Life Sciences and the Valley of Death

The ‘Valley of Death’ is a term coined for the period between U.S. Food and Drug Administration (FDA) approval and before payers (public and private) have either devised a payment methodology or made the decision to provide coverage for and price the product. Differences in standards between FDA approval and Medicare program coverage result from divergent statutory standards.
AEI’s Brian J. Miller will host a group of experts to discuss the differences between these standards, recent policy actions that undermine confidence in certain therapies and exacerbate the Valley of Death, and steps that regulators and lawmakers can take to close the gap without undermining each agency’s distinct mission.
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