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: "Prescription, Drug Promotions and Marketing," in FDLI's  Food and Drug Law Regulation 2011, 2nd edition; the FDLI Monograph Series article "Utilizing REMS to Mitigate the Safety Risks of Pharmaceuticals: Perspectives on FDA Guidance, Lifecycle Management and Creating a New Scientific Discipline," November 2010; Washington Legal Foundation article, "The Ever-Widening Legal Morass Around Off-Label Communication," (Contemporary Legal Note Series Number 63), September 2009; "New Risks, New Plan – Drug safety concerns show need for sophisticated risk management," Legal Times, Volume XXX, No 25; "Keys to Successful Interactions with Governing Bodies, Food and Drug Law Settlements and Negotiations," (Aspatore Books), 2006.

Selected speeches include: "FDA Watch" at the NCCN Academy for Excellence & Leadership in Oncology School of Pharmaceutical & Biotech Business in March 2011; "Regulatory and Legal Considerations on the Use of New Social Media – Twittering on Legal Trends" presented at the AdvaMed's Advertising and Promotion of Medical Devices in an Age of DTC and Social Media marketing Program in March 2011; "Healthcare Reform – New Path for Biosimilars," May 2010; "The Use of Social Media in Promotion of Medical Products," presented at PLI's Health Care  Conference, April 2010; "Legal Issues Arising from REMS Programs," presented at the ACI REMS Conference in New York, 2010.

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