United States Court of Appeals
FOR THE DISTRICT OF COLUMBIA CIRCUIT
Argued April 25, 2006 Decided June 2, 2006
No. 05-5256
JUDICIAL WATCH, INC.,
APPELLANT
v.
FOOD & DRUG ADMINISTRATION, ET AL.,
APPELLEES
Appeal from the United States District Court
for the District of Columbia
(No. 00cv02973)
Meredith L. Di Liberto argued the cause for appellant. With
her on the briefs was Paul J. Orfanedes.
Fred E. Haynes, Assistant U.S. Attorney, argued the cause
for appellees Food & Drug Administration. With him on the
brief were Kenneth L. Wainstein, U.S. Attorney, Michael J.
Ryan, and Eric M. Blumberg, Deputy Chief Counsel, Food &
Drug Administration. R. Craig Lawrence, Assistant U.S.
Attorney, entered an appearance.
Nancy L. Buc, Kate C. Beardsley, and Carmen M. Shepard
were on the brief for appellees Population Council, Inc. and
Danco Laboratories, LLC.
2
Before: SENTELLE, HENDERSON and GARLAND, Circuit
Judges.
Opinion for the Court filed by Circuit Judge SENTELLE.
SENTELLE, Circuit Judge: Judicial Watch filed an action in
the District Court for the District of Columbia, seeking
enforcement of its Freedom of Information Act (“FOIA”)
request for all documents related to the Food and Drug
Administration’s (“FDA”) approval of the drug mifepristone. It
now appeals from the District Court’s grant of summary
judgment in favor of the FDA. Although we affirm the District
Court’s decision in a number of respects, because the FDA
produced an inadequately detailed Vaughn index, we remand for
further explanation of some of the index’s entries.
I. Background
In September 2000, the FDA approved the drug
mifepristone, better known as RU-486, for “medical abortion”
during the first 49 days of pregnancy. Shortly thereafter,
Judicial Watch submitted a FOIA request seeking all
mifepristone-related documents in the FDA’s possession. A few
months later, having not received any documents, Judicial
Watch sought to enforce its request in the District Court. The
FDA requested a stay, which the District Court granted. The
District Court ordered the FDA to produce all responsive
documents by October 15, 2001.
After searching about 250,000 pages of information, the
FDA disclosed over 9,000 relevant pages to Judicial Watch on
a compact disc. It withheld over 4,000 other relevant documents
in their entirety and parts of almost 2,000 more. The FDA
compiled and produced a 1,500-page Vaughn index to
summarize the withholdings. See Vaughn v. Rosen, 484 F.2d
3
820 (D.C. Cir. 1973). In addition to its Vaughn index, the FDA
filed a supporting declaration by Andrea Masciale, who
supervised the FDA’s search and review of documents for
Judicial Watch’s FOIA request. The Masciale declaration
described the types of withheld information and defended the
application of FOIA Exemptions 3, 4, 5, and 6 to that
information. Danco Laboratories and Population
Council—mifepristone’s creator and manufacturer,
respectively—intervened in the suit and filed two additional
affidavits. The intervenors’ affidavits supported the FDA’s
reasons for using Exemptions 4 and 6 to withhold information
submitted to it during mifepristone’s approval.
The FDA moved for summary judgment. Judicial Watch
opposed the motion claiming the FDA performed an inadequate
search, filed an inadequately detailed Vaughn index, and
invoked several FOIA exemptions improperly. The District
Court granted summary judgment for the FDA as to all matters.
Judicial Watch now appeals the District Court’s judgment as to
the adequacy of the FDA’s Vaughn index and the exemptions.
We review de novo the District Court’s grant of summary
judgment. Chappell-Johnson v. Powell, 440 F.3d 484, 487
(D.C. Cir. 2006).
II. Adequacy of the Vaughn Index
Judicial Watch primarily argues that the FDA has produced
an inadequately detailed Vaughn index. In this section, we
consider—and reject—the challenge in its broadest sense, as a
facial attack on the structure of the Vaughn index. Although we
find nothing structurally wrong with the FDA’s submission, we
find merit in the narrower part of Judicial Watch’s adequacy
argument, specifically that the FDA has vaguely described some
individual documents. We defer discussion of the vagueness
inquiries until Section III and its subsections dealing with each
4
individual FOIA exemption at issue.
