Distribution of Off-Label Information By Pharmaceutical Manufacturers?
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0092-861.5/2001 Copyright 8 2001 Drug Infomiation Association Inc.
DISTRIBUTION OF OFF-LABEL INFORMATION BY PHARMACEUTICAL MANUFACTURERS?* MERYLWEISSROBINSON, PHARMD,BARRYGROBMAN, PHARMD, AND DAVIDGRAVES, PHARMD University of California San Francisco, San Francisco, California
The 1999 Washington Legal Foundation (WLF) decision stated that the Food and Drug Administration (FDA) was in violation of the pharmaceutical/ biotechnology industry’s right to commercial free speech by unduly limiting its ability to distribute truthful, nonmisleading information about off-label uses of its products. The objective of this survey was to assess pharmaceutical companies’ current practices f o r distributing peerreviewedjournal article reprints relating to off-label uses for their niedications in response to the 1999 district court’s judgment in favor of the WLE Respondents were employees in the medical information departments of 2 7 pharmaceutical/ biotechnology companies, 5 of which were unable to provide irlforniation. Seventythree percent (16/22) of the companies that participated in the survey were either distributing articles at the time of the survey or were planning to distribute articles under the WLF ruling. The sales force carried the responsibility for distributiori at 94% (15/16) of the conipariies surveyed. Seventyjive percent (12/16) of the companies surveyed affi-ired disclaimers to the articles that highlight the off-label nature of the described disorder and/or disclose the company 5. interest in the product. Key Words: Washington Legal Foundation; Off-label; FDA regulation; Pharmaceutical
industry
INTRODUCTION IN 1994, THE WASHINGTON Legal Foundation filed suit against the federal Food and Dmg Administration. The organization hoped to overturn the agency’s policy regarding in-
Presented at the Resident Poster session at the DIA Eleventh Annual “Symposium on Medical Communications,” March 2000, Washington, District of Columbia. Reprint address: Meryl Weiss Robinson, PharmD, Freelance Medical Writer, 204 Dubois Road, Ithaca, NY 14850. E-mail: [email protected]. *The research and manuscript preparation for this paper were done while one of the authors (Weiss Robinson) was a medical information resident at University of California San Francisco.
dustry-sponsored dissemination of truthful, nonmisleading information about off-label uses of products. On July 30, 1998, the district court found that the FDA was in violation of the pharmaceutical manufacturers’ First Amendment right to commercial free speech by unduly limiting their ability to distribute this information. The court held that the FDA cannot prohibit a pharmaceutical company from distributing reprints of articles that appeared in a bona fide, peerreviewed professional journal, distributing textbooks that are published by a bona fide, independent publisher, or from suggesting content or speakers to an independent continuing medical education program provider (1 2).
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