Parke, Davis & Co. v. Califano

• Citation: 623 F.2d 1
• Decision Date: 16 June 1980
• Docket Number: No. 78-1140,78-1140
• Parties: PARKE, DAVIS & COMPANY, Plaintiff-Appellee, v. Joseph A. CALIFANO, Secretary of Health, Education and Welfare et al., Defendants-Appellants.
• Court: United States Courts of Appeals. United States Court of Appeals (6th Circuit)

Page 1

623 F.2d 1

PARKE, DAVIS & COMPANY, Plaintiff-Appellee, v. Joseph A. CALIFANO, Secretary of Health, Education and Welfare et al., Defendants-Appellants.

No. 78-1140.

United States Court of Appeals,

Sixth Circuit.

Argued April 3, 1980.

Decided and Filed June 16, 1980.

James K. Robinson, U.S. Atty., Detroit, Mich., Leonard Schaitman, Barbara Babcock, Michael Jay Singer, U.S. Dept. of Justice, App. Section, Civil Division, Washington, D. C., Richard M. Cooper, Chief Counsel, Food and Drug Administration, Rockville, Md., for defendants-appellants.

Wolfgang Hoppe, Miller, Canfield, Paddock & Stans, Charles E. Lents, Detroit, Mich., Thomas Richard Spradlin, Clifford, Glass, McIlwain & Finney, Washington, D. C., for plaintiff-appellee.

Before LIVELY and BROWN, Circuit Judges, and PECK, Senior Circuit Judge.

LIVELY, Circuit Judge.

This is an appeal from summary judgment for the plaintiff in an action under the Freedom of Information Act (FOIA), 5 U.S.C. § 552 (1976). The general purpose of FOIA is to open the records of government agencies to public scrutiny. However, Congress provided for the exclusion of certain types of records from the provisions of the Act by creating seven "exemptions." This case concerns the fifth exemption.

I.

Parke, Davis & Company (Parke Davis) initiated a request for records of the Food and Drug Administration (FDA), a component agency of the Department of Health, Education and Welfare. The request, made in accordance with a provision of FOIA ¹ and applicable regulations, specified a large number of documents for disclosure. FDA eventually responded by furnishing some of the documents, advising that others could not be found, and denying the request as to portions or all of other designated documents on the ground that the withheld materials are exempt from disclosure under 5 U.S.C. § 552(b)(5) (Exemption 5). ²

After exhausting its administrative remedies, Parke Davis filed the present action pursuant to 5 U.S.C. § 552(a)(4)(B), which provides:

(B) On complaint, the district court of the United States in the district in which the complainant resides, or has his principal place of business, or in which the agency records are situated, or in the District of Columbia, has jurisdiction to enjoin the agency from withholding agency records and to order the production of any agency records improperly withheld from the complainant. In such a case the court shall determine the matter de novo, and may examine the contents of such agency records in camera to determine whether such records or any part thereof shall be withheld under any of the exemptions set forth in subsection (b) of this section, and the burden is on the agency to sustain its action.

When required pleadings had been filed, both parties made motions for summary judgment. The motion of FDA was accompanied by affidavits in which the government's position was stated. In brief, the affidavits asserted that the documents and portions of documents withheld by FDA "do not contain any factual data which is not revealed elsewhere . . . " and "were generated as part of two deliberative processes." The affidavits also stated that "(t)he disclosure of these documents would impair the deliberative process by inhibiting frank expressions of views and complete and candid advice."

The district court held a hearing on the cross-motions and received 22 disputed documents for in camera inspection. Shortly thereafter the court entered an order requiring disclosure of seventeen documents and denying disclosure of five upon a finding that they fell within Exemption 5. Parke Davis did not appeal the denial and the only issues before us relate to the 17 documents which were ordered disclosed. Of these, one had been withheld by FDA in its entirety and deletions had been made from the texts of the other 16.

II.