We also note at the outset that at oral argument Judicial
Watch appeared to concede the untenable position of its
challenge to the adequacy of detail regarding documents only
partially withheld. The FDA argued—and we agree—that the
released portion of each document satisfied its Vaughn burden
by supplementing the corresponding Vaughn index entries. The
released content of the documents served to illuminate the
nature of the redacted material, often limited to names or
addresses. Therefore, we find that the Vaughn index adequately
described the partially withheld documents. As with the
vagueness questions, we reserve until Section III our discussion
of the merits of the FDA’s decision to redact certain documents.
A. Functions of the Vaughn Index Requirement
Because of its unique evidentiary configuration, the typical
FOIA case “distorts the traditional adversary nature of our legal
system’s form of dispute resolution.” King v. U.S. Dep’t of
Justice, 830 F.2d 210, 218 (D.C. Cir. 1987) (quoting Vaughn,
484 F.2d at 824). When a party submits a FOIA request, it faces
an “asymmetrical distribution of knowledge” where the agency
alone possesses, reviews, discloses, and withholds the subject
matter of the request. Id. The agency would therefore have a
nearly impregnable defensive position save for the fact that the
statute places the burden “on the agency to sustain its action.”
5 U.S.C. § 552(a)(4)(B); see also Coastal States Gas Corp. v.
Dep’t of Energy, 617 F.2d 854, 861 (D.C. Cir. 1980) (“[T]he
burden is on [the agency] to establish [its] right to withhold
information from the public.”).
Possessing both the burden of proof and all the evidence,
the agency has the difficult obligation to justify its actions
without compromising its original withholdings by disclosing
5
too much information. The Vaughn index provides a way for
the defending agency to do just that. By allowing the agency to
provide descriptions of withheld documents, the index gives the
court and the challenging party a measure of access without
exposing the withheld information. The Vaughn index thereby
also serves three important functions that help restore a healthy
adversarial process:
[I]t forces the government to analyze carefully any material
withheld, it enables the trial court to fulfill its duty of ruling
on the applicability of the exemption, and it enables the
adversary system to operate by giving the requester as much
information as possible, on the basis of which he can
present his case to the trial court.
Keys v. U.S. Dep’t of Justice, 830 F.2d 337, 349 (D.C. Cir.
1987) (internal quotation marks and citation omitted).
As past cases demonstrate, we focus on the functions of the
Vaughn index, not the length of the document descriptions, as
the touchstone of our analysis. See, e.g., Tax Analysts v. IRS,
410 F.3d 715, 719-20 (D.C. Cir. 2005) (approving of Vaughn
index with short descriptions because a combination of
declarations and in camera review provided sufficient
information for the court to review the claimed exemptions);
Coastal States Gas, 617 F.2d at 861 (finding index with short
descriptions inadequate because the supporting affidavits made
“conclusory assertions of privilege”). Indeed, an agency may
even submit other measures in combination with or in lieu of the
index itself. Keys, 830 F.2d at 349 (“[I]t is the function, not the
form, of the index that is important.”). Among other things, the
agency may submit supporting affidavits or seek in camera
review of some or all of the documents “so long as they give the
reviewing court a reasonable basis to evaluate the claim of
privilege.” Gallant v. NLRB, 26 F.3d 168, 172-73 (D.C. Cir.
6
1994) (internal quotation marks and citation omitted). Any
measure will adequately aid a court if it “provide[s] a relatively
detailed justification, specifically identif[ies] the reasons why a
particular exemption is relevant and correlat[es] those claims
with the particular part of a withheld document to which they
apply.” Mead Data Cent., Inc. v. U.S. Dep’t of Air Force, 566
F.2d 242, 251 (D.C. Cir. 1977).
B. The Structure of the FDA’s Index
In this case, the FDA took a combined approach. In
response to Judicial Watch’s FOIA request, it produced a 1,500-
page Vaughn index and supplemented the index with the
supporting declaration of Andrea Masciale. The index itself
includes eleven categories, consisting of the following: (1) an
index identification number; (2) the document’s subject; (3) its
date; (4) the author; (5) the recipient; (6) the total number of
pages; (7) a category entitled “Attach Page”; (8) the disposition
(that is, whether entirely or partially withheld); (9) the reason for
being withheld; (10) the statutory authority for the withholding;
and (11) the number of pages containing withheld information.
