FDA Urged To Further Loosen Limits On Healthcare Economic Data Exchange

FDA needs to further loosen restrictions on exchange of healthcare economic information between manufacturers and payers to encourage a move to value-based payment, stakeholders argue in comments on the agency's January 2016 draft payer communication guidance. Stakeholders also seek more clarity on how FDA will handle information exchange related to unapproved off-label uses of approved products, and multiple industry groups believe a wider range of stakeholders involved in hammering out value-based arrangements need access to HCEI. FDA released a draft...