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Patient Testimonial Videos: FDA Actions on Risk Information Presentation

Patient Testimonial Videos: FDA Actions on Risk Information Presentation

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Published by Dale Cooke
This publication looks at several recent FDA enforcement actions for patient testimonials and provides lessons for compliant presentation of risk information.
This publication looks at several recent FDA enforcement actions for patient testimonials and provides lessons for compliant presentation of risk information.

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Categories:Types, Business/Law
Published by: Dale Cooke on Jun 20, 2013
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06/21/2013

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June 2013
regulatoryfocus.org1
By Dale A. Cooke
Patient testimonials can be powerul. People identiy with and trust someone like them.According to Pew Research, 24% o US adults have gotten “inormation and support romothers who have the same health condition” and 16% tried to fnd others online whoshared the same health concerns.
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Consequently, marketers requently develop patienttestimonials or promoting prescription products. In addition, as broadband Internetaccess has expanded,
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users are spending more time online with video,
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and patient testi-monials lend themselves to video treatments.At the same time, the US Food and Drug Administration (FDA) has taken numerousenorcement actions against the use o patient testimonials or product promotion. In theprocess, the agency has clearly designated as inappropriate certain ways o presentingrisk inormation. This article addresses what companies can learn about presenting riskinormation correctly in patient testimonial videos, based on FDA guidance and enorce-ment actions, to ensure the resulting promotional material is compliant.
A Caveat
It is important to note that simply not doing things previously cited by FDA as inractions isinsufcient to ensure compliance. However, it is certainly prudent to at least avoid repeat-ing the mistakes o others.
The Requirement
Promotions or prescription drugs are required to “present a air balance between inorma-tion relating to side eects and contraindications and inormation relating to eectivenesso the drug.”
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FDA has elaborated on that requirement in a drat guidance or industry.
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 The drat guidance emphasizes that the net impression o a piece taken as a whole (theeect created by the presentation o the risk inormation and the beneft inormation)
Patient Testimonial Videos: FDA Actionson Risk Information Presentation
 
June 2013
regulatoryfocus.org2
dictates whether it accomplishes the air balance requirement.
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FDA saw the need orguidance specifcally addressing the presentation o risk inormation because the omis-sion or minimization o risk inormation continues to be “the most requent violation o theregulations”
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cited in enorcement actions.In those actions, FDA has repeatedly invoked the principle that risk inormation mustbe presented “with a prominence and readability reasonably comparable” to the presenta-tion o the beneft inormation.
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Following are the some specifc ailings FDA has identifedin patient testimonial videos and other video ormats.
Risk Inormation on a Webpage Does not Sufce
In an enorcement action against Wyeth in August 2010, FDA noted that the patient tes-timonial videos on the brand website minimized risk inormation by “ailing to convey any risks associated with Premarin during these audio-visual presentations” and instead rel-egating the risk inormation “to the bottom portion o the webpage below the testimonialsin read-only text ormat.”
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Risk Inormation Must Be Included in the Video Itsel 
The above enorcement 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 inormation “during the efcacy presentation o the video.
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Minimal Risk Inormation in the Video Does not Sufce
While not ully explaining how much risk inormation must be presented with the efcacy claims during the body o the video, FDA has made clear that just including some doesnot sufce 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 inormation was not“reasonably comparable” to the beneft inormation.
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 Style and Quantity o Risk Presentation Must be Comparable
The Herceptin letter pointed out the “engaging and lively multi-media presentation” o thebeneft inormation.
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Similarly, a letter to Abbott or Kaletra mentioned the “engaging andlively discussion” o the benefts presentation.
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In both cases, it was not merely the quan-tity o the risk inormation that was deemed insufcient but also the contrast between theway the risk inormation was presented with the “engaging and lively” presentation o thebeneft inormation.
Risk Inormation in End Matter Does not Sufce
In the letters or Testopel, Kaletra and one sent to Johnson & Johnson or Ultram ER, FDAindicated that presenting the scrolling Important Saety Inormation at the conclusion o the video presentation minimized the risk inormation.
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Key Lessons
The central principle repeated requently by FDA is that risk inormation must be pre-sented in a manner “reasonably comparable” to that o the beneft inormation. While notstipulating identical presentations, this guidance provides certain constraints:
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Product beneft inormation in the body o the video requires risk inormation inthe body o the video.
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The quantity o the risk inormation in the body o the video must sufce to bal-ance the beneft presentation.
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“Engaging and lively” presentations o benefts requires using comparable tech-niques or the risk inormation.
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Benefts presented in the audio require risk inormation in the audio.

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