Eye on FDA Data Analysis Shows Videos Are Cited Most for Risk Minimization, Overstatement of Efficacy

Nov. 7, 2012 – Analysis of the FDA’s Office of Prescription Drug Promotion’s regulatory action letters since 2005 shows that although risk minimization and overstatement of efficacy are the most frequently cited alleged violations across the full array of media (64 percent combined), that number goes up considerably – to 80 percent combined – when breaking out videos and DVDs (not including DTC broadcast) from other media, according to a Nov. 6 blog entry on Eye on FDA.

“One can see that as a communications vehicle, videos have their own issues when it comes to staying within regulatory communications confines,” Mark Senak writes. He notes in the blog that patient or physician testimonials and the placement of risk information are particular challenges that industry faces when making videos.

To view the full Eye on FDA blog entry, go to: http://www.eyeonfda.com/eye_on_fda/2012/11/viewing-videos-regulatory-profile.html