FDA Seeks Feedback on Proposed Disclosure Studies, Color Additive Rules

The FDA is seeking comment on a proposal to study how advertising disclosure statements and drug promotion affect consumers.

The set of studies would address sponsors’ promotional claims on scopes of treatment and ease of use with test subjects, including consumer and healthcare professionals recruited from Internet panels. Little research exists on the effects of drug promotion disclosures, the agency said.

The FDA will evaluate subjects’ responses to mock advertisements representing three different medical conditions and gauge the subjects’ understanding of the different pieces.

The studies will also analyze whether the subjects read the mock disclosure statements, and for how long. The agency’s proposal is open to public comment for 60 days.