Whereas the index takes a document-specific approach, the
Masciale declaration steps through the claimed exemptions. It
avoids discussion of individual documents, instead describing
the kinds of information withheld and how they relate to the
exemptions. The intervenors filed two additional affidavits.
Each covers issues specific to the documents submitted to the
FDA during mifepristone’s approval process, including matters
ranging from competition in the abortion market to
confidentiality issues.
Judicial Watch argues that the FDA’s index/affidavit
combination fails because it does not treat each document
individually. Context dictates our approach to the particularity
required of agencies. An agency may not claim exemptions too
7
broadly, thereby sweeping unprotected information within the
statute’s reach. Mays v. DEA, 234 F.3d 1324, 1328 (D.C. Cir.
2000) (rejecting withholding of all documents containing
“investigative details” because Exemption 7 does not
automatically protect such details). Broad, sweeping claims of
privilege without reference to the withheld documents would
impede judicial review and undermine the functions served by
the Vaughn index requirement. The agency must therefore
explain why the exemption applies to the document or type of
document withheld and may not ignore the contents of the
withheld documents. Campbell v. U.S. Dep’t of Justice, 164
F.3d 20, 30-31 (D.C. Cir. 1998) (disapproving submission that
had no “language suggesting that the [agency] tailored its
response to a specific set of documents”).
On the other hand, abstraction can aid court review when
drawing from specific examples. We have never required
repetitive, detailed explanations for each piece of withheld
information—that is, codes and categories may be sufficiently
particularized to carry the agency’s burden of proof. See Keys,
830 F.2d at 349-50. Especially where the agency has disclosed
and withheld a large number of documents, categorization and
repetition provide efficient vehicles by which a court can review
withholdings that implicate the same exemption for similar
reasons. In such cases, particularity may actually impede court
review and undermine the functions served by a Vaughn index.
Seizing on the distinction between these two approaches,
Judicial Watch asserts that the FDA claimed exemptions only in
sweeping and conclusory generalities. We disagree. The FDA
explained itself through commonalities, not generalities.
Unsurprisingly, among thousands of withheld documents,
certain topics and exemptions arose on multiple occasions. The
index tied each individual document to one or more exemptions,
and the Masciale declaration linked the substance of each
8
exemption to the documents’ common elements. No rule of law
precludes the FDA from treating common documents
commonly. The FDA’s index/affidavit combination does not
resemble the general assertions of privilege that we have
rejected in the past.
And we do not fault the FDA for using the language of the
statute as part of its explanation for withholding documents. As
long as it links the statutory language to the withheld
documents, the agency may even “parrot[]” the language of the
statute. Landmark Legal Found. v. IRS, 267 F.3d 1132, 1138
(D.C. Cir. 2001). There are only so many ways the FDA could
have claimed Exemptions 4, 5, and 6 for the thousands of
documents generated during mifepristone’s approval. See id.
(“It is not the agency’s fault that thousands of documents
belonged in the same category, thus leading to exhaustive
repetition.”). Again, our focus is on the functions served by the
Vaughn index: to organize the withheld documents in a way
that facilitates litigant challenges and court review of the
agency’s withholdings. See Keys, 830 F.2d at 349. The FDA’s
decision to tie each document to one or more claimed
exemptions in its index and then summarize the commonalities
of the documents in a supporting affidavit is a legitimate way of
serving those functions.
III. The Claimed Exemptions: Vagueness and Merits
Challenges
Our holding that the FDA produced a structurally sound
Vaughn index does not address the entirety of Judicial Watch’s
challenge to the adequacy of the index. Judicial Watch also
argues that many of the index’s document descriptions are
indecipherable or lack information relevant to its merits claim.
It further challenges the merits of the FDA’s use of Exemptions
4, 5, and 6. Judicial Watch does not challenge the FDA’s
9
withholdings pursuant to FOIA Exemption 3. 5 U.S.C.
§ 552(b)(3).
