PhRMA Criticizes 'Exponential Pace' Of FDA Rx Drug Advertising Studies
US FDA responds to comments on proposed study of product disclosures and study of amount and location of risk information.
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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.
Office of Prescription Drug Promotion issued six enforcement letters and launched three research projects in 2021. There were more internal changes as the office switched to electronic submissions of promotional materials and went through year-end reorganization.
Multiple unfavorable court decisions have forced the agency to adjust its advertising enforcement strategies.