PhRMA Seeks US FDA Rationale For Rx Drug Advertising Studies
Trade association says research projects are often unnecessary, questions studies of low-internet users and how disclosures about a product affect viewer perceptions.
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PhRMA argued the study is duplicative of previous project and lacks practical utility. Agency says it is replicating the prior study in a new patient population and testing additional versions of accelerated approval disclosure. Agency makes minor revisions to the study questionnaire.
US FDA responds to comments on proposed study of product disclosures and study of amount and location of risk information.
Upcoming research projects will look at presentation of FDA approval status, timing of disease awareness ads, and healthcare professional views.