VIROPHARMA INCORPORATED, Plаintiff, v. DEPARTMENT OF HEALTH AND HUMAN SERVICES, and Food and Drug Administration, Defendants.
Civil Action No. 08-2189 (PLF).
United States District Court, District of Columbia.
March 16, 2012.
Michelle Lo, U.S. Attorney‘s Office, Washington, DC, for Defendants.
OPINION
PAUL L. FRIEDMAN, District Judge.
This matter is before the Court on cross-motions for summary judgment filed by the plaintiff, ViroPharma Incorporated, and the defendants, the Department of Health and Human Services (“HHS“) and
I. BACKGROUND
ViroPharma owns the new drug application (“NDA“) for Vancocin, a vancomycin hydrochloride capsule (“vancomycin“). Declaration of Thomas F. Doyle (“Doyle Decl.“) ¶ 2, May 27, 2010 [Dkt. No. 30-2]. Vancocin is indicated for the treatment of a dangerous gastrointestinal infection caused by Clostirdium difficile bacteria. Compl. ¶ 12. At present, there is no FDA-approved generic version of vancomycin, and Vancocin is the only FDA-approved drug to treat C. difficile infections. Id.
Prior to 2006 the FDA recommended using in vivo studies—which involve testing in humans—to establish the bioequivalence of generic versions of vancomycin. Doyle Decl. ¶¶ 3-4. ViroPharma contends that, in February 2006, FDA adopted a nеw policy, recommending in vitro studies—which do not require testing in humans—as sufficient to establish bioequivalence. Doyle Decl. ¶ 4. Allegedly, FDA did not publicly announce the change in policy, but provided information to companies that submitted inquiries regarding the bioequivalence standards for vancomycin. Id. ¶ 5. ViroPharma learned of these events through one such company, which publicly released the new standards, leading to a reduction in the value of ViroPharma‘s stock by roughly 40%. Id. ¶¶ 6-7.
On March 17, 2006, ViroPharma filed a citizen petition for a stay of any approvals of abbreviated new drug applications (“ANDA“) under FDA‘s new bioequivalenсe testing method. Doyle Decl. ¶ 8. On March 21, 2006, ViroPharma also filed a Freedom of Information Act request. Doyle Decl. ¶ 9. ViroPharma requested:
A copy of the entire administrative record of the decision of the Office of Generic Drugs (OGD) (including, but not limited to, documents related to reference number: OGD # 06-0200) that abbreviated new drug applications (ANDAs) or applications filed under
505(b)(2) for vancomycin hydrochloride capsules qualify for a waiver of in vivo bioequivalence and may demonstrate bioequivalence to the reference listed drug Vancocin® through in vitro dissolution testing.
Compl. ¶ 29. FDA logged the request into its tracking system and forwarded the request to the Division of Information and Disclosure Policy (“DIDP“) in FDA‘s Center for Drug Evaluation and Research. Declaration of Frederick J. Sadler (“Sadler Decl.“) ¶¶ 6-7, April 22, 2010 [Dkt. No. 28-2].
On December 16, 2008, FDA published a notice in the Federal Register entitled “Draft Guidance for Industry on Bioequivalence Recommendation for Vancomycin HCI; Availability.” Doyle Decl. Ex. 3. Although the notice did not contain the administrative record for FDA‘s March 2006 decision, it did limit the use of in vitro testing to generic vancomycin tablets
On December 16, 2008, ViroPharma filed this lawsuit to enforce FDA‘s obligations under the FOIA and submitted a sеcond FOIA request seeking records related to the 2008 Draft Guidance. Doyle Decl. ¶¶ 14-15. ViroPharma‘s second request sought
[a] copy of all records of the decision of the Food and Drug Administration (including, but not limited to, documents related [to] FDA‘s Draft Guidance for Industry on Bioequivalence Recommendation for Vancomycin HCL assigned docket number FDA-2008-D-0626) recommending in vitro dissolution studies for test formulations of Vancomycin HCL that are qualitatively (Q1) and quantitatively (Q2) the same as the reference listed drug with respect to inactive ingredients and recommending in vivo bioequivalence studies with clinical endpoints for test formulations that are not Q1 and Q2 the same as the RLD with respect to inactive ingredients; including ... [a]ny Agency communication(s) regarding the above recommendations with any third party outsidde of the FDA prior to December 15, 2008.
