Wolfe v. Weinberger, Civ. A. No. 74-454.

• Decision Date: 31 October 1975
• Docket Number: Civ. A. No. 74-454.
• Citation: 403 F. Supp. 238
• Parties: Sidney WOLFE, Plaintiff, v. Caspar W. WEINBERGER, Secretary of the Department of Health, Education and Welfare, Defendant.
• Court: U.S. District Court — District of Columbia

403 F. Supp. 238

Sidney WOLFE, Plaintiff, v. Caspar W. WEINBERGER, Secretary of the Department of Health, Education and Welfare, Defendant.

Civ. A. No. 74-454.

United States District Court, District of Columbia.

October 31, 1975.

Larry P. Ellsworth, Anita Johnson, Washington, D. C., for plaintiff.

Earl J. Silbert, U. S. Atty., Arnold T. Aikens, Peter C. Schaumber, Asst. U. S. Attys., Washington, D. C., for defendant; Peter Barton Hutt, Asst. Gen. Counsel, Thomas Scarlett, Atty., Food and Drug Div., Dept. of Health, Ed. and Welfare, Rockville, Md., of counsel.

MEMORANDUM OPINION

CHARLES R. RICHEY, District Judge.

I. BACKGROUND

This is an action in which plaintiff, Dr. Sidney Wolfe, seeks to compel the production by the Department of Health, Education, and Welfare of the transcripts of all meetings of the Food and Drug Administration's Over-the-Counter Antacid Drugs Advisory Review Panel (hereinafter, "the Antacid Panel"). The meetings in question took place between February 22, 1972, and January 9, 1973. On December 17, 1973, plaintiff Wolfe requested the transcripts from the FDA, which is a unit of the Department of Health, Education and Welfare, in a letter in which he invoked the Freedom of Information Act, 5 U.S.C. § 552, as the basis for his request. On January 21, 1974, his request was denied in a letter by the Acting Assistant Commissioner for Public Affairs of the FDA. On January 25, 1974, Wolfe appealed the denial to Dr. Charles C. Edwards, Assistant Secretary for Health, Education and Welfare. With his appeal unanswered, Wolfe filed this action on March 20, 1974. On May 15, 1974, Dr. Edwards denied Wolfe's request on appeal, concluding that "transcripts of those meetings must be regarded as internal agency records reflecting the deliberations of those engaged in the policy-making process, and thus exempt from disclosure under 5 U.S.C. § 552(b)(5) . . . ."¹

Jurisdiction in this case is based upon the Freedom of Information Act, 552(a) (3). Plaintiff claims that disclosure is compelled by 5 U.S.C. § 552(a)(3), which provides, in pertinent part, that: ". . . each agency, on request for identifiable records . . . shall make the records promptly available to any person." Plaintiff also contends that disclosure is required by § 10(b) of the Federal Advisory Committee Act, 5 U.S.C. App. I, which provides, in pertinent part, that: "... the records, reports, transcripts, minutes, . . . or other documents which were made available to or prepared for or by each advisory committee shall be available for public inspection . . . ." The defendant's response, as noted above, is that exemption five of the Freedom of Information Act, 5 U.S.C. § 552(b)(5), which protects "inter-agency or intra-agency memorandums or letters which would not be available by law to a party other than an agency in litigation with the agency," interposes a bar to discovery under the Act. With respect to plaintiff's claim under the Advisory Committee Act, defendant points out that the discovery rights granted by § 10(b) of that statute are specifically made "subject to section 552 of Title 5," including the exemptions thereto. Accordingly, defendant again invokes the (b)(5) exemption as to plaintiff's Advisory Committee Act claim.

The case is currently before the Court on cross-motions for summary judgment. Both parties assert, and the Court agrees, that no material facts are in issue. The case turns on the availability of the (b) (5) exemption, to shield records of this advisory committee, sought under the Freedom of Information Act and the Advisory Committee Act.

II. DISCUSSION

A. The Antacid Panel is not an Agency Within the Meaning of the (b)(5) Exemption.

As noted above, plaintiff claims that the transcripts of the panel's meetings must be disclosed as "identifiable records" under the Freedom of Information Act. Defendant apparently does not deny that the panel is an advisory committee,² that the transcripts are in the possession of the Department of Health, Education and Welfare,³ or that the transcripts are "records" within the meaning of the Freedom of Information Act.⁴ However, defendant submits that the panel functions "as an integral part of a public rulemaking process"⁵ and is a body consisting "of special government employees whose deliberations are functionally equivalent to those of full-time agency employees who review scientific problems and make recommendations for regulatory action."⁶ In short, the defendant's position would seem to be that, in addition to being an advisory committee, the panel is an agency within the meaning of the Freedom of Information Act, specifically exemption (b)(5), and that its deliberations are therefore entitled to protection from disclosure within the terms of that exemption.

