Lauren K. Roth

As a partner in our FDA and Life Sciences practice, Lauren leverages nearly two decades of experience in legal practice and senior roles at the FDA to advise clients on legal, regulatory, and compliance matters across FDA-regulated industries. Most recently, as FDA’s Associate Commissioner for Policy, Lauren played a key role in all major policy initiatives. Lauren translates her experience to help clients navigate the complex issues facing their businesses at the intersections of law, science, and policy.

Lauren brings a breadth of experience advising senior public officials and life sciences companies on legal, regulatory, and policy matters. As the Associate Commissioner for Policy from 2019-2024, Lauren led the Commissioner’s Office of Policy (OP), supervising issuance of all FDA regulations and guidance documents. She advised agency, HHS, and Administration officials on high priority and novel matters, including implementation of new authorities for drugs, devices, food, and cosmetics. She also served as FDA’s lead negotiator for the fifth medical device user fee agreement, playing a pivotal role in shaping current policies and practices related to premarket review, digital health, patient engagement, and use of real-world evidence.

Previously, Lauren was a Senior Advisor to FDA’s Chief of Staff (2017-2019) and the Associate Director for Strategy and Regulatory Operations within the Center for Devices and Radiological Health (2016-2017). In those roles, she advised on regulatory, legislative, and compliance matters, including strategic initiatives on device safety and tobacco product regulation.

Before joining FDA, Lauren served as Assistant General Counsel to an association of the United States’s leading manufacturers of innovative pharmaceutical products, Pharmaceutical Research and Manufacturers of America (PhRMA). She advised the association on issues related to government enforcement of healthcare fraud and abuse laws, corporate compliance programs, patient adherence and access programs, and drug distribution channels.

In private practice, Lauren advised companies on compliance with healthcare regulations, including the Federal Food, Drug, and Cosmetic Act; the False Claims Act; the anti-kickback statute; and exclusion and debarment laws. She also guided healthcare companies in government investigations (criminal and civil) and conducted internal investigations to analyze legal risk and compliance issues.

Lauren earned her J.D. from the University of Virginia, where she served as an Articles Editor for the Virginia Law Review.