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FDA Guidance Regarding the Promotion of Off-Label Uses of Drugs
Reviews FDA guidance regarding promotion of off-label drug use. Summarizes relevant provisions of the Federal Food, Drug, and Cosmetic Act (FFDCA) and related regulations that have been used to address misbranding violations of FFDCA that relate to pharmaceutical manufacturer promotion of off-label use; FDA previous off-label marketing provisions under the Food and Drug Administration Modernization Act (FDAMA) of 1997, which are no longer in effect; and Jan. 2009 guidance document and its similarities to and differences from the FDAMA provisions. Outlines First Amendment challenges to FDAMA and older FDA guidance documents addressing off-label promotion. Discusses nature of guidance documents, in contrast to rules promulgated under the Administrative Procedure Act, as well as administrative law issues associated with FDA issuance of the guidance. Provides overview of the False Claims Act and related qui tam cases that addressed off-label marketing practices of pharmaceutical companies, and analyzes interaction of the new guidance document and the FCA.
Record is based on bibliographic data in ProQuest U.S. Congressional Research Digital Collection (last viewed Dec. 2010). Reuse except for individual research requires license from ProQuest, LLC.
Library of Congress. Congressional Research Service.