The FDA’s new guidance on payer communications: Implications for real-world data and value-based contracts

Date: July 17, 2018
Journal: Health Affairs Blog
Citation: Neumann PJ, Weissman H. "The FDA’s New Guidance On Payer Communications: Implications For Real-World Data And Value-Based Contracts," Health Affairs Blog, July 17, 2018.

On June 13, the Food and Drug Administration (FDA) released its long-awaited final guidance on how drug and medical device companies may communicate information to payers and formulary committees. While FDA commissioner Scott Gottlieb lauded the guidance as part of the Trump administration’s efforts to reduce regulation, encourage competition, and promote value-based purchasing, its release, along with the simultaneous issuance of guidance on communications consistent with FDA-required labeling, is better interpreted as part of the FDA’s longer standing evolution toward allowing more flexibility for drug company-payer communications. The FDA’s January 2017 draft guidance on the topic—issued before the Trump administration assumed office—had already signaled a more accommodating FDA, although the new guidance suggests additional flexibility.

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