Viropharma Incorporated v. Department of Health and Human Services , 839 F. Supp. 2d 184 ( 2012 )

UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF COLUMBIA
____________________________________
)
VIROPHARMA INCORPORATED, )
)
Plaintiff, )
)
v. ) Civil Action No. 08-2189 (PLF)
)
DEPARTMENT OF HEALTH AND )
HUMAN SERVICES, and FOOD AND )
DRUG ADMINISTRATION, )
)
Defendants. )
____________________________________)
OPINION
This matter is before the Court on cross-motions for summary judgment filed by
the plaintiff, ViroPharma Incorporated, and the defendants, the Department of Health and Human
Services (“HHS”) and the Food and Drug Administration (“FDA”), and on ViroPharma’s motion
for in camera review. Upon consideration of the parties’ papers, the relevant statutes and case
law, and the entire record in this case, the Court will grant in part and deny in part defendants’
motion, and will deny plaintiff’s motions for summary judgment and for in camera review.1
1
The papers reviewed in connection with the pending motions include: plaintiff’s
complaint (“Compl.”) [Dkt. No. 1]; defendants’ motion for summary judgment (“Def. Mot.”)
[Dkt. No. 28]; plaintiff’s cross-motion for summary judgment and/or in camera review and
opposition to defendants’ motion (“Pl. Mot.”) [Dkt. Nos. 30, 32]; defendants’ reply to plaintiff’s
opposition and opposition to plaintiff’s motion (“Def. Reply”) [Dkt. No. 34]; and plaintiff’s reply
to defendants’ opposition (“Pl. Reply”) [Dkt. No. 37].
I. BACKGROUND
ViroPharma owns the new drug application (“NDA”) for Vancocin, a vancomycin
hydrochloride capsule (“vancomycin”). Declaration of Thomas F. Doyle (“Doyle Decl.”) ¶ 2,
May 27, 2010 [Dkt. No. 30-2]. Vancocin is indicated for the treatment of a dangerous
gastrointestinal infection caused by Clostirdium difficile bacteria. Compl. ¶ 2. At present, there
is no FDA-approved generic version of vancomycin, and Vancocin is the only FDA-approved
drug to treat C. difficile infections. Id.
Prior to 2006 the FDA recommended using in vivo studies — which involve
testing in humans — to establish the bioequivalence of generic versions of vancomycin. Doyle
Decl. ¶¶ 3-4. ViroPharma contends that, in February 2006, FDA adopted a new policy,
recommending in vitro studies — which do not require testing in humans — as sufficient to
establish bioequivalence. Doyle Decl. ¶ 4. Allegedly, FDA did not publicly announce the
change in policy, but provided information to companies that submitted inquiries regarding the
bioequivalence standards for vancomycin. Id. ¶ 5. ViroPharma learned of these events through
one such company, which publicly released the new standards, leading to a reduction in the value
of ViroPharma’s stock by roughly 40%. Id. ¶¶ 6-7.
On March 17, 2006, ViroPharma filed a citizen petition for a stay of any approvals
of abbreviated new drug applications (“ANDA”) under FDA’s new bioequivalence testing
method. Doyle Decl. ¶ 8. On March 21, 2006, ViroPharma also filed a Freedom of Information
Act request. Doyle Decl. ¶ 9. ViroPharma requested:
A copy of the entire administrative record of the decision of the
Office of Generic Drugs (OGD) (including, but not limited to,
documents related to reference number: OGD #06-0200) that
2
abbreviated new drug applications (ANDAs) or applications filed
under 505(b)(2) for vancomycin hydrochloride capsules qualify for
a waiver of in vivo bioequivalence and may demonstrate
bioequivalence to the reference listed drug Vancocin® through in
vitro dissolution testing.
Compl. ¶ 29. FDA logged the request into its tracking system and forwarded the request to the
Division of Information and Disclosure Policy (“DIDP”) in FDA’s Center for Drug Evaluation
and Research. Declaration of Frederick J. Sadler (“Sadler Decl.”) ¶¶ 6-7, April 22, 2010 [Dkt.
No. 28-2].
On December 16, 2008, FDA published a notice in the Federal Register entitled
“Draft Guidance for Industry on Bioequivalence Recommendation for Vancomycin HCI;
Availability.” Doyle Decl. Ex. 3. Although the notice did not contain the administrative record
for FDA’s March 2006 decision, it did limit the use of in vitro testing to generic vancomycin
tablets whose inactive ingredients are qualitatively and quantitatively the same as Vancocin; for
others, in vivo testing was recommended. Doyle Decl. ¶¶ 12-13.
