Marian J. Lee is a partner in Gibson, Dunn & Crutcher's Washington, D.C. office. She provides FDA regulatory and compliance counseling to life science and health care companies. Ms. Lee has significant experience advising clients on FDA regulatory strategy, risk management, and enforcement actions.
Ms. Lee's practice spans the product life cycle, including the conduct of pre-clinical and clinical studies, good manufacturing practices (GMP) and quality systems (QS), premarket approvals and clearances, scientific communications, product labeling and advertising, and post-market compliance. She regularly advises companies during FDA inspections and investigations, and she has led an array of regulatory assessments for mergers, acquisitions, and other transactions involving FDA-regulated entities. Ms. Lee also counsels on FTC matters relating to the marketing of foods, cosmetics, over-the-counter (OTC) drugs, and other health care products. She is a frequent speaker and author on developments in FDA and FTC law, including the evolving regulation of manufacturers' speech and off-label communications, mobile health, and medical software.
Law360 selected Ms. Lee as a "Rising Star," one of four attorneys recognized in her field nationwide. Legal Bisnow named her one of the "Top 40 Lawyers Under 40" in Washington, D.C. She is also listed in the 2018 edition of The Best Lawyers in America® under the category of FDA law. Ms. Lee has served on both the Food and Drug Law Institute's (FDLI) Policy Forum Advisory Board and the Law360 Life Sciences Editorial Advisory Board. She also 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 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.
- Conducted the FDA diligence assessments for St. Jude Medical, Inc. during its acquisition of Thoratec Corp. and for Allergan plc during its acquisition of ZELTIQ, Aesthetics, Inc.
- Seconded to an international biopharmaceutical company as FDA regulatory counsel for the flagship drug product.
- Defended a beverage and food manufacturer's compliance with nutrient content and other FDA food labeling requirements.
- Counseled companies through appeals of FDA decisions and the dispute resolution process, including issues relating to premarket pathways and product classifications.
- Prepared responses to FDA Form 483 observations and corporate Warning Letters.
- Advised manufacturer on FDA regulatory strategy for human cells, tissues, and cellular and tissue-based products (HCT/Ps) in response to FDA enforcement correspondence.
- Served as FDA regulatory advisor to a major medical device manufacturer during False Claims Act litigation involving allegations of off-label promotion. The case was dismissed.
- Led the regulatory diligence of a natural wellness and cosmetics company on behalf of a private equity firm.
- Advised on the regulation of clinical labs, and in vitro diagnostic (IVD) and research use only (RUO) products.
- Conducted an enterprise-wide risk assessment of a Fortune 50 company's healthcare communications, marketing, and social media practices.
- Assessed the implementation of complaint handling, adverse event reporting, and recall practices by FDA-regulated entities.
- Represented a coalition of manufacturers in a medical device reclassification matter and public hearing before FDA. The coalition prevailed.
- Advised a Fortune 50 company on the premarket pathway and clinical testing strategy for its first mobile health medical device. FDA cleared the device for marketing.
- Counseled companies on FDA and FTC regulatory strategies for digital health technologies, including mobile apps and telehealth devices.
- Assessed a firm's regulatory and compliance activities relating to the manufacture and marketing of animal drugs and veterinary products.
- Audited modifications to 510(k)-cleared devices and manufacturer "letters to file."
- Conducted training for FDA staff on FDA law and regulation.
Representative Publications and Speeches
- "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 (September 2016)
- "Labeling and Promotion," ACI FDA Boot Camp: Devices Edition (July 2016)
- "CDRH Innovation Pathways," FDLI Annual Conference (May 2016)
- "Post-market Issues and Strategies," FDLI Hot Topics in Medical Device Law (March 2016)
- Training of FDA/CDER Staff, "Expanded Access" (January 2016)
- "The Politics and Policies for Promotion of Drugs and Devices," ACI Summit on Promotional Review Compliance for Drugs & Devices (January 2016)
- "Health Care Law Institute 2015: Emerging Challenges and Trends in Reimbursement, Enforcement and Other Hot Topics," Practicing Law Institute (November 2015)
- "When Does Your Software Become Regulated?," Association of Food and Drug Officials (AFDO) Annual Conference (June 2015)
- "Advancements in Medical Device Software Technology," MedCon: FDA/Xavier University Conference (May 2015)
- "Significant Settlements," in Top 20 Food and Drug Cases, 2014 & Cases to Watch, 2015 (FDLI 2015)
- "FDA Regulation of Social Media: New Guidance and Developments to Watch," Q1 Productions Annual Customer Centric Medical Information Conference (May 2015)
- "Overcoming Constitutional Concerns with FDA Regulations," CBI Social Media & Digital Platforms: Compliance Strategies Summit (March 2015)
- "Mobilizing Health After the FDASIA Health IT Report," Medical Marketing & Media (June 2014)
- "Build and Enhance a Social Media Monitoring Watchdog System to Discover Non-Compliance Circulating on the Internet," CBI Compliance Monitoring Programs Conference (March 2014)
- "FDA Regulation of Health Information Technology: Medical Apps, Cybersecurity, and the Cloud," MedCon: FDA/Xavier University Conference (May 2014)
- "Beyond FDA: Emerging Regulations, Risks and Rewards for mHealth from FTC, FCC and the States," FDAnews Audioconference (October 2013)
- "Astiana v. Dreyer's Grand Ice Cream, Inc.," in Top 20 Food and Drug Cases, 2012 & Cases to Watch, 2013 (FDLI 2013)
- "Analyze the Impact of Life Sciences Regulations on Financial Reporting," CBI 9th Annual Pharma Accounting and Reporting Congress (March 2013)
- "Communication Strategies during Pre-Approval and Pre-Launch – How to Treat Emerging Clinical Data.," CBI 10th Annual Pharmaceutical Compliance Congress (January 2013)
- "Sorrell v. IMS Health, Inc.," in Top 20 Food and Drug Cases, 2011 & Cases to Watch, 2012 (FDLI 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 (June 2012)
- "Responding to Unsolicited Requests for Off-Label Information," Fx Conferences (March 8, 2012)
- "Overcome Common Challenges Faced by Promotional Review Committees," CBI Pharmaceutical Compliance Congress (January 2012)
- "Hughes v. Boston Scientific Corporation," in Top 20 Food and Drug Cases, 2009 & Cases to Watch, 2010 (FDLI 2010)