A. Exemption 4
Exemption 4 allows agencies to withhold documents
containing 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). Unlike many other types
of information subject to an agency’s control, materials
implicating Exemption 4 are generally not developed within the
agency. Instead, it must procure commercial information from
third parties, either by requirement or by request. The agency
thus has an incentive to be a good steward of that information:
Disclosure could result in competitive disadvantages to the
submitting entity, discouraging them from giving quality
information in the future. Critical Mass Energy Project v. NRC,
975 F.2d 871, 877-78 (D.C. Cir. 1992) (quoting Nat’l Parks &
Conservation Ass’n v. Morton, 498 F.2d 765, 766-70 (D.C. Cir.
1974)). The agency may therefore withhold involuntarily
submitted information as confidential if disclosure would (1)
impair the agency’s ability to get information in the future or (2)
cause substantial competitive harm to the entity that submitted
the information. Id. at 878 (citing Nat’l Parks, 498 F.2d at
770).1
The same incentive applies to the FDA approval process.
The FDA requires applying companies to submit volumes of
information related to a drug’s development, composition,
1
The District Court and intervenors suggest that at least some
of the information at issue was submitted voluntarily, making it
subject to the more expansive withholding standard applicable to such
information. See Critical Mass, 975 F.2d at 878-79, 880. We need
not resolve that issue at this point.
10
safety, and manufacture. 21 U.S.C. § 355(b)(1). A company
must submit this information in an Investigational New Drug
application (“IND”) even prior to conducting clinical trials of a
drug. 21 C.F.R. pt. 312. All the information from the IND also
goes into the company’s New Drug Application (“NDA”), the
formal application for sale and marketing approval from the
FDA. 21 C.F.R. pt. 314. Each stage of the FDA’s
administrative processes therefore depends directly on
submissions from outside the agency.
The submission-dependent nature of the approval process
means Exemption 4 extends to at least some information
contained in INDs and NDAs. If it did not, other companies
“could make use of the information in the INDs in order to
eliminate much of the time and effort that would otherwise be
required to bring to market a product competitive with the
product for which” the submitting company filed the IND. Pub.
Citizen Health Research Group v. FDA, 185 F.3d 898, 905
(D.C. Cir. 1999). Similarly, “[i]f a manufacturer’s competitor
could obtain all the data in the manufacturer’s NDA, it could
utilize them in its own NDA without incurring the time, labor,
risk, and expense involved in developing them independently.”
Webb v. HHS, 696 F.2d 101, 103 (D.C. Cir. 1982). Applicants
spend a great deal of resources to obtain data for an IND or
NDA, and the FDA could not expect full and frank disclosure if
it later released such proprietary information into the public
domain.
Exemption 4 does not categorically exempt all information
in INDs and NDAs, however, and the FOIA requester must have
adequate descriptions in order to distinguish between protected
and unprotected information. See Pub. Citizen, 185 F.3d at 906.
Judicial Watch argues that the index contains many
entries—such as document 3021 (“study 88/739/cn”) and
document 3023 (“study f/85/486/40”)—with descriptions too
11
vague to allow it to mount a merits challenge to the FDA’s
Exemption 4 claims. Its brief is littered with other entries of
which it can make neither heads nor tails, including Documents
1787 and 1788 (“table - main lab temp”) and Document 3331
(“references 89/11450gn”).
The FDA argues that each index entry must be considered
in relation to surrounding entries and to the additional
information listed in the index. Specifically, the FDA contends
that the index clearly relates Document 3331 (“references
89/11450gn”) with Document 3325 (“preclinical expert
evaluation of ru38 486 - cover pages - 89/11450gn”) and several
other nearby documents, including Document 3326 (“table of
contents 89/11450gn”). We agree that Document 3325 gives
enough description to explain the contents—that is, a preclinical
expert evaluation—of all 89/11450gn-related documents.
Other entries defy the FDA’s claim of definition by
association, though. For example, Documents 1787 and 1788
(“table - main lab temp”) appear to be freestanding documents.
In its brief, the FDA asserts that the description makes “apparent
that these records were collected during an FDA inspection of
a drug manufacturing facility.” We disagree. In no way do
these subject headings, or any other index information, connect
these documents to an FDA inspection or to any particular
manufacturing facility. Neither does the Masciale declaration.
Although it lists “information relating to the manufacturing
process” as one type of information redacted under Exemption
4, it never explains that these documents fall into that category.
