Kathleen M. Sanzo

Email: ksanzo@morganlewis.com

Washington, D.C.
1111 Pennsylvania Ave., NW
Washington, DC 20004-2541
Phone: 202.739.5209
Fax: 202.739.3001

education

George Washington University National Law Center, 1985, LL.M.

Emory University School of Law, 1982, J.D.

Duke University, 1979, A.B.

Publications

Date	Title	Publication
01/11/1201/11/12	FDA Gets (Un)Social View LawFlash	Life Sciences and Healthcare LawFlash
05/23/1105/23/11	FDA Requests Comments on the Development of a User Fee Program for Biosimilar and Interchangeable Biological Products View LawFlash	Life Sciences and Healthcare LawFlash
01/07/1101/07/11	FDA Food Safety Modernization Act Summary View Article	FDA and Healthcare LawFlash
12/23/1012/23/10	FDA Food Safety Modernization Act Greatly Expands FDA Enforcement Powers View LawFlash	FDA and Healthcare LawFlash
11/30/1011/30/10	Utilizing REMS to Mitigate the Safety Risks of Pharmaceuticals: Perspectives on FDA Guidance, Lifecycle Management and Creating a New Scientific Discipline, FDLI Monograph Series	Article
05/20/1005/20/10	Healthcare Reform—New Path for Biosimilars, presented at a Washington Legal Foundation Webcast View Presentation	Speech
05/19/1005/19/10	May 2010 Health Care Reform Update, presented at a BioNJ Legal Breakfast Briefing, Bridgewater, NJ View Presentation	Speech
04/26/1004/26/10	The Use of Social Media in Promotion of Medical Products, presented at PLI's Health Care 2010: Managing Risks in the New Compliance and Enforcement Environment Conference, New York View Presentation	Speech
04/19/1004/19/10	Legal Issues Arising from REMS Programs, presented at the ACI REMS Conference, New York View Presentation	Speech
04/15/1004/15/10	Healthcare Reform Law: A New Regulatory Pathway for Biosimilar Biological Products View LawFlash	Washington Government Relations and Public Policy LawFlash
04/15/1004/15/10	Healthcare Reform Law: Impact on Pharmaceutical Manufacturers View LawFlash	Washington Government Relations and Public Policy LawFlash
09/01/09September 2009	The Ever-Widening Legal Morass Around Off-Label Communication, Washington Legal Foundation's Contemporary Legal Note Series, No. 63 (click here to read the article)	Article
08/01/09August 2009	Regulatory Considerations and Evolving Issues Concerning REMS Programs View Presentation	Speech
06/18/0906/18/09	Life Sciences Summer Series: Drug and Device Off-Label Promotion (a Morgan Lewis Webinar) View Presentation	Webinar
03/25/0903/25/09	Regulatory and Litigation Strategies for Life Sciences Companies Post-Wyeth v. Levine, presented as a Morgan Lewis Webinar	Webinar
03/05/0903/05/09	U.S. Supreme Court Ruling in Wyeth v. Levine Rejects Preemption of Failure-to-Warn Claim View LawFlash	Litigation LawFlash
11/03/0811/03/08	The Consumer Product Safety Improvement Act of 2008: Deputizing State Attorneys General and Plaintiffs’ Lawyers View LawFlash	Litigation LawFlash
06/19/0806/19/08	Regulatory and Legal Developments Concerning Clinical Trials, presented at the 2008 BIO International Convention, San Diego, CA	Speech
02/19/0802/19/08	Negotiating and Living with Consent Decrees, presented at the 6th Annual Food and Drug Law Institute Enforcement and Litigation Conference, Washington, D.C.	Speech
01/29/0801/29/08	State Perspectives on Existing and Future Regulations Surrounding Sales and Marketing, presented at the 5th Annual Pharmaceutical Marketing Compliance Congress, Washington, D.C.	Speech
12/06/0712/06/07	Assessing and Reducing Risks Associated with Medical Information/Product Information Communications, presented at ACI's 6th Managing Legal Risks and Avoiding Conflicts of Interest in Medical Affairs Conference, Philadelphia	Speech
06/19/0706/19/07	Proactive Steps Every Provider Should Take to Avoid Government Scrutiny, presented at ACI's Preparing for Government Healthcare Fraud Enforcement Conference, Washington, D.C.	Speech
06/18/0706/18/07	New Risks, New Plan: Drug Safety Concerns Show Need for Sophisticated Risk Management, Legal Times, Vol. 30, No. 25 View Article	Article
05/17/0705/17/07	Compliant Models for Medical Device Grants, presented at CBI's Premier West Coast Conference on Bio/Pharmaceutical and Medical Device Grants, San Francisco	Speech
