Wolfe v. Weinberger

403 F. Supp. 238, 1975 U.S. Dist. LEXIS 15498
CourtDistrict Court, District of Columbia
DecidedOctober 31, 1975
DocketCiv. A. 74-454
StatusPublished
Cited by13 cases

This text of 403 F. Supp. 238 (Wolfe v. Weinberger) is published on Counsel Stack Legal Research, covering District Court, District of Columbia primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Wolfe v. Weinberger, 403 F. Supp. 238, 1975 U.S. Dist. LEXIS 15498 (D.D.C. 1975).

Opinion

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 *240 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 materia] facts are in issue. The ease 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 p'art 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 regula *241 tions 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.

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Bluebook (online)
403 F. Supp. 238, 1975 U.S. Dist. LEXIS 15498, Counsel Stack Legal Research, https://law.counselstack.com/opinion/wolfe-v-weinberger-dcd-1975.