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PUBLIC CITIZEN HEALTH RESEARCH GROUP v. FDA

March 11, 1998

PUBLIC CITIZEN HEALTH RESEARCH GROUP, Plaintiff,
v.
FOOD AND DRUG ADMINISTRATION, Defendant, HOECHST MARION ROUSSEL, INC., and SCHERING CORPORATION, Defendant-Intervenors.



The opinion of the court was delivered by: LAMBERTH

 This matter comes before the court on the parties' cross motions for summary judgment. Based upon the memoranda in support of and in opposition to the cross-motions, the entire record thereto and the relevant law, plaintiff's motion will be granted in part and denied in part; defendant FDA's motion will be denied in part and granted in part; defendant Schering Corporation's motion will be denied in full and defendant Hoechst Marion Roussel's motion will be granted in full.

 A. Factual and Procedural History

 This is an action under the Freedom of Information Act ("FOIA"), 5 U.S.C. § 552, as amended, by plaintiff Public Citizen Health Research Group ("Public Citizen") to compel production of records concerning pre-clinical and clinical studies for four experimental prescription drugs. For each of the drugs subject to the request, clinical trials were discontinued because of the death or serious injury of patients, or because of safety concerns arising out of pre-clinical studies.

 Public Citizen Health Research Group, a non-profit consumer advocacy organization devoted to promoting and protecting consumer health and safety, requested the data at issue in order to review whether FDA processes and procedures safeguard the health of human subjects who participate in drug trials. After some dispute as to whether FDA had a central file responsive to the initial letter request, the Food and Drug Administration ("FDA") identified 230 Investigational New Drug Applications ("IND"s) that were discontinued because of safety concerns between the dates of January 1, 1990, and July 12, 1993. FDA initially claimed that Public Citizen's request had failed to reasonably describe the records sought and moved to dismiss on that basis; this court denied FDA's motion and ordered the parties to reach an agreement on the search to be conducted. See Memorandum and Order, February 9, 1996. The FDA subsequently identified 14 of the 230 IND files as responsive to Public Citizen's FOIA request, but then contended that none of the documents in the 14 INDs could be released to Public Citizen because the sponsors notified FDA of their continuing proprietary interest in the data and information contained therein. See Letter from James A. O'Hara III, Associate Commissioner, FDA, to Brian Wolfman, Public Citizen (September 20, 1996) at 2. Specifically, FDA noted, "We have withheld the data and information obtained from the IND sponsors because these records consist of confidential commercial and/or trade secret data and information, the public disclosure of which would likely cause substantial harm to the competitive position of the sponsors of the INDs." Id.

 Three of the six IND sponsors -- Abbott Laboratories, Astra U.S.A. and Wyeth-Ayerst -- withdrew their objections to disclosure of the responsive records, and 13,626 pages of information on the investigational drugs' pre-clinical and clinical testing was forwarded to Public Citizen with limited redactions to protect personal privacy. Three other sponsors -- Hoechst Marion (subsequently Hoechst Marion Roussel ("HMR")), The R.W. Johnson Pharmaceutical Research Institute, and Schering Corporation moved to intervene as defendants. Plaintiff entered into settlement discussions with R.W. Johnson, and, as a result of those discussions, obtained the vast majority of responsive documents sought. R.W. Johnson was thereafter dismissed as a party to this action. See Stipulation of Settlement and Dismissal as to Defendant-Intervenor R.W. Johnson Pharmaceutical Research Institute, April 22, 1997. Only Schering and HMR remain as intervenor-defendants in this matter; Schering has five contested INDs, and HMR has one.

 B. The Regulatory and Statutory Framework

 Before a new drug may be marketed in the United States, it must be approved by the FDA. See 21 U.S.C. § 355(a); 21 C.F.R. part 314. The FDA will grant approval if the drug has been demonstrated to be safe and effective for its intended use on the basis of laboratory, animal and human testing. See 21 U.S.C. § 355(d). The approval process occurs in two steps.

 First, the sponsor gathers data about the drug's safety and effectiveness through pre-clinical (animal) and clinical (human) studies. Clinical studies may be commenced only after the sponsor has submitted an IND to FDA. 21 U.S.C. § 355(i)(1); 21 C.F.R. pt. 312. The IND must include the sponsor's pharmacological and toxicological studies of the drug, proposed clinical study protocols, chemistry manufacturing and control information, and summaries of previous human experiences with the drug on the basis of which FDA determines whether it is safe to conduct the proposed studies on humans. 21 C.F.R. § 312.23(a)(6)-(9). If FDA determines that the drug does not pose an unreasonable or significant risk to human subjects, the sponsor is permitted to go forward with the clinical trials.