Sadler Decl. Ex. B. FDA routed both of ViroPharma‘s requests to DIDP and the Office of the Executive Secretariat; Office of Legislation; Office of Policy, Planning, and Preparedness; and Office of the Chief Counsel. Sadler Decl. ¶¶ 8, 11.
On March 22, 2009, FDA produced documents in response to ViroPharma‘s FOIA requests from the Office of the Commissioner of the FDA. Doyle Decl. ¶ 16. On October 28, 2009, FDA produced additional documents from the Center for Drug Evaluation аnd Research. Id. Between November 11, 2009 and March 24, 2010, ViroPharma sent letters identifying documents it believed were responsive but had not been released. Id. ¶ 17. FDA released additional documents on December 9, 2009; February 24, 2010; and April 22, 2010. Id. ¶¶ 21, 25, 27. Throughout FDA‘s releases, it has withheld, in whole or in part, over 700 documents pursuant to the deliberative process privilege under FOIA Exemption 5. Sadler Decl. ¶¶ 23-24.2 It has withheld over 100 documents pursuant to Exemption 4. Sadler Decl. ¶ 28. And it has withheld a “handful of records[]” pursuant to Exemption 6. Sadler Decl. ¶ 35.
On April 22, 2010, defendants filed a motion for summary judgment in this case. With their motion, they included a Vaughn index listing the documents withheld; the documents’ length; whether the documents were withheld in whole or in part; and the justifications for the withholdings. Sadler Decl. Ex. C. ViroPharma filed a cross-motion for summary judgment on May 27, 2010. ViroPharma requested that the Court require FDA to provide it with a number of documents and portions of documents FDA is withholding under Exemptions 4 and 5, and to conduct an in camera review of the withheld documents. Pl. Mot. at 12, 24, 30. In concert with defendant‘s reply brief, FDA has released to ViroPharma several documents it had been withholding under Exemptions 4 and 5. See, e.g., Second Declaration of Frederick J. Sadler (“Sadler Decl. Reply“) ¶ 9, June 30, 2010 [Dkt. No. 34-2]; Second Declaration of Nancy B. Sager (“Sager Decl. Re-
II. LEGAL STANDARD
Under
The FOIA requires a federal agency to release all records responsive to a proper request except those protected from disclosure by one or more of nine enumerated exemptions set forth in
III. DISCUSSION
Defendants state that FDA‘s search was reasonably calculated to uncover all responsive records. Def. Mot. at 10. They provide declarations from FDA‘s Director of the Division of Freedom of Information and FDA‘s Director of Information Disclosure Policy describing the seаrch conducted in response to ViroPharma‘s requests. See Sadler Decl.; Declaration of Nancy B. Sager (“Sager Decl.“), April 22, 2010 [Dkt. No. 28-3]. ViroPharma does not contend that FDA‘s search was insufficient. Instead, ViroPharma argues that FDA improperly withheld relevant documents under Exemptions 4 and 5. Pl. Mot. at 2, 12, 24. In addition, ViroPharma argues that FDA did not properly segregate factual material that it is entitled to receive under the FOIA. Id. at 11. And finally, ViroPharma argues that in camera review is necessary in this case, primarily because, they assert, FDA has acted in bad faith. Pl. Reply at 21.3
FOIA Exemption 4 protects from disclosure matters that are “trade secrets and commerciаl or financial information obtained from a person and privileged or confidential.”