The same problems infect additional entries. For instance,
the FDA labeled Document 2567 as “report re: protocols
ch/88/486/26, ffr/88/486/03.” Surrounding entries look similar,
albeit with different reference numbers, and each refers to a
document of several hundred pages. In its brief, the FDA
12
characterizes two similar entries—Documents 3021 (“study
88/739/cn”) and 3023 (“study f/85/486/40”)—as “reference
identification numbers” for “clinical or preclinical studies
relating to the drug mifepristone.” The agency added that it
withheld the study titles themselves because they “constituted
confidential commercial information relating to unapproved
uses.” Presumably, the same holds true for Document 2567, but
we cannot tell without the FDA’s further explanation. The
document descriptions themselves shed little light individually,
and surrounding entries do not help.
Documents 1902 through 1924 (“subject records”) also
raise questions. At oral argument, the FDA’s counsel suggested
that these entries may describe personal records of test subjects,
which would explain the agency’s reliance on Exemption 6 and
personal privacy in addition to Exemption 4. Outside of
counsel’s post hoc explanation, though, the entries remain
sufficiently ambiguous to warrant further inquiry. Where the
document description only vaguely indicates the information
contained therein, the use of multiple exemptions for some
documents adds to the confusion about which withheld
information fits with which exemption.
The FDA asserts that its affidavit, along with those of the
intervenors, makes up for any deficiency in its document
descriptions. We agree that the three affidavits do a number of
positive things. They show that the documents containing
information from INDs or NDAs likely include either trade
secrets or commercial information that would be valuable to
competitors. They provide evidence, sufficient to satisfy the
requirements of Exemption 4, of competitive harm in the
medical abortion market that would result from the release of
information in the IND. Finally, they also provide sufficient
evidence to satisfy Exemption 4 of actual competition in
markets for nonapproved uses of mifepristone, including cancer
13
treatment. However persuasive, though, each of these points
goes to the merits and does little to flesh out the vague document
descriptions. Proving the merits of the exemption does no good
if the court cannot tie the affidavits to the documents.
It is no surprise that the FDA labeled many index entries
with scientific codes, lab jargon, or other identifications specific
to the agency. But the FDA may not create its own cryptolect,
unknown to the challenger and the court. Without a glossary or
technical dictionary, any lay person would be hard pressed to
understand the series of numbers and letters given as
descriptions in this index. Although the FDA’s brief gives
additional explanation for the examples raised by Judicial
Watch, countless others in the 1,500-page index remain
impenetrable for persons outside the FDA.
By using this shorthand, the FDA missed sight of the
Vaughn index’s purpose—to enable the court and the opposing
party to understand the withheld information in order to address
the merits of the claimed exemptions. Scientific lingo and
administrative slang, when unfamiliar, often baffle the brightest
among us. To prevent confusion and aid resolution of this case,
the FDA should have endeavored to make its technical world
appear a little less foreign—and its shorthand a little less
short—to Judicial Watch and the court. This is not to say that
the FDA could not demonstrate that it properly claimed
Exemption 4 as to these documents. Rather, the FDA “has
failed to supply us with even the minimal information necessary
to make a determination.” Coastal States Gas, 617 F.2d at 861.
We accordingly remand the case for further explanation of these
technical descriptions.
Judicial Watch also challenges the FDA’s decision to
withhold the names and addresses of Population Council’s
business partners under Exemption 4. We decline to address the
14
challenge because, as discussed below, we hold that the FDA
properly claimed Exemption 6 for the same information.
B. Exemption 5
Exemption 5 permits agencies to withhold “inter-agency or
intra-agency memorandums or letters which would not be
available by law to a party other than an agency in litigation
with the agency.” 5 U.S.C. § 552(b)(5). Such “memorandums
or letters” include those protected by the attorney–client
privilege and the deliberative process privilege. Coastal States
Gas, 617 F.2d at 862. The FDA relied on both privileges but
has since released all documents initially withheld under the
attorney–client privilege. Accordingly, we only address the
question of deliberative process privilege, which Judicial Watch
challenges on both adequacy grounds and the merits.
The deliberative process privilege protects agency
documents that are both predecisional and deliberative. Id. at
866. We deem a document predecisional if “it was generated
before the adoption of an agency policy” and deliberative if “it
reflects the give-and-take of the consultative process.” Id.
(emphasis omitted). Judicial Watch contends that the FDA has
not demonstrated the predecisional nature of documents without
dates or with dates coming after the agency approved
mifepristone. The entries without dates, it argues, can never
prove that a document came before the agency’s decision at
issue. The entries with later dates, it contends, are by definition
postdecisional.