We begin our consideration of this case by looking at the administrative processes of FDA which generated the documents in dispute. See NLRB v. Sears, Roebuck & Co., 421 U.S. 132, 138-44, 95 S.Ct. 1504, 1510-13, 44 L.Ed.2d 29 (1975); Renegotiation Board v. Grumman Aircraft Engineering Corp., 421 U.S. 168, 172-79, 95 S.Ct. 1491, 1494-97, 44 L.Ed.2d 57 (1975). The present action arose out of Parke Davis's long-standing effort to obtain certification from FDA for over-the-counter (OTC) sales of its product "Benylin" which is presently approved only for prescription sales. The procedures required for OTC approval are described in this court's opinion in an appeal from a district court judgment in a previous action between the parties. See Parke, Davis & Co. v. Califano, 564 F.2d 1200 (6th Cir. 1977), cert. denied, 435 U.S. 942, 98 S.Ct. 1522, 55 L.Ed.2d 539 (1978) (Parke Davis I ). As we pointed out in Parke Davis I, there were two available routes by which Parke Davis sought OTC approval for Benylin. One of these procedures, described in 21 C.F.R. § 330.100, provides for appointment of advisory review panels of qualified experts to advise the commissioner of FDA "on the promulgation of monographs establishing conditions under which OTC drugs are generally recognized as safe and effective and not misbranded." Parke Davis submitted a proposal to the appropriate review panel concerned with diphenhydramine hydrochloride (DPH), the active ingredient in Benylin. This panel eventually concluded that DPH is safe and effective as an antitussive (cough inhibitor) and it issued a "monograph" to that effect. As we note later, the commissioner "dissented" from this monograph and several of the FOIA requests involved in this appeal concern the advisory review panel monograph.

Most of the documents which the district court ordered disclosed were generated in Parke Davis's efforts to obtain OTC approval of Benylin under the "traditional" or "switch over" procedure prescribed in 21 C.F.R. § 310.200. Section 310.200(b) provides, "(a)ny interested person may file a petition seeking such exemption (from prescription limitations), stating reasonable grounds therefor, which petition may be in the form of a supplement to an approved new-drug application." Parke Davis petitioned by means of a "supplemental new drug application" for removal of the prescription-only restriction from FDA's previous approval of a new drug application (NDA) for Benylin.

The supplemental new drug application was subject to the provisions of law relating to approval for marketing new drugs. Section 505 of the Food, Drug and Cosmetic Act of 1938, 21 U.S.C. § 355, sets forth the procedure for obtaining this approval. After an application has been filed, the Secretary of HEW is required either to approve it or give notice to the applicant of an opportunity for a hearing on the question whether the application is to be approved. One action or the other must be taken by the Secretary within 180 days after the filing of the application. After an expedited hearing the Secretary must issue an order approving the application unless he finds it deficient under any of six criteria listed in 21 U.S.C. § 355(d):

If the Secretary finds, after due notice to the applicant in accordance with subsection (c) of this section and giving him an opportunity for a hearing, in accordance with said subsection, that (1) the investigations, reports of which are required to be submitted to the Secretary pursuant to subsection (b) of this section, do not include adequate tests by all methods reasonably applicable to show whether or not such drug is safe for use under the conditions prescribed, recommended, or suggested in the proposed labeling thereof; (2) the results of such tests show that such drug is unsafe for use under such conditions or do not show that such drug is safe for use under such conditions; (3) the methods used in, and the facilities and controls used for, the manufacture, processing, and packing of such drug are inadequate to preserve its identity, strength, quality, and purity; (4) upon the basis of the information submitted to him as part of the application, or upon the basis of any other information before him with respect to such drug, he has insufficient information to determine whether such drug is safe for use under such conditions; or (5) evaluated on the basis of the information submitted to him as part of the application and any other information before him with respect to such drug, there is a lack of substantial evidence that the drug will have the effect it purports or is represented to have under the conditions of use prescribed, recommended, or suggested in the proposed labeling thereof; or (6) based on a fair evaluation of all material facts, such labeling is false or misleading in any particular; he shall issue an order refusing to approve the application.

"Substantial evidence" as used in § 355(d) is defined as follows:

(T)he term "substantial evidence" means evidence consisting of adequate and well-controlled investigations, including clinical investigations, by experts qualified by scientific training and experience to evaluate the effectiveness of the drug involved, on the basis of which it could fairly and responsibly be concluded by such experts that the drug will have the effect it purports or is represented to have under the conditions of use prescribed, recommended, or suggested in the labeling or proposed labeling thereof.

FDA has adopted regulations related to administrative actions permitted on new drug applications. 21 C.F.R. §§ 314.100 et seq. In addition to requiring approval if none of the grounds specified in 21 U.S.C. § 355(d) is present, the regulations permit the commissioner of FDA to refuse to accept an application if stated requirements are not met. The regulations contain a statement of "principles (which) have been developed over a period of years and are recognized by the scientific community as the essentials of adequate and well-controlled clinical investigations." These principles, which are then listed, "provide the basis for the...