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Washington Attorneys Expect Aggressive Enforcement Related To FDA Regulated Medical Products in 2022

Practices: FDA Regulatory, Health Care, Litigation, Biomedical Research: Human, Animal and Bench Science, Digital Health, Business & Commercial Litigation

In a Law360 outlook article, life sciences regulatory & compliance partner Joshua Oyster, counsel Beth Weinman and associate Lauren Sager (all of Washington, D.C.) describe their expectations for an increasingly aggressive and emboldened U.S. Department of Justice in 2022 that is likely to continue to scrutinize companies making FDA regulated medical products for regulatory violations that can serve as predicates for a wide variety of criminal enforcement theories as well as civil False Claims Act enforcement.

The authors note the DOJ is likely to ride a wave of high-profile successes in key priority areas as well as departmental policy changes that will drive prosecutors to more aggressive criminal and civil False Claims Act enforcement related to illicit opioid distribution, pandemic fraud, and research misconduct, as well as other more typical Federal Food, Drug, and Cosmetic Act violations. 

According to the authors, a demonstrated commitment to compliance, evidenced by robust and well-resourced compliance programs and supported by leaders who can serve as role models for ethical and compliant behavior, will be critical to navigating the government inquiries that are sure to come.

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