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Use of Testimonials and Endorsements in Prescription Drug Advertisements

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Use of Testimonials and Endorsements in Prescription Drug Advertisements
Features | Posted: 9 September 2013

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By Mary Sullivan

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Testimonials and endorsements made by patients, healthcare professionals RELATED LINKS and celebrities are widely used in prescription drug advertising and promotional RAPS Store: FDA Requirements for labeling. The evidence of return on investment from endorsements is inherent Prescription Drug Promotion through their perpetuity in advertising for drugs and other commodities. For the purpose of this article, endorsements and testimonials will be considered synonymous, with the word endorsements used to describe both. Endorsements are defined by the Federal Trade Commission (FTC) as any advertising message (including verbal statements, demonstrations, or depictions of the name, signature, likeness or other identifying personal characteristics of an individual or the name or seal of an organization) that consumers are likely to believe reflects the opinions, beliefs, findings, or experiences of a party other than the sponsoring advertiser, even if the views expressed by that party are identical to those of the sponsoring advertiser.1 While endorsements have always been part of advertising for various products and services, the expansion of social media and digital media has made them more widely used.

Risks of celebrity endorsements

Celebrity endorsements may carry public relations risks as witnessed with the recent, highly publicized travails of Paula Deen, celebrity spokesperson for Novo Nordisks Victoza.2 Years earlier, a spotlight was placed on prescription drug endorsements by the use of Dr. Robert Jarvik as a celebrity/healthcare professional spokesperson for Pfizers Lipitor. In the ubiquitous direct-to-consumer (DTC) broadcast advertisements that featured Dr. Jarvik, inventor of the Jarvik artificial heart, Dr. Jarvik appeared to give medical advice, but had never obtained a license to practice medicine or prescribe medications.3 The advertising campaign was widely criticized as being misleading, with Dr. Jarviks educational background, compensation from Pfizer and even his rowing expertise held up to scrutiny and criticism.4,5 In early 2008, the Congressional Committee on Energy and Commerce issued a letter to Pfizer expressing its concern over the Jarvik campaign that ultimately led to Pfizers discontinuation of the campaign.6,7,8 The committee explained, When consumers see and hear a doctor endorsing medication, they expect the doctor is a credible individual with requisite knowledge of the drug.9 Indeed, in a survey conducted by Consumer Reports, the majority of consumer respondents indicated that the Jarvik advertisements conveyed the impression that leading physicians preferred Lipitor. Twenty nine percent of the respondents believed that Dr. Jarvik regularly treated patients; 65% believed the advertisement conveyed that Lipitor was the preferred brand by leading doctors.10 Even the appearance of an unidentified doctor in ads for a prescription drug has been shown to lead 20% of viewers to believe the medicine was more effective.11

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Trends in Personalized Medicine 30 October 2013 Industry Strategies for Linking Disease Awareness Websites to Product Promotions 22 October 2013 Summary Technical Documentation (STED): Harmonizing a Predictable Regulatory Submission 26 September 2013 Public Safety Concerns Support FDA Call for Compounding Pharmacy Regulation 23 September 2013 Book Excerpt: FDA Requirements for Prescription Drug Promotion 3 September 2013 A (Technologically Stunted) Ad/Promo Reviewer Looks at Techy Solutions to Regulatory Issues 2 September 2013

PhRMA Principles
In late 2008, following the Jarvik controversy, the Pharmaceutical Research and Manufacturers of America (PhRMA) issued Guiding Principles for Direct to Consumer Advertisements.12 The 2008 principles updated a 2005 version and included new issues, the addition of which appeared to have been influenced by the Dr. Jarvik controversy as well as previously issued principles from the American Medical Association. The new principles included the following: 10. Companies that choose to feature actors in the roles of healthcare professionals in a DTC television or print advertisement that identifies a particular product should acknowledge in the advertisement that actors are being used. Likewise, if actual healthcare professionals appear in such advertisements, the advertisement should include an acknowledgement if the healthcare professional was compensated for the appearance. 11. Where a DTC television or print advertisement features a celebrity endorser, the endorsements should accurately reflect the opinions, findings, beliefs or experience of the endorser. Companies should maintain verification of the basis of any actual or implied endorsements made by the celebrity endorser in the DTC advertisement, including whether the endorser is or has been a user of the product if applicable.13

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While the PhRMA Guiding Principles are not legally binding like the Code of Federal Regulations, more than 50 biopharmaceutical companies are members of PhRMA, and thus are committed to following the PhRMA principles. 14

FTC Guidance
Around the time the PhRMA guidelines were issued, the FTC (which has oversight of product advertising exclusive of prescription drugs) issued revisions to its Guides Concerning the Use of Endorsements and Testimonials in Advertising which are codified in 16 CFR 255.15 An important distinction between the PhRMA and FTC guidances concerns that which could be considered an anecdotal claim in an endorsement. Per FDA requirements and PhRMA Guiding Principle 2, advertisements for prescription drugs must be based on substantial evidence and consistent with the drugs labeling.16,17 Endorsements in advertisements under FTCs oversight require substantiation that the endorsers experience is representative of what consumers generally will achieve. In the absence of such substantiation, the advertisement should clearly and conspicuously disclose the generally expected performance in the depicted circumstances, and the advertiser must possess and rely on adequate substantiation for that representation.18 The US Food and Drug Administrations Office of Prescription Drug Promotion (OPDP, formerly DDMAC) has conveyed the expectation that sponsors should maintain verification that a spokespersoncelebrity or otherwiseis indeed a user of the drug being promoted. When seeking advisory comments from FDA for a DTC advertisement, the sponsor should include written verification of any endorsers experience with the drug.19,20 In 1997, DDMAC issued a Notice of Violation to Merck for DTC materials that incorporated images of baseball player Cal Ripken, Jr. In promotional materials for Prinivil, Ripkens name and image were connected with the drug. Claims such as, Both on the job. Everday, implied that Ripken was endorsing Prinivil and was ostensibly a user of the antihypertensive agent. In reality, the baseball star did not have hypertension and did not use Prinivil, a fact disclosed with less prominence elsewhere in the advertisement. It was thus the opinion of the agency that the advertisements for Prinivil featuring Cal Ripken were false and misleading.21