Because we have previously approved the application of the
deliberative process privilege for an “undated note,” we cannot
adopt Judicial Watch’s proposed categorical rule on undated
entries. Krikorian v. Dep’t of State, 984 F.2d 461, 466 (D.C.
Cir. 1993). Dates are but one way to illustrate a chronology, and
15
the FDA may have other ways to prove that the undated
documents were indeed predecisional. As an example, the FDA
asserts that Documents 1645 and 1646, though undated, are
predecisional because they concern mifepristone’s IND, filed far
in advance of the NDA and the FDA’s subsequent approval of
the NDA. Other undated documents in the index do not have the
benefit of the FDA’s explanation, though. We therefore remand
so that the FDA may provide more information, including dates
for documents that lack them or explanations where dates cannot
be found.
Likewise, documents dated after mifepristone’s approval for
abortion may still be predecisional and deliberative with respect
to other, nonfinal agency policies, including uses of the drug that
the agency has not approved. A contrary rule would undermine
the privilege’s purpose to encourage “honest and frank
communication within the agency” without fear of public
disclosure. Coastal States Gas, 617 F.2d at 866; see also Mead
Data Cent., 566 F.2d at 256 (“[T]he quality of administrative
decision-making would be seriously undermined if agencies
were forced to ‘operate in a fishbowl’ because the full and frank
exchange of ideas on legal or policy matters would be
impossible.”). The intervenors’ affidavits affirm that the
companies continue to pursue other avenues of medical uses for
the drug and may later seek FDA approval, which would require
further final action by the agency.
The FDA admits, though, that some of the postdated
documents have nothing to do with unapproved uses but instead
relate to other administrative decisions, including replies to
correspondence. The FDA’s failure to provide an adequate
explanation prevents us from determining whether every piece
of correspondence after a policy is decided constitutes a new
final agency action of its own. It may be that reflections on an
already-decided policy are neither predecisional nor indicative
16
of the deliberative process of the government. After all,
“Exemption five is intended to protect the deliberative process
of government and not just deliberative material.” Mead Data
Cent., 566 F.2d at 256 (citation omitted). On remand, the FDA
must provide additional information regarding these postdated
documents and the agency policies they predate and deliberate
over.
Judicial Watch also challenges many Exemption 5 entries
as vague, including the FDA’s use of otherwise commonly
understood words and phrases that it claims shed no light on the
documents. For example, Judicial Watch highlights such
nontechnical entries as Document 662 (“draft internal q&a”),
Document 2377 (“fda form w/attach”), and Document 3222
(“fax re: listing w/attach”). The FDA counters that anyone can
understand these descriptions, including “q&a,” the common
shorthand for “questions and answers.” Furthermore, the agency
argues that many entries labeled “draft” that were transmitted
between FDA employees clearly implicate the “deliberative
process privilege” by their very nature.
We conclude, however, that these entries suffer from
vagueness defects different in kind than those discussed in the
section on Exemption 4. These descriptions pose no problems
of technical knowledge, but neither do they describe the
withheld information. The word “fax,” though commonly
understood, tells the court little about the deliberative nature of
the information contained in the document in question.
Likewise, the term “q&a” says nothing about the information
conveyed in the questions and answers.
Certainly, the label “draft” goes to the merits of Exemption
5’s predecisional and deliberative elements, and the court may
take notice that a document passed between two FDA employees
and had a date prior to the FDA’s approval of mifepristone.
17
Coastal States Gas, 617 F.2d at 866 (stating Exemption 5
protects “draft documents”). The FDA did not label all
Exemption 5 entries as drafts, however, and we must bear in
mind “the strong policy of the FOIA that the public is entitled to
know what its government is doing and why.” Id. at 868.
Terms like “fax” and “q&a” standing alone give the court no
way to determine whether the withheld information is of a
deliberative nature. Accordingly, on remand the FDA must
provide more informative descriptions of these commonly
understood documents in addition to the less understood coding
of many Exemption 4 entries.
