The First Two Months: Understanding FDA, DOJ, and FTC in the New Administration

Lauren Roth is a Partner in the FDA and Life Sciences practice at King & Spalding, where she 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 (in 2019-2024), Lauren played a key role in all of FDA’s major policy initiatives, working with both the administrations of President Trump and President Biden on complex issues at the intersections of law, science, and public health. 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 a range of legislative and compliance matters, including medical device safety and tobacco product oversight. Lauren is the recipient of numerous FDA accolades, including the Award of Merit, FDA’s most distinguished honor award. Prior to government service, Lauren spent several years practicing healthcare law at an international law firm and, subsequently, as an Assistant General Counsel to the Pharmaceutical Research and Manufacturers of America (PhRMA). Lauren earned her J.D. from the University of Virginia School of Law, where she served as an Articles Editor for the Virginia Law Review.