On December 16, 2008, ViroPharma filed this lawsuit to enforce FDA’s
obligations under the FOIA and submitted a second FOIA request seeking records related to the
2008 Draft Guidance. Doyle Decl. ¶¶ 14-15. ViroPharma’s second request sought
[a] copy of all records of the decision of the Food and Drug
Administration (including, but not limited to, documents related
[to] FDA’s Draft Guidance for Industry on Bioequivalence
Recommendation for Vancomycin HCL assigned docket number
FDA-2008-D-0626) recommending in vitro dissolution studies for
test formulations of Vancomycin HCL that are qualitatively (Q1)
and quantitatively (Q2) the same as the reference listed drug with
respect to inactive ingredients and recommending in vivo
bioequivalence studies with clinical endpoints for test formulations
that are not Q1 and Q2 the same as the RLD with respect to
inactive ingredients; including . . . [a]ny Agency communication(s)
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regarding the above recommendations with any third party outsidde
of the FDA prior to December 15, 2008.
Sadler Decl. Ex. B. FDA routed both of ViroPharma’s requests to DIDP and the Office of the
Executive Secretariat; Office of Legislation; Office of Policy, Planning, and Preparedness; and
Office of the Chief Counsel. Sadler Decl. ¶¶ 8, 11.
On March 22, 2009, FDA produced documents in response to ViroPharma’s
FOIA requests from the Office of the Commissioner of the FDA. Doyle Decl. ¶ 16. On October
28, 2009, FDA produced additional documents from the Center for Drug Evaluation and
Research. Id. Between November 11, 2009 and March 24, 2010, ViroPharma sent letters
identifying documents it believed were responsive but had not been released. Id. ¶ 17. FDA
released additional documents on December 9, 2009; February 24, 2010; and April 22, 2010. Id.
¶¶ 21, 25, 27. Throughout FDA’s releases, it has withheld, in whole or in part, over
700 documents pursuant to the deliberative process privilege under FOIA Exemption 5. Sadler
Decl. ¶¶ 23-24.2 It has withheld over 100 documents pursuant to Exemption 4. Sadler Decl.
¶ 28. And it has withheld a “handful of records[]” pursuant to Exemption 6. Sadler Decl ¶ 35.
On April 22, 2010, defendants filed a motion for summary judgment in this case.
With their motion, they included a Vaughn index listing the documents withheld; the documents’
length; whether the documents were withheld in whole or in part; and the justifications for the
withholdings. Sadler Decl. Ex. C. ViroPharma filed a cross-motion for summary judgment on
May 27, 2010. ViroPharma requested that the Court require FDA to provide it with a number of
2
It also withheld documents under Exemption 5 on the basis of attorney-client
privilege and attorney work-product privilege. But those matters are no longer at issue in this
case. See infra at 12 n.6.
4
documents and portions of documents FDA is withholding under Exemptions 4 and 5, and to
conduct an in camera review of the withheld documents. Pl. Mot. at 12, 24, 30. In concert with
defendant’s reply brief, FDA has released to ViroPharma several documents it had been
withholding under Exemptions 4 and 5. See, e.g., Second Declaration of Frederick J. Sadler
(“Sadler Decl. Reply”) ¶ 9, June 30, 2010 [Dkt. No. 34-2]; Second Declaration of Nancy B.
Sager (“Sager Decl. Reply”) ¶¶ 6, 11, 21, June 24, 2010 [Dkt. No. 34-3].
II. LEGAL STANDARD
Under Rule 56 of the Federal Rules of Civil Procedure, summary judgment is
appropriate if the movant shows that there is no genuine issue as to any material fact and that the
movant is entitled to judgment as a matter of law. FED . R. CIV . P. 56(a). The movant bears the
burden of demonstrating the absence of a genuine issue of material fact. Celotex Corp. v.
Catrett, 477 U.S. 317, 322 (1986). Factual assertions in the moving party’s affidavits or
declarations may be accepted as true unless the opposing party submits its own affidavits or
declarations or documentary evidence to the contrary. Neal v. Kelly, 963 F.2d 453, 456 (D.C.
Cir. 1992).
