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Peter O. Safir

Senior Counsel

Washington +1 202 662 5162

  • About
  • Representative Matters
  • Credentials
  • About

    Peter 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, Peter has worked primarily with the research-based pharmaceutical industry concentrating on marketing practices, life cycle management, and issues involving drug quality and manufacturing.

    Peter 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.

    Peter 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.  Peter is a graduate of Princeton University and the Yale Law School.

    Areas of Expertise

  • Practices and Industries
  • 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.

    Areas of Expertise

  • Credentials
    Education
    • Yale Law School, J.D., 1972
    • Princeton University, A.B., 1967
    Bar Admissions
    • District of Columbia
    Accolades
    • The Food and Drug Law Institute, Distinguished Service and Leadership Award (2014)
    • 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 (2006-2023) and Life Sciences: Regulatory/Compliance (2014-2023).
    • Chambers Global, Life Sciences: Regulatory/Compliance (2020-2023)
    • 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 (2007-2022).
    • The Best Lawyers in America, Washington FDA Lawyer of the Year (2012)  
    • Legal 500 US, "Leading Lawyer" - Healthcare: Life Sciences (2014, 2019)
    • Legal 500 US, Healthcare: Life Sciences (2013-2017)
    • Washington DC Super Lawyers, FDA (2012-2023) 
    • LMG Life Sciences, "Life Science Star" (2013)
    • Washingtonian, Best Lawyers (2011, 2013)
    • 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)

    Areas of Expertise

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