 The authority to conduct clinical trials of investigational drugs may be withdrawn, suspended or terminated at any time during the investigation based upon a request of the sponsor or order of FDA. See 21 C.F.R. §§ 312.42, 312.44, and 313.45. Many INDs are withdrawn by sponsors or become inactive because sponsors fail to pursue the development of the project. A sponsor may elect to withdraw its application for a variety of reasons, including, but not limited to, disappointing trial results, faulty study design, changed market conditions, lack of commercial interest, or deaths, serious injury or adverse drug reactions. See Supplemental Declaration of Carolann W. Hooton ("Supplemental Hooton Declaration") P 11. The FDA may terminate an IND for a variety of reasons, including concerns about the study protocol, inadequate investigations supporting human testing, or adverse effects in trial participants. See 21 C.F.R. § 312.44. Or, the agency may temporarily suspend an investigation by placing it on "clinical hold." 21 C.F.R. § 312.42. Some INDs placed on clinical hold are ultimately withdrawn, while others become active again. Supplemental Hooton Declaration P 13.

 In the second stage of the drug development process, a sponsor presents to FDA the results of the clinical trials conducted under the IND, together with other information and data, in a formal New Drug Application (NDA). 21 U.S.C. § 355(b); 21 C.F.R. pt. 314. Agency reviewers evaluate all of the data in the NDA, including the results from the clinical trials under the IND, and determine whether the drug is safe and effective for its intended use.

 Disclosure of safety and effectiveness data is governed by the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 355(1), and agency regulations. Under the statute and the FDA regulations, safety and effectiveness data which has been supplied in an application "shall be made available to the public, upon request, unless extraordinary circumstances are shown" under five conditions, one of which is if "no work is being done or will be undertaken to have the application approved." 21 U.S.C. § 355(1)(1); 21 C.F.R. § 314.430(f)(1).

 II. ARGUMENT

 Summary judgment in a FOIA action is appropriate when the pleadings together with the declarations show that there is no genuine issue as to any material fact and that the moving party is entitled to judgment as a matter of law. See Fed. R. Civ. P. 56(c); Anderson v. Liberty Lobby, Inc. 477 U.S. 242, 247, 91 L. Ed. 2d 202, 106 S. Ct. 2505 (1986) (emphasis in original); Alyeska Pipeline Serv. Co. v. EPA, 272 U.S. App. D.C. 355, 856 F.2d 309, 313 (D.C. Cir. 1988) (mere conflict in affidavits not sufficient to preclude an award of summary judgment); Weisberg v. Department of Justice, 200 U.S. App. D.C. 312, 627 F.2d 365, 368 (D.C. Cir. 1980). In a FOIA action, the burden of justifying nondisclosure is on the agency and a district court is to determine the matter de novo. See 5 U.S.C. § 552(a)(4)(B); Department of Justice v. Reporters Comm. for Freedom of the Press, 489 U.S. 749, 755, 103 L. Ed. 2d 774, 109 S. Ct. 1468 (1989).

 In order to sustain its burden of proof in a FOIA case, the agency may rely upon the declarations of agency officials to show that its search was reasonable and that any withheld documents fall within one of the nine enumerated FOIA exceptions. See Oglesby v. Department of the Army, 287 U.S. App. D.C. 126, 920 F.2d 57, 68 (D.C. Cir. 1990); Goland v. CIA, 197 U.S. App. D.C. 25, 607 F.2d 339, 352 (D.C. Cir. 1978). The declarations submitted by the agency are to be accorded a presumption of expertise. Pharmaceutical Manufacturers Ass'n v. Weinberger, 411 F. Supp. 576, 578 (D.D.C. 1976). However, the declarations must be clear, specific and adequately detailed; they must describe the withheld information and the reason for nondisclosure in a factual and nonconclusory manner; and they must be submitted in good faith. See Hayden v. NSA, 197 U.S. App. D.C. 224, 608 F.2d 1381, 1387 (D.C. Cir. 1979). Unless the affidavits are deficient, the court need not conduct further inquiry into their veracity. 608 F.2d at 1387. The most commonly used device supporting an agency's summary judgment motion is the Vaughn index, which correlates each withheld document with a specific FOIA exemption, allowing the court to determine if the exemptions are validly asserted without having to physically inspect each of the documents. A Vaughn index also gives the opposing party some basis on which to oppose the motion. See Vaughn v. Rosen, 157 U.S. App. D.C. 340, 484 F.2d 820 (D.C. Cir. 1973). To have a triable issue of material fact that will preclude the award of summary judgment, the plaintiff must show that the claimed exemption is improperly asserted.

