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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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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