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Scharf-Norton Center for Constitutional Litigation at the
GOLDWATER INSTITUTE
Jonathan Riches (025712)
Aditya Dynar (031583)
500 E. Coronado Rd.
Phoenix, Arizona 85004
(602) 462-5000
Attorneys for Plaintiff
IN THE UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF ARIZONA
GOLDWATER INSTITUTE,
Plaintiff,
vs.
U.S. DEPARTMENT OF HEALTH AND
HUMAN SERVICES,
Defendant.
No. CV-15-01055-PHX-SRB
PLAINTIFF’S MEMORANDUM IN
SUPPORT OF ITS THIRD MOTION
FOR SUMMARY JUDGMENT
(Oral Argument Requested)
Introduction
The Freedom of Information Act (“FOIA”) requires that public records be disclosed
unless a specific exemption applies. But four years after the FOIA request was first filed,
Defendant Food and Drug Administration (“FDA”) is still withholding responsive records about
how life-saving drugs are made available in the United States, without even claiming that any
FOIA exemption applies.
The FDA contends that these records are “nonresponsive.” For one set of records—
those pertaining to personal importation of ZMapp—the Court has already determined that they
are. Pl.’s Separate Statement of Facts in Support of Pl.’s Third Renewed Mot. for Summ. J.
(“SSOF”), Ex. 15 at 10. This is law of the case. Without claiming an exemption (because none
applies) the personal importation records must be disclosed. For other records that the FDA has
Case 2:15-cv-01055-SRB Document 74 Filed 06/29/18 Page 1 of 15
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labeled “nonresponsive,” the Court must apply a “liberal construction” to determine whether
they are in fact responsive to the Goldwater Institute’s records request. Under a liberal
construction—indeed, even under a strict construction—several records the FDA has labeled
“nonresponsive” are responsive to the FOIA request.
Finally, after several years of litigation, the FDA has now re-categorized some records
from “nonresponsive” to responsive, but claims they are exempt from disclosure under
Exemption 5. The FDA cannot meet its burden to prove that it properly relied on Exemption 5
in withholding the public records at issue because they pertain to agency processes and
procedures that are not deliberative.
Statement of Facts and Statement of the Case
Plaintiff, Goldwater Institute, adopts by reference its statement of facts made in its initial
Cross-Motion for Summary Judgment filed with the Court on January 8, 2016 (Doc. 24), and
Plaintiff’s second Motion for Summary Judgment filed with the Court on June 19, 2017 (Doc.
50). Those and additional facts are provided in the Separate Statement of Facts accompanying
this motion.
After the second round of summary-judgment briefing, the Court ordered that Defendant
FDA produce yet another Vaughn index that more reasonably describes the records withheld
and the basis for withholding, including any claimed FOIA exemptions. SSOF ¶ 26. On March
8, 2018, Defendant submitted a Revised, Consolidated Vaughn Index accompanying Ms. Nancy
B. Sager’s Sixth Declaration. SSOF ¶ 29. In that document, the FDA held fast to its previous
conclusion that large portions of the records identified were “nonresponsive” to Plaintiff’s
FOIA request. The FDA also reclassified records that it has previously concluded were
“nonresponsive” to “responsive,” but exempt from disclosure under the FOIA. See SSOF Ex.
17.
In its January 24, 2018 Order, the Court said that it will “order additional summary
judgment briefing if plaintiff still believes that it is entitled to information contained in those
records.” SSOF Ex. 15 at 13.
Case 2:15-cv-01055-SRB Document 74 Filed 06/29/18 Page 2 of 15
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On May 1, 2018, the parties jointly proposed a scheduling order for a third round of
summary-judgment briefing, which the Court entered (Doc. 72). Plaintiff files this motion and
memorandum for summary judgment and supporting statement of facts pursuant to that Order.
Argument
The plain language of the FOIA, and its broad construction in favor of disclosure,
requires the release of public records pertaining to government processes and procedures, such
as those at issue here. “Each agency shall make available to the public … statements of the
general course and method by which its functions are channeled and determined, including the
nature and requirements of all formal and informal procedures available[.]” 5 U.S.C. §
552(a)(1)(B) (emphasis added). The purpose of the FOIA is to promote transparency, not to
protect agencies against disclosure. Congress enacted the FOIA to “pierce the veil of
administrative secrecy and to open agency action to the light of public scrutiny.” Dep’t of Air
Force v. Rose, 425 U.S. 352, 361 (1976). Unless a clearly delineated exemption applies,
“disclosure, not secrecy, is the dominant objective of the Act.” Id.
