Public Citizen Health Research Group v. Food & Drug Admin.

• Decision Date: 06 August 1999
• Docket Number: No. 98-5161,98-5161
• Parties: (D.C. Cir. 1999) Public Citizen Health Research Group, Appellee v. Food & Drug Administration, Appellant in 98-5161 Schering Corporation, Appellant in 98-5162 Consolidated with 98-5162
• Court: U.S. Court of Appeals — District of Columbia Circuit

Page 898

185 F.3d 898 (D.C. Cir. 1999)

Public Citizen Health Research Group, Appellee v. Food & Drug Administration, Appellant in 98-5161

Schering Corporation, Appellant in 98-5162

No. 98-5161 Consolidated with 98-5162

United States Court of Appeals

FOR THE DISTRICT OF COLUMBIA CIRCUIT

Argued May 11, 1999

Decided August 6, 1999

[Copyrighted Material Omitted] Appeals from the United States District Court for the District of Columbia(No. 94cv00018)

Marina Utgoff Braswell, Assistant U.S. Attorney, argued the cause for appellant Food & Drug Administration. With her on the briefs were Wilma A. Lewis, U.S. Attorney, and R. Craig Lawrence, Assistant U.S. Attorney.

Bruce N. Kuhlik argued the cause and filed the briefs for appellant Schering Corporation.

Amanda Frost argued the cause for appellee. With her on the brief was Brian Wolfman. Lucinda A. Sikes entered an appearance.

Marjorie E. Powell was on the brief for amicus curiae Pharmaceutical Research and Manufacturers of America.

Before: Ginsburg, Henderson, and Garland, Circuit Judges.

Opinion for the Court filed by Circuit Judge Ginsburg.

Opinion concurring in the result filed by Circuit Judge Garland.

Ginsburg, Circuit Judge:

Pursuant to the Freedom of Information Act, the Public Citizen Health Research Group asked the Food and Drug Administration for documents relating to drug applications that had been abandoned for health or safety reasons. The FDA denied this request and Public Citizen sued the agency in district court, where Schering Corporation, which had submitted five investigational new drug applications (INDs) of the sort requested by Public Citizen, intervened as a defendant. The FDA and Schering claimed that certain of the documents in those five INDs contained confidential commercial information and therefore could be withheld under Exemption 4 of the FOIA, 5 U.S.C. § 552(b)(4). Public Citizen argued that the documents could not be withheld under that exemption and that in any event disclosure was required under 21 U.S.C. § 355(l), which it asserted sets a standard for nondisclosure higher than that in Exemption 4 of the FOIA.

The district court ordered the release of all the disputed documents on the ground that, although some could be withheld under Exemption 4, the FDA had not met the higher standard of § 355(l). We affirm the judgment of the district court in part, albeit on a different ground, reverse it in part, and remand the case for further proceedings consistent with this opinion.

I. Background

Before marketing a new drug in the United States a manufacturer must obtain the approval of the FDA contingent upon clinical (i.e., human) tests showing that the drug is safe and effective. See 21 U.S.C. § 355(a), (d). Before a company may begin clinical testing, however, it must first submit an IND describing the drug, the results of laboratory and pre-clinical (i.e., animal) testing, and the proposed clinical testing. See id. § 355(i). An applicant may begin the proposed clinical testing 30 days after submitting its IND; the FDA, however, may place the testing on hold at any time.See 21 C.F.R. §§ 312.40(b), 312.42. During clinical testing the company must update its IND with safety reports, annual reports on the progress of the testing, any amendments to the testing protocols, and other information. See id. §§ 312.30-312.33. After clinical testing, the company must file a new drug application (NDA), which must include information about the results of both pre-clinical and clinical testing; information previously submitted in the IND may be incorporated by reference into the NDA. See 21 U.S.C. § 355(b); 21 C.F.R. § 314.50.

This case began when Public Citizen filed a FOIA request with the FDA for "[a]ll documents concerning pre-clinical and clinical studies for all prescription drugs which had a discontinuance of the clinical trials because of death or serious injury of patients or because of safety concerns from preclinical studies ... between January 1, 1990 and [July 12, 1993]."When the agency denied the request Public Citizen filed suit in the district court seeking release of the documents.

The FDA moved to dismiss, arguing that although a search of its database identified 230 INDs for which the agency had received safety reports and which were either withdrawn, terminated, or placed on hold by the FDA, it could not without an unduly burdensome manual search of each file determine which of these were discontinued "because of" health or safety concerns. The district court denied the motion to dismiss, and the agency then determined that 14 of the 230 INDs were responsive to the FOIA request; of those, only portions of the five filed by Schering are at issue in this appeal.

