FDA & Healthcare

The healthcare and life sciences industries operate in a complex, dynamic regulatory environment in the United States and around the world. Our seasoned and well-versed FDA and healthcare lawyers provide clients with insightful, effective, and creative solutions to address the myriad regulatory, transactional, and litigation issues they face. Our client service incorporates our deep familiarity with government agencies such as the US Food and Drug Administration (FDA), US Department of Health and Human Services (HHS) and its Office of the Inspector General, Centers for Medicare & Medicaid Services (CMS), US Department of Agriculture (USDA), and Federal Trade Commission (FTC), and the state agencies responsible for healthcare and consumer protection oversight, as well as their counterparts worldwide, including the European Medicines Agency, the United Kingdom’s Medicines and Healthcare Products Regulatory Agency, and China’s National Medical Products Administration.

Our clients include pharmaceutical, device, and healthcare technology manufacturers, and the providers and institutions that use and/or sell those products, including hospitals, health systems, health plans, drug and device distributors, pharmacies and retailers, home health and hospice providers, post-acute care and long-term care providers, and large physician practices, as well as public and private equity investors. With a deep knowledge of numerous regulatory structures and emerging industry developments and challenges, our lawyers provide sophisticated, strategic advice to help our healthcare and life sciences clients meet their legal and business objectives.

Many of our lawyers have held positions at key regulatory and enforcement agencies, including HHS and the US Department of Justice. Our keen understanding of these agencies' public health and enforcement goals and procedures enables our team to help clients manage risk, prevent unwarranted scrutiny, and ensure compliance with government policy.