Drugmakers Request Revisions to Draft Guidance on Sharing Information with Payors
Drugmakers are urging the FDA to revise draft guidance on the intended audiences for industry communications.
PhRMA notes that the agency’s definition of entities that should receive health care economic information (HCEI) specifically exempts “health care providers who are making individual patient prescribing decisions.” However, providers often serve on formulary committees, so the guidance should clarify that they should be included.
Abbvie agreed, noting that the guidance should make clear that any individuals or entities involved in population health decisions would be an appropriate audience.
Allergan questioned the draft guidance’s recommendations on disclosure of HCEI to payors as well and suggested drugmakers should only provide payors with detailed disclosures on request.