Education or Promotion?: Industry-Sponsored Continuing Medical Education (CME) as a Center for the Core/Commercial Speech Debate
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| dc.contributor.advisor |
Hutt, Peter Barton
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en_US |
| dc.contributor.author |
Chen, Peggy |
en_US |
| dc.date.accessioned |
2012-06-07T20:15:33Z |
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| dc.date.issued |
2003 |
en_US |
| dc.identifier.citation |
Education or Promotion?: Industry-Sponsored Continuing Medical Education (CME) as a Center for the Core/Commercial Speech Debate (2003 Third Year Paper) |
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| dc.identifier.uri |
http://nrs.harvard.edu/urn-3:HUL.InstRepos:8852134 |
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| dc.description.abstract |
Because of its importance to determining drug usage, information has always been an important part of the regulation of prescription drugs. The Food and Drug Administration (FDA) and the pharmaceutical industry are in a continuous battle over the dissemination of product information. This paper focuses on one of the battlegrounds on the speech issue, industry sponsorship of continuing medical education (CME). The FDA’s guidance on regulating industry-sponsored CME bans speech about off-label uses at CME and requires that other speech presented be truthful, non-misleading and fairly balanced. This guidance raises First Amendment issues, in particular because the speech presented at CME, although arguably commercial speech, appears at first glance to be core scientific speech meriting the highest constitutional protection. This paper first provides a background on the FDA’s regulatory authority over promotional activities, looking at the FDA’s authority to approve drugs, to declare drugs misbranded due to lack of adequate directions for use, and to regulate the labeling and advertising of drugs. Next, it discusses the Washington Legal Foundation cases, brought to challenge the CME guidance as an unconstitutional restriction on speech because it bans speech about off-label uses. It examines the district court’s holdings that industry-sponsored CME speech is commercial speech, and that the regulation is an unconstitutional regulation of commercial speech because it is considerably more extensive than necessary to further the government’s interest in getting new uses on-label. Lastly, it examines the problem of representational speech that arises when speech is tied to financial sponsorship, which is that the speech of the funded speaker cannot always be attributed to the financial sponsor. It finds that the guidance factors fail to establish a representative connection between the CME speaker and the pharmaceutical manufacturer necessary to hold the pharmaceutical manufacturer responsible for the speaker’s speech. Therefore, the CME guidance sweeps into its regulatory scheme not only commercial speech, but also core speech that deserves the highest First Amendment protection. |
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| dc.language.iso |
en_US |
en |
| dash.license |
LAA |
en_US |
| dc.subject |
Food and Drug Law |
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| dc.subject |
First Amendment |
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| dc.subject |
free speech |
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| dc.subject |
CME |
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| dc.title |
Education or Promotion?: Industry-Sponsored Continuing Medical Education (CME) as a Center for the Core/Commercial Speech Debate |
en |
| dc.type |
Paper (for course/seminar/workshop) |
en_US |
| dc.date.available |
2012-06-07T20:15:33Z |
|
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