The FOIA requires a federal agency to release all records responsive to a proper
request except those protected from disclosure by one or more of nine enumerated exemptions
set forth in 5 U.S.C. § 552(b). See 5 U.S.C. § 552(b). FOIA cases typically and appropriately
are decided on motions for summary judgment. See Defenders of Wildlife v. U.S. Border Patrol,
623 F. Supp. 2d 83, 87 (D.D.C. 2009); Bigwood v. U.S. Agency for Int’l Dev., 484 F. Supp. 2d
68, 73 (D.D.C. 2007). The agency opposing the grant of summary judgment has the burden of
5
proving that “each document that falls within the class requested either has been produced, is
unidentifiable, or is wholly exempt from the Act’s inspection requirements.” Goland v. CIA, 607
F.2d 339, 352 (D.C. Cir. 1978) (internal citation and quotation omitted); see Maydak v.
Department of Justice, 218 F.3d 760, 763-64 (D.C. Cir. 2000). The court may award summary
judgment to an agency solely on the basis of information provided in affidavits or declarations
that describe “the documents and the justifications for nondisclosure with reasonably specific
detail, demonstrate that the information withheld logically falls within the claimed exemption,
and are not controverted by either contrary evidence in the record nor by evidence of agency bad
faith.” Military Audit Project v. Casey, 656 F.2d 724, 738 (D.C. Cir. 1981); see Hertzberg v.
Veneman, 273 F. Supp. 2d 67, 74 (D.D.C. 2003). A Vaughn index is a common device used by
agencies to meet this burden of proof. See Judicial Watch v. FDA, 449 F.3d 141, 146 (D.C. Cir.
2006); Vaughn v. Rosen, 484 F.2d 820, 826 (D.C. Cir. 1973).
III. DISCUSSION
Defendants state that FDA’s search was reasonably calculated to uncover all
responsive records. Def. Mot. at 10. They provide declarations from FDA’s Director of the
Division of Freedom of Information and FDA’s Director of Information Disclosure Policy
describing the search conducted in response to ViroPharma’s requests. See Sadler Decl;
Declaration of Nancy B. Sager (“Sager Decl.”), April 22, 2010 [Dkt. No. 28-3]. ViroPharma
does not contend that FDA’s search was insufficient. Instead, ViroPharma argues that FDA
improperly withheld relevant documents under Exemptions 4 and 5. Pl. Mot. at 2, 12, 24. In
addition, ViroPharma argues that FDA did not properly segregate factual material that it is
6
entitled to receive under the FOIA. Id. at 11. And finally, ViroPharma argues that in camera
review is necessary in this case, primarily because, they assert, FDA has acted in bad faith. Pl.
Reply at 21.3
A. Exemption 4
FOIA Exemption 4 protects from disclosure matters that are “trade secrets and
commercial or financial information obtained from a person and privileged or confidential.”
5 U.S.C. § 552(b)(4). Typically, materials implicating Exemption 4 are not generated by the
agency, but are obtained from third parties either by request or by statutory or regulatory
requirements. Judicial Watch, Inc. v. FDA, 449 F.3d at 148. Such commercial or financial
information received from third parties is deemed confidential if disclosure of the information is
likely (1) to impair the government agency’s ability to obtain necessary information from third
parties in the future, or (2) to cause substantial harm to the competitive position of the person
from whom the information was obtained. Id.; Nat’l Parks and Conservation Ass’n v. Morton,
498 F.2d 765, 770 (D.C. Cir. 1974). ViroPharma disputes FDA’s withholding under
Exemption 4 with respect to two categories: information referencing pending ANDAs, and
incoming correspondence from drug manufacturers.
3
FDA has redacted portions of several documents under FOIA Exemption 6
because the sections contain personal identity information. See 5 U.S.C. § 552(b)(6); Sadler
Decl. ¶ 35, April 22, 2010 [Dkt. No. 38-2]. Exemption 6 “allows an agency to withhold
‘personnel and medical files and similar files the disclosure of which would clearly constitute an
unwarranted invasion of personal privacy.’” Reliant Energy Power Generation, Inc. v. FERC,
520 F. Supp. 2d 194, 207 (D.D.C. 2007). ViroPharma does not dispute the validity of these
withholdings, and the FDA has demonstrated that the redactions are appropriate under
Exemption 6. Consequently, the Court will grant defendants’ motion for summary judgment
with respect to these redactions.
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1. Documents Referencing Pending ANDAs
Defendants argue that all information referencing pending ANDAs may properly
be withheld under Exemption 4 because FDA is barred by its own regulations from releasing any
information about a drug application prior to its approval, see 21 C.F.R. §§ 314.430(d),
314.430(e); because “information about the existence, identity, and status for new drug
applications . . . constitutes ‘commercial’ information in that it reflects a company’s business
plans and marketing strategies”; and because “a company’s plans about prospective products are
closely guarded commercial secrets.” Def. Mot. at 23-25.4
ViroPharma accepts the proposition that “the identity of the ANDA filers,
information contained in the ANDAs, information regarding the approval status of the ANDAs,
trade secret information such as drug formulas or manufacturing processes, or confidential
commercial information” all are properly exempt under Exemption 4. Pl. Reply at 9.
