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Food and Drug Law Institute Sponsors Major Enforcement Conference
Date:12/20/2007

Top FDA and DOJ Officials, Legal Experts to Discuss Latest Criminal Cases, Decrees and How They Now Apply to Food and Dietary Supplement Industries

WASHINGTON, Dec. 20 /PRNewswire-USNewswire/ -- In the last year, mainstream drug and device companies have agreed to pay more than $1.9 billion in fines, civil settlements and penalties. Top drug company executives have paid multimillion dollar fines even though they did not participate in or know about the crimes.

With the Federal Government increasingly seeking legal action against pharmaceutical and device companies -- even those who didn't intend to do anything wrong -- there's a burgeoning need for food and drug industry stakeholder to stay current with federal enforcement developments.

To help meet those needs, the Food and Drug Law Institute is sponsoring its 6th Annual Conference on Enforcement & Litigation: Consent Decrees, Criminal Cases and Corporate Integrity Agreements, Feb. 19-20 at the L'Enfant Plaza Hotel in Washington, D.C.

At the conference, experts will discuss the latest enforcement actions and litigation and ways that voluntary implementation measures required by corporate integrity agreements and consent decrees can help food, drug and device firms stay clear of expensive and often demoralizing action.

Conferees will hear directly from Food and Drug Administration and Department of Justice officials, including luncheon speaker Gerald R. Masoudi, FDA's Chief Counsel and Eugene Thirolf, Director of DOJ's Office of Consumer Litigation. Other FDA officials include Deborah Autor, Director of Compliance, CDER; Joseph R. Baca, Director of Food Safety, CFSAN; Eric M. Blumberg, Deputy Chief Counsel for Litigation; Garry L. Coody, National Health Fraud Coordinator, Office of Enforcement, ORA; David K. Elder, Director, Office of Enforcement, Office of Regulatory Affairs; Annamarie Kempic, Associate Deputy for Litigation; Mary Anne Malarkey, Director, Office of Compliance & Biologics Quality, CBER; Vernessa T. Pollard, Associate Chief Counsel - Enforcement, OCC; Michael C. Rogers, Director, Office of Field Investigations, Office of Regulatory Affairs; Steven D. Silverman, Assistant Director, Officer of Compliance, CDER; Laura M. Tarentino, Office of Food Additive Safety, CFSAN; and Timothy A. Ulatowski, Director of Compliance, CDRH.

To register for the conference, visit http://www.fdli.org or call (800) 956-6923 or (202) 371-1420.

Founded in 1949, FDLI publishes the award-winning, peer-reviewed Food and Drug Law Journal; the bimonthly magazine Update; FDA Directory; and dozens of books and publications for attorneys, regulatory affairs practitioners, scientists, health care professionals, government employees and marketers in the food and drug field. For more information, visit http://www.fdli.org


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