Our biopharma and medical device attorneys provide practical, solutions-oriented advice to a broad array of biotechnology, pharmaceutical, and medical device companies and other organizations in the life sciences industry.
We advise clients in the following areas:
- Applying the federal anti-kickback statute and other fraud and abuse laws to clinical research activities
- Implementing comprehensive Patient Support Programs
- Following FDA advertising and promotion regulations, guidance, and warning letters; and reviewing in conjunction with product teams the advertising and promotion materials and field medical activities for both drugs and devices
- Structuring and implementing domestic and international clinical trials and creating and operationalizing data and biospecimen repositories for research use
- Responding to government or regulatory audits of research sponsors and investigators
- Complying with the CMS Open Payments Program (also known as the Physician Payment Sunshine Act)
- Complying with U.S. and foreign data protection laws and industry best practices (such as HIPAA, U.S. state privacy laws, the EU Data Protection Directive and General Data Protection Regulation (GDPR), and EU member states’ implementing laws)
- Applying government price reporting requirements (e.g., Medicare ASP, Medicaid AMP and BP, 340B) and consequences for pricing proposals, including value-based pricing arrangements
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