Kalah Auchincloss, J.D., M.P.H., has extensive knowledge of FDA regulation across an array of product types—including drugs and biologics, diagnostics, digital health, cosmetics, and cell and gene therapy—as well as compliance, enforcement, and policy issues. She has served in FDA leadership and on Capitol Hill, and has worked with clients in consulting, legal, and corporate advisory roles, bringing a multifaceted perspective to Canal Row.
Her expertise was developed over a six-year career at the FDA, where she was Deputy Chief of Staff to Commissioner Robert Califf. Working with other senior FDA leaders, she led crisis management, policy development, communications strategy, cross-center coordination with the Commissioner’s Office, and interaction with HHS, the White House, and other agencies.
While at the FDA, Ms. Auchincloss had a significant role in advancing the bipartisan 21st Century Cures Act, the signature law supporting biomedical innovation through FDA and NIH, and other FDA-related legislation as the agency’s representative working with the Senate Committee on Health, Education, Labor, and Pensions. She also served as Director of the Office of Unapproved Drugs and Labeling Compliance in the Center for Drug Evaluation and Research (CDER) Office of Compliance, as well as Director of the Office’s Division of Prescription Drugs. Leading a team of 50+ professional staff, Ms. Auchincloss oversaw compliance activities related to pharmacy compounding, unapproved drugs, over-the-counter drugs, and other enforcement activities. She joined the FDA as a regulatory counsel in CDER’s Office of Regulatory Policy and also practiced food and drug law as an associate with Foley Hoag, LLP.
Ms. Auchincloss recently founded a solo law practice dedicated to advising companies on FDA regulatory, legal, and policy matters. Prior to that, she spent eight years as a consultant providing strategic regulatory guidance, advisory services, and litigation support to life sciences clients.
Ms. Auchincloss serves on a number of life sciences boards and as an expert witness in cases involving questions of FDA regulation. She holds a J.D. from Georgetown University Law School and a Master of Public Health from Harvard University.