Foreign Corrupt Practices Act
Healthcare and life sciences companies face some of the most aggressive Foreign Corrupt Practices Act enforcement activity of any sector, driven by the U.S. Department of Justice and the U.S. Securities and Exchange Commission targeting third-party distributor arrangements, physician speaker programs, and customs facilitation payments across emerging markets. The 2020 FCPA Resource Guide, Second Edition, remains the operative compliance framework, and DOJ's Corporate Enforcement Policy creates direct consequences for how companies self-disclose and structure remediation. Cresthaven is actively monitoring this intersection for new enforcement actions, declination letters, and policy shifts as they enter our pipeline.
Watch
- DOJ Corporate Enforcement Policy: self-disclosure credit calculations for life sciences firms
- Third-party distributor contracts in China, India, and Brazil flagged in recent FCPA settlements
- SEC disgorgement demands in pharma FCPA cases following Liu v. SEC (2020)
- Physician engagement and speaker program payments reviewed as potential foreign official benefits
- Monitorship requirements: whether DOJ is attaching them to healthcare settlements in 2024-2025
Recent material activity in Healthcare & Life Sciences
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FDA issues Complete Response Letter for novel GLP-1 receptor agonist oral formulation
The FDA issued a CRL for a once-daily oral GLP-1 receptor agonist citing manufacturing consistency concerns at the primary production facility. The agency requested additional CMC data and a pre-approval inspection befor…
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