I. THE FDA CONTINUES TO WITHHOLD RESPONSIVE RECORDS WITHOUT CLAIMING ANY FOIA EXEMPTION.
In cases in which a FOIA exemption is not claimed by the agency, the analysis is simple:
An agency must respond to any request for records that “reasonably describes such records,”
and must promptly disclose them. 5 U.S.C. § 552(a)(3)(A). If an agency claims that a record is
nonresponsive, courts must apply a “liberal construction” in favor of finding the document
responsive. Yagman v. Pompeo, 868 F.3d 1075, 1080 (9th Cir. 2017).
In this case, the FDA has disclaimed the application of any exemption to certain records
identified in the Vaughn index. Therefore, the only inquiry is whether the records are
responsive to the FOIA request. If they are, the records must be promptly disclosed.
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A. The Court has already held that records regarding the personal importation of ZMapp are responsive to the Goldwater Institute’s request, and because the FDA does not claim any exemption, they must be disclosed.
This Court has already held that records “regarding personal importation of ZMapp …
are responsive to Plaintiff’s FOIA request.” SSOF Ex. 15 at 10. Consequently, “Defendant
must either disclose them or demonstrate their exemption.” Id. This finding is now law of the
case, which means that the Court is “precluded from reconsidering [the] issue.” United States v.
Alexander, 106 F.3d 874, 876 (9th Cir. 1997). The personal importation records should be
promptly disclosed.
Rather than claim an exemption, the FDA has chosen to hold fast to its prior
determination—now reflected in its third Vaughn index—that the personal importation records
are not responsive to the Goldwater Institute’s FOIA request. See SSOF Ex. 17 at lines 82–83,
85–86, 89, 91–95, 101, 103, 105, 107, 109–111, 113. Yet the plain language of that request
sought “[a]ny and all records that indicate the approval process … regarding provision or
approval of the drug and serum ‘ZMapp’ … under the ‘compassionate use’ process or any other
approval process at the FDA.” SSOF ¶ 7 (emphasis added). As the Court observed in its
January 24, 2018 Order, “any other approval process” includes “provision by importation.” See
SSOF Ex. 15 at 10 (“Assuming ‘EIND’ is shorthand for either emergency or expanded access
IND, it would defy logic to conclude that such records have nothing to do with the ‘provision or
approval’ of ZMapp to Ebola patients—namely, provision by importation.”).
The FDA’s own descriptions of the personal importation records also show that this
Court was correct in its reading of Plaintiff’s FOIA request to include the personal importation
records. See, e.g., SSOF Ex. 17, at lines 109–111 (Line 110: “FDA email to expanded access
and commercial IND sponsors responding to the email dated 09/14/14 at 7:04 PM regarding
importation of ZMapp for use under expanded access IND.”); Line 103 (“FDA email to
expanded access IND sponsor and third party treatment provider holding the ZMapp to be
imported for use under the expanded access IND, assigning expanded access IND number and
discussing submission of paperwork.”); Lines 91–95 (Line 91: “Internal FDA email forwarding
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emails between commercial IND sponsor and foreign treatment provider holding ZMapp
concerning safety and efficacy of ZMapp, shipment to the United States, and incoming
expanded access IND for emergency treatment use.”); see also Lines 89, 101, 105, 107, 113.
These are all records that pertain to the approval process and procedures that the FDA used
when it made ZMapp available in the United States, which of course was exactly what
Plaintiff’s FOIA request sought.
Indeed, the FDA’s actions in this case—of releasing the final approval records from the
personal importation IND on November 24, 2018—belie its argument that the records about its
approval process are nonresponsive. The FDA has already released “final approval records
regarding provision or approval” of ZMapp. SSOF ¶ 19. That is, it has admitted that the final
approval records are responsive. If the approval records are responsive, then records about that
process are also responsive. “Once an agency itself identifies a particular document or
collection of material—such as a chain of emails—as a responsive ‘record,’ the only
information the agency may redact from that record is that falling within one of the statutory
exemptions.” American Immigration Lawyers Ass’n v. Exec. Office for Immigration Review,
830 F.3d 667, 678–79 (D.C. Cir. 2016). The FDA has already identified records pertaining to
the personal importation of ZMapp as responsive by disclosing the approval records from that
process. SSOF ¶ 19. Because the agency does not claim an exemption to the other personal
importation documents, it must disclose them.
