Marian J. Lee is the co-chair of the FDA & Health Care Practice and a member of the Life Sciences Practice. She brings over 18 years of experience advising clients on strategic FDA regulatory and compliance matters, risk management, and enforcement actions.

Ms. Lee’s practice spans the product life cycle, including the conduct of preclinical and clinical studies, good manufacturing practices (GMP) and quality systems (QS), premarket approvals and clearances, scientific communications, product labeling and advertising, and postmarket compliance. She regularly advises companies during FDA inspections and investigations, and she has led an array of FDA legal assessments for corporate transactions. Ms. Lee also counsels on FTC matters relating to the marketing of health care products.

The Best Lawyers in America® recognizes Ms. Lee in the field of FDA law. Who’s Who Legal recognizes her for “Life Sciences – Regulatory” in its inaugural 2023 Who’s Who Legal Thought Leaders – USA and 2022 Who’s Who Legal Life Sciences guides.  Women We Admire includes her among the “Top 50 Women Leaders in Law 2022.” Law360 selected her as a “Rising Star,” one of four attorneys chosen in her field nationwide, and Legal Bisnow named her one of the “Top 40 Lawyers Under 40” in Washington, D.C. Ms. Lee is a member of the Food and Drug Law Institute’s Medical Products Committee. She previously served on the editorial advisory boards for the Food and Drug Law Journal and Law360 Life Sciences. She is a member of the Board of Ambassadors for the National Health Law Program and was a fellow to the Leadership Council on Legal Diversity (LCLD).

Ms. Lee graduated from Harvard Law School, where she was an editor of the Harvard Journal of Law and Technology.  She graduated from Harvard College, magna cum laude and Phi Beta Kappa, and received the Radcliffe College Presidential Award.  Prior to private practice, she taught in South Korea through the U.S. Fulbright Program and researched economic policy at Harvard Business School.

Representative Experience

• Advised a global manufacturer and distributor of drugs and medical devices on best practices and risk mitigation strategies for handling adverse events, product recalls, contract manufacturing issues, and supply chain disruptions.
• Led FDA legal and compliance assessments in connection with significant corporate transactions, such as St. Jude Medical, Inc.’s acquisition of Thoratec Corp. and Allergan plc’s acquisition of ZELTIQ Aesthetics, Inc.
• Defended the product labeling and marketing of drugs and medical devices against allegations of misbranding, pre-market promotion, unfair business practices, and consumer deception.
• Counseled manufacturers through appeals of FDA decisions and the dispute resolution process, including issues relating to premarket pathways and product classifications.
• Served as the FDA advisor to a global medical device manufacturer during a Department of Justice (DOJ) investigation into alleged violations of the Federal Food, Drug, and Cosmetic Act and the False Claims Act.
• Advised on Emergency Use Authorizations (EUA) and the development and testing of health care products during the COVID-19 public health emergency.
• Advised a Fortune 100 company on the premarket pathway and clinical testing strategy for its digital health device. FDA cleared the device for marketing.
• Counseled a multinational Fortune 100 company during congressional and state attorney general inquiries relating to the sale of controlled substances and prescription drug products.
• Advised a medical device manufacturer on FDA’s pre-sub process, premarket notifications (510(k)), and de novo classification.
• Defended a manufacturer during an FDA enforcement action relating to the marketing of human cells, tissues, and cellular and tissue-based products (HCT/Ps).
• Represented a coalition of medical device manufacturers regarding a proposed change in FDA requirements. After a public FDA hearing, including a vote by a scientific advisory committee, the coalition’s position prevailed.
• Advised clinical labs and manufacturers on the regulation of in vitro diagnostics (IVD) and research use only (RUO) products.
• Seconded to an international biopharmaceutical company as FDA regulatory counsel for the flagship drug product.

