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STERLING DRUG INC. v. HARRIS

January 7, 1980

STERLING DRUG INC., Winthrop Products Inc., and Breon Laboratories, Inc., Plaintiffs,
v.
Patricia R. HARRIS, Secretary of Health, Education and Welfare, Sherwin Gardner, Acting Commissioner of Food and Drugs, Food and Drug Administration and Department of Health, Education and Welfare, Defendants.



The opinion of the court was delivered by: STEWART

MEMORANDUM DECISION

This case presents the question of the scope of Exemption b(5) of the Freedom of Information Act ("FOIA"), 5 U.S.C. § 552 (1966). Plaintiffs brought this action under FOIA to compel the production of documents sought in connection with litigation concerning the Food and Drug Administration's ("FDA") proposal to withdraw approval of the New Drug Application ("NDA") for plaintiffs' prescription drug Alevaire. *fn1" The FDA has refused to disclose the requested documents, claiming that they are inter- or intra-agency memoranda that would not be available to a private party in litigation with the agency, and therefore are exempt under Exemption b(5).

 BACKGROUND

 The NDA for Alevaire was first approved in 1952, based on evidence that the drug was safe. In 1962, Congress amended the Federal Food, Drug, and Cosmetic Act to require proof of effectiveness as well as safety for approval of a NDA. FDA then began a review of pre-1962 approved drugs to determine the adequacy of proof of effectiveness. *fn2"

 After the study of Alevaire was completed, the agency began its "Drug Efficacy Study" review process, which included the preparation of statistical, medical and pharmacological reviews of the NDA. Based in part on these reviews, together with the report of the National Academy of Sciences and National Research Council *fn3" and FDA policy considerations, the agency undertook to institute proceedings to withdraw approval of the NDA for the drug Alevaire. Thus began the now eleven year old process, described in some detail in Sterling Drug v. Weinberger, 503 F.2d 675 (2d Cir. 1974), of determining whether there was a lack of substantial evidence based on adequate and controlled studies that the drug was effective. *fn4"

 The withdrawal proceeding now in progress before the FDA, for which the plaintiffs seek the documents at issue here, was instituted in March of 1979, when the FDA published a notice of hearing of their proposal to withdraw approval of the NDA for Alevaire. In May of 1979, a hearing was commenced before an Administrative Law Judge. In the course of that proceeding, the FDA filed about 300 documents in the public record, pursuant to the applicable FDA discovery regulation, 21 C.F.R. § 12.85. *fn5" The agency withheld a number of documents which were claimed to be properly excluded as privileged communications and secret, classified material. Plaintiffs, claiming that these documents are at the heart of the litigation before the Administrative Law Judge, moved for their production. The ALJ denied the motion, stating, however, that he thought that the plaintiffs were entitled to the documents and should pursue their remedies under FOIA.

 Plaintiffs had already filed a request under FOIA to obtain the documents withheld by the agency, which included all of the FDA's internal scientific and medical reviews concerning Alevaire. The agency produced some additional documents, but finally withheld disclosure of 85 documents in their entirety and deleted portions of 7 documents.

 Plaintiffs then brought this action and moved by order to show cause, seeking a de novo review of their FOIA claim and requesting immediate injunctive relief or a stay of the administrative proceeding pending a decision of their FOIA claim. A hearing was held on September 21, 1979, at which plaintiffs' motion for a stay and a preliminary injunction was denied. The Government informed the Court that it was in the process of itemizing and categorizing the documents, in accordance with the procedures set forth in Vaughn v. Rosen, 157 U.S. App. D.C. 340, 484 F.2d 820 (D.C. Cir. 1973). Decision on plaintiffs' request for an in camera review of the documents was reserved pending a determination of the adequacy of the index submitted by the Government. On October 22, 1979, the Government submitted an index of the documents in question and affidavits of various agency personnel concerning the circumstances surrounding the preparation of the documents, and then filed a motion for summary judgment, claiming that plaintiffs failed to exhaust their administrative remedies and the documents are exempt from disclosure under Exemption b(5) of FOIA. *fn6"

 Exhaustion of Administrative Remedies

 Defendants contend that plaintiffs' failure to appeal the Administrative Law Judge's denial of their discovery motion constitutes failure to exhaust their administrative remedies. We do not agree. The legislative history, implementing regulations, and the statute itself reflect Congress' intention to avoid delay in processing claims under FOIA. See, e.g., Information Acquisition v. Department of Justice, 444 F. Supp. 458, 462 (D.D.C.1978); 5 U.S.C. § 552(a)(6)(C) (Supp. V. 1975). The statute states: "Any person making a request to any agency for records . . . shall be deemed to have exhausted his administrative remedies with respect to such request if the agency fails to comply with the applicable time limit provisions of this paragraph." Id. Here, HEW failed to respond to plaintiffs' FOIA request within the twenty-day limit set forth in 45 C.F.R. § 5.85, the applicable agency regulation. Therefore, plaintiffs are deemed to have exhausted their administrative remedies.

 Defendants also moved for summary judgment as to the individual defendants Harris and Gardner. This motion is also without merit. The cases relied on by defendants in support of their motion are concerned with providing adequate notice to the agency and its responsible officials, see Ott v. Levi, 419 F. Supp. 750 (E.D.Mo.1976), and no other bases for this motion have been shown. Therefore, defendants' motion is denied as to the individual defendants. Accord, American Airlines, Inc. v. National Mediation Board, 453 F. Supp. 430 (S.D.N.Y.1978).

 EXEMPTION 5

 The Documents

 The documents at issue can be grouped into four categories. First, documents 1-9 and 11-16 consist primarily of summaries and medical, statistical and pharmacological reviews, which were prepared by the agency in the course of their on-going review of NDA's. Second, documents 10, 18-20, 22-23, 25, 29-31, 41, 74-78, 80-83, and deleted portions of 90-93 consist of communications and recommendations of administrators and their assistants concerning the withdrawal of the approval of the NDA for Alevaire. Third, documents 17, 21, 24, 27, 28, the first page of 32, 33-40, 42-73 and 91 consist of experts' reviews, reports and memoranda, prepared at the request of the legal staff or by the legal staff themselves in preparation for the ...


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