FDA Widens Scope Of Guidance On Communication To Payers

FDA finalized Tuesday (Jun 12) two guidances clarifying FDA’s rules for communicating health care economic information with payers and for promoting information that is consistent with, but absent from, a product’s label. The agency answered calls from industry to broaden the scope of the HCEI guidance, and one stakeholder noted that the consistent-with-labeling guidance “establishes brighter lines than the draft.” HHS Secretary Alex Azar and FDA Commissioner Scott Gottlieb say these guidances will help achieve the administration’s plan of encouraging...