Marc J. Scheineson

Practice Areas

Marc is an experienced former FDA associate commissioner and congressional insider experienced in strategically resolving regulatory and legislative issues for product manufacturers using the legal and policy levers available in Washington, D.C.

He advises companies on a wide range of issues, including product approvals, marketing, clinical studies, and enforcement. Previously, he served as the associate commissioner under then-FDA Commissioner David Kessler for legislative affairs of the Food and Drug Administration. He was involved there in many agency innovations, including prescription drug user fees, debarment, medical device amendments, and nutritional labeling. He was also counsel to the ranking member of the Health Subcommittee of the House of Representatives Committee on Ways and Means, and a senior vice president of Ketchum Communications. Marc 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 ACCME accreditation, and he advises on the FDA regulatory aspects of corporate acquisitions.

Education