ViroPharma argues that with respect to approximately 70 documents, however, FDA over-claims
Exemption 4 by removing all information that references pending ANDAs. Id. ViroPharma
appears to request that FDA release the portions of documents that “reference” pending ANDAs,
but are not covered within the above list. The Court, however, cannot discern any portion of the
documents that would “reference” pending ANDAs but does not discuss information contained
in the ANDAs or implicate the approval process. ViroPharma itself provides no indication of
what such information might be.
4
FDA also claims that the information referencing pending ANDAs is
nonresponsive because pending ANDA filings are not considered when developing FDA’s
bioequivalence recommendations for vancomycin. See Def. Mot. at 23. Because the Court
concludes that FDA has properly withheld this information under Exemption 4, it need not reach
this argument.
8
The content of pending drug applications may be withheld under Exemption 4
where it contains safety and effectiveness information obtained through preliminary trials,
evidence of side effects and their magnitude, or “drug product manufacturing information or drug
chemical composition and specifications.” Appleton v. FDA, 451 F. Supp. 2d 129, 141 n.7
(D.D.C. 2006). Although “[c]onclusory and generalized allegations of substantial competitive
harm . . . cannot support an agency’s decision to withhold requested documents[]” in the context
of pending drug applications, Public Citizen Health Research Group v. FDA, 185 F.3d 898, 906
(D.C. Cir. 1999) (quoting Public Citizen Health Research Group v. FDA, 704 F.2d 1280, 1291
(D.C. Cir. 1983)), ViroPharma acknowledges that the content of pending ANDAs for
vancomycin is protected by Exemption 4. See Pl. Reply at 9; see also Judicial Watch v. FDA,
449 F.3d at 148-49. Information that discusses or analyzes this protected content is similarly
properly withheld.5
ViroPharma lists specific documents in which whole paragraphs have been
redacted and argues that only the names of filers and the drug formula should have been redacted
and the rest of the paragraph released. Pl. Reply at 9-14. If it were the case that this was the only
information that could properly be redacted under Exemption 4, then the FDA would be required
to redact the name and formula and provide the rest. As noted, however, ViroPharma
acknowledges that Exemption 4 covers more than just the names of filers and drug formulas.
The Court concludes that FDA has properly redacted portions of these documents under the
5
To the extent that ViroPharma’s distinction between its list of properly withheld
material and documents “referencing” pending ANDAs is really a suggestion that FDA has failed
to properly segregate, the Court concludes that defendants have satisfied their segregability
requirements. See infra at 17-19.
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broader category of information referencing specific pending ANDAs and their contents.
Judicial Watch, Inc. v. FDA, 449 F.3d at 148-49; Appleton v. FDA, 451 F. Supp. 2d at 141-142
n. 7. That whole paragraphs have been redacted in some documents does not alone demonstrate
improper withholdings.
2. Incoming Correspondence
ViroPharma takes issue with FDA’s withholding of incoming correspondence
from drug manufacturers and other members of the industry that relate to the bioequivalence
standard for vancomycin. Pl. Reply at 4. For some of this correspondence, FDA has stated in
one of its declarations that “[t]he inquiries about the bioequivalence requirements . . . are
intertwined with other information about the inquiring entity and its proposed product.” Sadler
Decl. Reply ¶ 19 (discussing Vaughn index Nos. 908, 960 & 961). For other incoming
correspondence, FDA claims that the information need not be released because the documents
are nonresponsive. Def. Reply at 24-34; see e.g., Sadler Decl. Reply ¶¶ 17-19.
