Mark Mansour

Mark Mansour takes a holistic, business-oriented approach to finding solutions to the important issues that our clients are facing. Mark is renowned for his responsiveness, innovative approach, and practical business advice, and works closely with attorneys and business units to ensure that all objectives are clearly identified and met. Mark is a member of Butzel’s Intellectual Property and US Food & Drug Administration Regulation Practice Departments and has practiced food and drug law for more than two decades. He is additionally a member of Butzel’s Governmental Practice Department and Government Relations and Regulatory Specialty Team and has practiced in the areas of government relations and public policy for three decades. Mark is a Shareholder located in the firm’s Washington, D.C. office.

US Food and Drug Administration

Mark Mansour possesses long experience working with clients to resolve advertising issues involving the National Advertising Division (NAD) and the Federal Trade Commission (FTC). He has experience addressing social media regulation and has revised numerous corporate websites to ensure compliance with FTC requirements. He also assists clients and colleagues with FDA issues involving litigation and due diligence for corporate mergers and acquisitions and internal civil and criminal investigations. Mark has significant in-house experience as counsel with two major multinational companies. He is highly experienced in securing Food and Drug Administration (FDA) approvals for medical devices, managing medical device safety issues, managing recalls, market access issues, food and nutrition issues, dietary supplement regulation, agribusiness, and the regulation of cannabis products at the state and federal level.

Medical Devices

• Managing recalls and corporate crises
• Developing pathways for device approvals
• Applications for 510k and de novo approvals
• Compliance and enforcement advice
• Marketing advice
• Negotiating with FDA, including managing pre-submission meetings and follow-up

Food and Dietary Supplements

• Applications for health claims
• New dietary ingredient approvals
• Marketing, advertising and social media advice
• Negotiating enforcement actions with federal and state authorities
• Labeling advice

FTC regulation

• Assistance with National Advertising Division (NAD) complaints and negotiating resolutions
• Working with FTC on consent decrees, negotiating resolutions and follow-up work with clients to revise websites and social media strategies
• Working with state consumer protection authorities to resolve consumer complaints lodged against clients

Public Policy

• Comments regarding proposed legislation and rulemaking
• Citizen petitions
• Working with FDA to advance the business objectives of clients by making suggestions for future rulemaking

Government Relations and Public Policy

Mark Mansour possesses decades of public policy and government relations experience, honed during his time spent as a legislative staffer in the US House and Senate. Mark collaborates with colleagues on our highly experienced Government Relations and Regulatory Specialty Team to help Butzel’s business clients navigate Washington, all while getting to know what’s most important to how our clients do business. By pairing his knowledge and understanding of Congress, the executive branch—including the White House—and a wide variety of federal agencies with his deep academic background in international affairs and his multilingual education, Mark assists the firm’s international clients to navigate Washington. He has a demonstrated understanding of the cultural and political constraints inherent to international clients.

Over the course of his lengthy experience navigating a multitude of government relations and public policy issues, Mark Mansour has developed the level of skill and diplomacy required to step in when difficult issues arise for our clients. Mark’s strategic advice has helped clients to achieve their objectives with Congress and the executive branch. He has the capacity to grasp the policy context of clients’ goals and anticipates issues and identifies legislative and regulatory initiatives that affect our clients’ interests. Mark is experienced in the development and execution of strategies and understands the levers of social media. His abilities include advocacy before governments, political intelligence gathering, public policy research and analysis, and legislative drafting.

• Successfully secured Congressional intercession with FDA that led to a client’s application receiving approval after several years of delay
• Represented several companies in securing provisions in several farm bills
• Represented several companies in securing provisions in several authorizations of the Prescription Drugs User Fee Act
• Represented several companies in securing provisions in several authorizations of the Medical Devices User Fee Act
• Representates a foreign government involved in a dispute with FDA; successfully interceded with Congress to help secure a positive result
• Represented numerous companies in successfully securing assistance in disputes with government agencies, including FDA, FTC and the Department of Energy
• Represented medical device, pharmaceutical and food companies before the White House Office of Science and Technology, FDA, National Institutes of Health and both houses of Congress
• Represented food manufacturers before the governments of the United Kingdom, the European Commission and member states and international standard setting bodies; successfully secured favorable standards and regulations and assisted in defeating adverse regulations
  
  

All Related Practice Areas

Education

Georgetown University, JD

Harvard University, MA

Georgetown University, BS, cum laude, Phi Beta Kappa

Admissions

Memberships

• Food and Drug Law Institute
• American Bar Association Section of Administrative Law & Regulatory Practice
• District of Columbia Bar Regulatory Section

Languages

Awards & Recognitions

Super Lawyers, Washington, D.C.

LMG Life Sciences Americas Star Award

Momenta Pharmaceuticals, Inc. v. Amphastar Pharmaceuticals, Inc., United States District Court, Dist Massachusetts, 834 F. Supp. 2d 29 (D. Mass 2011)