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Online but unlawful sales of unapproved and misbranded prescription drugs: Internet pharmacy compliance with Food and Drug Administration warning letters
Journal of Consumer Affairs ( IF 2.603 ) Pub Date : 2023-02-16 , DOI: 10.1111/joca.12515
Yam B. Limbu 1 , Bruce A. Huhmann 2
Affiliation  

Consumers increasingly use online pharmacies. However, illicit online pharmacies endanger consumer welfare with unapproved and counterfeit drugs. By linking Food and Drug Administration (FDA) warning letter content with observations of the 1108 websites cited in those letters, we identify factors associated with FDA-requested compliance and active/inactive website status. One in five online pharmacies failed to comply with FDA recommendations. Findings support the cost/benefit, social norm, and instrumental theories of compliance. Compliance declines with cost (e.g., when the FDA requests changes to more drug categories). Organized crime's social norms encourage law breaking; thus, illicit pharmacies comply less than other online pharmacies. Instrumental theory suggests perceived severity and certainty of penalties influences compliance. In support, when political will and attention focused on the opioid crisis, the FDA cited primarily opioid-related violations and these opioid-related letters increased compliance and website closures. Finally, we recommend improved consumer protection efforts to address internet pharmaceutical distribution challenges.

中文翻译:

在线但非法销售未经批准和贴错标签的处方药:互联网药房遵守美国食品和药物管理局警告信

消费者越来越多地使用网上药店。然而,非法网上药店的未经批准的假药危及消费者的福利。通过将美国食品和药物管理局 (FDA) 警告信内容与这些信中引用的 1108 个网站的观察结果联系起来,我们确定了与 FDA 要求的合规性和活动/非活动网站状态相关的因素。五分之一的在线药店未能遵守 FDA 的建议。研究结果支持成本/效益、社会规范和合规工具理论。合规性随着成本的增加而下降(例如,当 FDA 要求更改更多药物类别时)。有组织犯罪的社会规范鼓励违法行为;因此,非法药店的合规性低于其他网上药店。工具理论表明,感知的惩罚严重性和确定性会影响遵守情况。作为支持,当政治意愿和注意力集中在阿片类药物危机时,FDA 主要列举了与阿片类药物相关的违规行为,这些与阿片类药物相关的信件增加了合规性和网站关闭。最后,我们建议加强消费者保护工作,以应对互联网药品分销挑战。
更新日期:2023-02-16
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