Industry Missing A Public Health Opening With DTC Ads, FDA’s Hamburg Says
The messages conveyed through pharmaceutical direct-to-consumer advertising, and FDA’s role in regulating such promotions, are ripe for re-examination, Commissioner Margaret Hamburg said July 25.
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DTC Pre-Review Guidance In The Works For Rx TV Ads, FDA’s Abrams Says
Certain drug classes will be required to submit certain types of ads, according to Tom Abrams, director of CDER’s recently elevated Office of Prescription Drug Promotion, but specifics will await the guidance itself.
FDA Considers Allowing "Broad Disease Information" In DTC Ads
A planned study will examine the impact of including descriptions of the disease that go beyond a product's labeled claims.
Pressure For More DTC Ad Regulation Begins Again With PDUFA V
Industry should be prepared for the fight over user fees for direct-to-consumer advertising to be revived during the fifth round of reauthorization of the Prescription Drug User Fee Act