Scott Cunningham

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. Mr. Cunningham 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. Mr. Cunningham 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. 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. HONORS AND RANKINGS Chambers USA - America's Leading Business Lawyers, Healthcare: Pharmaceutical/Medical Products Regulatory (2012) Washington DC Super Lawyers, FDA (2013) 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. PUBLICATIONS AND SPEECHES "2012 End-of-Year Summary of FDA Promotional Enforcement Activity," Covington E-Alert (3/18/2013), Co-Author "Clinical Trial Developments in 2012," Covington E-Alert (2/1/2013), Co-Author "Second Circuit Recognizes Significant First Amendment Protections for Off-Label Promotion," Covington E-Alert (12/7/2012), Co-Author