DTC Ads: Citizen Petition Pushes For Narrow But Strict Music Ban
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.
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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.
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.
FDA indicates it expects sponsors and other government agencies to come up with ways to fulfill its request for placebo-controlled studies post-emergency use authorization of COVID-19 vaccines, but neither it nor vaccines advisory committee see a clear way to do this.