Overview
The past several years have seen a distinct upward trend in enforcement actions against some Patient Assistance Programs (PAPs). PAPs assist patients with healthcare costs through various means, including pharmaceutical manufacturer-established foundations, independent charities, and direct pharmaceutical company assistance. Although properly structured PAPs are vital for helping patients in need, some PAPs have recently come under scrutiny for alleged violation of the federal Anti-Kickback statute. The webinar will cover the various forms of PAPs, recent enforcement actions, best practices from both the manufacturer and charity perspectives, advertising and promotion implications, adverse event reporting, and anticipated future developments.
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ALAN BALCH is Chief Executive Officer at Patient Advocate Foundation. Dr. Balch has over fifteen years of executive leadership in the non-profit sector with an emphasis on consensus-building and collaboration. He has led numerous federal advocacy efforts on a range of issues both at the legislative and regulatory level. He became the CEO of both PAF and NPAF in 2013. From 2006-2013, he served as Vice President of the Preventive Health Partnership — a national health promotion collaboration between the American Cancer Society, American Diabetes Association, and American Heart Association. Prior to his work with the Preventive Health Partnership, Dr. Balch was the Executive Director of Friends of Cancer Research.
MARK GAYDOS is Vice President and Head of both Region North America General Medicines & Established Products and US Advertising & Promotion within Sanofi’s Global Regulatory Affairs organization. In this role, Mark is accountable for regulatory leadership and strategy for marketed products, including lifecycle management, and development projects. He also oversees regulatory review of promotional activities across US business united to ensure compliance.
ALAN KIRSCHENBAUM is a Director of Hyman, Phelps & McNamara, P.C. in Washington, D.C. For more than 25 years, he has advised pharmaceutical and medical device companies on the marketing and promotion of their products. He specializes in the intersection of laws that govern these activities, including health care fraud and abuse laws, FDA restrictions on promotion, government pricing and price reporting requirements, and state laws affecting drug and device marketing. He has authored numerous articles and given frequent lectures on legal issues relating to pharmaceutical and device promotion, marketing, and pricing. Mr. Kirschenbaum is a member of the American Health Lawyers Association. He is a graduate of the University of Pennsylvania and Harvard Law School.Speakers
Alan Balch, CEO, Patient Advocate Foundation
Mark Gaydos, VP, NA Gen Med & US Advertising & Promotion, Global Regulatory Affairs, Sanofi
Erica Jackson, Partner, K&L Gates
Moderated by Alan Kirschenbaum, Director, Hyman, Phelps & McNamara, PC
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