Sara Frank is a principal in Choate’s Government Enforcement & Compliance and Healthcare Groups. Her practice focuses primarily on the life sciences sector.
Sara provides legal and compliance advice to companies and individuals, most often based on Anti-Kickback Statute, False Claims Act, HIPAA, and Food, Drug, and Cosmetic Act concerns.
Sara’s knowledge and insight earned while working as the U.S. Compliance Officer for one of the oldest independent biotech companies in the world make her a valuable contributor in complex investigations and a trusted advisor in times of critical decision-making for her clients.
Working with Choate’s healthcare clients, Sara advises providers and life sciences companies in handling compliance and regulatory issues. This work includes helping emerging companies develop and implement key compliance initiatives and helping more established companies assess the legal risks associated with new business plans, conduct internal investigations, and manage government inquiries.
Sara has experience in policy writing and implementation, training, monitoring and creating monitoring programs, compliance committees, educational grant committees, promotional review committees, international compliance issues, structuring compliance programs, written information security programs, expanded access, pre-commercial activities, patient assistance programs, aggregate spend reporting and corporate compliance matters. She has served on task forces for both PhRMA and BIO trade groups and has been active in national pharmaceutical and biotechnology compliance forums. She is certified in healthcare compliance by the Healthcare Compliance Association.