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P220: Trends in OPDP Consumer Enforcement from 1997 to the Present: The Effect of Marketing Spend

Poster Presenter

      Katie Graham

      • McKoy Consulting
        United States


The purpose of this poster presentation is to assess the correlation, if any, between consumer marketing spend on OPDP 2253 submissions and corresponding enforcement trends.


We examined warning letters and untitled letters issued by DDMAC and OPDP found dated from the year 2015 and 2021. We tabulated and compared the number of enforcement action based on number and type of audience, compared to number and audience type submitted on form 2253.


Since first being introduced in 1981, the number of consumer directed drug promotion has continued to increase. In 2015, 28% of the 2253 submissions were for the consumer audience, with 22% of the 9 enforcement actions being written regarding consumer materials. Pharmaceutical companies spent 6.58 billion dollars on direct-to-consumer advertising in 2020 with the majority of this spend on tactics in the digital space. In 2020, 34% of the 2253 submissions were for materials directed to the consumer, with 67% of the 6 enforcement actions being written based on marketing violations in consumer materials.


Based on the trajectory of increasing consumer spend and the complexity of the digital pieces, we expect an increased proportion of enforcement in the consumer space relative to the total number of consumer materials submitted on 2253 illustrating an increased attention and scrutiny of receiving an enforcement action when marketing in this space.