05/17/0705/17/07	Regulatory and Corporate Considerations in Life Sciences Industry Investments, presented at a Morgan Lewis Seminar, Palo Alto	Speech
04/17/0704/17/07	The AdvaMed Code of Ethics, presented at the AdvaMed MTLI Conference: The Regulation of Advertising, Promotion, and Sales of Medical Devices, Washington, D.C.	Speech
01/01/072007	Keys to Successful Interactions with Governing Bodies, Inside the Minds: Food and Drug Law Settlements and Negotiations View Article	Article
12/04/062006/07	Overview of Healthcare Fraud Investigations in the U.S., PLC Cross-border Life Sciences Handbook 2006/07 View Chapter	Chapter
07/18/0607/18/06	Crossing Paths with the FDA—Regulatory Influence on the Defense of Drug and Device Products, presented at the Defense Research Institute Teleconference	Speech
03/29/0603/29/06	Generic Drug Issues: Authorized Generics, presented at the Temple University School of Pharmacy FDA/Industry Conference	Speech
03/07/0603/07/06	The New Medicare Act and Its Effects on Life Sciences Companies, presented to the New Jersey Technology Council Life Sciences Industry Network	Speech
01/01/052005/06	Overview of Healthcare Fraud Investigations in the U.S., ^PLC Cross-border Life Sciences Handbook	Chapter
08/02/04July/August 2004	New Medicare Act Provides New Competitive Landscape for the Pharmaceutical Industry, FDLI Update, Vol. 36 View Article	Article
02/28/0302/28/03	FDA Must Clarify Drug Makers' Ability to Publicly Defend Products, Litigation Legal Foundation Legal Update, Vol. 13, No. 7 View Article	Article
11/04/0211/04/02	Navigating a Pathway to FDA Approval View Presentation	Speech
09/06/0209/06/02	FTC, Not FDA, Should Regulate Online Food Information, Legal Backgrounder, Vol. 17, No. 38	Article
08/01/0208/01/02	FDA Challenges to Pharmaceutical Company Control of Product Lifecycle Management, FDLI Update View Article	Article
08/01/02August 2002	Market Exclusivity: New Legal Developments and Pharmaceutical Marketing Implications, Regulatory Affairs Focus	Article
04/23/0204/23/02	HIPAA: What Medical Device Firms Should Be Doing Now View Presentation	Speech
04/01/0204/01/02	Be Wary of HP Lawsuits: Emerging Firms, presented to AvaMed, Washington, D.C. View Presentation	Speech
03/01/02March 2002	Pharmaceutical Pricing: System Changes And Global Effects, Metropolitan Corporate Counsel	Article
02/01/0202/01/02	Corporate Response to CPSC Challenge - Legal, Technical, and Public Relations Issues, presented at the ICPHSO 9th Annual Meeting of the ABA Product Safety Seminar, Washington, D.C. View Presentation	Speech
01/02/022003	Consumer Products Regulation (Chapter 13), Developments in Administrative Law and Regulatory Practice 2002-2003 (ABA Section on Administrative Law)	Chapter
08/01/01August 2001	U.S. Pharmaceutical Pricing: System Changes and Global Effects, Life Sciences Industry Report	Article
01/01/01January 2001	It's Worse Than You Think: US Regulatory Changes Require Pharmaceutical Company Attention, International Financial Law Review: Competition & Antitrust (Special IFLR Supplement)	Article
01/01/01January 2001	New Proposed Policy Regarding Imposition of Reporting Requirements on Products Sold Outside of the United States View White Paper	White Paper
12/01/0012/01/00	Regulatory Litigation in the Innovator Pharmaceutical Industry, presented at the FDLI's Conference on Hatch-Waxman: Past, Present and Future, Washington, D.C. View Presentation	Speech
11/01/00November 2000	California Trial Court Finds Ford Acted Fraudulently by Not Reporting Safety Information to Federal Agenices View White Paper	White Paper
09/04/0009/04/00	Expect Big Change in Drug Pricing System, The National Law Journal View Article	Article
06/01/00June 2000	Providing Off-Label Use Information: New Decision Sends Industry One-Half Step Back, Regulatory Affairs Focus	Article
02/01/0002/01/00	CPSC 15(b) Reporting Requirements: A Practical Guide to Knowing When and What to Report, presented to the American Bar Association, Orlando, FL	Speech
11/08/9911/08/99	Marketing Your Product as a Drug or Dietary Supplement: Legal Risks and Benefits: Outline Presentation, The German-American Chamber of Commerce, Inc. and The Association of the German Pharmaceutical Industry Conference on the Regulatory Framework for OTC Drugs and Dietary Supplements, Washington, D.C. View Presentation	Speech
