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The following is an excerpt from Practice Perspectives: Vault's Guide to Legal Practice Areas.

John Manthei, Global Chair of the Healthcare & Life Sciences Practice, advises on regulatory matters involving the U.S. Food and Drug Administration (FDA) for the medical device, pharmaceutical, and biotechnology industries. He has been involved extensively in Administrative Procedure Act litigation. Since 2000, Mr. Manthei has represented industries as counsel in nearly every major FDA legislative initiative. He has testified before Congress on several occasions and is ranked Band 1 by Chambers USA 2022 for Healthcare: Pharmaceutical/Medical Products Regulatory - District of Columbia. He was inducted into the “Hall of Fame” by The Legal 500 US.

Elizabeth (Liz) Richards, a Healthcare & Life Sciences partner, helps clients navigate FDA-related regulatory, compliance, enforcement, transactional, and legislative/policy matters. She counsels clients traversing the legal labyrinth to introduce new products and maintain compliance once commercialized, advocating for them before the FDA. She advises medical device and pharmaceutical clients on contracts related to all aspects of preclinical and clinical research. She regularly advises on regulatory matters in connection with capital markets, private equity, and M&A transactions involving FDA-regulated entities. Ms. Richards has been recognized by multiple publications, including in Chambers USA 2022, The Legal 500 US, LMG Life Sciences, and The Diversity Journal.

Describe your practice area and what it entails.

Liz: Our practice covers four major areas. First is our core work focused on regulatory counseling of clients whose products and businesses are subject to FDA oversight (including clients who are developing new and innovative drugs, medical devices, digital health products/apps, cosmetics, foods, dietary supplements, and other kinds of products). Second, we partner with our colleagues across the firm on transactions involving such entities or their products, including M&A, capital markets deals like initial public offerings, private equity investments, and financings. Third, we work together with our firm’s litigation teams on litigation matters as subject matter experts advising on the FDA regulatory framework, where the litigation at issue may be predicated on a regulatory issue, where the regulatory issues can dictate litigation strategy or where we bring suit against the FDA challenging an FDA policy or decision under the Administrative Procedure Act. Finally, we lead the negotiation of our clients’ preclinical and clinical trials-related contracts, facilitating agreements with investigators, clinical sites, clinical research organizations, and other third-party vendors whom our clients rely on to generate data to support marketing applications for our clients’ products.

What types of clients do you represent? 

John: Our team guides the world’s leading medical device, pharmaceutical, and biotechnology companies, from innovative startups to mature public companies. Simply put, we advise the companies at the heart of healthcare and medical innovation.

What types of cases/deals do you work on? 

Liz: My practice is a good mix of the areas I’d mentioned earlier, and on any given day I am working on a range of matters for 10 to 15 different clients.

John: Our practice covers the gamut of deals and regulatory counseling matters involving FDA-regulated entities, from M&A to private equity investment to investigations. And we’ve served as outside counsel on every major legislative initiative affecting the industry for the last 20 years, helping Congress understand the policies it proposes and helping companies navigate the laws Congress ultimately passes and the regulations the FDA ultimately promulgates.

How did you choose this practice area?

Liz: I have always wanted to work in healthcare and initially was pre-med in college but wasn’t sure it would be the best fit. I explored other opportunities in this industry and decided to attend law school in a joint Master of Public Health/JD program. I learned there are a number of different specialties within the practice of healthcare law beyond FDA regulatory work. I sought out firms with strong and growing healthcare practices with a range of specialties. This naturally led me to Latham. During my time in the firm’s Unassigned Program as a first-year associate, I sought out work in the healthcare and life sciences practice group and I fell in love with the FDA regulatory practice.

John: The variety and constant change of pace drew me into the FDA regulatory practice. The matters we work on involve incredibly challenging and novel legal issues, and we face them head-on at every stage of the product life cycle. Originally, I thought I wanted to be a litigator, but in this practice I probably do more advocacy work on a daily basis than I would in another practice.