Where documents reference pending ANDAs, FDA has properly redacted this
information, see supra at 8-10, and has also demonstrated that it has segregated non-exempt
information. See infra at 17-19. To the extent that the incoming correspondence discusses drug
products other than vancomycin, see Def. Reply at 25, it is nonresponsive and FDA is not
required to release it. But with regard to the portions of documents that discuss FDA’s
bioequivalence recommendations for vancomycin generally without reference to a drug
manufacturer’s pending ANDA filing, FDA must produce this information so long as it is
segregable from the properly exempt information. Such information is responsive to
10
ViroPharma’s FOIA request, which must be read broadly. See Milner v. Department of the
Navy, 131 S. Ct. 1259, 1265 (2011) (FOIA strongly favors openness and “‘broad disclosure’”
with narrowly construed exemptions). The Court therefore will require FDA to supplement its
declarations and Vaughn index to establish whether any requests for information on
bioequivalence recommendations for vancomycin by drug manufacturers in their incoming
correspondence can be segregated from the properly exempt information. See Sadler Decl. Ex. C
(Vaughn index Nos. 2, 9-10, 92-93, 95, 178, 197-99, 208-09, 235, 271-73, 282, 282, 355, 390,
397-403, 407, 409, 424, 434, 442-47, 465, 474-75, 481-83, 489, 493, 499, 504, 906-08, 960-63,
1197-98 & 1200-02).
B. Exemption 5
FOIA Exemption 5 protects from disclosure “inter-agency or intra-agency
memorandums or letters which would not be available by law to a party . . . in litigation with the
agency.” 5 U.S.C. § 552(b)(5); see Ancient Coin Collectors Guild v. Department of State, 641
F.3d 504, 512 (D.C. Cir. 2011). It “incorporates the traditional privileges the Government could
assert in civil litigation against a private litigant — including . . . the attorney-client privilege, the
work product privilege, and the deliberative process privilege — and excludes these privileged
documents from FOIA’s reach.” Loving v. Dep’t of Defense, 550 F.3d 32, 37 (D.C. Cir. 2008)
(internal quotations omitted); see also Wilderness Soc. v. Department of Interior, 344 F. Supp. 2d
1, 9 (D.D.C. 2004); Defenders of Wildlife v. Department of Agriculture, 311 F. Supp. 2d 44, 57
(D.D.C. 2004). ViroPharma disputes FDA’s withholdings under Exemption 5’s deliberative
11
process privilege with respect to three groups of documents: draft documents; internal review
documents; and laboratory data.6
The deliberative process privilege protects agency documents that are both
predecisional and deliberative. Ancient Coin Collectors Guild v. Department of State, 641 F.3d
at 512; Judicial Watch, Inc. v. FDA, 449 F.3d at 151. A document is “predecisional” if it was
generated before the agency action was finally adopted, and “deliberative” if it “reflects the
give-and-take of the consultative process.” Public Citizen, Inc. v. OMB, 598 F.3d 865, 874
(D.C. Cir. 2010) (internal quotations omitted). The deliberative process privilege encourages
open, frank discussions by agency policy makers, protects against premature disclosure of
proposed policies before they are finally adopted, and protects against confusing the issues and
misleading the public about reasons and rationales that, in the end, were not in fact among the
grounds for decision. See id.; Appleton v. FDA, 451 F. Supp. 2d at 142.
1. Draft Documents
The FDA has withheld draft versions of numerous documents under the
deliberative process privilege. While acknowledging that the deliberative process may be
protected, ViroPharma argues that FDA must provide the factual content and recitations of past
final agency decisions that are contained within the drafts. Pl. Reply at 15-18.
6
FDA has withheld several documents under the attorney work-product privilege
and the attorney-client privilege. See 5 U.S.C. § 552(b)(5); Def. Mot. at 19-22. ViroPharma
does not dispute the validity of these withholdings, and the Court concludes that FDA has
demonstrated that the redactions are appropriate under Exemption 5. Consequently, the Court
will grant defendants’ motion for summary judgment with respect to the redactions under the
work-product and attorney-client privileges.
12
Although there is a longstanding distinction between factual and deliberative
materials under Exemption 5, see Goodrich Corp. v. EPA, 593 F. Supp. 2d 184, 189 (D.D.C.
2009) (citing EPA v. Mink, 410 U.S. 73, 79 (1973)), ViroPharma is incorrect when it argues that
FDA must segregate and disclose the factual background and recitations of past agency final
decisions from the draft documents in this case. “Exemption 5 was intended to protect not
simply deliberative material, but also the deliberative process of agencies.” Montrose Chemical
Corp. v. Train, 491 F.2d 63, 71 (D.C. Cir. 1974) (emphasis added). Thus, “in some cases
selection of facts or summaries may reflect a deliberative process which exemption 5 was
intended to shelter.” Id.; see also Mead Data Cent., Inc. v. Department of the Air Force, 566 F.2d
242, 256 (D.C. Cir. 1977) (“In some circumstances, . . . the disclosure of even purely factual
material may so expose the deliberative process within an agency that it must be deemed
exempted[.]”).