06/29/9906/29/99	Medical Device Update, presented to the Food and Drug Law Institute, Washington, D.C.	Speech
12/07/9812/07/98	Strategies for Obtaining Market Exclusivity for Genetic Discoveries: Patent, FDA, and Contract Mechanisms, Decision Resources, Inc.	Article
01/01/98January 1998	FDA Takes Important Step Toward Liberalizing Its Direct-to-Consumer Broadcast Advertising Policy, Food, Drug, Cosmetic and Medical Device Law Digest, Vol. 15, No. 1	Article
11/01/97November 1997	New FDA Regulations Implementing the Dietary Supplement Health and Education Act of 1994, Legal Mind, Vol. 164, Japan	Article
05/22/9705/22/97	Voluntary Standards for Consumer Products - An Antitrust Checklist, presented to the American Bar Association, Section of Administrative Law and Regulatory Practice, Washington, D.C.	Speech
11/01/96November 1996	U.S. Product Liability and Preemption Under the Medical Device Amendments: The Business Implications of the Supreme Court's Medtronic Decision, Legal Mind, Vol. 152, Japan	Article
09/17/9609/17/96	Regrouping and Responding After a Failed New Drug Pre-Approval Inspection by the FDA, presented at the Conference for the Institute for International Research, Philadelphia	Speech
08/01/9608/01/96	Product Liability and Preemption Under the Medical Device Amendments: The Business Implications of Medtronic, Inc. v. Lohr View White Paper	White Paper
01/01/961996	Recalls of Consumer Products in U.S. Distribution, Product Safety (First Edition) (London)	Article
04/01/94April 1994	Legal Considerations in Agreements for Manufacturing and Distribution of Biotechnology Products, Legal Mind (Japan), Vol. 121	Article
03/01/9403/01/94	Reinvigorated Regulation of Consumer Product Safety Commission Expected with Confirmation of New Chair: ML&B White Paper View Morgan Lewis Title	White Paper
02/13/9402/13/94	The Relationship Between Product Tampering and Product Liability, presented at Closure Manufacturers Association Annual Meeting, Washington, D.C.	Speech
11/08/9311/08/93	Checklist of Legal Considerations in Agreements for Manufacturing and Distribution of Biotechnology Products, presented at the Biotechnology and Business Conference, Prague, Czech Republic	Speech
09/01/93September 1993	The Admissibility of 'Junk Science' Evidence: Regulatory Effects, Regulatory Affairs Professionals Society News View Article	Article
09/01/9209/01/92	New Federal Reporting Regulations for Consumer Products: ML&B White Paper View Morgan Lewis Title	White Paper
11/01/9111/01/91	Consumer Product Defects -- New Federal Reporting Obligations Concerning Product Liability Lawsuits and Injuries Caused By Consumer Products: ML&B White Paper View Morgan Lewis Title	White Paper
01/01/9101/01/91	New Federal Reporting Obligations Concerning Defects in Consumer Products: ML&B White Paper View Morgan Lewis Title	White Paper
06/01/90June 1990	U.S. Product Liability Considerations For Exposure To Pesticides From Food, Legal Mind (Japan), Vol. 76	Article

Date	Title	Description
May 28, 2010	Attorneys See Uncertainty in FDA's Implementation of Biosimilar Approvals, Life Sciences Law & Industry Report
Sep 24, 2009	Morgan Lewis Advises LEO Pharma on $1 Billion Acquisition	Morgan Lewis represented LEO Pharma in the $1 billion acquisition of exclusive product licensing rights and inventories from LEO Pharma by Warner Chilcott plc.
Dec 20, 2006	Morgan Lewis's Life Sciences Practice Recognized in ^PLCCross-border Life Sciences Handbook	Morgan Lewis is pleased to announce that the Life Sciences Interdisciplinary Practice and several of its attorneys are recognized in the ^PLCCross-border Life Sciences Handbook 2006/07.
Dec 13, 2005	Morgan Lewis’ Life Sciences Practice Recommended in ^PLC Cross-border Life Sciences Handbook	Morgan Lewis is pleased to announce that Practical Law Company recommends the firm’s Life Sciences Practice and its attorneys in the ^PLCCross-border Life Sciences Handbook 2005/06.

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Kathleen M. Sanzo

education

Publications

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