Life Sciences - Compliance

McGuireWoods advises a broad range of businesses on the creation and establishment of life sciences-related compliance programs, with an emphasis on pharmaceutical and medical device manufacturers. Ranked by Chambers USA among the top healthcare regulatory and litigation practices in the United States, we have extensive experience as counsel to a diverse group of service providers, including retail pharmacies, pharmacy benefits managers (PBMs), medical manufacturers, pharmaceutical manufacturers, physician groups, ambulatory care providers and group purchasing organizations.

We represent businesses and individuals in matters arising under the Health Insurance Portability and Accountability Act of 1996 (HIPAA) and the Health Information Technology for Economic and Clinical Health Act (the HITECH Act). We also represent clients in matters related to agency regulations accompanying these laws, and other federal and state data privacy, data security and data breach laws. We counsel clients in the development and implementation of HIPAA compliance programs, preparation and negotiation of business associate agreements, breach assessment and reporting, and responses to government investigations, including investigations by the Office for Civil Rights. Committed to increasing industry and client knowledge, our attorneys regularly speak at conferences and webinars and publish articles on the intersection of technology and privacy.

Our compliance team has sector-specific experience with the laws and agency guidelines that influence the design, testing, manufacture, sale and promotion of drugs, biologics and medical devices, among other products. We advise clients on managed pharmacy benefit management programs and provide guidance in connection with Part D regulatory and reimbursement issues. We also advise clients on the False Claims Act, Food and Drug Administration (FDA) regulations, Medicare Part D and Part B reform, federal and state anti-kickback and fraud and abuse laws, and self-referral laws, including the federal Stark Law.

When government or law-enforcement investigations arise, we counsel clients on applicable Department of Justice (DOJ) practices, as well as on federal sentencing guidelines. We also assist clients in developing enterprisewide risk management solutions and in the conduct of internal investigations. We help clients address FDA-related product and marketing issues, design and assessment of global compliance systems, pharmaceutical price reporting, third-party negotiations, and other sales and marketing requirements. For participants in life sciences research, we provide counsel on clinical trial review processes and human subject protection.