Sidney M. Wolfe v. Department of Health and Human Services

839 F.2d 768, 268 U.S. App. D.C. 89, 56 U.S.L.W. 2459, 1988 U.S. App. LEXIS 2390
CourtCourt of Appeals for the D.C. Circuit
DecidedFebruary 5, 1988
Docket86-5017
StatusPublished
Cited by206 cases

This text of 839 F.2d 768 (Sidney M. Wolfe v. Department of Health and Human Services) is published on Counsel Stack Legal Research, covering Court of Appeals for the D.C. Circuit primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Sidney M. Wolfe v. Department of Health and Human Services, 839 F.2d 768, 268 U.S. App. D.C. 89, 56 U.S.L.W. 2459, 1988 U.S. App. LEXIS 2390 (D.C. Cir. 1988).

Opinions

Opinion for the court filed by Circuit Judge BORK in which STARR, SILBERMAN, BUCKLEY, WILLIAMS, D.H. GINSBURG and SENTELLE, Circuit Judges, join.

Dissenting opinion filed by Chief Judge WALD with whom SPOTTSWOOD W. ROBINSON, III, MIKVA, HARRY T. EDWARDS and • RUTH BADER GINSBURG, Circuit Judges, join.

Dissenting opinion filed by Circuit Judge HARRY T. EDWARDS with whom WALD, Chief Judge, SPOTTSWOOD W. ROBINSON, III, MIKVA, and RUTH BADER GINSBURG, Circuit Judges, join.

Dissenting .opinion filed by Circuit Judge RUTH BADER GINSBURG with whom WALD, Chief Judge, SPOTTSWOOD W. ROBINSON, III, MIKVA, and HARRY T. EDWARDS, Circuit Judges, join.

BORK, Circuit Judge:

The plaintiffs-appellees, members of the Public Citizen Health Research Group, requested access under the Freedom of Information Act (“FOIA”), 5 U.S.C. § 552 (1982), to records which indicate what actions have been completed by the Food and Drug Administration (“FDA”) but which await final decision or approval by the Secretary of Health and Human Services (“HHS”) or the Office of Management and Budget (“OMB”). HHS refused plaintiffs’ requests, contending that the information sought was exempt under FOIA Exemption 5, which shields from disclosure those documents that would not be routinely available in civil litigation with the agency. See 5 U.S.C. § 552(b)(5) (1982). The govern[770]*770ment claimed that the information should be exempt under the deliberative process privilege. The district court granted summary judgment for the plaintiffs. A divided panel of this court affirmed the district court. The full court granted review in order to address the proper scope of the deliberative process privilege as it is applied through Exemption 5. We hold that the privilege protects against disclosure of the information requested and therefore reverse the district court.

I.

Plaintiffs filed the instant FOIA request in order to influence decision-makers more efficiently during predecisional deliberations and in order to locate the cause of what they allege to be unreasonable delay in the issuance of FDA regulations. This case reflects dissatisfaction with the results of the development of formal presidential oversight of executive branch rule-making. See DeMuth & Ginsburg, White House Review of Agency Rulemaking, 99 Harv.L.Rev. 1075 (1986). Two developments within the last seven years have sparked this particular attack. First, in 1981 the Secretary of HHS withdrew the delegation of power to the FDA to issue regulations that it deemed in the public interest. Instead, such regulations now must first be reviewed and approved by the Secretary. See 21 C.F.R. § 5.11 (1987). Second, on February 17, 1981, the President issued Executive Order No. 12,291 which requires all agencies considering issuance of a rule to submit any draft proposed rule and any draft final rule for review by OMB. See Exec. Order No. 12,-291, Section 3(c)(1) & (2), 3 C.F.R. 127 (1981), reprinted in 5 U.S.C. § 601 note (1982).1 OMB, insofar as the relevant statutory law permits, reviews the rule for consistency with presidential policies and for net gain as shown by cost benefit analysis. Thus, before a rule can be proposed or promulgated by FDA it must be reviewed and approved first by the Secretary of HHS and then by OMB.

Members of the public are excluded only from the inter-agency stages of the rule-making process. After FDA, HHS, and OMB have approved a regulatory proposal, members of the public are guaranteed an opportunity to comment on the proposed rule. The APA requires that the FDA publish a general notice specifying the time and place of the rulemaking proceedings, 5 U.S.C. § 553(b)(1) (1982), and guarantees the public the opportunity to comment on the proposed rule. 5 U.S.C. § 553(c) (1982). There may be an opportunity for oral argument. Id. Thereafter the FDA is required to consider relevant comments presented to it and to incorporate in any rule adopted a concise and general statement of its basis and purpose. Id. The draft final rule is then reviewed by OMB. Plaintiffs, unsatisfied with their statutorily guaranteed input, during the comment period seek the ability to influence the inter-agency stage in the rulemaking process.

In essence, plaintiffs wish to be able to identify, in general, which regulatory actions have been proposed by FDA and to know how long regulatory actions initiated by FDA are spending at each stopping point along the approval route from FDA to HHS to OMB and back to HHS, so that they can identify decision-makers and contest delays in the consideration of FDA regulations. Plaintiffs began by submitting on July 18, 1984, a written request to HHS for access to records indicating which FDA proposals were then pending for review by HHS or OMB. Joint Appendix (“J.A.”) at 8. HHS denied this request by letter dated August 23,1984, on the ground that the information sought is exempt from disclosure under FOIA Exemption 5. Id. at 9. Plaintiffs renewed their request by letter dated March 7, 1985, to which they received no formal response. Id. at 11. Plaintiffs then filed this action in the dis[771]*771trict court on April 1, 1985. By letter dated April 16,1985, plaintiffs submitted to HHS a second request for the same information and in addition sought access to the dates of transmittal of proposed rules from FDA to HHS, from HHS to OMB, and from OMB back to HHS. Id. at 15. On April 19, 1985, HHS denied this second request on the same 'ground as the denial of the first request. Id. at 16. On April 25,1985, plaintiffs appealed by letter their April 16 request. Id. at 18. The appeal was formally denied on May 31, 1985. Id. at 19. On June 14, 1985, plaintiffs amended their complaint in this action to include their second request.

While plaintiffs’ case was pending in district court, HHS disclosed that it maintains a log (the “Regulations Log”) that contains, among other things, all the information sought by plaintiffs. The Regulations Log is used by HHS as an internal tracking device that allows the Secretary to monitor actions moving through the clearance process. It lists by title regulatory action proposed by FDA, the date on which the proposal was received by HHS, and, if applicable, the date on which HHS sent it on to OMB. The Log also contains information about the offices and persons within HHS to which the matter has been routed, but plaintiffs have not sought access to this information.2 Plaintiffs’ access to the Regulations Log is limited by their original FOIA request which seeks the dates on which regulatory proposals, identified by subject matter title, were transmitted from one agency to another.3

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839 F.2d 768, 268 U.S. App. D.C. 89, 56 U.S.L.W. 2459, 1988 U.S. App. LEXIS 2390, Counsel Stack Legal Research, https://law.counselstack.com/opinion/sidney-m-wolfe-v-department-of-health-and-human-services-cadc-1988.