The choice of what factual material and prior final agency opinions to include or
remove during the drafting process is itself often part of the deliberative process, and thus is
properly exempt under Exemption 5. See Reliant Energy Power Generation, Inc. v. FERC, 520
F. Supp. 2d at 204 (“‘[D]isclosure of editorial judgments — for example, decisions to insert or
delete material or to change a draft’s focus or emphasis — would stifle the creative thinking and
candid exchange of ideas[.]’”) (quoting Dudman Commc’ns Corp. v. Department of the Air
Force, 815 F.2d 1565, 1569 (D.C. Cir. 1987)). In Goodrich Corp. v. EPA, 593 F. Supp. 2d 184(D.D.C. 2009), for example, Judge Bates permitted the EPA to withhold the factual content and
data contained within a draft model under Exemption 5 because “evolving iterations of the
model’s inputs and calibration reflect the opinions of the staff currently developing the model,
13
which may not represent EPA’s ultimate opinions relating to these matters. . . . [E]ven if the data
plugged into the model is itself purely factual, the selection and calibration of data is part of the
deliberative process to which Exemption 5 applies.” Id. at 189. The Court is persuaded by the
defendants’ submission that such is the case here.
ViroPharma relies on Brinton v. Department of State, 636 F.2d 600 (D.C. Cir.
1980), in which the court of appeals stated that “Exemption 5 does not protect final statements of
policy or final actions of agencies.” Id. at 605. The court in Brinton, however, was referring to
documents that were themselves final agency opinions, not recitations of final opinions contained
within subsequent deliberative recommendations. Indeed, the documents in question in Brinton
were properly withheld under Exemption 5, and the court did not require any portions of them to
be segregated. Id. (“The requested documents in this case, however, bear no indicia of finality.”).
2. Internal Review Documents
“Purely factual material usually cannot be withheld under Exemption 5 unless it
reflects an ‘exercise of discretion and judgment calls.’” Ancient Coin Collectors Guild v.
Department of State, 641 F.3d at 513 (quoting Mapother v. Department of Justice, 3 F.3d 1533,
1539 (D.C. Cir. 1993)). While factual material need not be segregated from draft documents
because the choice to include or remove such material in each draft reflects the agency’s
deliberative process, see supra at 13-14, this rationale does not apply to internal documents
generally. But where factual material is “assembled through an exercise of judgment in
extracting pertinent material from a vast number of documents for the benefit of an official called
upon to take discretionary action[,]” the information may be withheld. Ancient Coin Collectors
14
Guild v. Department of State, 641 F.3d at 513 (quoting Mapother v. Department of Justice,
3 F.3d at 1539).
ViroPharma requests that the factual information and recitations of settled agency
policy that are contained in internal review documents be segregated and released. Pl. Reply
at 12-13. For the reasons previously discussed, the majority of these documents are properly
redacted under Exemption 5 as part of the deliberative process, see Sadler Decl. Ex. C (Vaughn
index Nos. 295, 318, 414, 415, 645 & 646); supra at 13-14, or under Exemption 4 because they
reference pending ANDAs. See Sadler Decl. Ex. C (Vaughn index Nos. 498, 510, 522, 523, 645,
646 & 905); supra at 8-10. But one portion of one document is redacted because it contains a
summary of the regulatory background of vancomycin, although it does not appear to be a draft.
See Sadler Decl. Ex. C (Vaughn index No. 235). In addition, ViroPharma singles out four
documents from the medical officer’s review of pending ANDAs that ViroPharma contends are
withheld in full. Pl. Reply at 12. The justification for withholding these documents is that they
contain internal deliberations and reference pending ANDAs. Sadler Decl. Ex. C (Vaughn index
Nos. 495, 497, 507 & 509).
In reviewing defendants’ Vaughn index and declarations, the Court cannot discern
whether factual portions of these internal review documents were or were not withheld in full or
were provided in redacted form. The Court therefore will require FDA to supplement its
declarations and Vaughn index to establish whether factual portions of non-draft review
documents were redacted and why they were redacted; or, if they were withheld in full, why they
cannot be provided in redacted form. See Sadler Decl. Ex. C. (Vaughn index Nos. 235, 495, 497,
507 & 509).
15
In addition, ViroPharma asserts that FDA withheld a paragraph of a 2006 review
document that contains FDA control numbers of incoming communications, which ViroPharma
wishes to review in order to determine the number of letters submitted to FDA. Pl. Reply at 14
(referencing Vaughn index Nos. 295, 318, 414-15, & 645-46). The Court cannot discern, from
the Vaughn index and the parties’ filings, whether the documents ViroPharma points to contain
the withheld paragraph, or for what reason FDA is claiming the information should be withheld.
