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How FDAMA Section 114 Helps Pharma Inform Payers

Section 114 of the Food and Drug Administration Modernization Act of 1997 (FDAMA) was designed to allow pharmaceutical manufacturers to share health economic information with payers. This study shows how, by working in partnership with a pharmaceutical manufacturer, our scientists assessed COPD-related outcomes based on administrative claims data among combination therapy–naive patients—and enabled the client to engage payers on the benefits of its treatment.

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Precision Medicine Group is an integrated team of experts in fields from advanced lab sciences to translational informatics and regulatory affairs, payer insights to marketing communications. Together, we help our pharmaceutical and life-sciences clients conquer product development and commercialization challenges in a rapidly evolving environment.