Sarah is an essential resource for individuals and companies navigating the ever-changing industries of health care and life sciences. Her practice focuses on complex health care litigation, investigations, regulatory compliance, and fraud and abuse. When clients develop new technologies or have questions about evolving government standards, she counsels them on how to meet their businesses’ objectives while ensuring compliance with the law. Sarah holds a degree in biology and worked with a pharmaceutical consulting firm early in her career, serving as the independent review organization (IRO) for a top pharmaceutical company. Her science background paired with her legal experience offers clients and their in-house counsel a second set of eyes – and options – when dealing with complex regulatory challenges. Sarah’s clients include clinical and commercial pharmaceutical, biotechnology, and medical device companies and clinical laboratories, as well as individuals in the health care space, such as physicians and sales representatives. Her experience includes defending health care and life sciences companies and individuals in criminal and civil False Claims Act investigations regarding complex government theories of health care fraud, false claims, misbranding, off-label promotion and kickbacks. This includes negotiating and implementing settlements and corporate integrity agreements, and advising clients on regulatory self-disclosures.
Her expertise also involves advising companies on the Anti-Kickback Statute, fraud and abuse laws, FDA and regulatory compliance matters, transparency laws, and industry codes of conduct. This includes conducting internal compliance investigations, advising on promotional practices, implementing and improving corporate compliance programs, compliance auditing and monitoring, and transactional diligences. Sarah counsels boards of directors, compliance committees, and management executives on compliance and regulatory issues. She also develops and conducts compliance training programs for sales representatives, promotional review committees, and management teams.
Articles in the National Law Review database by Sarah K. diFrancesca