On cross-motions for summary judgment, the district court first held that the disputed documents in the five INDs could be withheld under Exemption 4, because they contain "commercial or financial information obtained from a person [that is] privileged or confidential." 5 U.S.C. § 552(b)(4). Schering's affidavits demonstrated to the court that disclosure would "cause substantial harm to [its] competitive position."National Parks & Conservation Ass'n v. Morton ("National Parks I"), 498 F.2d 765, 770 (D.C. Cir. 1974). The district court then held that under 21 U.S.C. § 355(l)(1) the FDA must nonetheless disclose the same documents absent "extraordinary circumstances." Finding no such circumstances here, the court granted summary judgment for Public Citizen and ordered the agency to release the disputed documents.Both the FDA and Schering appealed to this court.

II. Analysis

The FDA and Schering argue that the agency may under § 355(l) withhold any data pertaining to the safety and effectiveness of an abandoned drug that it may withhold under Exemption 4 of the FOIA--in other words, that the standards in the two statutes are the same. Public Citizen contends that § 355(l) imposes a more stringent standard for nondisclosure than that in Exemption 4. We need not resolve this dispute over the relationship between the two statutes, however, because we hold that § 355(l) does not apply to INDs.Viewing the documents solely through the lens of Exemption 4, we conclude that the FDA has justified withholding at least some information in four of the five INDs.

A. Section 355(l)

Section 355(l) requires the FDA, upon request, to disclose "[s]afety and effectiveness data and information which has been submitted in an application under subsection (b) [of § 355] for a drug" that subsequently was abandoned by its sponsor, "unless extraordinary circumstances are shown." 21 U.S.C. § 355(l)(1). No one disputes that an "application under subsection (b)" is an NDA. Schering argues that § 355(l), therefore, simply does not apply to information in an IND, which is submitted under subsection (i), not subsection (b). That is indeed the plain meaning of the provision, and we cannot understand how "submitted in an application under subsection (b)" could include anything other than information submitted in an NDA. Public Citizen's arguments to the contrary are not convincing.

First, Public Citizen contends that the agency applies § 355(l) to the disclosure of material submitted in an IND and that we should accord "substantial weight" to the FDA's view of its regulatory structure. As Schering notes, however, the FDA has never promulgated a regulation--nor are we apprised of any FDA decision or other document--so interpreting § 355(l). More important, it is apparent that the Congress has spoken to "the precise question at issue" here, Chevron U.S.A. Inc. v. NRDC, 467 U.S. 837, 842-43 & n.9 (1984): § 355(l) by its terms applies only to "safety and effectiveness data and information" submitted in an NDA. Therefore, even if the agency had interpreted the phrase "subsection (b)" in § 355 to include information submitted in an IND, we could not defer to that interpretation.

Second, Public Citizen argues that to read § 355(l) as applying only to NDAs is erroneous because "the IND and NDA are not two distinct stages" in the drug approval process. In support of this view, Public Citizen points out that the FDA stores information related to the approval of a drug in its IND file even after an NDA is submitted. The fact remains, however, that NDAs and INDs are the subject of separate subsections of § 355 and the Congress referred only to one of them in § 355(l). We cannot help but conclude, therefore, that the statute treats the submission of an NDA as a discrete event in the drug approval process, regardless how the FDA maintains its files.

Third, Public Citizen contends that a plain meaning approach to § 355(l) leads to an illogical result: data and information submitted in an IND which later, rather than being resubmitted in an NDA, are incorporated by reference into the NDA would not be "submitted in an application under subsection (b)," that is, an NDA. The FDA and Schering offer a more sensible view, however: to incorporate IND materials by reference into an NDA is indeed to submit those materials as part of the NDA. By the same token, once those materials are incorporated by reference into an NDA, their disclosure is subject to the standard in § 355(l) even if the FDA keeps them in an IND file.

Finally, Public Citizen argues that "[i]t makes no sense to assume Congress enacted a statute mandating disclosure of safety and effectiveness data only when the sponsor had filed an NDA ..., but not when the sponsor had abandoned the drug earlier in the process." In this regard Public Citizen points out that the FDA accords the same treatment to such data regardless whether they were submitted in an NDA or an IND. Specifically, the FDA by regulation (21 C.F.R. § 312.130(b)) provides that disclosure of information in an IND "will be handled in accordance with" the regulation governing disclosure of information in an NDA (21 C.F.R. § 314.430(f)).

Nonetheless, when the Congress enacted § 355...