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December 20, 1979


The opinion of the court was delivered by: OBERDORFER


Plaintiffs are two leading manufacturers of pharmaceutical drugs and the Pharmaceutical Manufacturers' Association (PMA).* They sue the Food and Drug Administration (FDA) of the Department of Health and Welfare to prevent FDA from approving any application by a competing drug manufacturer for the right to market a generic version of a drug previously approved by FDA, unless the competing applicant has filed reports of clinical tests of that drug and the "raw data" underlying those tests is available to the FDA. Intervenor Internal Medications, Inc. (IMS), a potential competitor of one of the plaintiffs, has won FDA approval of an application covering a generic version of a drug pioneered by that plaintiff, without supplying fresh clinical reports and "raw data". IMS is aligned here with the defendants.

 The cases have evolved through extended briefing, oral argument, post-argument submissions of proposed findings of fact, and finally, a proposed order, submitted jointly by all three plaintiffs. That proposed order would declare that a July 31, 1978, memorandum from Marion J. Finkel, M. D., Associate Director for New Drug Evaluation, to Division Directors in the Bureau of Drugs to the effect that FDA would approve post-1962 duplicate new drug applications in reliance on published reports without fresh clinical investigations or available "raw data," *fn1" was a rule adopted without notice or opportunity for comment as required by the Administrative Procedure Act (APA) (5 U.S.C. § 553) and FDA regulations (21 C.F.R. § 10.40). The proposed order would also declare that, treated as a rule, the Finkel memorandum violates the Food, Drug, and Cosmetic Act (the Act) and FDA regulations promulgated thereunder.

 The matter is now before the Court on plaintiffs' motions for a preliminary injunction and cross-motions by the parties, including intervenor, for summary judgment. For reasons more fully stated below, the Court concludes that plaintiffs have failed to invoke or exhaust their remedy under APA Section 553(e) to petition the FDA Commissioner for a decision as to whether:

(1) the Finkel memorandum should be issued as a rule or is a general statement of policy, exempt from the notice and comment requirement of APA and FDA regulations, and
(2) any provision of the Act or any regulation requires that an applicant for approval of the safety and efficacy of a generic version of a previously-approved drug support that application by filing or making available fresh clinical studies and "raw data," where there are full reports of investigations in published literature evidencing the safety and efficacy of the previously-approved drug.

 Therefore, summary judgment will be entered for defendants.


 Under the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 355, no person may market any new drug unless that person has obtained an approved "new drug application" (NDA) from the Food and Drug Administration. The FDA may not approve an NDA unless, inter alia, it has substantial evidence of the safety and efficacy of the drug in question. Over the years since 1962, FDA has processed thousands of applications for approval of "new drugs."

 Many of these applications relate to drugs which were never before marketed. They came to FDA for approval directly from the laboratory with nothing probative of their safety and efficacy except reports of laboratory and clinical experience and published literature about that experience.

 Other applications relate to generic versions of drugs previously marketed by their pioneer manufacturer, or previously marketed for a different purpose. Some of these duplicate applications relate to drugs already on the market in 1962 when Congress amended the Food, Drug and Cosmetic Act to require FDA approval of the efficacy (in addition to the safety) of all drugs. Other (and fewer) duplicate applications relate to new manufacturers or new uses of previously-approved drugs originally approved and marketed for the first time after 1962 (post-1962 drugs). These latter duplicate applications for approval of new manufacturers or new uses of post-1962 drugs have only recently begun to appear at FDA; patents issued in 1962 expire in 1979.

 With respect to new drugs not previously marketed, FDA has almost universally required the pioneer applicant to support its application with detailed clinical reports of safety and effectiveness studies verified, or verifiable, by "raw data" as described in 21 C.F.R. § 314.1(c)(2)12c. This regulation states that a new drug application

"should include adequate information concerning each subject treated with the drug or employed as a control . . . and a statement of where the underlying data are available for inspection."

 Since 1963, nevertheless, FDA has approved thousands of applications by plaintiffs, PMA members and others for approval of generic versions of previously-approved drugs marketed before 1962 in reliance primarily upon published reports about them and the opinion of the National Science Foundation or the National Research Council. Generally, these pre-1962 applications have not been supported by the clinical reports and "raw data" described in this regulation. 21 C.F.R. § 314.1(c)(2)12c. Although the "raw data" made available by the pioneer applicant is protected and not available as such either to the duplicate applicant or FDA, it is undisputed that the fact that the drug has been ...

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