Withholding documents about the personal importation process now also runs counter to
standard FOIA practice as advised by the U.S. Department of Justice. See The United States
Department of Justice, FOIA Update, Vol. XVI, No. 3 (1995)1 (“There should be no ‘scoping’
within any document page. If any of the information on a page of a document falls within the
subject matter of a FOIA request, then that entire page should be included as within the scope of
that request.”)
1 https://www.justice.gov/oip/blog/foia-update-oip-guidance-determining-scope-foia-request.
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Accordingly, the records regarding personal importation of ZMapp were already found
to be responsive by this Court, as well as by tacit admission by the FDA in its previous
disclosures, and they should, as a matter of routine FOIA practice, be promptly disclosed.
B. There are other records identified in the Vaughn index as nonresponsive,
and for which the FDA claims no exemption, that are responsive to Plaintiff’s FOIA request.
There are additional records identified in the Vaughn index that pertain to the timing,
information sought, and procedural characteristics of the IND submission process that the FDA
claims are “nonresponsive” that are responsive and should be disclosed. See SSOF Ex. 17 at
lines 3, 7, 18–19, 23, 38, 60, 72, 79.
Questions regarding whether a FOIA request “reasonably describes” a record, or
whether a record is “responsive,” must be construed liberally in favor of the requester. “Liberal
construction is warranted to achieve the core purpose of FOIA: allowing the public to find out
‘what their government is up to.’” Yagman, 868 F.3d 1075 at 1080 (quoting U.S. Dep’t of
Justice v. Reporters Comm. for Freedom of Press, 489 U.S. 749, 773 (1989).
But even under a strict construction of the requests, the records that the FDA is
withholding are responsive and are subject to disclosure under the FOIA. Several records the
FDA calls “nonresponsive” pertain to the timing of the IND submissions, which respond
directly to the request for records that “indicate the approval process” and decisions made
“during that process.” For example, SSOF, Ex. 17, Line 3, identifies records “concerning
timing of submission of expanded access IND … and potential place of treatment in preparation
for incoming expanded access IND.” Line 18 identifies records “addressing timing of expanded
access IND submission.” Line 19 describes an “[i]nternal FDA email regarding timing of
submission of information from expanded access IND sponsor and information to be requested
from and provided to expanded access IND sponsor” (emphasis added). These records appear
to pertain directly to government process and procedures about what approval process was used
and how it was used in the case of the ZMapp INDs.
Indeed, the Vaughn index itself discloses facts about the timing of the IND approvals;
namely, the speed with which they were approved after submission. SSOF ¶¶ 36–38. Each of
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the three INDs identified in these records were approved for use in less than an hour, and in one
case, within 12 minutes of submission. Id. For example, the first IND authorization was
submitted at 9:47 pm on August 1, 2014; it was authorized for use at 10:16 pm the same day—
29 minutes after it was submitted. Id. ¶ 36. The second IND authorization appears to have been
submitted at or around 3:15 pm on August 5, 2014 2; it was approved for use at 4:05 pm the
same day. Id. ¶ 37. Remarkably, the third IND submission was sent at 6:34 pm on September
14, 2014 and was authorized for use at 6:46 pm the same day. SSOF ¶ 38.
These observations regarding the timing of the IND submission and the approval leave
one to wonder—how the approval process worked in this case. More specifically, if it only
takes 12 minutes for the agency to authorize an IND submission, what other process was used,
and what other decisions were made, outside this short time period? Federal regulations require
the FDA to evaluate several factors in determining whether or not to authorize an IND for use.
See 21 C.F.R. §§ 312.305(a), 312.310. How can the agency have possibly made the necessary
evaluation in 12 minutes? And if it was not made after the IND was submitted, what other
process, procedure, or determination was made, and when, to authorize the IND?
