dictates whether it accomplishes the air balance requirement.
FDA saw the need orguidance specifcally addressing the presentation o risk inormation because the omis-sion or minimization o risk inormation continues to be “the most requent violation o theregulations”
cited in enorcement actions.In those actions, FDA has repeatedly invoked the principle that risk inormation mustbe presented “with a prominence and readability reasonably comparable” to the presenta-tion o the beneft inormation.
Following are the some specifc ailings FDA has identifedin patient testimonial videos and other video ormats.
Risk Inormation on a Webpage Does not Sufce
In an enorcement action against Wyeth in August 2010, FDA noted that the patient tes-timonial videos on the brand website minimized risk inormation by “ailing to convey any risks associated with Premarin during these audio-visual presentations” and instead rel-egating the risk inormation “to the bottom portion o the webpage below the testimonialsin read-only text ormat.”
Risk Inormation Must Be Included in the Video Itsel
The above enorcement action and several others or video testimonials and other videopromotions, including ones or Genentech’s Herceptin and Slate’s Testopel in 2010, notedthe need to include risk inormation “during the efcacy presentation o the video.”
Minimal Risk Inormation in the Video Does not Sufce
While not ully explaining how much risk inormation must be presented with the efcacy claims during the body o the video, FDA has made clear that just including some doesnot sufce or compliance. The Herceptin letter noted that the body o the video includedonly two statements related to risk: “I had mild atigue,” and “I had some serious issueswith atigue, and with muscle and joint pain.” In the context o a 5½ minute “engaging andlively multi-media presentation” the agency said inclusion o this risk inormation was not“reasonably comparable” to the beneft inormation.
Style and Quantity o Risk Presentation Must be Comparable
The Herceptin letter pointed out the “engaging and lively multi-media presentation” o thebeneft inormation.
Similarly, a letter to Abbott or Kaletra mentioned the “engaging andlively discussion” o the benefts presentation.
In both cases, it was not merely the quan-tity o the risk inormation that was deemed insufcient but also the contrast between theway the risk inormation was presented with the “engaging and lively” presentation o thebeneft inormation.
Risk Inormation in End Matter Does not Sufce
In the letters or Testopel, Kaletra and one sent to Johnson & Johnson or Ultram ER, FDAindicated that presenting the scrolling Important Saety Inormation at the conclusion o the video presentation minimized the risk inormation.
The central principle repeated requently by FDA is that risk inormation must be pre-sented in a manner “reasonably comparable” to that o the beneft inormation. While notstipulating identical presentations, this guidance provides certain constraints:
Product beneft inormation in the body o the video requires risk inormation inthe body o the video.
The quantity o the risk inormation in the body o the video must sufce to bal-ance the beneft presentation.
“Engaging and lively” presentations o benefts requires using comparable tech-niques or the risk inormation.
Benefts presented in the audio require risk inormation in the audio.