Marc J. Scheineson, Former FDA Associate Commissioner, Joins Alston & Bird

FDA Experience Bolsters Firm’s Health Care and Life Sciences Practices

Marc J. Scheineson joins the law firm Alston & Bird as a partner practicing in the firm’s Washington, D.C. office. He is a former Associate Commissioner of the Food and Drug Administration (FDA) under the FDA Commissioner David Kessler. A recognized expert in regulatory and legislative matters, Mr. Scheineson is the co-chair of the American Bar Association’s Committee on Food, Drug and Cosmetic Law. Prior experience includes serving as head of Reed Smith’s food and drug practice and working for the Congress.

“We are very pleased that Marc Scheineson has joined Alston & Bird,” said Alston & Bird Managing Partner Ben F. Johnson III. “As Alston & Bird builds a full-scale health care policy/regulatory team, Marc’s FDA expertise combined with the breadth and depth of his experience in regulatory and legislative matters, will enhance the firm’s already strong national health care practice.”

The announcement comes on the heels of the firm’s appointment of such notables as former United States Senator Bob Dole; the former Bush administration official who headed the Centers for Medicare & Medicaid Services (CMS) Tom Scully; and former Senate Finance Committee lead staffer on the Medicare bill Colin Roskey.

Mr. Scheineson has been involved in some of the highest profile regulatory matters at the FDA including Canadian imports, fast tracking reviews, prolonging product exclusivity and streamlining the FDA regulatory process. Also, representing some of the United States’ largest pharmaceutical and medical device manufacturers, he has handled a broad spectrum of extremely sophisticated products in obtaining marketing clearance and approval from the FDA. Experience in other cutting-edge regulatory issues include the protection of human research subjects, clinical trial law, anti-kickback rules for promoting medical products to physicians, and the Health Insurance Portability & Accountability Act of 1996 (HIPAA) privacy regulation.

Mr. Scheineson joins Alston & Bird’s nationally recognized health care practice, comprised of 60 attorneys and one of the largest among U.S. law firms. Along with Tom Scully and Bob Dole members of the group are medically trained with degrees and backgrounds in medicine and surgery; nursing; microbiology/biology; medical technology; genetics/molecular biology; chemistry/biochemistry/chemical engineering and public health.

Frequently quoted as an expert on the FDA’s regulatory practices, Mr. Scheineson is a drug and device lawyer with more than 20 years of experience. At the FDA he was involved in many innovations including: prescription drug user fees, debarment, medical device amendments and nutritional labeling. He is a graduate of the University of Cincinnati College of Law, where he received his J.D., and Georgetown University Law Center where he received an LL.M.