ABSTRACT

COVID-19 poses a challenge beyond the virus itself, in that lockdown has been associated increased use of the internet and social media. Disinformation about prevention and treatment strategies for COVID-19 can have lethal consequences. The United States Food and Drug Administration (USFDA) is currently monitoring the compliance of manufacturing firms as well as medicinal product advertisers to the Federal Food, Drug, and Cosmetic Act, 21 USC § 321(h) regulations. In the event of noncompliance in the form of advertising products without prior USFDA approval for specific indications, doses, or route of administration, warning letters (WLs) are issued. WLs are intended to address the concerns identified by USFDA and encourage the recipient to take corrective steps to avoid similar instances in the future. We analyzed 182 WLs that were issued for noncompliance with drugs/devices related to either treatment, prevention, or testing of COVID-19 infections. The medicinal product website was identified as the major source of disinformation, followed by disseminated information on Facebook, Twitter, and Instagram. Nearly four-fifths were related to drugs, followed by devices and biologicals. Several biologicals, as well as allopathic, herbal, and non-herbal drugs were identified in the WLs. We observed that noncompliance with the USFDA regulations in terms of advertising a variety of products for prevention and treatment of COVID-19 infection was widely prevalent. More efforts are required by the respective national drug regulatory authorities to initiate or continue their monitoring of disinformation that may have lethal consequences.

摘要

COVID-19 带来的挑战超出了病毒本身，因为封锁与互联网和社交媒体使用的增加有关。有关 COVID-19 预防和治疗策略的虚假信息可能会造成致命后果。美国食品和药物管理局 (USFDA) 目前正在监督制造公司和医药产品广告商遵守《联邦食品、药品和化妆品法》21 USC § 321(h) 规定的情况。如果在未经 USFDA 事先批准特定适应症、剂量或给药途径的情况下以广告形式出现不合规情况，将发出警告信 (WL)。WL 旨在解决 USFDA 确定的问题，并鼓励接收者采取纠正措施以避免将来发生类似情况。我们分析了 182 份因不遵守与 COVID-19 感染的治疗、预防或检测相关的药物/设备而签发的 WL。医药产品网站被确定为虚假信息的主要来源，其次是 Facebook、Twitter 和 Instagram 上传播的信息。将近五分之四与药物有关，其次是设备和生物制品。在 WL 中确定了几种生物制品以及对抗疗法、草药和非草药。我们观察到，在为预防和治疗 COVID-19 感染的各种产品做广告时，不遵守美国食品和药物管理局规定的情况非常普遍。各国药品监管机构需要做出更多努力，以启动或继续监测可能产生致命后果的虚假信息。