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.
`
`
`
`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
`
`the drug
`the FDA approved
`In September 2000,
`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
`in camera review provided sufficient
`declarations and
`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,
`
`1The 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
`
`to withhold
`Finally, Exemption 6 allows agencies
`“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
`
`
`
`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 ad
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