1. Documents Referencing Pending ANDAs
Defendants argue that all information referencing pending ANDAs may properly be withheld under Exemption 4 because FDA is barred by its own regulations from releasing any information about a drug application prior to its approval, see
ViroPharma accepts the proposition that “the identity of the ANDA filers, information contained in the ANDAs, information regarding the approval status of the ANDAs, trade secret information such as drug formulas or manufacturing processes, or confidential commercial information” all are properly exempt under Exemption 4. Pl. Reply at 9. ViroPharma argues that with respect to approximately 70 documents, however, FDA over-claims Exemption 4 by removing all information that references pending ANDAs. Id. ViroPharma appears to request that FDA release the portions of documents that “reference” pending ANDAs, but are not covered within the above list. The Court, however, cannot discern any portion of the documents that would “reference” pending ANDAs but does not discuss information contained in the ANDAs or implicate the approval process. ViroPharma itself provides no indication of what such information might be.
ViroPhаrma lists specific documents in which whole paragraphs have been redacted and argues that only the names of filers and the drug formula should have been redacted and the rest of the paragraph released. Pl. Reply at 9-14. If it were the case that this was the only information that could properly be redacted under Exemption 4, then the FDA would be required to redact the name and formula and provide the rest. As noted, however, ViroPharma acknowledges that Exemption 4 covers more than just the names of filers and drug formulas. The Court concludes that FDA has properly redacted portions оf these documents under the broader category of information referencing specific pending ANDAs and their contents. Judicial Watch, Inc. v. FDA, 449 F.3d at 148-49; Appleton v. FDA, 451 F. Supp. 2d at 141-142 n. 7. That whole paragraphs have been redacted in some documents does not alone demonstrate improper withholdings.
2. Incoming Correspondence
ViroPharma takes issue with FDA‘s withholding of incoming correspondence from drug manufacturers and other members of the industry that relate to the bioequivalence standard for vancomycin. Pl. Reply at 4. For some of this correspondence, FDA has stated in one of its declarations that “[t]he inquiries about the bioequivalence requirements ... are intertwined with other infоrmation about the inquiring entity and its proposed product.” Sadler Decl. Reply ¶ 19 (discussing Vaughn index Nos. 908, 960 & 961). For other incoming correspondence, FDA claims that the information need not be released because the documents are nonresponsive. Def. Reply at 24-34; see e.д., Sadler Decl. Reply ¶¶ 17-19.
Where documents reference pending ANDAs, FDA has properly redacted this information, see supra at 190, and has also demonstrated that it has segregated non-exempt information. See infra at 195. To the extent that the incoming correspondence discusses drug products other than vancomycin, see Def. Reply аt 25, it is nonresponsive and FDA is not required to release it. But with regard to the portions of documents that discuss FDA‘s bioequivalence recommendations for vancomycin generally without reference to a drug manufacturer‘s pending ANDA filing, FDA must produce this information so long as it is segregable from
B. Exemption 5
FOIA Exemption 5 protects from disclosure “inter-agency or intra-agency memorandums or letters which would not be available by law to a party ... in litigation with the agency.”
The deliberative process privilege protects agency documents that are both predecisional and deliberative. Ancient Coin Collectors Guild v. Department of State, 641 F.3d at 512; Judicial Watch, Inc. v. FDA, 449 F.3d at 151. A document is “predecisional” if it was generated before the agency action was finally adopted, and “deliberative” if it “reflects the give-and-take of the consultative process.” Public Citizen, Inc. v. OMB, 598 F.3d 865, 874 (D.C. Cir. 2010) (internal quotations omitted). The deliberative process privilege encourages open, frank discussions by agency policy makers, protects against premature disclosure of proposed policies before they are finally adopted, and protects against confusing the issues and misleading the public about reasons and rationales that, in the end, were not in fact among the grounds for decision. See id.; Appleton v. FDA, 451 F. Supp. 2d at 142.
