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As part of the Affordable Care Act of 2010, the Sunshine Act was enacted. This law is designed to inject greater transparency for the public to understand the relationship between pharmaceutical and medical device companies and the physicians and teaching hospitals that are most likely prescribing their products. The Sunshine Act imposes a duty on “applicable manufacturers” of “covered” drugs and devices to both track and disclose not only payments made to physicians and teaching hospitals in the form of consulting fees, honoraria, etc., but also any other provision of an item or service that has a value to such recipients, including meals, trips, research equipment, etc. And, annually all such payments need to be submitted to a website maintained by the Center for Medicare and Medicaid Services (CMS) for public review. This tutorial will explore in detail the Sunshine Act’s requirements, including any potential exemptions, and also the unique way that the Sunshine Act deals with research-related payments, which overlaps in part with the separate provisions in 21 CFR Part 54 that FDA imposes for the disclosure of financial interests held by clinical investigators. The basics of the system and process for submitting the required disclosures to the CMS “Open Payments” database and suggestions on how to implement processes at their companies to ensure compliance with the Act’s requirements will be discussed.
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