Marian J. Lee is the Co-Chair of the FDA & Health Care Practice and a member of the Life Sciences Practice. She brings over 17 years of experience advising clients on strategic FDA regulatory and compliance matters, risk management, and enforcement actions.

Ms. Lee’s practice spans the FDA-regulated 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 foods, cosmetics, over-the-counter (OTC) drugs, medical devices, and other health care products.

The Best Lawyers in America® recognizes Ms. Lee in the field of FDA law. Law360 selected her as a “Rising Star,” one of four attorneys chosen in her field nationwide. 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 Journal’s Editorial Advisory Board and a member of the Board of Ambassadors for the National Health Law Program. She also was a Leadership Council on Legal Diversity (LCLD) Fellow and a member of the Law360 Life Sciences Editorial Advisory Board.

Ms. Lee graduated from Harvard Law School, where she was an editor of the Harvard Journal of Law and Technology.  She graduated with a Bachelor of Arts, magna cum laude and Phi Beta Kappa, from Harvard College, where she 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 companies on the CARES Act and federal emergency regulations and policies relating to the funding, development, marketing, and use of COVID-19 therapies, testing, personal protective equipment, and other healthcare products.
• Led FDA legal assessments for St. Jude Medical, Inc.’s acquisition of Thoratec Corp. and for Allergan plc’s acquisition of ZELTIQ Aesthetics, Inc.
• Advised a Fortune 100 company during congressional inquiries relating to the marketing of opioids and unapproved drugs.
• Defended a multinational beverage and food manufacturer facing class action allegations relating to FDA nutrient content and labeling requirements.
• Assessed the marketing and sale of cannabidiol (CBD) products by a major manufacturer of hemp-based products.
• Advised a Fortune 100 company on the premarket pathway and clinical testing strategy for its digital health device. FDA cleared the device for marketing.
• Defended a manufacturer facing FDA enforcement action relating to the marketing of human cells, tissues, and cellular and tissue-based products (HCT/Ps).
• Conducted FDA diligence for PepsiCo’s acquisition of SodaStream International.
• Served as the FDA advisor to a global medical device manufacturer during a Department of Justice (DOJ) investigation into allegations that the company had failed to comply with FDA requirements and had violated the False Claims Act. The DOJ declined to intervene.
• Led the FDA legal assessments for CVC Capital Partners’ acquisition of Petco and C.J. Foods’ acquisition of Lortscher Animal Nutrition.
• Conducted an internal FDA assessment during a DOJ investigation into a global medical device manufacturer’s premarket submissions, product testing, marketing claims, and postmarket compliance.
• Counseled companies through appeals of FDA decisions and the dispute resolution process, including issues relating to premarket pathways and product classifications.
• Conducted an enterprise-wide risk assessment of a Fortune 100 company’s health care communications, marketing, and social media practices.
• Led the FDA legal assessment for a private equity fund’s acquisition of a global contract manufacturer of pharmaceuticals.
• 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 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 Law and Regulation Training Course for CDRH employees (2021, 2018)
• “The New Drug Approval Process: New Drug Research and Development,” Food and Drug Law Institute (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)
• FDLI Introduction to U.S. Drug Law and Regulation Conference (2020, 2019, 2018, 2017)
• “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)