One of the most important provisions of the 21st Century Cures Act, signed by the president on Dec. 13, is the substantial change in the historic, restrictive position of the US Food and Drug Administration regarding what evidence can be provided by drug manufacturers to buyers and prescribers regarding the performance of drugs and biologics.
The new act, at Section 3037, authorizes for the first time the dissemination of health care economic information (HEI) for use by those selecting drugs and biologics for coverage and reimbursement. The broad authorization to use HEI is likely to be one of the most far-reaching practical changes for the biopharma industry resulting from the act, for both product manufacturers and for payors, and can be expected to significantly transform the selection process of drugs and biologics and the evidence developed to promote their use.
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