Education or Promotion?: Industry-Sponsored Continuing Medical Education (CME) as a Center for the Core/Commercial Speech Debate

August 2003

Issue: 58 FOOD AND DRUG LAW JOURNAL 473-510 (2003).

This article focuses on one of the recurring battlegrounds of the speech issue—industry sponsorship of continuing medical education (CME). The Food and Drug Administration's (FDA's) guidance on industry-sponsored CME bans speech about off-label uses, and requires that other speech presented at CME settings be truthful, nonmisleading, and fairly balanced. This article provides background on the FDA's regulatory authority over drug promotional activities, including drug approval, misbranding due to lack of adequate directions for use, and labeling and advertising. It also discusses the Washington Legal Foundation cases, which were brought to challenge the CME guidance as an unconstitutional restriction because it bans speech about off-label uses. The article examines the district court's holdings that industry-sponsored CME speech is commercial speech, and that FDA's regulation is unconstitutional because it is considerably more extensive than necessary to further the government's interest in getting new uses on-label. Lastly, the article examines the problem of representational speech, which arises when speech is tied to financial sponsorship. It finds that the guidance factors fail to establish a representative connection between the CME speaker and the pharmaceutical manufacturer such that the pharmaceutical manufacturer may be held responsible for the speaker's speech. Therefore, the CME guidance sweeps into its regulatory scheme not only commercial speech, but also core scientific speech that deserves the highest First Amendment protection.


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