Peter O Safir

Peter Safir is a partner and co-chairman of the Food and Drug practice group. Mr. Safir has been practicing in the food and drug field for over 25 years and is widely recognized in the pharmaceutical industry as one of the leading food and drug regulatory lawyers in the country. In recent years, Mr. Safir has worked primarily with the research-based pharmaceutical industry concentrating on marketing practices, life cycle management, and issues involving drug quality and manufacturing. Mr. Safir has conducted numerous internal investigations for pharmaceutical and medical device companies involving fraud and abuse, advertising, and promotional practices. He has defended enforcement actions in the marketing and manufacturing areas representing both companies and corporate executives targeted by the FDA. Mr. Safir has published and spoken widely in the area of drug regulation and has been a Professorial Lecturer in Food and Drug Law at George Washington University Law School since 1991. Mr. Safir is a graduate of Princeton University and the Yale Law School. REPRESENTATIVE MATTERS Represented PhRMA in the drafting of the PhRMA Code on the relationship between PhRMA members and healthcare professionals. Represented Johnson & Johnson in obtaining pediatric exclusivity for Duragesic and successfully defended FDA grant in the District Court and Court of Appeals. Represented Pfizer in obtaining pediatric exclusivity for Diflucan and successfully defended the grant in District Court. Counsel to the Independent Panel of Guidant Corporation investigating implantable defibrillators. Counsel to numerous research based companies on FDA regulatory strategies. HONORS AND RANKINGS The International Who's Who of Life Sciences Lawyers (2012) PLC Life Sciences, Which Lawyer? for Regulatory (2005-2012) Recognized in the Legal Times "Leading Lawyers" series as being a top food & drug attorney in Washington DC (2005-2006). Named in Best Lawyers In America for his work in FDA law (2007-2012). The Best Lawyers in America, Washington FDA Lawyer of the Year (2012) Chosen by Chambers & Partners to appear in their Chambers USA Guide as a leading Washington, DC attorney in the field of Healthcare: Pharmaceutical/Medical Products Regulatory (2006-2012). Washington DC Super Lawyers, FDA (2012-2013) Washingtonian, Best Lawyers (2011) Named in Euromoney's Expert Guides to the World's Leading Lawyers as being a leading attorney in the healthcare field (2006). MEMBERSHIPS AND AFFILIATIONS Princeton University Class of 1967, Class Secretary (1992-2002) Princeton University Class of 1967, Vice President Corcoran Gallery of Art, Trustee (1992-1994) Corcoran College of Art and Design, Board of Overseers (1996-2002)