2022 Enforcement Review for FDA-Regulated Products: Back to Basics

As the COVID-19 public health emergency has slowly receded from the headlines, the U.S. Food and Drug Administration (“FDA”) and its enforcement partner, the Department of Justice (“DOJ”), have spent much of the past year focused on traditional areas of enforcement, including manufacturing practices, product safety, data integrity, and the removal of unapproved products from the market. Although we expect enforcement action in connection with COVID-19-related fraud to continue, FDA appears highly motivated to clear its inspection backlog and ramp up enforcement for manufacturing and data integrity-related deficiencies. Industry stakeholders would be well advised to ensure their compliance infrastructures are appropriately focused on core FDA issues like product quality and ensuring appropriate product approval prior to marketing.

This 2022 enforcement review highlights key trends and developments relating to enforcement that may be of interest to FDA-regulated companies when considering risks in 2023, including:

• A renewed focus on food safety
• A continuing emphasis on drug quality and current good manufacturing practices (“cGMPs”)
• The invocation of rarely used medical device authorities
• The viability of FDA’s authority over certain stem cell products
• A new FDA focus on product fulfillment platforms
• Continued scrutiny of clinical trial fraud
• More aggressive enforcement against noncompliant tobacco products
• New DOJ expectations for post-resolution compliance in actions involving alleged violations of the Federal Food, Drug, and Cosmetic Act (“FDCA”).