Marc Shapiro

Law Office of Marc Shapiro
Washington, District of Columbia 20001

919-402-8969



Areas Of Practice

Business
Civil
Commercial
Food and Drug
Healthcare
Product Liability

 
 



PROFESSIONAL HISTORY:


January, 2010 – Present: Established and maintain private legal practice as an attorney specializing in food and drug law and related areas. Provide advice and counsel to life science companies developing and/or marketing drugs and devices, and other categories of products regulated by the Food and Drug Administration, the Federal Trade Commission, the Drug Enforcement Administration, and the Consumer Product Protection Agency.


March, 2001 – December, 2009:   Vice-President and Managing Director, Hyman, Phelps & McNamara, P.C.    Established and managed the Raleigh-Durham, North Carolina office of the Washington, D. C.-based firm, specializing in the practice of food and drug law and related practice areas.


August, 1984- March, 2001:  Associate General Counsel, Glaxo Wellcome Inc. Joined Glaxo Inc.  in 1984 and held a variety of increasingly senior legal and non-legal positions, including a Washington D. C.-based position in Glaxo’s Regulatory  Affairs Department as Director, Federal Agency Relations from 1989 to 1991


August, 1975- August, 1984:  Attorney, Kleinfeld, Kaplan and Becker.  Specialized in the practice of food and drug law and related practice areas.


SUMMARY
OF PROFESSIONAL RESPONSIBILITIES:

  • *Over 30 years of legal experience representing clients in private and in-house practice
  • *Certified North Carolina Superior Court Mediator
  • *Established the North Carolina office of Hyman, Phelps and McNamara, P.C.
  • *Head of the FDA Regulatory Section of the Glaxo Wellcome Legal department, a practice group providing advice and counsel on food and drug law, product safety, federal regulatory matters, product liability counseling and contracting with investigational sites, contract research organizations and site management organizations for clinical trials and related drug development activities
  • *Senior Lecturing Fellow, Duke University School of Law for the academic years 2000, 2001 and 2002; taught a three- hour credit course in Food and Drug Law
  • *Primary Counsel to Glaxo Wellcome Research and Development
  • *Member of Glaxo Wellcome Legal Management Committee
  • *Chairman of the FDA Regulatory Law Focus Group of the Pharmaceutical Research and Manufacturers Association (“PhRMA”) Law Section, May, 1999 to March, 2001.
  • *Member of Glaxo Wellcome Inc. Labeling Oversight Committee
  • *Member of Glaxo Wellcome Medical Review Group, an international committee of senior medical, regulatory and legal personnel responsible for  safety and medical issues  relating to the Company’s products worldwide
  • *Active participant in the PhRMA Law Section and member of several  PhRMA committees and task forces including the FDA Modernization Act Design Team, the Drug Law Focus Group, the Ad HocTask Force on Pediatric Issues, and the Task Force on the Safe Use of Pharmaceuticals
  • *Held a Washington D. C.-based position in Glaxo Regulatory Affairs Department from 1989 to 1991 as Director, Federal Agency Relations.  Among other responsibilities, coordinated all interactions with the FDA’s Division of Drug Marketing, Advertising and Communications on matters pertaining to drug advertising and promotion
  • *Past Member of the Food and Drug Law Institute’s Academic Program Committee
  • *Served as a member of the faculty of the Food and Drug Law Institute’s Basic Drug Law Workshop and frequent lecturer at FDLI, PhRMA  and other educational conferences


EDUCATION:


J. D., 1975, University of Virginia School of Law, Charlottesville, Virginia

B.A., 1972, University of North Carolina, Chapel Hill, North Carolina, Phi Beta Kappa


ADMITTED
TO PRACTICE:


District of Columbia,  North Carolina

Marc Shapiro is an attorney specializing in the practice of food and drug law and related areas.  With over 30 years of experience in private practice and as in-house counsel in a world-leading pharmaceutical company, as a past Chairman of the FDA Regulatory Law Focus Group of the Pharmaceutical Research and manufacturers Association (“PhRMA”) Law section, and as a former Senior Lecturing Fellow in food and drug law at Duke University School of Law, Mr. Shapiro is one of the country’s most knowledgeable and experienced practitioners of food and drug law.

 
He provides advice and counsel on a variety of FDA and related legal matters to life-science companies throughout the United States, including North Carolina, where he resides and practices.  As described in more detail in SERVICES, this includes advice and counsel on matters pertaining to prescription drugs and biologics, OTC drugs and cosmetics, foods and dietary supplements, tobacco, healthcare fraud and abuse laws, compliance and enforcement, corporate transactions, and child-resist packaging laws and regulations.
 

Mr. Shapiro is available to speak on, or offer training in, a variety of subjects and topics of interest in food and drug law related matters.

 

Mr. Shapiro is also a certified North Carolina Superior Court mediator and is available to provide mediation services to help resolve business and commercial disputes without having to resort to litigation or to conduct mediated settlement conferences in the state and Federal courts in North Carolina.

 

 

301 Lancaster Drive
Chapel Hill, NC 27517


(919) 402-8969