21st Century Cures Act: Allowing the FDA To Address Modern Value Communication Needs

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How do you prove the real – and implicit – economic value of pharma products to payers and other stakeholders while FDA regulatory approvals adhere to a historically rigid stand of proof based on randomized tests against placebo in a controlled patient population? The 21st Century Cures Act may finally be extending a new path forward that offers legislative endorsement for use of a greater variety of evidence. What the FDA decides to do on this score is emerging as a key issue for biopharma in 2017.

Read the article for more insight into the provisions of the act and the value communication needs across various decision-makers and their influencers.

About the Expert

Ed Schoonveld is a Managing Principal at ZS and is the leader of the firm’s Value and Access solution area. In this role, he provides strategic consulting and research solutions to healthcare industry clients. He is considered to be one of the world’s leading experts on global pharmaceutical pricing and market access and has unparalleled experience as head of global market access and pricing functions at Wyeth, Lilly, and BMS, and as a consulting leader at Cambridge/IMS and a number of other organizations.