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Washington Legal Foundation v. Kessler

880 F. Supp. 26 (1995)

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Washington Legal Foundation v. Kessler

United States District Court for the District of Columbia
880 F. Supp. 26 (1995)

MP

Facts

Washington Legal Foundation (WLF) (plaintiff), a public-interest group, brought a First Amendment challenge on behalf of doctors against the Food and Drug Administration (FDA) for its policy restricting drug and medical device manufacturers’ distribution of enduring materials (medical journals, articles, textbooks, and educational medical symposia) that contain information regarding off-label uses of the manufacturers’ products. The alleged policy considers the distribution of such information to constitute improper labeling or promotion in violation of the Federal Food, Drug, and Cosmetic Act (FDCA). The FDA argued that because it was in the process of revising its policies on industry-sponsored promotion of off-label uses of medical products and it had only produced a Draft Policy Statement that had not yet been adopted as official FDA policy, there was no final agency action ripe for judicial review. The WLF argued that notwithstanding the lack of formal finality, the FDA and its employees nevertheless acted as if there was official policy on this issue by issuing regulatory letters and giving informal advice and public statements that manufacturer-supported distribution of information about off-label use violates the FDCA which, the WLF argued, has resulted in preventing doctors from getting information.

Rule of Law

Issue

Holding and Reasoning (Lamberth, J.)

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