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
Journal article
Vreugdenberg, Thomas D., Willis, Cameron D., Mundy, Linda and Hiller, Janet E.. (2013). 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. Internal Medicine Journal. 43(1), pp. 53 - 58. https://doi.org/10.1111/j.1445-5994.2011.02625.x
Authors | Vreugdenberg, Thomas D., Willis, Cameron D., Mundy, Linda and Hiller, Janet E. |
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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 |
Year | 2013 |
Journal | Internal Medicine Journal |
Journal citation | 43 (1), pp. 53 - 58 |
Publisher | Wiley-Blackwell Publishing Asia |
ISSN | 1444-0903 |
Digital Object Identifier (DOI) | https://doi.org/10.1111/j.1445-5994.2011.02625.x |
Scopus EID | 2-s2.0-84872584721 |
Page range | 53 - 58 |
Publisher's version | File Access Level Controlled |
Grant ID | NHMRC/565501 |
Place of publication | Australia |
https://acuresearchbank.acu.edu.au/item/86x26/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
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