Finding answers to these questions was the entire reason the Goldwater Institute
submitted its FOIA request. And the FDA is required to make records available that describe
“the general course and method by which its functions are channeled and determined, including
the nature and requirements of all formal and informal procedures available[.]” 5 U.S.C. §
552(a)(1)(B) (emphasis added). Thus, the records pertaining to the timing of the IND
submissions that the FDA has labeled “nonresponsive” are plainly responsive.
There are other records regarding categories of information sought, status updates, and
procedural matters that also appear to be responsive and which the FDA must disclose. For
example, SSOF Ex. 17, line 79 identifies an “[i]internal FDA email responding to email dated
[08/05/14] at 3:53 PM, providing status update, and identifying IND number to be assigned to
2 It is unclear from the Vaughn index whether a formal IND submission for this authorization ever occurred. The only record identifying the submission is an “[i]nternal FDA email forwarding and discussing expanded access IND submission.” SSOF ¶ 37 and SSOF Ex. 17, line 76 (emphasis added).
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expanded access IND.” Several of these things, such as “identifying IND number” are purely
procedural components that “indicate the approval process.” Also, a “status update” that
occurred 12 minutes before this IND was authorized for use would seem to respond to the
request seeking information about what approval process was used and how was ZMapp made
available in this case. See also id. line 23. Likewise, Line 7, describing an internal FDA email
about an “upcoming discussion with expanded access IND sponsor in preparation for incoming
expanded access IND” would also fall into this category. And Lines 60 and 72 pertain to
information sought by the FDA during the IND approval process, that also falls within the scope
of Plaintiff’s FOIA request.
It seems both plain and reasonable that records about the timing and other procedural
aspects of how these INDs were authorized are responsive to the Goldwater Institute’s request
seeking information about what government processes were used, whether those processes were
followed, and what decisions were made. This is particularly true given the liberal construction
to be applied to FOIA requests. Absent a claimed exemption, these records should be disclosed.
C. The FDA’s consideration of what contents are “part of the IND file” do not supersede the requirements of federal law.
Yet, the FDA falls back on the argument that – even if responsive and not exempt under
the FOIA—the agency may withhold the records pursuant to agency regulations. It is, of
course, axiomatic that an agency cannot by regulation or policy “nullify a congressionally
enacted law.” Teich v. FDA, 751 F. Supp. 243, 247 (D.D.C. 1990). Yet, in arguing that because
the FDA has a broad and unilateral policy about how it keeps IND files it can withhold
responsive and nonexempt records, that is precisely what the FDA is asking this Court to hold.
In her Sixth Declaration, Ms. Sager makes plain that she gets to determine what
information is properly housed in the IND file, whether or not that information is exempt from
disclosure under the FOIA. SSOF ¶ 31 (describing the contents of the Third Vaughn index and
“the reason(s) why I consider each e-mail to be part of the expanded access IND file.”
(emphasis added)). The FDA goes even further, arguing that responsive, non-exempt records
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may nonetheless be withheld purportedly pursuant to the agency’s regulations. See SSOF Ex.
16 ¶ 12 (“If non-deliberative records such as the ones FDA has withheld are not considered part
of the IND file and therefore are not protected under FDA’s NDA and IND regulations…their
release would disclose the existence of an IND, in contravention of FDA’s NDA and IND
regulations.”).
There are two threshold matters that plainly belie the FDA’s purported concerns
regarding the contents of the IND file. First, the regulations the FDA is relying on do not apply
to the records sought in this case. See Pl.’s Mem. in Supp. of Cross-Mot. for Summ. J. dated
January 8, 2016 (Doc. 25 at 8–9). Second, the existence of an IND for ZMapp, and the three
eINDs at issue in this case, have already been publicly disclosed. See SSOF Ex. 7 ¶ 3 (“The
existence of a commercial IND for ZMapp has been publicly disclosed by LeafBio, the sponsor
of the application.”); see also SSOF Ex. 12 ¶¶ 6–8 (disclosing existence of all eINDs at issue
here). So the FDA’s claimed justification for withholding responsive records to prevent the
disclosure of “the existence of an IND” (SSOF Ex. 16 at ¶ 11) is illusory.
