Patient Testimonial Videos: FDA Actions on Risk Information Presentation

By Dale A. Cooke Patient testimonials can be powerful. People identify with and trust someone like them. According to Pew Research, 24% of US adults have gotten information and support from others who have the same health condition and 16% tried to find others online who shared the same health concerns.1 Consequently, marketers frequently develop patient testimonials for promoting prescription products. In addition, as broadband Internet access has expanded,2 users are spending more time online with video,3 and patient testimonials lend themselves to video treatments. At the same time, the US Food and Drug Administration (FDA) has taken numerous enforcement actions against the use of patient testimonials for product promotion. In the process, the agency has clearly designated as inappropriate certain ways of presenting risk information. This article addresses what companies can learn about presenting risk information correctly in patient testimonial videos, based on FDA guidance and enforcement 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 infractions is insufficient to ensure compliance. However, it is certainly prudent to at least avoid repeating the mistakes of others.

The Requirement
Promotions for prescription drugs are required to present a fair balance between information relating to side effects and contraindications and information relating to effectiveness of the drug.4 FDA has elaborated on that requirement in a draft guidance for industry.5 The draft guidance emphasizes that the net impression of a piece taken as a whole (the effect created by the presentation of the risk information and the benefit information)
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dictates whether it accomplishes the fair balance requirement.6 FDA saw the need for guidance specifically addressing the presentation of risk information because the omission or minimization of risk information continues to be the most frequent violation of the regulations7 cited in enforcement actions. In those actions, FDA has repeatedly invoked the principle that risk information must be presented with a prominence and readability reasonably comparable to the presentation of the benefit information.8 Following are the some specific failings FDA has identified in patient testimonial videos and other video formats. Risk Information on a Webpage Does not Suffice In an enforcement action against Wyeth in August 2010, FDA noted that the patient testimonial videos on the brand website minimized risk information by failing to convey any risks associated with Premarin during these audio-visual presentations and instead relegating the risk information to the bottom portion of the webpage below the testimonials in read-only text format.9 Risk Information Must Be Included in the Video Itself The above enforcement action and several others for video testimonials and other video promotions, including ones for Genentechs Herceptin and Slates Testopel in 2010, noted the need to include risk information during the efficacy presentation of the video.10 Minimal Risk Information in the Video Does not Suffice While not fully explaining how much risk information must be presented with the efficacy claims during the body of the video, FDA has made clear that just including some does not suffice for compliance. The Herceptin letter noted that the body of the video included only two statements related to risk: I had mild fatigue, and I had some serious issues with fatigue, and with muscle and joint pain. In the context of a 5 minute engaging and lively multi-media presentation the agency said inclusion of this risk information was not reasonably comparable to the benefit information.11 Style and Quantity of Risk Presentation Must be Comparable The Herceptin letter pointed out the engaging and lively multi-media presentation of the benefit information.12 Similarly, a letter to Abbott for Kaletra mentioned the engaging and lively discussion of the benefits presentation.13 In both cases, it was not merely the quantity of the risk information that was deemed insufficient but also the contrast between the way the risk information was presented with the engaging and lively presentation of the benefit information. Risk Information in End Matter Does not Suffice In the letters for Testopel, Kaletra and one sent to Johnson & Johnson for Ultram ER, FDA indicated that presenting the scrolling Important Safety Information at the conclusion of the video presentation minimized the risk information.14