C. Exemption 6
Finally, Exemption 6 allows agencies to withhold
“personnel and medical files and similar files the disclosure of
which would constitute a clearly unwarranted invasion of
personal privacy.” 5 U.S.C. § 552(b)(6). Citing Exemption 6
for many partially withheld documents, the FDA redacted the
names of agency personnel and private individuals and
companies who worked on the approval of mifepristone. In
addition, it redacted the street addresses of the intervenors and
all business partners associated with the manufacturing of the
drug. Judicial Watch argues that the FDA cannot claim this
exemption for these names and addresses because they are not
in files “about an individual.” The case law, however, does not
support Judicial Watch’s crabbed reading of the statute.
The Supreme Court has read Exemption 6 broadly,
concluding the propriety of an agency’s decision to withhold
information does not “turn upon the label of the file which
contains the damaging information.” U.S. Dep’t of State v.
Washington Post Co., 456 U.S. 595, 601 (1982). We have also
read the statute to exempt not just files, but also bits of personal
18
information, such as names and addresses, the release of which
would “create[] a palpable threat to privacy.” Carter v. U.S.
Dep’t of Commerce, 830 F.2d 388, 391 (D.C. Cir. 1987). The
statute does not categorically exempt individuals’ identities,
though, because the “privacy interest at stake may vary
depending on the context in which it is asserted.” Armstrong v.
Executive Office of the President, 97 F.3d 575, 582 (D.C. Cir.
1996). Therefore, to determine whether the FDA appropriately
withheld these names and addresses, “we must balance the
private interest involved (namely, ‘the individual’s right of
privacy’) against the public interest (namely, ‘the basic purpose
of the Freedom of Information Act,’ which is ‘to open agency
action to the light of public scrutiny’).” Horowitz v. Peace
Corps, 428 F.3d 271, 278 (D.C. Cir. 2005), cert. denied, 126 S.
Ct. 1627 (2006) (citation omitted).
As its privacy interest, the FDA cited the danger of
abortion-related violence to those who developed mifepristone,
worked on its FDA approval, and continue to manufacture the
drug. The supporting affidavits detail evidence of abortion
clinic bombings. They also describe websites that encourage
readers to look for mifepristone’s manufacturing locations and
then kill or kidnap employees once found. Based on these
declarations, the FDA fairly asserted abortion-related violence
as a privacy interest for both the names and addresses of persons
and businesses associated with mifepristone. The privacy
interest extends to all such employees, and the FDA need not
“justify the withholding of [names] on an individual-by-
individual basis under FOIA Exemption 6.” Gallant, 26 F.3d at
173.
This asserted privacy interest must be weighed against
whatever public interest exists in having the names and
addresses disclosed. The FDA starts from a strong position. We
have previously held that individuals have a “privacy interest in
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the nondisclosure of their names and addresses in connection
with financial information,” surely a weaker interest than
avoiding physical danger. Lepelletier v. FDIC, 164 F.3d 37, 47
(D.C. Cir. 1999). The opposing public interest in knowing these
names and addresses is not immediately apparent, though.
Judicial Watch argues that the public needs the information
because mifepristone may pose dangerous health risks to women
who use it. The argument is a non sequitur: Even if
mifepristone has significant health risks, these names and
addresses prove nothing about the nature or even the existence
of the risks. In the absence of a legitimate public interest, the
private interest in avoiding harassment or violence tilts the
scales. Accordingly, the FDA has properly used Exemption 6
“to protect [those associated with mifepristone] from the injury
and embarrassment that can result from the unnecessary
disclosure of personal information.” Washington Post, 456 U.S.
at 599.
IV. Conclusion
The FDA argues that it could have short-circuited many of
Judicial Watch’s claims by producing a summary index or
taking a categorical approach instead of producing a full index.
But the fact that the agency might have gone down a different
route does not mean it can produce an inadequate submission of
another variety. On remand, though, we do not expect the FDA
to engage in a full reappraisal of its index. As we held above,
the defects in the index are specific to the descriptions and not
structural. The FDA can clarify many vague document
descriptions by producing a technical lexicon for the benefit of
Judicial Watch and the District Court. As always, the goal
should be to allow the court to understand the withheld
information to the extent necessary to address the merits. With
these considerations in mind, we remand for further explanation
of the entries in the Vaughn index for documents withheld, in
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their entirety, under Exemptions 4 and 5. We affirm the District
Court’s grant of summary judgment in all other respects,
including as to the information withheld under Exemption 6.
So ordered.