More importantly, the FDA does not get to decide what is and is not disclosable under
the FOIA—by agency regulation, policy, fiat, or otherwise. “A basic policy of FOIA is to
ensure that Congress and not administrative agencies determines what information is
confidential.” Lessner v. U.S. Dep’t of Commerce, 827 F.2d 1333, 1335 (9th Cir. 1987); see
also City of Arlington, Tex. v. FCC, 569 U. S. 290, 327 (2013) (Roberts, C. J., dissenting) (“We
do not leave it to the agency to decide when it is in charge”).
The agency also cannot avoid its disclosure obligations based on the method it chooses
to use in organizing or housing its records. “The focus of the FOIA is information, not
documents.” ACLU of N. Cal. v. U.S. Dep’t of Justice, 880 F.3d 473, 489 (9th Cir. 2018)
(citation omitted). In other words, it does not matter how records are stored, maintained, or
organized. The question in FOIA cases is whether the information contained in those records,
however stored, is responsive to a FOIA request. If the information is responsive, and not
exempt, it must be disclosed. See FOIA Update, supra (“Agencies should be mindful of this
inherent conflict between standard recordkeeping and FOIA-processing practices.”).
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On the question of whether information contained in certain files is disclosable, it is for
Congress, not the FDA, to decide. According to the FDA, “because the agency considers all
information in an IND file to be CCI, release of the records withheld by FDA would also
contravene 21 C.F.R. § 20.61, which prohibits public release of confidential commercial
information.” SSOF Ex. 16 ¶ 12 (emphasis added). Even assuming the regulation does what
the FDA claims, which Plaintiffs do not assume, the Ninth Circuit has already rejected the
assertion that agencies and not Congress get to determine what is and is not confidential under
the FOIA. Lessner, 827 F.2d 1333 (Congress, and not administrative agencies determine what
is exempt as “confidential” under the FOIA and refusing to defer to agency interpretations of
the FOIA). Thus, the Ninth Circuit has already addressed the question of whether an agency
can determine what is or is not exempt under the FOIA—it cannot. Only Congress can do that.
This holding is, of course, also consistent with the general principle that regulations may
not conflict with statutes. U.S. v. Doe, 701 F.2d 819, 823 (9th Cir. 1983) (“Where an
administrative regulation conflicts with a statute, the statute controls.”). This applies whether
the agency has adopted an internal policy, or whether the agency has adopted a formal
regulation. Id.; see also Nat’l Tour Brokers Ass’n v. Interstate Commerce Comm’n, 671 F.2d
528, 531 (D.C. Cir. 1982) (“Clearly the rulemaking power of a federal agency does not
encompass the power to make law or to repeal law.”); Dalton v. U.S., 816 F.2d 971, 974 (4th
Cir. 1987) (it is a “well-established rule” that an administrative agency “lacks power even by a
regulation adopted after strict compliance with the Administrative Procedure Act … to repeal,
modify, or nullify a statute.”). It is obvious that administrative agencies like the FDA cannot
supersede the requirements of federal law in determining—by regulation or otherwise—what
information is responsive to records requests or is exempt under the FOIA.
In fact, the issue of whether information contained within an IND file can be withheld
pursuant to agency regulation has already been addressed twice by the District of Columbia
District Court. The FDA’s argument that agency regulations dictate the contours of FOIA
disclosure was rejected in both cases.
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In Gov’t Accountability Project v. U.S. Dep’t of Health & Human Servs., 691 F. Supp.
2d 170, 178 (D.D.C. 2010), the FDA withheld records related to an investigational drug,
arguing that the information was exempt from disclosure under Exemption 4 and citing an
agency regulation as an additional basis for withholding the information. The Court found that
the FDA’s “citations to and reliance on the above-quoted statutory and regulatory provisions are
irrelevant to the only question now before the Court—namely, whether the redacted information
was properly withheld under FOIA Exemption 4.” In other words, the regulatory citations were
irrelevant to the question of whether the information is exempt under FOIA or not.
In Teich v. FDA, 751 F. Supp. 243, 245 (D.D.C. 1990), a FOIA requester sought
information about animal studies and consumer complaints pertaining to silicone breast
implants. There, as here, the FDA argued that an agency regulation pertaining to presubmission
review prevented the disclosure of the requested information. The District Court invalidated the
regulation, finding that it was “clearly an attempt by the agency to nullify congressionally
enacted law.” Id. at 247. The Court went on to write, “While certainly the agency can deny
access to records that the FOIA itself protects, its presubmission review cannot be used to forge
a Northwest passage around the FOIA.” Id.
