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.