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Type: Journal article
Title: Pre-market approval and post-market direct-to-consumer advertising of medical devices in Australia: a case study of breast cancer screening and diagnostic devices
Author: Vreugdenburg, T.
Willis, C.
Mundy, L.
Hiller, J.
Citation: Internal Medicine Journal, 2013; 43(1):53-58
Publisher: Blackwell Publishing Asia
Issue Date: 2013
ISSN: 1444-0903
Statement of
T. D. Vreugdenburg, C. D. Willis, L. Mundy and J. E. Hiller
Abstract: While research investigating direct-to-consumer advertising of therapeutic goods in Australia has historically focused on prescription medicines, recent action taken by regulators against companies promoting medical devices has placed the industry into the spotlight. Despite the need to effectively regulate direct-to-consumer advertising of medical devices due to its potential harms, inadequacies in the current regulatory system have been noted. Under the present system, devices with a questionable evidence base may enter the Australian marketplace without an evaluation of their effectiveness, and regulators are reliant on industry self-regulation and consumer complaints to draw attention to cases of advertising misconduct. Although some successes in the present system have been observed, we argue that the outlined inadequacies continue to enable the promotion of medical devices to consumers without thorough or sufficient examination of evidence.
Keywords: direct-to-consumer advertising
breast cancer
Australian health policy
medical devices
Rights: © 2011 The Authors
DOI: 10.1111/j.1445-5994.2011.02625.x
Appears in Collections:Aurora harvest
Public Health publications

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