Morgan Lewis today announced that Alexis Reisin Miller has returned to the firm as a partner in its FDA & Healthcare Practice, resident in Washington, D.C. Ms. Miller most recently served as regulatory counsel to senior policy officials and science division directors at the FDA’s Center for Drug Evaluation and Research. She was previously an associate in Morgan Lewis’s FDA and Healthcare Practice from 2006 to 2010 and, before that, served as in-house counsel at a Washington-based biotechnology consulting firm.
“Having worked on complex food and drug regulatory issues from every vantage point—in the FDA, as outside counsel, as well as in-house—Alexis brings a valuable perspective to our clients,” noted Kathleen Sanzo, leader of the FDA & Healthcare Practice at Morgan Lewis. “We are thrilled to welcome her back to the team.”
Ms. Miller focuses her practice primarily on regulatory issues pertaining to pharmaceuticals, medical devices, cosmetics, and foods and dietary supplements, including product development, manufacturing, and marketing. She 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 drug approval and regulatory pathway issues, pharmacovigilance reporting, and the regulation of proprietary names and drug and device advertising and promotion by the FDA. 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 counseled clients in matters before the Consumer Product Safety Commission (CPSC). She re-joins one of the most comprehensive life sciences practices of any U.S. law firm, with more than 200 lawyers, scientists and other technical specialists across the firm who focus on the industry, including two dozen dedicated specifically to FDA and healthcare regulatory issues.
