FacultyFaculty/Author Profile

Marian J Lee

Gibson Dunn & Crutcher LLP

Washington, DC, USA


Marian J. Lee is a partner in Gibson, Dunn & Crutcher's Washington, DC office.  As a member of the FDA and Health Care Practice and Life Sciences Practice, 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 health care 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, advertising and promotion, post-market reporting, and recalls.  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 life science companies.  Ms. Lee also counsels on FTC regulatory matters relating to the marketing of health care products.  She is a frequent speaker and author on developments in FDA law, including the evolving regulation of manufacturer speech, mobile health products, and software.

Law360 selected Ms. Lee as a "Rising Star," one of four attorneys recognized in her field nationwide.  She serves on the Food and Drug Law Institute's (FDLI) Policy Forum Advisory Board and the Law360 Life Sciences Editorial Advisory Board.  She is 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 and the David Herbert Donald Prize for American history.  Prior to private practice, she served as a teacher in South Korea through the U.S. Fulbright Program and researched economic policy issues at Harvard Business School.

Representative Experience

Seconded to an international pharmaceutical company as FDA regulatory counsel for the flagship drug product.

Advised on the resolution of FDA Form 483 observations and corporate Warning Letters.

Represented a coalition of manufacturers in a medical device reclassification matter and public hearing before FDA.  The coalition prevailed.

Counseled companies through appeals of FDA decisions and the dispute resolution process, including issues relating to premarket pathways and product classifications.

Advised manufacturer on FDA regulatory strategy for human cells, tissues, and cellular and tissue-based products (HCT/Ps).

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.

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 and procedures.

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.

Advised on the regulation of clinical labs, and in vitro diagnostic (IVD) and research use only (RUO) products.

Conducted training for FDA staff on FDA law and regulation.

Led 510(k) audits of modifications to medical devices and "letters to file."

Evaluated regulatory risks associated with clinical study arrangements, such as informed consent and financial disclosure issues.

Counseled companies on FDA and FTC regulatory strategies for digital health technologies, including mobile apps and telehealth devices.

Advised on the development and implementation of social media policies and communications by life science companies.

Assessed manufacturer compliance issues relating to animal drugs and veterinary products.

Representative Publications and Speeches 

"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)

PRACTICE 

FDA and Health Care Administrative Law and Regulatory Practice

Life Sciences

EDUCATION

Harvard University 2004 - Juris Doctor

Harvard University 1999 - Bachelor of Arts

ADMISSIONS 

District of Columbia Bar Maryland Bar

Marian J Lee is associated with the following items:
Web Segment  Web Segment Current Developments in eHealth and mHealth - Health Care Law Institute 2016: Emerging Challenges and Trends in Reimbursement, Enforcement, Compliance and other Hot Topics, Friday, December 16, 2016
MP3 Audio  MP3 Audio Current Developments in eHealth and mHealth - Current Developments in eHealth and mHealth , Friday, December 16, 2016
MP4 - Mobile Video Seg  MP4 - Mobile Video Seg Current Developments in eHealth and mHealth - Current Developments in eHealth and mHealth , Friday, December 16, 2016
On-Demand Web Programs  On-Demand Web Programs Health Care Law Institute 2016: Emerging Challenges and Trends in Reimbursement, Enforcement, Compliance and other Hot Topics, Tuesday, January 03, 2017, New York, NY
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