The Court therefore also will require FDA to supplement its Vaughn index and declaration with
respect to Nos. 295, 318, 414-15, and 645-46.
3. Laboratory Data
Finally, ViroPharma objects to FDA withholding laboratory data contained within
records prepared to assist the agency’s development of its bioequivalence recommendations.
Def. Reply at 21; Pl. Reply at 18; Sadler Decl. Ex. C (Vaughn index Nos. 46, 48, 53, 54).
ViroPharma argues that the laboratory data must be segregated from the sections containing
deliberations and must be released. It cites Bristol-Myers Co. v. FTC, 424 F.2d 935 (D.C. Cir.
1970), which states that “[p]urely factual reports and scientific studies cannot be cloaked in
secrecy by an exemption designed to protect . . . internal working papers in which opinions are
expressed[.]” Id at 939 (emphasis added) (internal quotations omitted). That case is not directly
on point, however, because the preliminary reports that ViroPharma requests are not purely
factual reports, but contain the internal deliberations of the FDA, including the analysis of the
data found in those studies. Sager Decl. Reply ¶ 16.
16
Defendants argue “that preliminary scientific data are properly part of an agency’s
deliberative process[.]” Def. Reply at 21. Defendants cite Chemical Manufacturers Ass’n v.
Consumer Product Safety Commission, 600 F. Supp. 114 (D.D.C. 1984), for the proposition that
preliminary scientific data generated in connection with an ongoing policy deliberation may
properly be withheld under Exemption 5. Id. at 118. ViroPharma responds that the laboratory
data cannot be withheld because deliberations are no longer ongoing, the reports were prepared
for a 2009 dissolution study, and the study has now been released. Pl. Reply at 20.
It is not clear to the Court what bioequivalence recommendation the reports were
prepared for. FDA merely states that the records were prepared “in the course of [FDA’s]
development of a bioequivalence recommendation[.]” Sager Decl. Reply ¶ 16. The Court
therefore will require FDA to supplement its Vaughn index and declarations to establish which
bioequivalence recommendation the laboratory results were originally prepared for and why the
documents are properly withheld. See Sadler Decl. Ex. C. (Vaughn index nos. 46, 48, & 53-54).
C. Segregability
Under the FOIA, “[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). “‘It has long been the rule in this Circuit that non-exempt portions of a
document must be disclosed unless they are inextricably intertwined with exempt portions.’”
Wilderness Soc. v. Department of Interior, 344 F. Supp. 2d at 18 (quoting Mead Data Cent., Inc.
v. Department of Air Force, 566 F.2d at 260); see also Zavala v. Drug Enforcement Admin.,
667 F. Supp. 2d 85, 102 (D.D.C. 2009). And the agency has “the burden of demonstrating that
17
[the] withheld documents contain no reasonably segregable factual information.” Mokhiber v.
Department of the Treasury, 335 F. Supp. 2d 65, 68-69 (D.D.C. 2004). “The adequacy of the
Vaughn index in regard to the segregability question turns on whether the agency has sufficiently
explained why there was no reasonable means of segregating factual material from the claimed
privileged material.” Wilderness Soc. v. Department of Interior, 344 F. Supp. 2d at 18. “[A]
blanket declaration that all facts are so intertwined to prevent disclosure under the FOIA does not
constitute a sufficient explanation of non-segregability.” Id. at 19; see Barnard v. Department of
Homeland Sec., 531 F. Supp. 2d 131, 140 (D.D.C. 2008).
Defendants argue that they have satisfied their segregability obligations because
all records responsive to ViroPharma’s request were reviewed “line-by-line” and the agency
redacted only portions of documents where appropriate. Def. Mot. at 27-28. Regardless of
whether a declaration that an agency conducted a “line-by-line” search is sufficient to satisfy an
agency’s obligations in and of itself, compare Elec. Privacy Info. Ctr. v. Transp. Safety Admin.,
Civil Action No. 03-1846, 2006 WL 626925, at *8 (D.D.C. Mar. 12, 2006) (finding that an
avowal of a “line-by-line” search is not determinative as to whether the agency satisfied its
segregability obligations), with Perry-Torres v. Department of State, 404 F. Supp. 2d 140, 144
(D.D.C. 2005) (“At a minimum, the explanation should state that a line-by-line analysis of each
document was conducted[.]”), a statement representing that a “line-by-line” search was
conducted along with a sufficiently detailed Vaughn index and declarations enumerating the
reasons why each document was properly withheld is “sufficient to fulfill the agency’s
obligation” regarding segregability. Elec. Privacy Info. Ctr. v. Transp. Safety Admin., 2006 WL
626925, at *8 (quoting Johnson v. Executive Office for United States Attorneys, 310 F.3d 771,
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776 (D.C. Cir. 2002)). Having reviewed the Vaughn index and the declarations submitted by the
defendants, the Court concludes that, except as discussed supra at 10-11, 15-17, defendants have
satisfied their segregability obligations for all documents that they have withheld or withheld in
part under an enumerated exemption.