 The purpose of FOIA is "to ensure an informed citizenry, vital to the functioning of a democratic society, needed to check against corruption and to hold the governors accountable to the governed." NLRB v. Robbins Tire & Rubber Co., 437 U.S. 214, 242, 57 L. Ed. 2d 159, 98 S. Ct. 2311 (1978). FOIA is a pro-disclosure statute, and agency records must be disclosed when properly requested unless exempt under one of nine enumerated exemptions or specifically excluded from the act's coverage. See 5 U.S.C. § 552(a); NLRB v. Sears, Roebuck and Co., 421 U.S. 132, 136, 44 L. Ed. 2d 29, 95 S. Ct. 1504 (1975).

 In this matter, FDA, Schering and HMR rely upon Exemption 4, 5 U.S.C. § 552(b)(4), as the basis for non-disclosure. *fn1" Exemption 4 protects from disclosure (i) commercial or financial information, (ii) obtained from a person, (iii) that is privileged or confidential. *fn2" National Parks and Conservation Ass'n v. Morton, 162 U.S. App. D.C. 223, 498 F.2d 765 (D.C. Cir. 1974) It is undisputed that prongs one and two of the National Parks test are satisfied. See, e.g., Public Citizen, 227 U.S. App. D.C. 151, 704 F.2d 1280 at 1290 (holding that the term "commercial" is not confined to records that reveal basic commercial operations and that drug manufacturers have a commercial interest in health and safety information concerning their products, and that such documents are submitted by a person); see also Public Citizen Health Research Group v. Food and Drug Administration, 964 F. Supp. 413, 414 (D.D.C. 1997). Whether commercial or financial information is confidential is dependent upon whether disclosure of that information will either (i) impair the government's ability to obtain necessary information in the future or (ii) cause substantial harm to the competitive position of the person who submitted the information. See National Parks 498 F.2d at 770. *fn3" In this matter, the parties properly focus their attention upon the "substantial competitive harm" element of the test. See Public Citizen, 704 F.2d at 1290-91, 1291 n.29; Public Citizen, 964 F. Supp. at 415 (noting that any arguments about impairment were unjustified). In order to support the withholding of documents under the substantial competitive harm prong, the party seeking to prevent disclosure "need not 'show actual competitive harm'; evidence revealing 'actual competition and the likelihood of substantial competitive injury' is sufficient to bring commercial information within the realm of confidentiality." Public Citizen, 704 F.2d at 1291 (quoting Gulf & Western Industries, Inc. v. United States, 199 U.S. App. D.C. 1, 615 F.2d 527, 530 (D.C. Cir. 1979).

 Plaintiff Public Citizen contends that the information sought is not exempt from disclosure, and offers two arguments in support. First, typical to almost all exemption 4 disputes, it contends that defendant and defendant-intervenors have not, based on the materials submitted to the court, adequately sustained their burden of showing "a likelihood of substantial competitive injury" from release of the data. (The existence of "actual competition" in the pharmaceutical industry is not contested.) Second, Public Citizen looks to the FDA regulations concerning release of safety and effectiveness data upon abandonment of an application -- and the subsequent codification of those regulations by Congress -- as separate grounds directing disclosure. Public Citizen notes that safety and effectiveness data on abandoned INDs must be made public except in "extraordinary circumstances" and goes on to assert that the requirement of "extraordinary circumstances" must be construed to be a higher threshold than a "likelihood of substantial commercial harm." Defendant and defendant-intervenors counter this latter claim by arguing that reliance upon 21 U.S.C. § 355(1) and 21 C.F.R. § 314.430 is misplaced. And, even if not misplaced, they claim that those provisions do not create a more liberal disclosure policy because "extraordinary circumstances" should be interpreted as coextensive with a "likelihood of substantial competitive injury." Because the success or failure in adequately demonstrating a likelihood of substantial competitive harm under FOIA exemption 4 affects the latter inquiry, both contentions will both be addressed by the court.

