DTC Trouble: ‘Attention-Grabbing Visuals’ Undermine Risk Info, FDA Tells Celgene, Sanofi
US agency is taking a stand against TV ads that present a drug’s serious risks as people are dancing to music or engaging in other compelling activities.
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Total ban on background music is unnecessary, agency says in denying KEI’s petition. FDA points to new ‘major statement’ rule and its previous letters objecting to a sponsor’s use of music in ads and says it will continue case by case analysis of ‘all of the elements’ in an ad.
KEI argues a wholesale ban on music during the presentation of risk information in drug ads would be a more clear-cut way for FDA to enforce its existing goals. Others say the ban goes much further than past FDA policy and enforcement.
Clearer US guidance on DTC TV advertising and stronger enforcement would help reduce misleading claims and encourage drug makers to include more qualitative benefit/risk information in ads, according to a new study from Yale University researchers published in the Journal of General Internal Medicine.