Subscribe

  • How Can We Help You?

    Global Problem Solving from Covington: Deal with Complex Problems Anywhere in the World

Cunningham_Scott_1000x714_ENV

Scott Cunningham

Partner

San Francisco +1 415 591 7089

  • About
  • Representative Matters
  • Credentials
  • About

    Scott Cunningham is a member of the firm’s Food and Drug practice group.  He represents pharmaceutical, biotechnology, and medical device companies as well as trade associations in matters before the FDA, Congress, state and federal courts, and other regulatory and enforcement agencies.  Scott has significant experience in areas including new product development and clinical trials; IRBs; new product approvals; Hatch-Waxman exclusivities and product life-cycle management; advertising and promotion; False Claims Act and Anti-Kickback compliance issues and pharmaceutical investigations; Orphan Drug; pediatric exclusivity; manufacturing and cGMPs; import/export; controlled substances; SEC disclosure; and other aspects of federal and state regulation of pharmaceuticals, biologics, and medical devices.

    Scott also has an active pro bono practice where he regularly serves as a Guardian ad Litem representing children in neglect & abuse and child custody cases.

    Areas of Expertise

  • Practices and Industries
  • Representative Matters
    • Represented major pharmaceutical company working with the FDA to avoid market entry of unsafe or ineffective generic products.  This representation included developing and filing petitions with the agency and developing a potential litigation strategy.
    • Assisted early-stage medical device company in developing compliance policies for marketing and promotion, interactions with health care professionals, conflicts of interest, and providing scientific research and educational grants.
    • Represented manufacturer of a biological product in an effort to reverse a negative coverage decision by a major health insurance organization.

    Areas of Expertise

  • Credentials
    Education
    • University of Pennsylvania Law School, J.D., 2000
        • cum laude
    • University of Pennsylvania, B.A., 1994
    Bar Admissions
    • California
    • District of Columbia
    • New York
    Judicial Clerkship
    • Hon. R. Barclay Surrick, U.S. District Court, Eastern District of Pennsylvania, 2000 - 2001
    Languages
    • French
    Pro Bono
    • Represented boys aged nine and fourteen as Guardian ad Litem in child custody dispute between biological parents in Washington, D.C. Superior Court.
    • Defended Maryland citizen in criminal drug possession charges in Maryland criminal court.
    • Represented five year old girl as Guardian ad Litem in neglect and abuse proceedings in Washington, D.C. Superior Court.
    Accolades
    • Chambers USA - America's Leading Business Lawyers, Healthcare: Pharmaceutical/Medical Products Regulatory (2012)
    • Washington DC Super Lawyers, FDA (2013-2014)

    Areas of Expertise

News and Insights

Events