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Blank Rome LLP is pleased to announce that <a href="/people/thomas-m-sundlof/" id="18273">Tom Sundlof</a>, former senior attorney at the U.S. Food and Drug Administration (“FDA”), has joined the firm’s Washington, D.C., office as a partner in the <a href="/services-and-industries/life-sciences/" id="18576">Life Sciences</a> industry team and <a href="/services-and-industries/corporate/" id="18405">Corporate, M&amp;A, and Securities</a> practice group. Tom brings more than two decades of government experience to Blank Rome, including key legal positions at the FDA and the U.S. House of Representatives. Tom’s FDA practice was wide-ranging, including leading the agency on regulatory, compliance, and enforcement matters for medical devices, combination products, and other FDA-regulated products. Tom joins Blank Rome from the FDA’s Office of the Chief Counsel, where he served as Associate Chief Counsel and Assistant Deputy Chief Counsel (Acting), advising on high-profile regulatory actions, enforcement, and policy development. 

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Tom’s arrival follows the recent addition of Life Sciences industry team partners <a href="/people/rachael-g-pontikes/" id="18670">Rachael G. Pontikes</a> and <a href="/people/emily-l-hussey/" id="18672">Emily L. Hussey</a>, nationally recognized for their work representing clients in the life sciences and healthcare industries. Together, this team reflects Blank Rome’s strategic expansion to meet the evolving needs of clients in the life sciences and healthcare sectors as they interact with the FDA, Drug Enforcement Administration, state regulators, and other regulatory bodies on critical issues.

“We are thrilled to welcome Tom to the firm,” said <a href="/people/grant-s-palmer/" id="19377">Grant S. Palmer</a>, Blank Rome’s Chair and Managing Partner. “Tom’s substantial government and FDA background will provide immense value to our life sciences and healthcare clients, especially those navigating the complexities of marketing medical devices and combination products. His comprehensive, client-focused approach, combined with his experience as a litigator, will help us deepen relationships with existing clients and reach new ones. With Tom aboard, we further bolster our Life Sciences and Healthcare industry teams, reinforcing our commitment to strategic growth and exceptional client service in rapidly evolving sectors.”

At Blank Rome, Tom will help domestic and international clients successfully access the market by guiding them through the complex landscape of FDA regulations—from designing clinical trials and managing investigational uses to determining the right authorization pathways and crafting compelling applications. Following market authorization, Tom is positioned to advise clients on maintaining post-market compliance with evolving standards that affect everything from manufacturing processes to advertising and labeling practices. Leveraging his experience with federal agencies, Congress, and the White House, Tom will also advocate for clients’ interests in regulatory and legislative matters, ensuring their voices are heard during rulemakings and policy development. Should clients face investigations or enforcement actions, Tom will serve as a steadfast advocate, helping them minimize potential risks and navigate any resulting challenges with confidence.

<a href="/people/louis-m-rappaport/" id="19355">Louis M. Rappaport</a>, partner and co-chair of the Corporate, M&amp;A, and Securities practice group, said, “With Tom’s unique experience at the FDA and his deep understanding of regulatory and compliance issues, our life sciences and healthcare industry clients will benefit from expanded strategic guidance and support. His addition strengthens our ability to provide sophisticated and tailored counsel on complex transactions and regulatory challenges, and we are excited to have him on the team.” 

During his tenure at the FDA, Tom led teams of attorneys in developing legal strategy and for major rulemakings, high-profile enforcement actions, and precedent-setting premarket decisions. In doing so, he advised agency leadership, Congress, and the White House on regulatory and policy matters. He has extensive experience counseling on medical devices and combination product matters, leading legal review of major rulemakings, guidances, jurisdictional determinations, premarket review decisions, and enforcement matters. Tom has been recognized for his outstanding service and multidisciplinary collaboration, receiving multiple awards for his contributions to the FDA’s mission and public health initiatives. Prior to his FDA service, Tom was a litigator for the U.S. House of Representatives’ Office of General Counsel, representing members and committees in federal district and appellate courts on all matters, including constitutional and legislative matters.&nbsp;

“I am excited to join Blank Rome and collaborate with such a talented group of attorneys who are committed to helping clients succeed,” said Tom. “Blank Rome’s collaborative culture, impressive client base, and commitment to strategic growth in the dynamic life sciences and healthcare industries, including MedTech and agriculture, make it the ideal place to build my practice and help clients navigate the challenges and opportunities presented by FDA regulations.”&nbsp;

Tom earned his J.D. from The George Washington University Law School and his B.A. in Economics and Government from the University of Maryland, College Park.&nbsp;

FDA Veteran Tom Sundlof Joins Blank Rome as Partner in Washington, D.C., Strengthening National Life Sciences Team

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FDA Veteran Tom Sundlof Joins Blank Rome as Partner in Washington, D.C., Strengthening National Life Sciences Team

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