1. Draft Documents
The FDA has withheld draft versions of numerous documents under the deliberative process privilege. While acknowledging that the deliberative process may be protected, ViroPharma argues that FDA must provide the factual content and recitations of past final agency decisions
Although there is a longstanding distinction between factual and deliberative materials under Exemption 5, see Goodrich Corp. v. EPA, 593 F. Supp. 2d 184, 189 (D.D.C. 2009) (citing EPA v. Mink, 410 U.S. 73, 79, 93 (1973)), ViroPharma is incorrect when it argues that FDA must segregate and disclose the factual background and recitations of past agency final decisions from the draft documents in this case. “Exemption 5 was intended to protect not simply deliberative material, but also the deliberative process of agencies.” Montrose Chemical Corp. v. Train, 491 F.2d 63, 71 (D.C. Cir. 1974) (emphasis added). Thus, “in some cases selection of facts or summaries may reflect a deliberative process which exemption 5 was intended to shelter.” Id.; see also Mead Data Cent., Inc. v. Department of the Air Force, 566 F.2d 242, 256 (D.C. Cir. 1977) (“In some circumstances, ... the disclosure of even purely factual material may so expose the deliberative process within an agency that it must be deemed exempted[.]“).
The choice of what factual material and prior final agency opinions to include or remove during the drafting process is itself often part of the deliberative process, and thus is properly exempt under Exemption 5. See Reliant Energy Power Generation, Inc. v. FERC, 520 F. Supp. 2d at 204 (“‘[D]isclosure of editorial judgments—for example, decisions to insert or delete material or to change a draft‘s focus or emphasis—would stifle the creative thinking and candid exchange of ideas[.]‘“) (quoting Dudman Commc‘ns Corp. v. Department of the Air Force, 815 F.2d 1565, 1569 (D.C. Cir. 1987)). In Goodrich Corp. v. EPA, 593 F. Supp. 2d 184, for example, Judge Bates permitted the EPA to withhold the factual content and data contained within a draft model under Exemption 5 because “evolving iterations of the model‘s inputs and calibration reflect the opinions of the staff currently developing the model, which may not represent EPA‘s ultimate opinions relating to these matters.... [E]ven if the data plugged into the model is itself purely factual, the selection and calibration of data is part of the deliberative process to which Exemption 5 applies.” Id. at 189. The Court is persuaded by thе defendants’ submission that such is the case here.
ViroPharma relies on Brinton v. Department of State, 636 F.2d 600 (D.C. Cir. 1980), in which the court of appeals stated that “Exemption 5 does not protect final statements of policy or final actions of agencies.” Id. at 605. The court in Brinton, however, was referring to documents that were themselves final agency opinions, not recitations of final opinions contained within subsequent deliberative recommendations. Indeed, the documents in question in Brinton were properly withheld under Exemption 5, and the court did not require any portions of them to be segregated. Id. (“The requested documents in this case, however, bear no indicia of finality.“).
2. Internal Review Documents
“Purely factual material usually cannot be withheld under Exemption 5 unless it reflects аn ‘exercise of discretion and judgment calls.‘” Ancient Coin Collectors Guild v. Department of State, 641 F.3d at 513 (quoting Mapother v. Department of Justice, 3 F.3d 1533, 1539 (D.C. Cir. 1993)). While factual material need not be segregated from draft documents because the choice to include or remove such material in each draft reflects the agency‘s deliberative process, see supra at 193, this rationale does not apply to internal documents generally. But where factual material is “assembled through an exercise of judgment in ex-
ViroPharma requests that the factual information and recitations of settled agency policy that are contained in internal review documents be segregated and released. Pl. Reply at 12-13. For the reasons previously discussed, the majority of these documents are properly redacted under Exemption 5 as part of the deliberative process, see Sadler Decl. Ex. C (Vaughn index Nos. 295, 318, 414, 415, 645 & 646); supra at 193, or under Exemption 4 because they reference pending ANDAs. See Sadler Decl. Ex. C (Vaughn index Nos. 498, 510, 522, 523, 645, 646 & 905); supra at 190. But one portion of one document is redacted because it contains a summary of the regulatory background of vancomycin, although it does not appear to be a draft. See Sadler Decl. Ex. C (Vaughn index No. 235). In addition, ViroPharma singles out four documents from the medical officer‘s review of pending ANDAs that ViroPharma contends are withheld in full. Pl. Reply at 12. The justification for withholding these documents is that they contain internal deliberations and reference pending ANDAs. Sadler Decl. Ex. C (Vaughn index Nos. 495, 497, 507 & 509).
