Marc Scheineson is a partner in the Washington, D.C. office where he heads the firm's Food and Drug Law Practice. He has practiced food and drug law, health care law and administrative law for over 25 years in national law firms and at the Food and Drug Administration (FDA). His practice focuses on determining the “regulatory course of least resistance” to market medical products, and assisting clients with legal research issues, drug and device application, compliance and enforcement matters. Mr. Scheineson provides legal, regulatory and legislative counsel to a variety of product manufacturers, marketers, research institutions and professional associations of pharmaceutical and biologic drug products, medical devices, dietary supplements, cosmetics and traditional foods. He is also experienced with the application of the OIG anti-kickback statute, HIPAA privacy rules, patent term exclusivity, institutional review board regulation, human research protection, scientific misconduct, technology transfer and licensing, advertising and promotion law and advises on the FDA regulatory aspects of health care transactions.

Prior to joining Alston & Bird, Mr. Scheineson served as the FDA Associate Commissioner for Legislative Affairs to Health and Human Services Secretary, Louis Sullivan and FDA Commissioner, David Kessler. There, he was involved in many agency innovations including, prescription drug user fees, debarment, medical device amendments and nutritional labeling. He came to Washington, D.C. in 1980 to serve as legislative assistant and counsel to Rep. Bill Gradison (R-OH), the ranking member of the Health Subcommittee of the Committee on Ways and Means. In addition, he worked as a senior vice president of Ketchum Communications serving the public affairs needs of medical industry clients. Mr. Scheineson is a former chair of the American Bar Association’s Committee on Food and Drug Law, where he chaired it’s Task Force on FDA Reform, and is a former chair of the Young Lawyers section of the Bar Association of the District of Columbia. He is the author of dozens of articles on FDA regulation and legislation, the chair of the Editorial Board of Update Magazine, published by the Food and Drug Law Institute, a member of the Editorial Advisory Board of FDANews Washington Drug Letter, a frequent speaker at educational forums and provides in-house training to the FDA for its drug and device reviewers and regulatory officials.

Marc Scheineson received a L.L.M. degree from the Georgetown University Law Center, and his B.A. and J.D. degrees from the University of Cincinnati and its College of Law. He is a member of the board of the Law School Alumni Association and the university’s foundation. Marc also serves on the board of the Washington section of the Anti-Defamation League and the Washington chapter of the American-Israeli Public Affairs Committee.