Monday, July 15, 2013

Bio on Jeffrey K. Francer Assistant General Counsel PHRMA Who will Testify Before the House At the Reforming the Drug Compounding Regulatory Framework

Jeffrey K. Francer
Assistant General Counsel
PHRMA
Jeff Francer is Assistant General Counsel of the Pharmaceutical Research and Manufacturers of America (PhRMA), where he provides advice and advocacy on FDA regulatory and policy matters.  Mr. Francer counsels the association and member companies on a wide range of issues relating to the regulation of drugs and biological products, including: drug approval and postmarketing requirements, product labeling and promotion, direct-to-consumer advertising, clinical trials, and current Good Manufacturing Practice (cGMP).  Mr. Francer also advises and participates in the committees that draft PhRMA’sCode on Interactions with Healthcare Professionals (the PhRMA Code), its Principles on Conduct of Clinical Trials and Communication of Clinical Trial Results, and its Guiding Principles on DTC Advertising.  In addition, Mr. Francer represents PhRMA in discussions of the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) relating to its Marketing Code and Joint Positions on clinical trial transparency.

Mr. Francer served as Associate Chief Counsel of the Food and Drug Administration from 2003-2005 where he advised agency leaders on a wide range of issues involving the regulation of drugs and biologics including clinical investigation and emergency use of medical products, enforcement matters, and legislative matters.

Immediately prior to joining PhRMA, Mr. Francer served as Associate General Counsel, U.S. Compliance Officer, and Acting International Compliance Officer of Biogen Idec, Inc.  At Biogen Idec, Mr. Francer was the primary in-house counsel on FDA issues, fraud and abuse, and patient privacy.  Mr. Francer was also responsible for overseeing the U.S. and international corporate compliance program.

            Mr. Francer received his A.B. in Public Policy and Economics from Brown University, his M.P.P. from Harvard University, and his J.D. from the University of Virginia.

quoted from here

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