Alexis Reisin Miller

Partner

Alexis Reisin Miller is a partner in Morgan Lewis's FDA Practice. Ms. Miller focuses her practice primarily on regulatory issues pertaining to pharmaceuticals, medical devices, cosmetics, foods and dietary supplements, including product development, manufacturing, and marketing. Additionally, Ms. Miller has advised clients on regulatory issues relating to food and drug additives, and has experience with regulatory aspects of product liability litigation involving pharmaceutical products. She also counsels clients on the full array of regulatory issues affecting drug manufacturers and distributors in both pre- and post-market contexts.

Ms. Miller has experience in regulatory pathway and drug approval issues, pharmacovigilance reporting, and the regulation of drug and device labeling, advertising, and promotion by the FDA, including proprietary naming. Her experience also includes advising clients on Federal Trade Commission (FTC) consumer protection matters, including food, dietary supplement, cosmetic, and consumer product marketing, and Internet sales and related regulation. Ms. Miller also has provided extensive counsel to clients in matters before the Consumer Product Safety Commission (CPSC).

Prior to joining Morgan Lewis in 2011, Ms. Miller served as Regulatory Counsel to senior policy officials and science division directors at the FDA's Center for Drug Evaluation and Research. She also previously served as an associate in Morgan Lewis's FDA and Healthcare Practice from 2006 to 2010, during which she was seconded for extended periods of time to two large international pharmaceutical clients. Earlier in her career Ms. Miller also worked in-house, having served counsel at a Washington, D.C.-based biotechnology research and consulting firm.

Ms. Miller earned her J.D. from the Catholic University of America, Columbus School of Law in 2003 and her B.A., with honors, in international business and international relations from New York University in 1999. She is fluent in both written and spoken Spanish.