Peter O. Safir

Peter O. Safir is a food and drug partner in the firm Covington & Burling. Mr. Safir has been practicing in the food and drug field for nearly 30 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, although he has also advised clients on food additive and medical device issues. Mr. Safir recently advised PhRMA in drafting the new PhRMA Code and has advised many companies on complying with the Code as well as with Federal and State Anti-Kickback statutes. He has conducted numerous internal investigations involving fraud and abuse, advertising and promotional practices and drug and device GMP compliance issues and has defended enforcement actions in the marketing and GMP 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. He has also appeared as an expert witness in cases involving Hatch Waxman issues both before the Federal Trade Commission and in private litigation.