OFAC compliance
Healthcare and life sciences companies face a distinct OFAC compliance pressure point: sanctions exposure runs through drug supply chains, clinical trial partnerships, and medical device distribution in ways that generic compliance programs rarely capture. The U.S. Department of the Treasury's Office of Foreign Assets Control maintains sector-specific enforcement expectations, and the U.S. Department of Justice has coordinated with OFAC on voluntary self-disclosure outcomes that directly affect how life sciences firms calculate penalty risk. SDN list hits tied to foreign contract manufacturers and API suppliers have driven enforcement actions in this sector before, and that pattern has not gone quiet.
Watch
- OFAC 50 Percent Rule: how it applies to foreign clinical research organizations
- Voluntary Self-Disclosure framework: DOJ-OFAC coordination on penalty mitigation for life sciences
- API supplier SDN screening gaps flagged in recent Treasury enforcement correspondence
- Foreign distributor contracts in sanctioned jurisdictions: exposure under existing authorizations
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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