Wolfe v. Department of Health and Human Services

• Decision Date: 05 February 1988
• Docket Number: No. 86-5017,86-5017
• Parties: , 56 USLW 2459 Sidney M. WOLFE, et al. v. DEPARTMENT OF HEALTH AND HUMAN SERVICES.
• Court: U.S. Court of Appeals — District of Columbia Circuit

Page 768

839 F.2d 768

268 U.S.App.D.C. 89, 56 USLW 2459

Sidney M. WOLFE, et al. v. DEPARTMENT OF HEALTH AND HUMAN SERVICES.

No. 86-5017.

United States Court of Appeals, District of Columbia Circuit.

Argued En Banc Dec. 2, 1987.

Decided Feb. 5, 1988.

Appeal from the United States District Court for the District of Columbia (Civil Action No. 85-1033).

James M. Spears, Deputy Asst. Atty. Gen., with whom Richard K. Willard, Asst. Atty. Gen., Joseph E. diGenova, U.S. Atty., Robert Kopp, Leonard Schaitman and Alfred Mollin, Dept. of Justice, were on the brief, for appellant.

William B. Schultz, with whom Alan B. Morrison was on the brief, for appellees.

Before WALD, Chief Judge, ROBINSON, MIKVA, EDWARDS, RUTH BADER GINSBURG, BORK, STARR, SILBERMAN, BUCKLEY, WILLIAMS, D.H. GINSBURG and SENTELLE, Circuit Judges.

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. Sec. 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. Sec. 552(b)(5) (1982). The government 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 rulemaking. 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. Sec. 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. Sec. 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 rulemaking 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. Sec. 553(b)(1) (1982), and guarantees the public the opportunity to comment on the proposed rule. 5 U.S.C. Sec. 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 district 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

Although plaintiffs do not seek access to the specific substance of the proposed rules, they already know the general identity of important regulations and other FDA projects under consideration because "these matters are generally known to those with an interest in the FDA." Brief of Appellees at 3. In addition, as plaintiffs point out, the FDA publishes a semi-annual Regulatory Agenda that lists all current and projected rulemaking being considered by the FDA, all existing FDA regulations presently under review, and all actions that have been completed by the FDA within the prior six months. Id. Thus, if the information requested is made public and shows a transmittal from the FDA to HHS, it is known that the FDA has proposed to regulate a particular subject, and if no transmittal is shown, it is known that the FDA has decided not to recommend such regulation or not to recommend it yet. If no transmittal to OMB is shown, HHS is known to have disapproved the FDA's proposal. If a transmittal is shown but no regulation is put out for notice and comment, OMB is known to have disapproved the regulatory proposal. At oral argument, plaintiffs' counsel conceded that plaintiff was not entitled to information which would reveal that a recommendation to regulate had been made. ⁴

The district court ruled that FOIA Exemption 5 did not apply to this case because the information requested does not fall under the deliberative process privilege. The district judge reasoned that none of the policies underlying the privilege would be significantly implicated by disclosure of the requested material and concluded that the mere fact that "a recommendation has been made by one agency to another" is not information "sufficiently 'deliberative' to trigger the protections of the privilege." Wolfe v. Department of Health & Human Serv., 630 F.Supp. 546, 550 (D.D.C.1985). Accordingly, the district court granted summary judgment for plaintiffs, denied defendant's cross-motion for summary judgment, and ordered disclosure of the requested information within thirty days. HHS filed a timely appeal, and on January 17, 1986, a panel of this court granted the agency's unopposed motion for a stay of the district court's order pending appeal.

On appeal the government continued to argue that the information requested is protected by the common law deliberative process privilege. ⁵ A majority of the panel affirmed the district court's grant of summary judgment to the plaintiffs....