In order to determine whether the panel is an agency within the meaning of (b)(5), it is first necessary to briefly consider the nature of the panel's role in the FDA's Over-the-Counter (OTC) Drug Review Program. The goal of the program as a whole is to establish regulations specifying the conditions under which over-the-counter drugs, divided into various therapeutic categories (such as antacids) for purposes of the program, are to be considered as safe and effective and not misbranded. For each therapeutic category, a panel of experts (such as the Antacid Panel) is appointed to receive and evaluate information on drugs. The panel receives written data and views and hears oral presentations from all interested parties. It also discusses and evaluates such submissions and presentations. (In the case of the Antacid Panel, those discussions were closed to the public and are the subject of the transcripts to which the plaintiff seeks access in this action.) The end product of the panel's deliberations is a report to the Commissioner of the FDA containing the panel's conclusions as well as recommended regulations. The Commissioner reviews the panel's recommendations and formulates proposed regulations for publication in the Federal Register. The Commissioner can, and on occasion does, simply adopt in toto the panel's recommendations. Opportunity for public comment and objection is provided before the Commissioner promulgates the final regulations.

It cannot be doubted that OTC panels perform a crucial role in the decision-making process. In the instant case, the Commissioner adopted the OTC Antacid Panel report as his own. But, as the Court of Appeals for this Circuit has stated, ". . . the degree of scrutiny its an advisory panel's decisions are given on review is . . . beside the point" in determining whether that panel is an agency. Washington Research Project, Inc. v. Department of Health, Education and Welfare, 164 U.S.App.D.C. 169, 504 F.2d 238, 248 (1974). "The important consideration," the court continued, "is whether it has any authority in law to make decisions." Id. The FDA has, in effect, admitted (and the description of the drug review program contained in the pleadings in this case certainly indicates) that the OTC Antacid Panel has no such authority. In the final regulations adopted as a result of the review of the over-the-counter antacid drugs by the panel and the Commissioner, the Commissioner noted:

"Some of the comments reflected an erroneous impression about the role of a panel in the OTC drug review. Pursuant to section 9(b) of the Federal Advisory Committee Act, the OTC drug review panels are utilized solely for advisory functions. Determinations of action to be taken and policy to be expressed with respect to matters upon which an advisory committee reports or makes recommendations to the Food and Drug Administration must be made solely by the Commissioner." 39 Fed.Reg. 19862 (June 4, 1974) (emphasis added).

It is clear to this Court that the Antacid Panel does not have that "substantial independent authority in the exercise of specific functions" which would qualify it as an "agency" within the meaning of the Freedom of Information Act. Soucie v. David, 145 U.S.App.D.C. 144, 448 F.2d 1067, 1073 (1971). Accordingly, the (b)(5) exemption to the Act for "inter-agency or intra-agency memorandums" is not available to prevent disclosure of the panel's deliberations as recorded in the transcripts, for the panel is not an "agency" within meaning of the Act and, specifically, the (b) (5) exemption.

B. The (b)(5) Exemption is Inapplicable to the Antacid Panel Under the Scheme of the Federal Advisory Committee Act, as Read in Conjunction with the Freedom of Information Act.

Defendant asserts that the Federal Advisory Committee Act explicitly recognizes an advisory committee's right to invoke (b)(5), for discovery of advisory committee records under the Act is made subject to the Freedom of Information Act, including the exemptions thereto. This Court's reading of the two statutes leads to precisely the opposite conclusion. In Gates v. Schlesinger, 366 F.Supp. 797 (D.D.C.1973), appeal dismissed, D.C. Cir. No. 74-2013 (Jan. 23, 1975), Judge Aubrey Robinson articulated a convincing argument to the effect that an advisory committee cannot have a "double identity" as an agency and thus cannot invoke the (b)(5) exemption:

"The Federal Advisory Committee Act utilizes the definition of agency contained in the Administrative Procedure Act, 5 U.S.C. § 551(1), which is applicable also to the Freedom of Information Act. It is significant that the Federal Advisory Committee Act contains a separate and distinct definition of an `advisory committee,' thus supporting the proposition that an advisory committee is not an `agency'." 366 F.Supp. at 798-99 (footnote omitted).

The Court concurs in Judge Robinson's reasoning. The Court also notes that the definition of "advisory committee" in the Advisory Committee Act specifically excludes "any committee which is composed wholly of fulltime officers or employees of the Federal Government," thus providing further evidence that "agency" and "advisory committee"...