In FOIA cases, the FDA may only withhold records in one circumstance: When a
statutory FOIA exemption applies. The agency cannot otherwise limit the contours of the
FOIA, or the public’s right to access public information—by rule, policy, regulation, or
declaration. Its attempt to do so here should be rejected.
II. THE FDA HAS RECATEGORIZED CERTAIN RECORDS FROM “NONRESPONSIVE” TO “RESPONSIVE-BUT-EXEMPT,” BUT HAS FAILED TO PROVE THAT THE NEWLY CLAIMED FOIA EXEMPTIONS APPLY.
Now in its third iteration of a Vaughn index and its sixth declaration from its records
custodian, the FDA has again shifted course and re-categorized certain records from non-
responsive to responsive-but-exempt, purportedly under FOIA Exemption 5. See SSOF Ex. 17,
lines 31, 35–36. These records pertain to: (1) the “status of [an] expanded access IND
submission” and the agency’s “next steps” in acting on that submission (lines 35–36, 98); and
(2) “additional information to be obtained” from the IND sponsor “in evaluating whether to
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authorize the expanded access IND to proceed”. Id., line 31. Once again, the FDA has failed to
show that these records are exempt from disclosure. These records are not deliberative within
the meaning of Exemption 5, and that exemption simply does not apply.
This set of records that the FDA is only now, for the first time, claiming is exempt does
not pertain to sensitive communications between agency personnel that “is so candid or personal
in nature” that their disclosure would cause injury to the quality of the agency’s decisions. See
Coastal States Gas Corp. v. Dep’t of Energy, 617 F.2d 854, 866 (D.C. Cir 1980). To be
protected by the deliberative process privilege, documents must be both “predecisional” and
“deliberative.” Assembly of State of Cal. v. U.S. Dep’t of Commerce, 968 F.2d 916, 920 (9th
Cir. 1992). The purpose of Exemption 5 “is to prevent injury to the quality of agency
decisions.” NLRB v. Sears, Roebuck & Co., 421 U.S. 132, 151 (1975). Exemption 5, like all
FOIA exemptions, must be “given a narrow compass.” Dep’t of Interior v. Klamath Water
Users Protective Ass’n, 532 U.S. 1, 7 (2001) (citation omitted).
The deliberative prong of Exemption 5 applies only to documents that “reveal the mental
processes of decision-makers.” Assembly of State of Cal., 968 F.2d at 921 (citation omitted).
Records may be deliberative if they “reflect the personal opinions of the writer rather than the
policy of the agency.” Coastal States Gas Corp., 617 F.2d at 866 (emphasis added). “To test
whether disclosure of a document is likely to adversely affect the purposes of the privilege,
courts ask themselves whether the document is so candid or personal in nature that public
disclosure is likely in the future to stifle honest and frank communication within the agency.”
Id. (emphasis added). When the information is purely factual and does not reveal official
agency reasoning, it will not be “deliberative” and it falls outside the protection of Exemption 5.
In this case, records pertaining to the status of an IND application and the agency’s next
steps regarding that application are purely factual in nature. They consist of applications of the
agency’s existing policy, not the subjective, candid or personal thoughts of agency employees.
Indeed, the status of an IND application goes to the factual, government processes sought in this
FOIA request. The records in question do not apply in any way that would harm or interfere
with agency decision-making.
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The same is true of information to be obtained from the IND sponsor in evaluating
whether to authorize the IND to proceed. This would appear to refer to factual data that applies
to existing agency policy. Interestingly, the FDA identifies this set of records as “evaluating
whether to authorize the expanded access IND to proceed.” SSOF Ex. 17, line 31. But the
records in question were created at 8:50 pm on August 1, 2014, and the expanded access IND
was not submitted for IND until 10:16 pm that day. SSOF ¶ 36. Which raises the question:
How can the agency be evaluating information for an eIND that has not yet been submitted?
