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Journal of Long-Term Effects of Medical Implants
Abstract of "Ethical Considerations Regarding Direct-To-Consumer Advertising of Medical Devices"
Department of Orthopaedics Surgery and Rehabilitation Medicine, SUNY Downstate Medical Center, 450 Clarkson Ave, Brooklyn, NY 11203
William P. Urban
Department of Orthopaedic Surgery and Rehabilitation Medicine, State University of New York (SUNY), Downstate Medical Center, Brooklyn, NY
With medical device manufacturers increasingly employing direct-to-consumer (DTC) advertising, many have voiced concerns over the ethical implications of such a practice. While by no means an altogether new phenomenon, the increasing prevalence of this marketing strategy has garnered the attention of medical professionals, lawmakers, and the public alike. Those in favor of DTC advertising have argued that it simply acts to educate the public, and thus poses a societal benefit. However, opponents are not so readily comforted by such claims. With many physicians expressing frustration over what they perceive as misleading information and unrealistic patient expectations as a result of DTC advertising, calls for intervention and regulation have grown stronger. While the Food and Drug Administration has thoroughly regulated the informational content of pharmaceutical advertisements, it has not yet intervened as extensively into the marketing of restricted medical devices. Ultimately, as is the case with all advertising, direct-to-consumer marketing may very well be manipulating the consumer by simplifying and compressing complex product information. In addition, with the FDA's Center for Devices and Radiological Health, by its own admission, lacking the budgetary and personnel resources to oversee the growing tide of medical device advertisements, the result is a marketing environment lacking supervision. While there may be truth to the argument that direct-to-consumer advertising has increased public awareness and even encouraged patients to be more involved in their treatment, without a reliable means to evaluate advertisements' informational content, their educational merits become more questionable. As such, while calls for increased regulation (analogous to that of the pharmaceutical industry) are a logical response, one must consider whether expanding the resources of the FDA in the context of medical device advertisements would not be equally as necessary.
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