Will FDA’s View On Health Economic Claims Change With More Government-Funded Research?
Health care economic information that is disseminated to formulary committees must be based on “competent and reliable scientific evidence.” Yet FDA has traditionally applied a more restrictive “substantial evidence” standard in its enforcement approach, said panelists at a recent conference, who questioned whether the growing government involvement in funding comparative effectiveness research would change this approach.
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US FDA should apply same regulatory protections to manufacturer communications with payers about unapproved uses that agency draft guidance provides to information exchanges about investigational products, biopharma companies say.
FDA’s Bob Temple dismisses the notion that drug companies, even with FDA’s regulation of product promotions, do not have the ability to challenge comparative effectiveness research findings they believe to be false or misleading. He says FDA is in no way trying to “deny them that right.”
Pharma companies’ comparative effectiveness research should be “in sync” with nationalized approach that the Patient-Centered Outcomes Research Institute will bring, Clyde Yancy, member of the new institute’s Methodology Committee, suggests.