That question, again, goes to the heart of this FOIA inquiry. What government processes were
used and how were these drugs made available in these cases? Whatever the answer to that will
ultimately turn out to be, the information sought here—in an effort to learn the answer to that
question—is information that relates to applying existing agency policies, not information about
the mental processes of policy makers. It is therefore categorically outside Exemption 5.
III. RESPONSIVE INFORMATION IS SEGREGABLE FROM RECORDS THE FDA CLAIMS IS EXEMPT FROM DISCLOSURE, AS IS APPARENT FROM THE DESCRIPTIONS IN THE NEW, CONSOLIDATED VAUGHN INDEX.
The new consolidated Vaughn identified several records that Defendant FDA previously
claimed as exempt under the FOIA, which either do not appear to be exempt based on the
descriptions in the new Vaughn, or for which exempt information can be redacted and
responsive information segregated and disclosed. The FOIA requires that “[a]ny reasonably
segregable portion of a record shall be provided to any person requesting such record after
deletion of the portions which are exempt.” 5 U.S.C. § 552(b). Moreover, “it is error for a
district court to simply approve the withholding of an entire document without entering a
finding on segregability, or the lack thereof.” Church of Scientology of Cal. v. U.S. Dep’t of
Army, 611 F.2d 738, 744 (9th Cir. 1979), overruled on other grounds by Animal Legal Defense
Fund v. FDA, 836 F.3d 987 (9th Cir. 2016) (en banc). Courts are therefore required to
determine whether any of the documents contain material that can be segregated or disclosed
without violating an exemption. Krikorian v. Dep’t of State, 984 F.2d 461 (D.C. Cir. 1993).
In its prior Orders, the Court determined that records the FDA previously claimed are
exempt under Exemptions 4 or 5 are exempt under those FOIA exemptions. Based on the
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FDA’s new, consolidated Vaughn, it appears, however, that portions of records that the FDA
previously claimed are exempt under Exemptions 4 and 5, are both responsive and nonexempt.
See SSOF Ex. 17, lines 2, 8, 13, 16, 22, 27–34, 41, 53–44, 47–50, 56–58, 76, 80–81, 96–98,
100, 104. Therefore, Plaintiff respectfully requests that the Court enter a segregability finding
under the new, consolidated Vaughn for records that appear responsive and reasonably
segregable from documents the Court previously determined were exempt from disclosure.
Conclusion
Based on the foregoing, summary judgment should be entered in Plaintiff’s favor with
an Order from the Court to produce the following records identified in Defendant’s Revised,
Consolidated Vaughn Index:
(1) Personal Importation Records Labelled “Nonresponsive:” SSOF Ex. 17, lines 82–83,
85–86, 89, 91–95, 101, 103, 105, 107, 109–111, 113.
(2) Other Records Labelled “Nonresponsive:” Id., lines 3, 7, 18–19, 23, 38, 60, 72, 79.
(3) Reclassified Records Claiming Exemption 5: Id., lines 31, 35–36.
(4) Information that is Reasonably Segregable from Records the Court Previously
Determined are Exempt from Disclosure3: Id., lines 2, 8, 13, 16, 22, 27–34, 41, 53–44, 47–50,
56–58, 76, 80–81, 96–98, 100, 104.
RESPECTFULLY SUBMITTED this 29th day of June, 2018 by:
__/s/ Jonathan Riches_____________
Jonathan Riches (025712)
Aditya Dynar (031583)
Scharf-Norton Center for Constitutional Litigation
at the GOLDWATER INSTITUTE
Attorneys for Plaintiff
3 Plaintiff does not waive its right to appeal other records identified in the Vaughn index for which the Court has already determined that a FOIA Exemption applies.
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CERTIFICATE OF SERVICE
Document Electronically Filed and Served by ECF and Copies sent via e-mail
this 29th day of June, 2018 to:
Peter M. Lantka U.S. Attorney’s Office Two Renaissance Square 40 North Central Avenue, Suite 1200 Phoenix, Arizona 85004 [email protected] Leslie Cohen U.S. Dept. of Health & Human Svcs. Office of the General Counsel Food and Drug Admin. 10903 New Hampshire Ave. WO Bld. 32, RM 4301 Silver Spring, MD 20993 [email protected]
/s/ Kris Schlott
Kris Schlott
Case 2:15-cv-01055-SRB Document 74 Filed 06/29/18 Page 15 of 15
