Distribution of Off-Label Information by Pharmaceutical Manufacturers? *

Abstract

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 for distributing peer-reviewed journal article reprints relating to off-label uses for their medications in response to the 1999 district court's judgment in favor of the WLF. Respondents were employees in the medical information departments of 27 pharmaceutical/biotechnology companies, 5 of which were unable to provide information. Seventy-three 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 distribution at 94% (15/16) of the companies surveyed. Seventy-five percent (12/16) of the companies surveyed affixed disclaimers to the articles that highlight the off-label nature of the described disorder and/or disclose the company's interest in the product.