS's Office of the Assistant Secretary for Public Affairs. Pl.'s Local Rule 56(a)(1) Statement ¶¶ 28-29. Plaintiffs received a January 29, 2015 letter from HHS's Division of FOIA Services acknowledging receipt of the administrative appeal. Id. ¶¶ 30-31.

         On February 19, 2015, Catherine Teti, the Executive Officer and Deputy Agency Chief FOIA Officer in the HHS's Office of the Assistant Secretary for Public Affairs, sent a letter to Plaintiffs affirming the denial of their request for expedited processing. Pl.'s Local Rule 56(a)(1) Statement ¶ 32. Ms. Teti's letter explained that Plaintiffs had failed to show a “compelling need” that justified expedited processing pursuant to 21 C.F.R. § 20.44(a), whether by showing that a “failure to obtain records on an expedited basis could reasonably be expected to pose an imminent threat to the life or physical safety of an individual” or that Plaintiffs were “person[s] primarily engaged in disseminating information” and that there was “a demonstrated urgency to inform the public concerning actual or alleged Federal Government activity.” Teti Letter at 1-2, ECF No. 19-8. Ms. Teti's letter also explained that the Plaintiffs' FOIA requests had been placed in the “complex queue” of the FDA's Center for Drug Evaluation and Research, with an expected processing time of 18 to 24 months.[1] Id. at 3.

         On April 1, 2015, Plaintiffs sent another letter to the Defendants, requesting the reconsideration of the denial of their Administrative Appeal. Pl.'s Local Rule 56(a)(1) Statement ¶ 35. Defendants did not respond to this request. Id. ¶ 36. On June 25, 2015, Plaintiffs filed their complaint in this case. ECF No. 1. Defendants' filed their motion for a stay on November 12, 2015, requesting a 14-month stay to allow Defendants to process Plaintiffs' request in accordance with the FDA's first-in, first-out multi-track processing system.[2] ECF No. 16.

         Plaintiffs moved for partial summary judgment regarding their entitlement to expedited processing on December 7, 2015. ECF No. 19. Defendants filed a cross-motion for partial summary judgment on January 29, 2016, arguing that Plaintiffs are not, in fact, entitled to expedited processing. ECF No. 37. Plaintiffs moved for leave to file supplemental materials on August 12, 2016. ECF No. 56. Defendants filed a response to this motion on August 28, 2016, and represent that Plaintiff's request is now at the top of the queue. ECF No. 61 at 3 n.5, ECF No. 61-1. Defendants represent that, because of the breadth of Plaintiffs' FOIA request and the time required to review and redact potentially relevant documents, the full response will now be provided to Plaintiffs by March 31, 2017.[3] Philips Decl. ¶¶ 7-10, ECF No. 61-1.

         B. FDA FOIA Processing

         The Division of Information and Disclosure Policy (“DIDP”) within the FDA's Center for Drug Evaluation and Research (“CDER”) is the branch of the FDA processing the Plaintiffs' FOIA request. Def.'s Motion for Stay at 2, ECF No. 16. Between 2012 and 2014, DIDP received the following numbers of requests each year: 2012 (2, 364), 2013 (2, 868), 2014 (3, 017). Sager Decl. at 12, ECF No. 16-1. DIDP processed approximately 3, 122 requests in 2014, 105 more than it received. Id. at 7. In relation to its motion to stay filed in November 2015, the Defendants indicated that DIDP received 2, 522 FOIA requests between January 1, 2015 and September 30, 2015. Id. at 12. In that same period, DIDP processed 2, 507 requests, only 115 less than it received. Id. at 7. As of September 30, 2015, DIDP had a backlog of 600 FOIA requests. Id. Between 2012 and 2014, DIDP's backlog has been at the following sizes: 2012 (777), 2013 (690), 2014 (585). Id. at 12. A comparison of the increase in DIDP FOIA requests between 2012 and 2014 and the decrease in DIDP's backlog is as follows. Between 2012 and 2014, DIDP received 28% more requests in 2014 than in 2012. Id. at 12. During this period, DIDP also reduced its backlog by 24%.[4] See id.