Representative Publications and Speeches

• “Medical Device Cybersecurity,” Food and Drug Law Institute (FDLI) Annual Conference (2022)
• “Medical Device Law and Regulation Training Course” for CDRH employees (2022, 2021, 2018)
• “Accelerated Approval,” FDLI Drug and Device Law and Regulation for Patient Organizations (2021)
• “The New Drug Approval Process: New Drug Research and Development,” FDLI Drug Law and Regulation Conference (2021)
• “FDA’s Case for Quality in Medical Devices and Harmonization of Quality System Regulation,” FDLI Annual Conference (2020)
• “The Legalization of Hemp,” FDLI Magazine (February/March 2019)
• “Regulating Artificial Intelligence,” Gibson Dunn Presentation (2019)
• “FDA Enforcement Trends Within the Diagnostics Industry,” IVD Clinical and Regulatory Affairs Conference (2019)
• “Exploring the Expedited Approval Process,” ACI FDA Boot Camp (2019)
• “Medical Device Promotion and Advertising,” FDLI Introduction to Medical Device Law and Regulation Conference (2018)
• “The Rise of Health Care Related Legislation & Prosecution on a Global Scale,” Sixth Annual ABA London White Collar Crime Institute (2017)
• “Understanding FDA Enforcement,” ACI FDA Boot Camp (2017)
• “Current Developments in eHealth and mHealth,” PLI Health Care Law Institute (2016)
• “Implications and Preparations for FDA LDT Oversight,” Q1 Productions Clinical Affairs & Regulatory Approvals for Diagnostics (2016)
• “Direct-to-Consumer Advertising,” FDLI Advertising & Promotion Conference (2016)
• “Labeling and Promotion,” ACI FDA Boot Camp: Devices Edition (2016)
• “CDRH Innovation Pathways,” FDLI Annual Conference (2016)
• “Postmarket Issues and Strategies,” FDLI Hot Topics in Medical Device Law (2016)
• “The Politics and Policies for Promotion of Drugs and Devices,” ACI Summit on Promotional Review Compliance for Drugs & Devices (2016)
• “Health Care Law Institute 2015: Emerging Challenges and Trends in Reimbursement, Enforcement and Other Hot Topics,” Practicing Law Institute (2015)
• “When Does Your Software Become Regulated?,” Association of Food and Drug Officials (AFDO) Annual Conference (2015)
• “Advancements in Medical Device Software Technology,” MedCon: FDA/Xavier University Conference (2015)
• “Significant Settlements,” in Top 20 Food and Drug Cases, 2014 & Cases to Watch(2015)
• “FDA Regulation of Social Media: New Guidance and Developments to Watch,” Q1 Productions Annual Customer Centric Medical Information Conference (2015)
• “Overcoming Constitutional Concerns with FDA Regulations,” CBI Social Media & Digital Platforms: Compliance Strategies Summit (2015)
• “Mobilizing Health After the FDASIA Health IT Report,” Medical Marketing & Media(2014)
• “Build and Enhance a Social Media Monitoring Watchdog System to Discover Non-Compliance Circulating on the Internet,” CBI Compliance Monitoring Programs Conference (2014)
• “FDA Regulation of Health Information Technology: Medical Apps, Cybersecurity, and the Cloud,” MedCon:  FDA/Xavier University Conference (2014)
• “Beyond FDA:  Emerging Regulations, Risks and Rewards for mHealth from FTC, FCC and the States,” FDAnews Audioconference (2013)
• “Astiana v. Dreyer’s Grand Ice Cream, Inc.,” in Top 20 Food and Drug Cases, 2012 & Cases to Watch(2013)
• “Analyze the Impact of Life Sciences Regulations on Financial Reporting,” CBI 9th Annual Pharma Accounting and Reporting Congress (2013)
• “Communication Strategies during Pre-Approval and Pre-Launch – How to Treat Emerging Clinical Data,” CBI 10th Annual Pharmaceutical Compliance Congress (2013)
• “Sorrell v. IMS Health, Inc.,” in Top 20 Food and Drug Cases, 2011 & Cases to Watch(2012)
• “Revolutionizing Corporate Social Media Policies to Adapt to FDA’s Evolving Position on Off-Label Communications,” ACI 8th Advanced Summit on Off-Label Communications ( 2012)
• “Responding to Unsolicited Requests for Off-Label Information,” Fx Conferences (2012)
• “Overcome Common Challenges Faced by Promotional Review Committees,” CBI Pharmaceutical Compliance Congress (2012)