What is a typical day like and/or what are some common tasks you perform?

John: A typical day simply doesn’t occur in our practice—I like that unpredictability from day to day. I may work with a medical device company on an approval, then help with a merger agreement, before jumping on a call with a private equity sponsor to discuss an investment. I can count on a variety of issues to address each day, and I’ve come to learn that the only thing to expect for the day ahead is that it will differ from the day prior.

What training, classes, experience, or skills development would you recommend to someone who wishes to enter your practice area?

Liz: Take a class in administrative law; not only is the material interesting, but it also equips law students with an understanding of how the administrative agencies like the FDA procedurally engage in their regulatory functions and how they fit within the U.S. legal system—an understanding essential to this practice, as it enables lawyers to identify the pressure points in advocating for our clients’ positions. Our practice frequently involves direct engagement with the FDA, including in meetings with the agency regarding a particular product application, through submission of comments on a proposed rulemaking or draft guidance, and preparing citizen petitions requesting the agency take or refrain from taking certain actions, among many others. Many of these avenues for industry advocacy before their regulator are taught in administrative law.

What do you like best about your practice area?

Liz: Most importantly the practice is focused at the highest level on improving public health and getting patients the care they need.

John: Harnessing and assisting innovators in the medical field, working on everything from new treatments for cancer to disease prevention, always feels rewarding. I get to work with the most brilliant clients trying to solve our most pressing issues in healthcare, and I get to do so surrounded by the highest level of talent.

What misconceptions exist about your practice area?

John: People perceive regulatory lawyers as “by the book” individuals who take pleasure in saying “No.” But our practice is quite commercially minded, and we understand that our clients are businesses. As a practice, we always try to creatively address novel issues in the law in a way that takes into account the client’s business needs.

Also, when you build a regulatory practice, the immediate thought isn’t that you’ll be involved with advocacy, private equity, M&A, investigations, and so on. But our integration with other practices in the firm means we explore many facets of the law. That’s something unique about our practice at Latham.

What are some typical tasks that a junior lawyer would perform in this practice area?

John: Fundamentally, our junior lawyers help us determine what is being regulated and why, and then take those answers and develop the broader strategy. Junior associates play an instrumental role in figuring out the solutions we offer to clients. Early on, tasks primarily include research and writing, but we facilitate client interaction as quickly as possible. As soon as a junior lawyer can handle that direct interaction, we open up those opportunities to them.

Liz: We recognize that junior lawyers in an FDA practice often face a steep learning curve. We work to compensate for that by investing a lot of time training our people. The work that junior lawyers do in our practice brings them up to speed on the substance, unlocking new opportunities to them as they become conversant in the regulatory frameworks applicable to our clients. We also staff our matters leanly, often with just one partner and one junior associate. Consequently, from the day they begin their legal careers, junior associates get access to and learn from lawyers who have developed the expertise in their area of practice and have been doing this work for a very long time.

What are some typical career paths for lawyers in this practice area?

Liz: Our practice is intentionally sized to give lawyers the training and personal attention they need to take on any role a lawyer may want to eventually seek, whether that’s counsel or partner at the firm, in-house in the private sector, or a move into the government, including the Department of Justice, Congress, or the FDA (each have been landing pads for our associates in recent years). We pride ourselves on keeping open lines of communication with our associates regarding career opportunities and progression. Our FDA lawyers generally do not leave Latham to work at a different firm’s FDA practice, which is a testament to the group here at Latham. However, we support our attorneys in any moves they may pursue—for example, we have had several associates come to leadership to express an interest in roles in the government, and we have assisted those attorneys in identifying those opportunities, including an associate who recently moved to a policy role at the FDA and another who left for an incredible opportunity on the Hill. Our goal is to create the best lawyers that we can, and then position them for wherever they want their career to go. While we hope that means remaining at Latham, we are fully supportive if attorneys want to explore other opportunities.