The dynamic nature of the COVID-19 pandemic demanded an all-hands-on-deck approach to enforcement in 2020 by the U.S. Food and Drug Administration (“FDA”), the Department of Justice (“DOJ”), and other regulatory and law enforcement agencies. Protecting the public from those who sought to exploit opportunities to make a quick buck by marketing quack COVID-19 cures, unproven COVID-19 prevention products and substandard personal protective equipment quickly emerged as top government enforcement priorities. This review revisits the year’s key FDA and DOJ enforcement actions related to FDA-regulated products, and offers insights into likely enforcement priorities for 2021.
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