Mello et al's Direct-to-Consumer Advertising and Shared Liability for Pharmaceutical Manufacturers

Mello et al's Direct-to-Consumer Advertising and Shared Liability for Pharmaceutical Manufacturers

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current as of March 24, 2010. Online article and related content http://jama.ama-assn.org/cgi/content/full/289/4/477 . 2003;289(4):477-481 (doi:10.1001/jama.289.4.477) JAMA Michelle M. Mello; Meredith Rosenthal; Peter J. Neumann Pharmaceutical Manufacturers Direct-to-Consumer Advertising and Shared Liability for Correction Contact me if this article is corrected. Citations Contact me when this article is cited. This article has been cited 11 times. Topic collections Contact me when new articles are published in these topic areas. Therapy, Other Medical Practice; Law and Medicine; Drug Therapy; Adverse Effects; Drug Related Letters . 2003;289(20):2646. JAMA George W. Evans et al. . 2003;289(20):2646. JAMA David Shein. Liability for Adverse Events in Direct-to-Consumer Advertising http://pubs.ama-assn.org/misc/permissions.dtl [email protected] Permissions http://jama.com/subscribe Subscribe [email protected] Reprints/E-prints http://jamaarchives.com/alerts Email Alerts at Princeton University on March 24, 2010 www.jama.com Downloaded from
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COMMENTARY Direct-to-Consumer Advertising and Shared Liability for Pharmaceutical Manufacturers Michelle M. Mello, JD, PhD Meredith Rosenthal, PhD Peter J. Neumann, ScD D URING THE LAST SEVERAL YEARS, THE MARKETING of prescription drugs has undergone substantial change, facilitated by changes in the regulatory environment governing direct-to-consumer ad- vertising (DTCA). Since the release in 1997 of new draft guid- ance by the Food and Drug Administration (FDA), 1 con- sumer-oriented drug marketing has become pervasive, particularly in broadcast media. Ninety-one percent of US individuals report having seen consumer-oriented drug ad- vertisements, and the pharmaceutical industry spent nearly $2.5 billion on DTCA in 2000. 2 Health services researchers are hard at work trying to understand the impact of DTCA on the marketplace, the patient-physician relationship, and public health. Mean- while, the courts and the FDA are reviewing the existing legal structures to determine whether they require modifi- cation in light of the upsurge in DTCA. 3 Historically, under a common-law doctrine called the learned interme- diary rule (LIR), manufacturers have only been required to provide risk information to physicians; there has been no independent legal duty to warn consumers directly of drug risks. The theory was that physicians, who are in a better position than consumers to understand complicated drug package inserts, would pass along the information to patients. Academic commentators 4,5 and 1 closely-watched state supreme court 6 have suggested that DTCA has so fundamentally transformed physician and patient roles in prescribing decisions that the traditional justifications for the LIR no longer apply. In this article, we examine the question of whether the
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This note was uploaded on 04/13/2010 for the course PSYCH 101 taught by Professor Gabbart during the Spring '08 term at Union College.

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Mello et al's Direct-to-Consumer Advertising and Shared Liability for Pharmaceutical Manufacturers

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