Mr. Marc Scheineson

Council Member Biography

Marc Scheineson is a Partner with Alston & Bird 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 20 years in national law firms and at the 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, and patent term exclusivity. Previously, Mr. Scheineson served as FDA Associate Commissioner for Legislative Affairs to Health and Human Services Secretary Louis Sullivan and FDA Commissioner David Kessler where he spearheaded prescription drug user fees, debarment, medical device amendments, and nutritional labeling. Prior to that he was Counsel to Rep. Bill Gradison (R-OH), the ranking member of the Health Committee of the Committee on Ways and Means. Mr. Scheineson is Co-Chairman of the American Bar Association’s Committee on Food and Drug Law, and provides in-house training to the FDA of its drug reviewers and regulatory officials. (This is me - Update Profile)

Employment History

2004 - Unspecified

Partner & Chair, Food and Drug Practice, ALSTON & BIRD LLP

1996 - 2004

Partner & Chair, Food and Drug, REED SMITH LLP

1993 - 1996

Senior Vice President, KETCHUM COMMUNICATIONS HOLDINGS, INC.

1992 - 1993

Associate Commissioner for Legislative Affairs, FOOD & DRUG ADMINISTRATION