2021 Enforcement Review: FDA Regulated Medical Products – Food, Drug, Healthcare, Life Science
United States: 2021 Enforcement Review: FDA Regulated Medical Products
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Although the continuing public health emergency related to COVID-19 remained an obstacle to many Food and Drug Administration (“FDA”) inspections in 2021, the pandemic did not prevent criminal and civil actions. related to major violations of FDA regulations, particularly matters that have been under investigation since before the pandemic. The Department of Justice (“DOJ”) has announced numerous indictments, civil and criminal settlements, and criminal convictions involving individuals accused of violating the Federal Food, Drug, and Cosmetic Act (“FDCA”) ) and other laws related to product schemes. COVID-19 fraud remained a top priority, as did cases involving opioids and clinical trial fraud.
This 2021 law enforcement review covers major criminal and civil actions against life sciences companies, starting with those related to the ongoing COVID-19 pandemic. It then discusses actions involving the illicit distribution of opioids, which continue to be a DOJ priority, and then focuses on a new area of interest for law enforcement: clinical trial fraud. The article then examines other enforcement actions brought under the FDCA and related criminal statutes, as well as civil misrepresentation law, which are based on a somewhat broader variety of alleged violations of the FDA regulations. The article ends by looking forward to what FDA-regulated companies can expect on the enforcement horizon in 2022.
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