Duane Morris San Diego Office Adds Special Counsel Michael A. Swit, from PharmaLive.com

SAN DIEGO, April 24, 2012—Duane Morris is pleased to announce that Michael A. Swit has joined the firm’s Trial Practice Group as special counsel in its San Diego office. Swit’s arrival further bolsters Duane Morris’ life sciences practice, particularly in U.S. Food and Drug Administration (FDA) regulatory matters. Prior to joining Duane Morris, he served for seven years as vice president of The Weinberg Group, Inc.—a scientific and regulatory consulting firm.

Swit focuses his practice on counseling life sciences firms in complying with the FDA’s statutory and regulatory requirements to develop and market safe and effective drugs, biologics, medical devices, IVDs and other products. His work includes FDA development strategies, compliance and enforcement initiatives, recalls and crisis management, submissions, labeling and advertising, and clinical research efforts. He has also advised regulated firms on drug and device approvals, dietary supplement health claims and corporate acquisitions.

Swit brings more than a decade of in-house leadership experience at companies with substantial business interests in the activities of the FDA. While at The Weinberg Group, he developed and ensured execution of a broad array of regulatory and other services to clients. Earlier in his career, he served for more than three years as corporate vice president, general counsel and secretary of Par Pharmaceutical Inc., a prominent and publicly traded generic drug company. Swit then served for more than four years as CEO of FDAnews.com, a publisher of FDA regulatory newsletters and other specialty information products.

Swit has taught and written on numerous subjects relating to the FDA and related commercial activities. Since 1989, he has co-directed a three-day intensive course on the generic drug approval process, and edited a guide titled “Getting Your Generic Drug Approved.” A former member of the Food and Drug Law Journal editorial board, Swit also has spoken at numerous conferences sponsored by the Food and Drug Law Institute (FDLI), the Regulatory Affairs Professionals Society (RAPS) and the Drug Information Association (DIA).
for more of Swit's bio, http://pharmalive.com/News/index.cfm?articleid=836374&categoryid=22

DIA 2012 Collaborate to Innovate

48th Annual Meeting
June 24-28, 2012
Philadelphia, PA
Pennsylvania Convention Center

#21: FDA Enforcement: Understanding the Agency's Authority, How Violations Occur, How to Prevent Them, and How to Respond If Violations Do Occur

Instructor(s):Michael A. Swit, JD
Special Counsel
Duane Morris, LLP, United States

Day & Time:
June 24, 8:30AM - 12:00PM

This tutorial is designed for all personnel responsible for ensuring compliance with FDA requirements, particularly those under the GMP and GCP rules, regardless of whether in a supervisory or direct role.
This tutorial will review and discuss the legal, regulatory, and practical challenges of (1) FDA enforcement priorities for 2012 and beyond (e.g., application integrity policy and GMP/GCP requirements), (2) FDA administrative enforcement weapons and how the Agency uses them (e.g., inspections, warning letters, publicity, recalls, and investigator disqualification proceedings), and (3) the civil and criminal penalties for violations (e.g., seizure, injunction, criminal prosecution). Included in our focus will be FDA's renewed commitment to enforcement as articulated in an August 2009 speech by Commissioner Margaret Hamburg. We also will address how to handle an FDA enforcement action should you face one, particularly in the wake of an inspection or Warning Letter and the impact of the new initiatives related to responding to 483s and Warning Letters implemented in 2009 following Commissioner's Hamburg's pledge to boost enforcement. These interactive discussions will focus on how FDA operates and makes decisions and how to respond effectively, using tactics ranging from negotiation to, when appropriate, litigation.