The New-Look FDA: What's on the Horizon? – FDA Watch
In this episode, Shelly and Wayne chat with Marc J. Scheineson, a former FDA Associate Commissioner and currently Senior Counsel in the Washington, D.C., office of Alston & Bird; and Steven A. Grossman, President of HPS Group, a policy and regulatory consulting firm, and author of “FDA Matters: The Grossman FDA report.”
You’ll hear their thoughts on what to expect from FDA under the new administration, including the transition process, Robert F. Kennedy Jr.’s role, staffing issues, funding, possible changes in standards for safety and efficacy, the fate of user fees, and more.
This episode and all future bonus episodes do not include the usual Headlines and Resources Links segments.
About Our Guests
Marc J. Scheineson
Marc J. Scheineson is a Partner in the Washington, D.C., office of Alston & Bird. 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 FDA. His practice focuses on determining the “regulatory course of least resistance” to market medical products, and assisting clients with legal and regulatory issues, drug and medical device applications, marketing, compliance, and enforcement matters.
Scheineson provides legal, regulatory, and legislative counsel to a variety of marketers, research institutions, professional associations, and manufacturers of pharmaceutical and biological drug products, medical devices, cosmetics, dietary supplements, and traditional foods.
He is also experienced with the application of the Office of Inspector General (OIG) anti-kickback statute, HIPAA privacy rules, clinical trial 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. He previously served as Associate Commissioner for Legislative Affairs at the FDA.
Marc is also an Adjunct Law Professor at the University of Cincinnati College of Law. He came to Washington, D.C., to work as Legislative Assistant and Counsel to Rep. Bill Gradison (R-OH), the ranking member of the Health Committee of the Committee on Ways and Means. In addition, he has worked as Senior Vice President of Ketchum Communications and as a Principal in its government relations unit. Scheineson is a former Co-Chairman of the American Bar Association’s Committee on Food and Drug Law, chaired the Task Force on FDA Reform, and is a former Chairman of the Young Lawyers Section of the Bar Association of the District of Columbia.
Steven A. Grossman
Steven A. Grossman, J.D., is President of HPS Group and author of “FDA Matters: The Grossman FDA report.”
Grossman co-founded and later served as Executive Director of the Alliance for a Stronger FDA. Earlier in his career, he was Health Staff Director on the Senate HELP Committee and a Deputy Assistant Secretary for Health at HHS.
In recognition of his advocacy and policy leadership, he was recently honored by the Reagan-Udall Foundation.
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