Key Lessons
The central principle repeated frequently by FDA is that risk information must be presented in a manner reasonably comparable to that of the benefit information. While not stipulating identical presentations, this guidance provides certain constraints: Product benefit information in the body of the video requires risk information in the body of the video. The quantity of the risk information in the body of the video must suffice to balance the benefit presentation. Engaging and lively presentations of benefits requires using comparable techniques for the risk information. Benefits presented in the audio require risk information in the audio.
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References 1. Pew Research Center. Health Online 2013. http://pewinternet.org/Reports/2013/Health-online.aspx . Published 15 January 2013. Accessed 14 June 2013. 2. According to eMarketer.com February 2013, 70.3% of US households have a fixed wire (i.e., not wireless) broadband connection to the Internet. 3. YouTube. http://www.youtube.com/yt/press/statistics.html. Over 6 billion hours of video are watched each month on YouTube. Accessed 9 May 2013. 4. 21 CFR 202.1(e)(5)(ii). 5. Draft Guidance for Industry Presenting Risk Information in Prescription Drug and Medical Device Promotion (Presenting Risk). FDA website. http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm064956.htm. Accessed 28 November 2011. 6. Ibid, page 4. 7. Ibid, page 3. 8. Enforcement letters using this language include: MACMIS #18956: Letter to Wyeth Pharmaceuticals for promotional materials for Premarin (conjugated estrogens tablets, USP) 27 August 2010:4. FDA website. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/ EnforcementActivitiesbyFDA/WarningLettersandNoticeofViolationLetterstoPharmaceuticalCompanies/UCM225561.pdf. Accessed 18 August 2011. MACMIS #18408: Letter to Genentech for promotional materials for HERCEPTIN (trastuzumab) Intravenous Infusion. 26 March 2010:4. FDA website. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/ WarningLettersandNoticeofViolationLetterstoPharmaceuticalCompanies/UCM209522.pdf. Accessed 18 August 2011. MACMIS #18584: Letter to Alkermes for promotional materials for Vivitrol (naltrexone for extended-release injectable suspension).4 November 2010:1. FDA website. http://www.fda. gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/ WarningLettersandNoticeofViolationLetterstoPharmaceuticalCompanies/UCM233866.pdf. Accessed 18 August 2011. 9. MACMIS #18956 (Premarin), page 4. Note that a comparable claim is made in MACMIS #15563: Letter to Shire for promotional materials for Adderall XR Capsules, 25 September 2008. FDA website. http:// www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/ WarningLettersandNoticeofViolationLetterstoPharmaceuticalCompanies/ucm053995.pdf. Accessed 18 August 2011. In the case of Shire letter, however, the video, which was originally posted to an Adderall website, was reposted to YouTube. com. The FDA letter does not note any risk information provided on the page. 10. MACMIS #18378: Letter to Slate Pharmaceuticals for promotional materials for Testopel Pellets (testosterone), CIII. 24 March 2010:3. FDA website. http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/ EnforcementActivitiesbyFDA/WarningLettersandNoticeofViolationLetterstoPharmaceuticalCompanies/ucm259232.htm. Accessed 18 August 2011. See also MACMIS # 15563 (Adderall), page 4. 11. MACMIS #18408 (Herceptin), pages 4-5. In addition, see MACMIS #18166: Letter to Bayer Healthcare for promotional materials for Mirena (levonorgestrel-releasing intrauterine system). 30 December 2009. http:// www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/ WarningLettersandNoticeofViolationLetterstoPharmaceuticalCompanies/UCM197229.pdf. Accessed 18 August 2011. See also MACMIS #17660: Letter to Abbott Laboratories, for promotional materials for Kaletra (lopinavir & ritonavir) Tablets. 14 July 2009:4. FDA website. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/ EnforcementActivitiesbyFDA/WarningLettersandNoticeofViolationLetterstoPharmaceuticalCompanies/UCM173184.pdf. Accessed 18 August 2011. 12. MACMIS #18408 (Herceptin), pages 4-5. 13. MACMIS #17660 (Kaletra), page 4. 14. MACMIS #18378 (Testopel), page 3 and MACMIS #17660 (Kaletra), page 4. See also MACMIS #17464: Letter to Johnson & Johnson for promotional materials for Ultram ER (tramadol HCl) Extended-Release Tablets. 12 May 2009. FDA website. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/ WarningLettersandNoticeofViolationLetterstoPharmaceuticalCompanies/UCM153130.pdf. Accessed 18 August 2011. 2013 by the Regulatory Affairs Professionals Society. All rights reserved.

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