United States District Court, D. Connecticut
TREATMENT ACTION GROUP and GLOBAL HEALTH JUSTICE PARTNERSHIP, Plaintiff,
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
A. Bolden United States District Judge
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.
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.
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.
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.
STATEMENT OF FACTS
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.
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),
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.
Plaintiff's FOIA Request
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. ¶¶
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
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.
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. Id. at 3.
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. ECF No. 16.
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. Philips Decl. ¶¶ 7-10,
ECF No. 61-1.
FDA FOIA Processing
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
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.
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.
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).
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).