         In addition to FOIA requests, DIDP also responds to document requests from Congress, the United States Government Accountability Office (“GAO”), and various other governmental agencies, including foreign, state, local, and other U.S. federal agencies. Sager Decl. at 7. Defendants report that these requests require the “attention of up to three DIDP employees, ” who are then unable to devote their time to FOIA requests. Id. at 8. The DIDP also faces additional burdens related to productions arising out of litigation. Id. at 8-9. It is also under additional information production obligations imposed by the Food and Drug Administration Amendments Act of 2006 (“FDAAA”). Id. at 9-10. Defendants do not offer any quantitative measures of the resources taken up by litigation-related or FDAAA-related obligations.

         As for agency resources, DIDP had 18 full-time employees in 2002, 25 full-time employees in 2003, and it currently has 40 full-time employees and one additional full time contractor. Sager Decl. at 16. The FDA had 33 full-time employees and two full-time contractors in 2009. See Buc v. Food & Drug Admin, 762 F.Supp.2d 62, 72 (D.D.C. 2011). DIDP has also implemented organizational changes intended to increase efficiency by creating new “non-supervisory team lead positions” to focus on “ways to improve production and increase the quality of work of the team.” Sager Decl. at 17. Before these changes, each supervisor reviewed the work of 10-15 people, but with the new team lead positions, one person manages the work of every five to six people. Id.

         II. STANDARD

         Where an agency denies a request or affirms a denial of a request for expedited processing under FOIA, the decision to deny such a request is “subject to judicial review . . . based on the record before the agency at the time of the determination.” 5 U.S.C. § 552(a)(6)(E)(iii). District courts have “jurisdiction to enjoin the agency from withholding agency records and to order the production of any agency records improperly withheld” and make such determinations de novo. 5 U.S.C. § 552(a)(4)(B); see also Bloomberg, L.P. v. United States Food & Drug Admin., 500 F.Supp.2d 371, 374 (S.D.N.Y. 2007) (“The Court reviews agency decisions, including those regarding expedited processing of FOIA requests, de novo.”) While the burden is on the agency to sustain its action in cases involving the improper withholding of records under claimed FOIA exemptions, 5 U.S.C. § 552(a)(4)(B), the requestor has the burden to “demonstrate[] a compelling need” for expedited processing. 5 U.S.C. § 552(a)(6)(E)(i); see also Wadelton v. Dep't of State, 941 F.Supp.2d 120, 122 (D.D.C. 2013) (explaining that “[t]he requestor bears the burden of proof” in expedited processing cases).

         The Court will grant a motion for summary judgment if it determines that there is no genuine dispute of material fact and the movant is entitled to judgment as a matter of law. Fed.R.Civ.P. 56(c). The moving party bears the burden of showing that no genuine dispute of material fact exists. Carlton v. Mystic Transp., Inc., 202 F.3d 129, 133 (2d Cir. 2000). “A dispute regarding a material fact is genuine if the evidence is such that a reasonable jury could return a verdict for the nonmoving party.” Williams v. Utica Coll. Of Syracuse Univ., 453 F.3d 112, 116 (2d Cir. 2006) (quoting Stuart v. Am. Cyanamic Co., 158 F.3d 622, 626 (2d Cir. 1998)). The substantive law governing the case identifies which facts are material, and “only disputes over facts that might affect the outcome of the suit under the governing law will properly preclude the entry of summary judgment.” Boubolis v. Transp. Workers Union of Am., 442 F.3d 55, 59 (2d Cir. 2006) (citing Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 248 (1986)). When reviewing the record on a motion for summary judgment, the Court must “assess the record in the light most favorable to the non-movant” and “draw all reasonable inferences in its favor.” Weinstock v. Columbia Univ., 224 F.3d 33, 41 (2d Cir. 2000).

         III. ...


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