In reviewing defendants’ Vaughn index and declarations, the Court cannot discern whether factual portions of these internal review documents were or were not withheld in full or were provided in redacted form. The Court therefore will require FDA to supplement its declarations and Vaughn index tо establish whether factual portions of non-draft review documents were redacted and why they were redacted; or, if they were withheld in full, why they cannot be provided in redacted form. See Sadler Decl. Ex. C. (Vaughn index Nos. 235, 495, 497, 507 & 509).
In addition, ViroPharma asserts that FDA withheld a paragraph of a 2006 review document that contains FDA control numbers of incoming communications, which ViroPharma wishes to review in order to determine the number of letters submitted to FDA. Pl. Reply at 14 (referencing Vaughn index Nos. 295, 318, 414-15, & 645-46). The Court cannot discern, from the Vaughn index and the parties’ filings, whether the documents ViroPharma points to contain the withheld paragraph, or for what reason FDA is claiming the information should be withheld. The Court therefore also will require FDA to supplement its Vaughn index and declaration with respect to Nos. 295, 318, 414-15, and 645-46.
3. Laboratory Data
Finally, ViroPharma objects to FDA withholding laboratory data contained within records prepared to assist the agency‘s development of its bioequivalence recommendations. Def. Reply at 21; Pl. Reply at 18; Sadler Decl. Ex. C (Vaughn index Nos. 46, 48, 53, 54). ViroPharma argues that the laboratory data must be segregated from the sections containing deliberations and must be released. It cites Bristol-Myers Co. v. FTC, 424 F.2d 935 (D.C. Cir. 1970), which states that “[p]urely factual reports and scientific studies cannot be cloaked in secrecy by an exemption designed to protect ... internal working papers in which opinions are expressed[.]” Id. at 939 (emphasis added) (internal quotations omitted). That case is not directly on point, however, because the preliminary reports that ViroPharma requests are not purely factual reports, but contain the internal deliberations of the
Defendants argue “that preliminary scientific data are properly part of an agency‘s deliberative process[.]” Def. Reply at 21. Defendants cite Chemical Manufacturers Ass‘n v. Consumer Product Safety Commission, 600 F. Supp. 114 (D.D.C. 1984), for the proposition that preliminary scientific data generated in connection with an ongoing policy deliberation may properly be withheld under Exemption 5. Id. at 118. ViroPharma responds that the laboratory data cannot be withheld because deliberations are no longer ongoing, the reports were prepared for a 2009 dissolution study, and the study has now been released. Pl. Reply at 20.
It is not clear to the Court what bioequivalence recommendation the reports were prepared for. FDA merely states that the records were prepared “in the course of [FDA‘s] development of а bioequivalence recommendation[.]” Sager Decl. Reply ¶ 16. The Court therefore will require FDA to supplement its Vaughn index and declarations to establish which bioequivalence recommendation the laboratory results were originally prepared for and why the documents are properly withheld. See Sadler Decl. Ex. C. (Vaughn index nos. 46, 48, & 53-54).
C. Segregability
Under the FOIA, “[a]ny reasonably segregable portion of a record shall be provided to any person requesting such record after deletion of the portions which are exempt.”
