Kathleen M. Sanzo

Partner

Kathleen M. Sanzo is a partner in and leader of Morgan Lewis's FDA and Healthcare Practice. Ms. Sanzo's practice focuses on all regulatory and compliance matters of the Food and Drug Administration relating to bulk and finished prescription and OTC drug and biologic manufacture, approval, marketing, and distribution; pre-clinical and clinical testing; drug and device promotional and labeling issues; food additive and dietary supplement matters; state and federal privacy regulatory and compliance issues; healthcare regulatory and enforcement matters of the Office of Inspector General of the Department of Health and Human Services and the Centers for Medicare and Medicaid Services; and regulatory and compliance matters of the Consumer Product Safety Commission and related state enforcement agencies.

Ms. Sanzo is vice-chair of the Consumer Product Regulation Committee of the American Bar Association Section of Administrative Law and Regulatory Practice.

Following graduation from Duke University in 1979, Ms. Sanzo received her J.D. from Emory Law School in 1982, and her LL.M. from The George Washington University National Law Center in 1985, where she was selected as the Food and Drug Law Institute Fellow, and worked at the Office of General Counsel of the Food and Drug Administration.

Ms. Sanzo is the author or co-author of numerous speeches and publications, including the following: Washington Legal Foundation article, The Ever-Widening Legal Morass Around Off-Label Communication (Contemporary Legal Note Series Number 63), September 2009; Prescription Drug Promotion and Marketing, in FDLI’s Food and Drug Law Regulation 2008; New Risks, New Plan - Drug safety concerns show need for Sophisticated Risk Management, Legal Times, Volume XXX, No 25; Prescription Drug Promotions and Marketing, Food and Drug Law Institute, Food and Drug Law Regulation 2008; Keys to Successful Interactions with Governing Bodies, Food and Drug Law Settlements and Negotiations (Aspatore Books), 2006; How to Get Your New Drug Approved in How to Work with the FDA, Tips from the Experts, 2003.

Selected speeches include the following: Legal and Regulatory Considerations in Using Social Media, Twittering on Trends, November 2009; Regulatory and Other Considerations Concerning Drug Safety, Food and Drug Law Institute Annual Meeting, April 2009; Issues Concerning FDA Implementation of REMS Authority, January 2009; Negotiating and Living with Consent Decrees, Food and Drug Law Institute Enforcement and Litigation Conference, February 2008; Compliant Models for Medical Device Grants, May 2007; The AdvaMed Code of Ethics, April 2007; Crossing Paths with the FDA—Regulatory Influence on the Defense of Drug and Device Products, July 2006; Generic Drug Issues: Authorized Generics, March 2006.

Ms. Sanzo is admitted to practice in the District of Columbia.