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Analysis of FDA Form 2253 Data Shows Dramatic Increase in #Pharma Internet Promotion, Especially to Consumers

Analysis of FDA Form 2253 Data Shows Dramatic Increase in #Pharma Internet Promotion, Especially to Consumers | Pharma Industry Regulation | Scoop.it

The volume of prescription drug promotion over time is often measured by assessing changes in ad spending. However, this method obscures the fact that some types of advertising are more expensive than others. Another way to measure the changes in prescription drug promotion over time is to assess the number of promotional pieces submitted to the U.S. Food and Drug Administration (FDA). Form FDA 2253 collects information such as the date submitted and the type of material submitted. We analyzed data from Forms FDA 2253 received from 2001–2014. We examined the frequency of submissions by audience (consumer and healthcare professional) and type of promotional material. There was a noted increase in prescription drug promotion submissions across all media in the early 2000s. Although non-Internet promotion submissions have since plateaued, Internet promotion continued to increase. These results can help public health advocates and regulators focus attention and resources.

 

Form FDA 2253 collects information such as the date submitted and the type of material submitted. FDA uses codes to classify the promotional materials submitted on Form FDA 2253 into categories (e.g., television ad). Some of these codes have changed over time. Notably, Internet promotion (including websites, web videos, web audio, sponsored links, social media, mobile applications, and emails) was not categorized separately for consumers and healthcare professionals until 2011.

 

We analyzed data from Forms FDA 2253 received from 2001–2014.

 

Some top-level results:

 

  • FDA received approximately three times as many non-Internet submissions directed toward healthcare professionals as submissions directed toward consumers from 2001–2014. This gap was smaller for Internet submissions, at approximately 1.5 times as many healthcare professional submissions for 2011–2014.

 

  • Submissions for non-Internet promotion directed toward consumers increased from 6,870 in 2001 to 15,993 in 2009, and then plateaued, with 15,186 in 2014.

 

  • Non-Internet promotion directed toward healthcare professionals shows a similar trend: submissions increased from 25,378 in 2001 to 47,071 in 2007, and then plateaued, with 39,983 in 2014.

 

  • In contrast, submissions for Internet promotion steadily increased from 2001–2014. In fact, from 2011–2014 (the years during which Internet promotion submissions were separated by audience) Internet promotion was the single largest category of FDA Form 2253 submissions for both consumer and healthcare professionals.

 

Further Reading:

“Internet/Social Media Direct-to-Consumer Drug Ads More Compliant with FDA Regulations Than Are Print & TV Ads”; http://sco.lt/5Ip9fN

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