Source: s3://data.kl3m.ai/documents/govinfo/USCOURTS/USCOURTS-caDC-05-05256/USCOURTS-caDC-05-05256-0/pdf.json

Nature of Suit Code: 895
Nature of Suit: Freedom of Information Act of 1974
Cause of Action: 

---

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.

USCA Case #05-5256 Document #971501 Filed: 06/02/2006 Page 1 of 20
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

USCA Case #05-5256 Document #971501 Filed: 06/02/2006 Page 2 of 20
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

USCA Case #05-5256 Document #971501 Filed: 06/02/2006 Page 3 of 20
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

USCA Case #05-5256 Document #971501 Filed: 06/02/2006 Page 4 of 20
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.

USCA Case #05-5256 Document #971501 Filed: 06/02/2006 Page 5 of 20
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

USCA Case #05-5256 Document #971501 Filed: 06/02/2006 Page 6 of 20
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

USCA Case #05-5256 Document #971501 Filed: 06/02/2006 Page 7 of 20
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

USCA Case #05-5256 Document #971501 Filed: 06/02/2006 Page 8 of 20
9

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.

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,

USCA Case #05-5256 Document #971501 Filed: 06/02/2006 Page 9 of 20
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

USCA Case #05-5256 Document #971501 Filed: 06/02/2006 Page 10 of 20
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

USCA Case #05-5256 Document #971501 Filed: 06/02/2006 Page 11 of 20
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

USCA Case #05-5256 Document #971501 Filed: 06/02/2006 Page 12 of 20
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

USCA Case #05-5256 Document #971501 Filed: 06/02/2006 Page 13 of 20
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

USCA Case #05-5256 Document #971501 Filed: 06/02/2006 Page 14 of 20
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

USCA Case #05-5256 Document #971501 Filed: 06/02/2006 Page 15 of 20
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.

USCA Case #05-5256 Document #971501 Filed: 06/02/2006 Page 16 of 20
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

USCA Case #05-5256 Document #971501 Filed: 06/02/2006 Page 17 of 20
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-byindividual 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

USCA Case #05-5256 Document #971501 Filed: 06/02/2006 Page 18 of 20
19

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

USCA Case #05-5256 Document #971501 Filed: 06/02/2006 Page 19 of 20
20

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.

USCA Case #05-5256 Document #971501 Filed: 06/02/2006 Page 20 of 20