The following is an excerpt from Practice Perspectives: Vault's Guide to Legal Practice Areas.
Sandra (“Sandy”) M. DiVarco counsels hospitals and health systems regarding all aspects of health law transactions and health system restructurings. A significant component of her practice also involves assisting health care providers with regulatory, licensure, and accreditation issues, including state-level and Centers for Medicare and Medicaid Services (CMS) survey responses, formulation of successful plans of correction, Joint Commission complaint responses, and Emergency Medical Treatment and Active Labor Act (EMTALA)/regulatory investigations. Drawing on her experience as a registered nurse who holds a current license in the state of Illinois, Sandy brings a pragmatic, firsthand perspective to her clients’ complex and mission-critical matters.
Anisa Mohanty is a former Regulatory Counsel at the U.S. Food and Drug Administration (FDA). Anisa advises medical device, biotech, and pharmaceutical companies on FDA premarket strategy and post-market compliance issues, from advertising and promotion to disclosure and periodic reporting. She offers guidance to her clients in connection with premarket pathways; Good Laboratory Practice and Good Clinical Practice and Good Manufacturing Practice; Quality System requirements; and the development, creation, and review of advertising and promotional materials for FDA-regulated products. Anisa also supports investors and companies engaged in transactions and investments involving FDA-regulated drugs, medical devices, and other products.
Describe your practice area and what it entails.
Sandy: I represent hospitals and health care systems in all aspects of their operations, advising on both transactions and regulatory matters. My background as a registered nurse and risk manager gives me a unique perspective on clinical care and quality/safety matters as well. In 2020, I took on a leadership role in the firm’s comprehensive COVID-19 response efforts. That means that not only do I advise health care industry clients on their changing operations and the rapidly evolving pandemic regulatory environment, I’m also engaged as part of the cross-practice, firmwide team of attorneys tasked with providing COVID-related guidance to clients across every other industry—everything from cruise lines to national event organizers and media companies.
Anisa: The bulk of my practice falls into three areas: 1) advising traditional FDA clients related to advertising and promotion, pre-market pathways, and traditional compliance and enforcement matters; 2) providing FDA guidance in connection with life sciences transactions of all types across product areas; and 3) regulatory issues that arise as part of research collaborations, joint ventures, and clinical trial agreements.
What types of clients do you represent?
Sandy: I primarily advise nonprofit hospitals and health care systems, ranging from small, independent community hospitals to the largest national and international systems. Given the depth of McDermott’s Healthcare group, and the breadth of our firm’s clients, I also routinely assist a broad range of other health care providers as well.
Anisa: I primarily work with medical device and drug manufacturers, innovative technology companies entering the digital health space, and companies investing in these spaces.
We both also regularly advise on the regulatory aspects of private equity transactions and platform company operations after acquisitions.
What types of cases/deals do you work on?
Sandy: Traditionally, my practice has centered upon health care transactions of all types and regulatory advice on mission-critical health care operations and complex patient care matters. In 2020 in particular, much of my day-to-day (and sometimes late-night!) work focused on advising clients on pandemic-related regulatory and patient care matters, including establishment of alternate care sites and, now, vaccination protocol compliance.
Anisa: Our FDA practice focuses heavily on medical devices and digital health products, and we also have expertise in pharmaceuticals and related patent and Hatch-Waxman Act matters. We work on transactions involving everything from traditional FDA-regulated product manufacturing to food products to dietary supplements and more.
How did you choose this practice area?
Sandy: I practiced as a registered nurse at a large academic medical center before attending law school, so health law was a natural focus for me. But having a health care background is not a prerequisite to being a health care lawyer. There are a lot of ways to become a health lawyer, and successful health care lawyers may have experience in health care administration or public health or even no health background at all.
Anisa: I served as Regulatory Counsel at FDA for about six years. When I decided to make the move to private practice, I reached out to McDermott based on the firm’s solid health law reputation. Luckily, the firm happened to be in the process of building out its FDA practice. The timing was perfect.
What is a typical day like and/or what are some common tasks you perform?
Sandy: It’s interesting to contemplate what a typical day has looked like since March 2020. Regulatory guidance early on changed literally multiple times a day. We issued client alerts on every new development and responded to questions from clients in every industry. I spend a lot of time providing real-time advice and counsel to clients. No two days are the same—but that’s part of what makes practice in this area so dynamic.
Anisa: The best thing I can say about my practice is that there is no such thing as typical. On any given day, I may be engaged on 15 completely unique matters. Today, I worked on a co-development agreement, provided advice around marketing claims, assessed the regulatory status of a new COVID test, and coordinated the audit parameters for the target company as part of an acquisition. The variety and the pace keep every day interesting.
