At the request of the pharmaceutical industry, FDA is modifying the questions subjects will be asked in a study to assess the impact of limiting the risk information presented in direct-to-consumer television ads to risks that are “serious and actionable.”
DTC Ad Risk Disclosures Could Be Limited To ‘Serious And Actionable’
Despite PhRMA’s concerns, FDA is proceeding with a study using modified versions of existing TV ads, but agency will revise study questions to focus on value of the ‘major statement’ and not other aspects of ads.