D. In Camera Review and Bad Faith
In support of its motion for in camera review, ViroPharma’s central argument is
that FDA has acted in bad faith in replying to ViroPharma’s FOIA request. For this argument,
ViroPharma relies primarily on FDA’s rolling release of documents during the course of this
litigation. Pl. Reply at 21-22. The argument that such a rolling release indicates bad faith has
been “emphatically reject[ed]” by the D.C. Circuit. Meeropol v. Meese, 790 F.2d 942, 953 (D.C.
Cir. 1986) (quoting Military Audit Project v. Casey, 656 F.2d at 754). It is established that
“continuing discovery and release of documents . . . shows good faith on the part of the agency
that . . . continues to search for responsive documents.” Landmark Legal Foundation v. EPA,
272 F. Supp. 2d 59, 63 (D.D.C. 2003) (citing Meeropol v. Meese, 790 F.2d at 952-53) (emphasis
added). Accepting ViroPharma’s argument “would work mischief in the future by creating a
disincentive for an agency to reappraise its position, and when appropriate, release documents
previously withheld.” Meeropol v. Meese, 790 F.2d at 953 (quoting Military Audit Project v.
Casey, 656 F.2d at 754).
ViroPharma argues that supplemental releases may indicate bad faith if supported
by other evidence. Pl. Reply at 21. The “other evidence” ViroPharma points to is that, after one
set of documents was released, FDA expressed to ViroPharma that it was “confident” that it had
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met its obligations but then, months later, released another set of documents. Pl. Reply at 21.
ViroPharma’s argument is unpersuasive. After an agency has released documents, it is certainly
reasonable for it to believe it has met its FOIA obligations. FDA’s statement was not an
indication that FDA would not continue to respond to ViroPharma’s inquiries. Indeed, after the
initial release, the parties continued to correspond with each other and to litigate this case,
leading to the further release of documents. This is exactly what the good faith presumption for
subsequent releases is meant to encourage.
As ViroPharma acknowledges, in camera review is committed to the discretion of
the district court. See Juarez v. Department of Justice, 518 F.3d 54, 59-60 (D.C. Cir. 2008);
Quinon v. FBI, 86 F.3d 1222, 1227 (D.C. Cir. 1996). While the FOIA provides district courts the
“option” to conduct in camera review, “it by no means compels the exercise of that option.”
Juarez v. Department of Justice, 518 F.3d at 60. The Court, in its discretion, does not find any
basis to conduct an in camera review in this case. The Court therefore will deny ViroPharma’s
request.7
7
ViroPharma has provided the Court with a notice of supplemental authority [Dkt.
No. 39]. ViroPharma provides documents relating to an FDA employee who allegedly engaged
in insider trading and documents, which, it asserts, indicate that FDA did not locate all relevant
documents. The first set of documents have no bearing on this case; the individual FDA
employee had no involvement in FDA’s vancomycin approval process. The second set of
documents is not supplemental at all; the documents are several years old and already before the
parties and the Court.
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IV. CONCLUSION
For the foregoing reasons, the Court will require defendants to supplement the
Vaughn index and declarations with respect to Vaughn index Nos. 2, 9-10, 46, 48, 53-54, 92-93,
95, 178, 197-99, 208-09, 235, 271-73, 282, 282, 295, 318, 355, 390, 397-403, 407, 409, 414-15,
424, 434, 442-47, 465, 474-75, 481-83, 489, 493, 495, 497, 499, 504, 507, 509, 645-46, 906-08,
960-63, 1197-98, and 1200-02. Defendants’ motion for summary judgment will be granted with
respect to all other documents and denied without prejudice with respect to the above listed
documents. Plaintiff’s motion for summary judgment and motion for in camera review will be
denied. An Order consistent with this Opinion shall issue this same day.
SO ORDERED.
/s/
PAUL L. FRIEDMAN
DATE: March 16, 2012 United States District Judge
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