Defendants argue that they have satisfied their segregability obligations because all records responsive to ViroPharma‘s request were reviewed “line-by-line” and the agency redacted only portions of documents where appropriate. Def. Mot. at 27-28. Regardless of whether a declaration that an agency conducted a “line-by-line” search is sufficient to satisfy an agency‘s obligations in and of itself, compare Elec. Privacy Info. Ctr. v. Transp. Safety Admin., Civil Action No. 03-1846, 2006 WL 626925, at *8 (D.D.C. Mar. 12, 2006) (finding that an avowal of a “line-by-line” search is not determinative as to whether the agency satisfied its segregability obligations), with Perry-Torres v. Department of State, 404 F. Supp. 2d 140, 144 (D.D.C. 2005) (“At a minimum, the explanation should state that a line-by-line analysis of each document was conducted[.]“), а statement representing that a “line-by-line” search was conducted along with a sufficiently detailed Vaughn index and declara-
D. In Camera Review and Bad Faith
In support of its motion for in camera review, ViroPharma‘s central argument is that FDA has acted in bad faith in replying to ViroPharma‘s FOIA request. For this argument, ViroPharma relies primarily on FDA‘s rolling release of documents during the course of this litigation. Pl. Reply at 21-22. The argument that such a rolling release indicates bad faith has been “emphatically reject[ed]” by the D.C. Circuit. Meeropol v. Meese, 790 F.2d 942, 953 (D.C. Cir. 1986) (quoting Military Audit Project v. Casey, 656 F.2d at 754). It is established that “continuing discovery and release of documents ... shows good faith on the part of the agency that ... continues to search for responsive documents.” Landmark Legal Foundation v. EPA, 272 F. Supp. 2d 59, 63 (D.D.C. 2003) (citing Meeropol v. Meese, 790 F.2d at 952-53) (emphasis added). Accepting ViroPharma‘s argument “would work mischief in the future by creating a disincentive for an agency to reappraise its position, and when appropriate, release documents previously withheld.” Meeropol v. Meese, 790 F.2d at 953 (quoting Military Audit Project v. Casey, 656 F.2d at 754).
ViroPharma argues that supplemental releases may indicate bad faith if supported by other evidence. Pl. Reply at 21. The “other evidence” ViroPharma points to is that, after one set of documents was released, FDA expressed to ViroPharma that it was “confident” that it had met its obligations but then, months later, released another set of documents. Pl. Reply at 21. ViroPharma‘s argument is unpersuasive. After an agency has released documents, it is certainly reasonable for it to believe it has met its FOIA obligations. FDA‘s statement was not an indication that FDA would not continue to respond to ViroPharma‘s inquiries. Indeed, after the initial release, the parties continued to correspond with each other and to litigate this case, leading to the further release of documents. This is exactly what the good faith presumption for subsequent releases is meant to encourage.
As ViroPharma acknowledges, in camera review is committed to the discretion of the district court. See Juarez v. Department of Justice, 518 F.3d 54, 59-60 (D.C. Cir. 2008); Quinon v. FBI, 86 F.3d 1222, 1227 (D.C. Cir. 1996). While the FOIA provides district courts the “option” to conduct in camera review, “it by no means compels the exercise of that option.” Juarez v. Department of Justice, 518 F.3d at 60. The Court, in its discretion, does not find any basis to conduct an in camera review in this case. The Court therefore will deny ViroPharma‘s request.7
For the foregoing reasons, the Court will require defendants to suрplement the Vaughn index and declarations with respect to Vaughn index Nos. 2, 9-10, 46, 48, 53-54, 92-93, 95, 178, 197-99, 208-09, 235, 271-73, 282, 282, 295, 318, 355, 390, 397-403, 407, 409, 414-15, 424, 434, 442-47, 465, 474-75, 481-83, 489, 493, 495, 497, 499, 504, 507, 509, 645-46, 906-08, 960-63, 1197-98, and 1200-02. Defendants’ motion for summary judgment will be granted with respect to all other documents and denied without prejudice with respect to the above listed documents. Plaintiff‘s motion for summary judgment and motion for in camera review will be denied. An Order consistent with this Opinion shall issue this same day.
SO ORDERED.
PAUL L. FRIEDMAN
UNITED STATES DISTRICT JUDGE