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.
Our keen grasp of regulations and subregulatory guidance from the Centers for Medicare & Medicaid Services, including local coverage decisions and national coverage determinations, gives our clients a critical advantage in coverage and payment matters arising under Medicare, Medicaid, and other federal healthcare programs. Our services include the following:
Our healthcare team assists clients in the public policy sphere to interpret, monitor, and influence US congressional legislation, federal rules and regulations, and policies issued by the executive branch. The experience of many of our lawyers who served in government healthcare oversight agencies allows us to offer clients astute analysis of rapidly evolving developments and timely guidance on matters critical to their businesses.
We advise clients on the full spectrum of privacy and security compliance matters, including those related to the following:
Our team also handles the following:
Cutting-edge digital health technologies are revolutionizing healthcare and helping patients in new and innovative ways. Rules impacting these digital health technologies are evolving quickly as well to guide the lawful use of these tools. Our lawyers help navigate digital health clients through CMS and FDA regulations, privacy and cybersecurity concerns, private and governmental reimbursement matters, FCC and telecommunications regulation, state licensure and scope of practice rules, intellectual property matters, and transactions related to government contracts, venture capital, financing, mergers and acquisitions, and initial public offerings (IPOs), among other matters.
We advise clients across the digital health landscape, including companies focused on the following areas:
Medical device law is being dramatically reconfigured in response to rapidly evolving technology. These changes affect small startups and large multinationals alike. Companies need sophisticated and experienced guidance to navigate issues related to the Center for Devices and Radiological Health.
Within this new and complicated regulatory environment, our strategic assistance at the premarket stage focuses on avoiding costs and saving time. We assist with the following:
At the post-market stage, we help clients ensure that product marketing strategies are optimized, while compliance and other liability exposures are controlled. To maximize market potential, we provide creative promotional, reimbursement, marketing, and distribution strategies and support day-to-day compliance activities by offering technical advice on such issues as medical device reporting, cGMPs, and recalls and field corrections. We also anticipate, and seek to contain, product liability exposure.
When enforcement concerns arise, we leverage our experience with some of the largest and most complex government investigations and settlements of the last decade. As the FDA, DOJ, Health Care Financing Administration (HCFA), and the HHS’s Office of Inspector General (OIG) continue to take an aggressive enforcement stance, we help clients respond to civil and criminal enforcement and compliance actions, including the following:
Morgan Lewis counsels early-stage and mature global pharmaceutical and biotech companies from product development through the product life cycle. This includes clinical trial design, FDA regulatory approval, manufacturing and current good manufacturing practices (cGMPs), supply chain issues, promotions and marketing, pricing, and distribution. We also advise companies on the FDA and related regulatory aspects of corporate transactions, as well as government enforcement and investigations.
Our clients call on us for help in many areas, including the following:
Our keen grasp of government pricing regulations and subregulatory guidance across multiple government healthcare programs gives our clients a critical advantage in staying ahead of the curve, ensuring compliance and maximizing business advantage. Our services include the following:
Our keen grasp of federal government procurements, government funded research and development (R&D), and government contract regulations gives our clients a critical advantage in bidding for, capturing, and successfully performing government contracts. Our services include the following:
Morgan Lewis assists manufacturers file new dietary ingredient and 30-day market claim notices with the FDA. We also help determine the appropriateness of new or novel dietary supplement ingredients, and whether a product’s delivery mechanism affects its regulatory status. To help companies avoid more rigorous regulation, we advise clients on the types of health claims and structure and function claims that are appropriate for dietary supplements. We provide strategic, creative solutions in connection with broadcast, print, and online advertising and we help prepare defensible labeling to support claims that the supplement or food provides an enhanced function, while reducing the risk of additional FDA regulation.
We represent the full spectrum of companies that develop, market, and distribute a wide array of foods and food additives and we advise on labeling and marketing health and structure/function claims for foods. Our clients’ businesses include the following:
Our team assists clients with the appropriate safety assessment and submissions for food ingredients, including the following: