Industries: Life Sciences

Compliance

Confronted by an ever-changing landscape of federal regulations governing the design, testing, manufacture, sale and promotion of drugs, biologics, and medical devices, McGuireWoods lawyers have sector-specific experience in the laws impacting this industry including:

• False Claims Act
• Food and Drug Administration regulations
• Federal and state anti-kickback, and fraud and abuse laws
• Federal and state self-referral laws, including the federal Stark Law
• Federal and state privacy laws, including the Health Insurance Portability and Accountability Act (HIPAA)

We advise management regarding the establishment of compliance programs, with an emphasis on the compliance guidance for pharmaceutical and medical device manufacturers, Department of Justice guidelines for prosecutions, and the Federal Sentencing Guidelines. Our compliance team also assists clients in:

• Enterprise-wide risk management solutions
• FDA-related product and marketing issues
• Global compliance systems design and assessment
• Pharmaceutical price reporting and third party negotiations
• Internal and government initiated investigations
• Sales and marketing compliance
• Pharmacy benefit management relationships
• Clinical trials review and human subjects protection
• Federal, state and international regulatory and business matters
• Implications of legislative change, including Medicare Part D and Part B reform