DAVID M. HOFFMEISTER

Partner
Corporate

EXPERIENCE:

David Hoffmeister is a partner at Wilson Sonsini Goodrich & Rosati, where he plays a major leadership role in the firm's drug and device regulatory and healthcare law practice. David was named as one of the "25 Leading Biotech Attorneys" in California in 2011 by the Daily Journal, and is recognized as one of the leading food and drug regulatory lawyers in the country.

David brings more than 25 years of experience in drug and device regulatory and healthcare law to the firm. He represents pharmaceutical, biotechnology, medical device, diagnostic, and dietary supplement clients, advising them on a variety of regulatory and healthcare issues, such as strategies for obtaining FDA product approvals and clearances, recalls, labeling, and claim support for advertising and promotional materials. He has also conducted numerous internal investigations for pharmaceutical and medical device companies involving fraud and abuse, advertising and promotional practices, and clinical research practices.

Before joining Wilson Sonsini Goodrich & Rosati, David was senior counsel for drug and device law at Syntex U.S.A., Inc., where his primary focus was advising senior management on worldwide issues affecting the ability of the corporation and its affiliates to develop, manufacture, and distribute pharmaceutical, device, diagnostic, and over-the-counter drugs in compliance with the Federal Food, Drug, and Cosmetics Act, as well as implementing regulations and applicable state and federal healthcare laws.

SELECT CLIENTS:
  • Align Technology, Inc.
  • Becton Dickenson (BD Rx)
  • Cutera
  • Heidelberg Engineering
  • InSound Medical
  • Instrumentation Laboratories
  • Insulet
  • Mylan
  • Varian Medical Systems
EDUCATION:
  • J.D., University of San Francisco School of Law, 1987
  • B.S., Business Administration, University of the Pacific, 1982
ASSOCIATIONS AND MEMBERSHIPS:
  • Member, Editorial Advisory Board, Thompson FDA Advertising and Promotion Manual
  • Member, Food and Drug Law Institute
HONORS:
  • Named among the Daily Journal's "25 Leading Biotech Attorneys" in California, 2011
  • Selected as a "Highly Recommended Life Sciences Regulatory Attorney in the United States and Silicon Valley," Global Counsel 3000 (2002-2005 editions)
  • AV Preeminent Peer Review Rating, Martindale-Hubbell
SELECT PUBLICATIONS:
SELECT SPEAKING ENGAGEMENTS:
  • Speaker, "Off-label Promotion – Minimizing the Risk," FX Conferences, October 16, 2015
  • "Gaining Control When a Badge Walks through the Door," Food and Drug Law Institute, Advanced Enforcement Conference, Washington, D.C., June 2001
  • "Marketing in the 21st Century, The Changing Legal and Regulatory Landscape," Keynote Speech, Medical Marketing Association National Conference, Scottsdale, June 2000
  • "The Need to Implement a Product Recall Policy," Food and Drug Law Institute Recall Conference, Irvine, California, March 1999
  • "The Food and Drug Administration Modernization Act of 1997, An Overview," Ernst & Young Life Sciences Conference, Tel Aviv, Israel, 1998
ADMISSIONS:
  • State Bar of California
  • Various federal courts, including the U.S. Supreme Court