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Viropharma Incorporated v. Department of Health and Human Services

March 16, 2012


The opinion of the court was delivered by: Paul L. Friedman United States 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 the Food and Drug Administration ("FDA"), and on ViroPharma's motion for in camera review. Upon consideration of the parties' papers, the relevant statutes and case law, and the entire record in this case, the Court will grant in part and deny in part defendants' motion, and will deny plaintiff's motions for summary judgment and for in camera review.*fn1


ViroPharma owns the new drug application ("NDA") for Vancocin, a vancomycin hydrochloride capsule ("vancomycin"). Declaration of Thomas F. Doyle ("Doyle Decl.") ¶ 2, May 27, 2010 [Dkt. No. 30-2]. Vancocin is indicated for the treatment of a dangerous gastrointestinal infection caused by Clostirdium difficile bacteria. Compl. ¶ 2. At present, there is no FDA-approved generic version of vancomycin, and Vancocin is the only FDA-approved drug to treat C. difficile infections. Id.

Prior to 2006 the FDA recommended using in vivo studies - which involve testing in humans - to establish the bioequivalence of generic versions of vancomycin. Doyle Decl. ¶¶ 3-4. ViroPharma contends that, in February 2006, FDA adopted a new policy, recommending in vitro studies - which do not require testing in humans - as sufficient to establish bioequivalence. Doyle Decl. ¶ 4. Allegedly, FDA did not publicly announce the change in policy, but provided information to companies that submitted inquiries regarding the bioequivalence standards for vancomycin. Id. ¶ 5. ViroPharma learned of these events through one such company, which publicly released the new standards, leading to a reduction in the value of ViroPharma's stock by roughly 40%. Id. ¶¶ 6-7.

On March 17, 2006, ViroPharma filed a citizen petition for a stay of any approvals of abbreviated new drug applications ("ANDA") under FDA's new bioequivalence testing method. Doyle Decl. ¶ 8. On March 21, 2006, ViroPharma also filed a Freedom of Information Act request. Doyle Decl. ¶ 9. ViroPharma requested:

A copy of the entire administrative record of the decision of the Office of Generic Drugs (OGD) (including, but not limited to, documents related to reference number: OGD #06-0200) that abbreviated new drug applications (ANDAs) or applications filed under 505(b)(2) for vancomycin hydrochloride capsules qualify for a waiver of in vivo bioequivalence and may demonstrate bioequivalence to the reference listed drug Vancocin® through in vitro dissolution testing.

Compl. ¶ 29. FDA logged the request into its tracking system and forwarded the request to the Division of Information and Disclosure Policy ("DIDP") in FDA's Center for Drug Evaluation and Research. Declaration of Frederick J. Sadler ("Sadler Decl.") ¶¶ 6-7, April 22, 2010 [Dkt. No. 28-2].

On December 16, 2008, FDA published a notice in the Federal Register entitled "Draft Guidance for Industry on Bioequivalence Recommendation for Vancomycin HCI; Availability." Doyle Decl. Ex. 3. Although the notice did not contain the administrative record for FDA's March 2006 decision, it did limit the use of in vitro testing to generic vancomycin tablets whose inactive ingredients are qualitatively and quantitatively the same as Vancocin; for others, in vivo testing was recommended. Doyle Decl. ¶¶ 12-13.

On December 16, 2008, ViroPharma filed this lawsuit to enforce FDA's obligations under the FOIA and submitted a second FOIA request seeking records related to the 2008 Draft Guidance. Doyle Decl. ¶¶ 14-15. ViroPharma's second request sought [a] copy of all records of the decision of the Food and Drug Administration (including, but not limited to, documents related [to] FDA's Draft Guidance for Industry on Bioequivalence Recommendation for Vancomycin HCL assigned docket number FDA-2008-D-0626) recommending in vitro dissolution studies for test formulations of Vancomycin HCL that are qualitatively (Q1) and quantitatively (Q2) the same as the reference listed drug with respect to inactive ingredients and recommending in vivo bioequivalence studies with clinical endpoints for test formulations that are not Q1 and Q2 the same as the RLD with respect to inactive ingredients; including . . . [a]ny Agency communication(s) regarding the above recommendations with any third party outsidde of the FDA prior to December 15, 2008.

Sadler Decl. Ex. B. FDA routed both of ViroPharma's requests to DIDP and the Office of the Executive Secretariat; Office of Legislation; Office of Policy, Planning, and Preparedness; and Office of the Chief Counsel. Sadler Decl. ¶¶ 8, 11.

On March 22, 2009, FDA produced documents in response to ViroPharma's FOIA requests from the Office of the Commissioner of the FDA. Doyle Decl. ¶ 16. On October 28, 2009, FDA produced additional documents from the Center for Drug Evaluation and Research. Id. Between November 11, 2009 and March 24, 2010, ViroPharma sent letters identifying documents it believed were responsive but had not been released. Id. ¶ 17. FDA released additional documents on December 9, 2009; February 24, 2010; and April 22, 2010. Id. ¶¶ 21, 25, 27. Throughout FDA's releases, it has withheld, in whole or in part, over 700 documents pursuant to the deliberative process privilege under FOIA Exemption 5. Sadler Decl. ¶¶ 23-24.*fn2 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. Reply") ¶¶ 6, 11, 21, June 24, 2010 [Dkt. No. 34-3].


Under Rule 56 of the Federal Rules of Civil Procedure, summary judgment is appropriate if the movant shows that there is no genuine issue as to any material fact and that the movant is entitled to judgment as a matter of law. FED. R. CIV. P. 56(a). The movant bears the burden of demonstrating the absence of a genuine issue of material fact. Celotex Corp. v. Catrett, 477 U.S. 317, 322 (1986). Factual assertions in the moving party's affidavits or declarations may be accepted as true unless the opposing party submits its own affidavits or declarations or documentary evidence to the contrary. Neal v. Kelly, 963 F.2d 453, 456 (D.C. Cir. 1992).

The FOIA requires a federal agency to release all records responsive to a proper request except those protected from disclosure by one or more of nine enumerated exemptions set forth in 5 U.S.C. § 552(b). See 5 U.S.C. § 552(b). FOIA cases typically and appropriately are decided on motions for summary judgment. See Defenders of Wildlife v. U.S. Border Patrol, 623 F. Supp. 2d 83, 87 (D.D.C. 2009); Bigwood v. U.S. Agency for Int'l Dev., 484 F. Supp. 2d 68, 73 (D.D.C. 2007). The agency opposing the grant of summary judgment has the burden of proving that "each document that falls within the class requested either has been produced, is unidentifiable, or is wholly exempt from the Act's inspection requirements." Goland v. CIA, 607 F.2d 339, 352 (D.C. Cir. 1978) (internal citation and quotation omitted); see Maydak v. Department of Justice, 218 F.3d 760, 763-64 (D.C. Cir. 2000). The court may award summary judgment to an agency solely on the basis of information provided in affidavits or declarations that describe "the documents and the justifications for nondisclosure with reasonably specific detail, demonstrate that the information withheld logically falls within the claimed exemption, and are not controverted by either contrary evidence in the record nor by evidence of agency bad faith." ...

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