DTC Regs: Merck Study May Seal Fate Of "Dual Modality" Risk Presentation
A Merck study could tip the argument against FDA requiring that direct-to-consumer broadcast ads present the major statement of risk information in both audio and video format
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Merck study reverses the conclusion of the firm’s earlier research and finds that the simultaneous presentation of risk information in audio and text format boosts consumer recall.
PhRMA’s assistant general counsel says that FDA’s draft might increase expenses because of the need to submit final ads in advance and the potential to be asked for extensive revisions.
Agency says it will be flexible in assessing if risk information in consumer-focused ads are "clear, conspicuous and neutral," but proposed rule also seeks comment on whether such information should be presented simultaneously in audio and video format.