FDA Week - 09/13/2019

Gottlieb: As FDA Advances RWE Use, Groups Other Than ICER Needed

By David Roza / September 11, 2019 at 1:59 PM
Former FDA Commissioner Scott Gottlieb said that as FDA stands up a framework for using real-world evidence (RWE) to make postmarket decisions, the health care system will need to have several impartial entities compete in the market to conduct independent, impartial assessments of new therapies. The Institute for Clinical and Economic Review (ICER), which produces reports for insurance companies on how much it thinks new drugs should cost, will not be able to handle the new RWE framework, Gottlieb said...

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