What training, classes, experience, or skills development would you recommend to someone who wishes to enter your practice area?
Sandy: While not required by any means, exposure to health care operations/businesses or health law courses can be helpful in hitting the ground running in advising hospitals and health systems. Early participation in the Health Law Bar through the American Health Law Association and/or local state associations is also a great way to get exposure to timely subject matter and get to know future colleagues practicing in this area.
Anisa: People ask me if you need to serve at the FDA before entering private practice as an FDA lawyer. It’s certainly not a prerequisite, but having career experience on the FDA side makes it easier to understand the regulator’s perspective, better assess where they might place their priorities, and more accurately benchmark risk. I’d say FDA service is a more efficient way to gain that insight than, perhaps, working for 20 or 30 years in the field. Either way, I’d absolutely recommend getting involved with the Food & Drug Law Institute and its New to Food and Drug Law (NFDL) group in particular. Their conferences and other educational opportunities are great. But perhaps even more importantly, the Food and Drug Bar is a relatively small ecosystem, and it helps to get to know practitioners in the same space with whom you will likely work with down the road.
You’ll have to forgive the self-promotion, but we also have to say that the entire calendar of McDermott health care conferences and webinars provides some of the best industry education in the field.
What misconceptions exist about your practice area?
Sandy: It’s not uncommon for people to equate health law with medical malpractice or personal injury. But in fact that’s a tiny fraction of health-related legal practice. We joke that health care is the most highly regulated industry next to nuclear energy—and if that’s not the truth, we have to be close! That’s what’s really at the core of not just my practice, but health care law as a field—the industry’s amazingly complex regulatory scheme.
Anisa: Many people don’t understand what an FDA lawyer does. They don’t realize how much the FDA regulates. In fact, 20 cents of every dollar spent in the U.S. is on FDA-regulated products. The agency is responsible for the oversight of more than $2.8 trillion in consumption of food, medical products, and tobacco. That means that there are all kinds of companies who are impacted by FDA regulations and need guidance to navigate them. [*Source: https://www.fda.gov/about-fda/fda-basics/fact-sheet-fda-glance].
What is unique about your practice area at your firm?
Sandy: McDermott’s Healthcare practice is one of the firm’s marquee practice areas, which means that every client benefits from one of the broadest possible bases of knowledge and experience, capable of providing total life cycle counseling on any issue our clients might encounter. That’s what’s most unique about the Hospital and Health System practice area at the firm—that in virtually every instance, the counsel I provide is one piece of a multifaceted legal strategy that holistically benefits every aspect of our clients’ operations.
Anisa: A lot of other FDA practices are hyper-specialized, which means they lack access to other important specialty expertise and can’t provide counsel on non-FDA issues. Because our practice sits within the Healthcare practice—which is somewhat unusual—we’re able to serve all of our clients’ needs beyond strictly FDA counseling, including pricing and reimbursement, fraud and abuse issues, and deal-making.
What are some typical career paths for lawyers in this practice area?
Sandy: You can be a very junior lawyer and still play a meaningful role on a hospital or health system deal. That’s part of the McDermott Healthcare advantage: You’ll be working on a team with a diversity of experience and exposure to health care at different levels and in many parts of health care operations. One of the keys to success, I’d say, is a mind for solving puzzles. Our challenge is to fit our clients’ business objectives within regulatory frameworks that don’t always keep pace with current operations or current thinking from a clinical standpoint. It’s often our job to fit a square peg into a round hole.
Anisa: The most exciting thing about an FDA practice career path at McDermott is that you are encouraged to take ownership of a particular sub-specialty area and carve out your niche. There is a virtually endless slate of FDA-related subjects and products, and each is highly complex and technical.
How has the digital health market affected your practice?
Sandy: Digital health is an ancillary to my core practice, providing guidance on licensing and accreditation. We’re applying long-time health regulatory constructs in whole new ways. For example, how does provider licensing work in the context of telemedicine? How and where does a provider need to be licensed if he or she is delivering care in-person as well as via telemedicine?
Anisa: FDA’s framework for traditional medical devices is what is applied to digital health products, and it’s definitely an imperfect fit. And as is true with most other regulators, FDA often isn’t moving nearly as quickly as industry. It’s very challenging to advise clients on how evolving regulations might impact the long-term viability of their products and solutions. But at the same time, we have an exciting opportunity to proactively engage with FDA and other regulators and help them think strategically about digital health product categories as they formulate new guidance. We’re actively partnering every day with both the industry and the regulators to help shape the future.