 A. Have Defendants Sustained Their Burden of Showing How Release of the Requested Information Will Cause a "Likelihood of Substantial Competitive Harm"?

 This circuit has previously recognized that the type of safety and effectiveness information at issue in Public Citizen's request may be of great assistance to competing drug manufacturers, and therefore a potential cause of "substantial commercial injury" as those terms are understood for exemption 4 purposes. In Webb v. HHS, 225 U.S. App. D.C. 19, 696 F.2d 101, 103 (D.C. Cir. 1982), the court noted:

 
a drug manufacturer which has submitted an NDA has a competitive interest in seeing that the information contained in its NDA is not prematurely released to the public. If 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.

 This exact language was relied upon in Public Citizen Health Research Group v. FDA, Civ. A. No. 94-0017 (RMU) (D.D.C. April 10, 1995) ("Public Citizen slip op."), a case filed in this district on the same date as the instant matter. As with this case, Public Citizen filed a FOIA suit seeking all records concerning preclinical and clinical trials concerning a drug -- fialuridine ("FIAU") -- for which clinical trials were halted because of irreversible liver damage and the eventual death of five patients. Id. at 2. In determining that FOIA exemption 4 was properly asserted, Judge Urbina noted the immense amount of time and money that would be saved if other companies could obtain the information contained in the FIAU IND, even if FIAU itself was not being developed by competitors. Id. at 12. Upon review of all the information supplied by the defendants and intervenor-defendants, Judge Urbina concluded that the sponsors would "clearly suffer substantial competitive injury if the [safety and effectiveness] information is released because of the nature of the drug approval process." See id. at *17. See also Citizens Comm'n on Human Rights v. FDA, Civ. A. No. 92-5313 (JMI), slip op. at 17 (C.D. Cal. May 10, 1993) (determining that based upon an analysis of the drug approval process and the nature of the withheld information, that release of the requested information would be likely to cause substantial competitive injury), remanded in part on unrelated grounds, 45 F.3d 1325 (9th Cir. 1995). These cases stand for the proposition that release of the types of data and information contained in NDA and IND files have been previously held to satisfy the "substantial commercial harm" exemption 4 standard.

 1. Schering's INDs

 Schering has five INDs for which Public Citizen would like safety and effectiveness data disclosed pursuant to its FOIA request. The first three are applications for an antifungal agent -- INDs 35757, 34465, and 31911. As to the documents as a group, Schering contends that it is presently building on the results of its IND experience to develop a successor drug currently in clinical testing. See Declaration of George H. Miller ("Miller Declaration") PP 9, 14. Disclosure of the IND would potentially allow one or more of its competitors to follow in Schering's footsteps, and thereby get a competitive product to the market sooner than otherwise. Id. P 14, 17-21, 22-24, 25-26, 27. Furthermore, revealing prematurely the particular fungal infection targeted by the IND would reflect Schering's judgment that the fungus was one that was not well-controlled by existing drugs, and, therefore, other companies would know to devote their energies in that direction. Id. P 4. As evidence of the confidentiality of the information, the company notes that Schering personnel could only gain access on a need-to-know basis, and the information would only be released to third parties when confidentiality agreements were obtained. Id. P 12.

 Schering goes on to describe in some detail the specific classes of documents contained in the IND files about which they are concerned and the precise manner in which those documents would be used by competitors if the information was publicly available. The Miller Declaration explains that the pre-clinical pharmacology data reflects basic research on the mechanisms by which fungal infections occur and may be treated. The data also reflect disease models that are a valuable product of the company's research and development efforts, and the models would be valuable to competitors. Id. PP 17-21; Schering Memorandum at 13. The toxicology studies have allowed the company to link the chemical structure of the drugs with specific toxicological problems, which has allowed Schering to develop new compounds critical to the development of the successor product. Id. P 23. This data would also be applicable to products with identical or similar metabolites. Id. P 24. The Miller Declaration goes on to explain the value of the clinical protocols; namely, that they reflect the testing required in order to examine safety and effectiveness. Id. P 26. Finally, the Miller Declaration addresses the clinical studies (test results and annual and supplemental reports), noting that they reflect basic research product on the type of compound in the IND and the pharmacology, toxicology and protocols which would direct competitors as to which paths to take based on Schering's reported successes and ...


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