Arnold & Porter has one of the world's foremost practices in assisting clients in the legal challenges confronting the development, approval, manufacture, and marketing of products regulated by the US Food and Drug Administration, European health authorities, and other regulatory bodies. Our practice is broad-based, but with a particular emphasis on challenging drug, biologic, device, and diagnostic matters. Every day we assist our clients in addressing regulatory issues, resolving their concerns, and supporting key business operations. Our capabilities include, but are not limited to, managing clinical trial complexities and crises, developing and implementing approval and clearance strategies, reviewing promotional materials, advising on compliance programs, executing strategies to maximize product exclusivities, responding to inspections and enforcement, and managing crises such as major safety issues and recalls. We are a leader in obtaining coverage and reimbursement for medical products, and implementing strategies to demonstrate product value and optimize payment under healthcare programs. Our highly sophisticated fraud and abuse, contracting, and pricing lawyers regularly assist biopharmaceutical and medical device companies in navigating the challenges associated with anti-kickback laws, complex price reporting systems, and contracting with government programs. Unlike other firms in the field, all of these regulatory capabilities are integrated into one practice, providing clients with seamless advice and representation.
Members of the European team have either worked closely with the European national agencies or have served at a senior level in European regulatory agencies or advisory groups. A key member of our team, Dr. Lincoln Tsang, was Head of Biologicals and Biotechnology at the United Kingdom Medicines Control Agency; he held memberships and chairmanships in a number of UK, European, and international advisory groups, including the World Health Organization.
We provide sophisticated US and EU compliance experience and advocacy, drawing on a deep understanding of both the full range of healthcare laws and regulations and the practices of the pharmaceutical and biotech industries. In particular, our team has extensive experience representing manufacturers on FDA compliance matters and the full range of issues arising under the Medicare/Medicaid Anti-Kickback statute, the False Claims Act, the Medicaid rebate statute, and other federal and state fraud and abuse laws. We also regularly assist clients in performing preventative self-evaluative audits, designing compliance and corrective action plans, training internal company audiences on compliance matters, and mitigating exposure—where appropriate—by developing and implementing strategies for disclosing violations to regulatory authorities.
Our US lawyers include former senior officials with the US Department of Justice, the US Food and Drug Administration, the Department of Health and Human Services Office of the Inspector General, the Centers for Medicare and Medicaid Services, and congressional committees. Their experience enables our team to provide clients with insight into the current and future regulatory and enforcement environment, including how these agencies operate and how companies can effectively interact with these agencies.
Regulatory FDA: Medical Devices (2013-2017)