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Substantial Evidence Required

Sponsors of prescription drug advertisements should be aware that according to FDA requirements for promotion, statements that represent normal conversational claims must be supported by substantial evidence. For example, the term lifesaver is used frequently to describe common household items in advertisements. The same word would have a significantly different connotation in a prescription drug advertisement. Prescription drug sponsors must ensure consistency with labeling with respect to indication, dosing and administration, duration and onset of effect, risk information and efficacy as has been demonstrated in the pivotal trials. Of course, as is imperative in any advertisement or promotional labeling, the appropriate balance of benefits with risk information is required.

False and Misleading Ads

A review of recent enforcement letters issued by OPDP illustrates how endorsements or testimonials may render an advertisement false or misleading: Quality of Life (QOL) Claims A common citation in OPDP letters concerns statements that represent unsupported QOL claims. A 2005 Warning Letter was issued in response to a testimonial appearing on a website for Quadramet, an analgesic indicated for cancer pain. The patient in the advertisement stated, Now I have time to enjoy life, and Quadramet can give you around-the-clock pain relief for up to 16 weeks.... The implication that the drug would enable patients to resume normal daily activities was not supported by the pivotal trials. Moreover, pain as graded by the patients in the pivotal trials did not reach 0 with Quadramet therapy, thus the claim of pain relief was deemed to overstate the drugs analgesic efficacy.22 Onset of Action A testimonial for the Premarin brand of estrogen included the claim, I went to my doctor. She put me on Premarin. She put me on the lowest dose. I noticed the changes immediately. In contrast, the pivotal trial that supported the approval of Premarin did not support the claim of immediate symptom relief. In the pivotal trial, a statistical difference in menopause symptoms between Premarin and placebo was not demonstrated until after four weeks of therapy.23 Duration of Efficacy A Warning Letter issued for a Magic Johnson testimonial video promoting Kaletra cited the statement, Well the good thing is, Kaletra is a part of my regimen, and for five years I have been undetectable, so I just hope that that continues. Kaletra, indicated in HIV/AIDS, had not demonstrated efficacy in antiretroviral-experienced patients for five years or more through substantial evidence, an implication that had been made in the video.24 Similarly, a testimonial for Vivitrol, indicated in alcohol dependence, featured patient representations of treatment with the drug for 12 and 18 months, respectively. As the pivotal trials ended after 24 weeks, these representations were considered by FDA to overstate the efficacy of Vivitrol.25 Overstatement of Efficacy A patient with multiple sclerosis (MS) appeared in a video for Ampyra, a drug indicated to improve walking in MS as

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demonstrated by increased walking speed. The patient made claims that with Ampyra she was able to use her cane less frequently and could walk farther distances. The implication that Ampyra therapy could result in decreased cane usage and increased walking distance was beyond the improved walking speed that was measured as an endpoint in the pivotal trial and, as such, considered an overstatement of efficacy.26 Minimization of Risk The most commonly cited violation in all drug advertisements, including endorsements and testimonials, is that of omission or minimization of risk.27 A webcast for Ultram, indicated in chronic pain, featured a celebrity testimonial accompanied by a physicians discussion about pain treatment. The webcast, which was seven minutes long, relegated risk information to the last minute of the video. In comparison to the lively six-minute discussion that promoted the drug, the risk information appeared in a rapidly scrolling text format. The net impression of the webcast undermined the communication of important safety information, resulting in a Warning Letter.28 Other FDA letters that can serve to inform on the use of testimonials, endorsements, or case studies in prescription drug promotion can be accessed on the FDA website and include Notices of Violation and Warning Letters issued in response to promotional labeling for Adderall, Copaxone, Incivek and Testopel, among others.29, 30, 31, 32

Conclusions
In summary, be aware when reviewing prescription drug endorsements and testimonials that even if all statements regarding the drug reflect actual experience, they still need to be supported by substantial evidence and be consistent with the labeling. Additionally: 1. In endorsements and testimonials, the risk information should be presented in the same format as the benefit. Audio-visual discussions of benefits should be integrated with audio-visual risk information to avoid minimization of risk. Consult the FDA Draft Guidance on the Presentation of Risk Information for a review of the agencys expectations for risk presentation that includes useful examples.33 2. Maintain verification that any patient or celebrity who represents him or herself as an actual user of the product is or has used the promoted drug. Provide the written verification of the endorsers experience when submitting a draft DTC advertisement for OPDP advisory comments. 3. Be aware that any images or general disease state information included with a testimonial for a prescription drug will be considered claims for the drug and, as such, must be supported by substantial evidence and consistent with labeling. 4. Before filming a testimonial, the companys promotion review committee should review and approve topics for discussion. For example, there is little benefit in asking patients to talk about the therapies they took prior to treatment with the advertised drug. The response likely would be considered a suggested comparative claim between drugs and, as such, be considered misleading if used in promotion. 5. When actors are used to represent healthcare professionals, a clear and conspicuous statement informing the viewer must be included. When actual healthcare professionals are used, a statement disclosing that they have been compensated must be included. 6. Remember that all sponsored, branded testimonials, regardless of the media in which they appear, are promotional labeling or advertisements and must be submitted to OPDP with Form FDA 2253 at the time of first use. 7. It is important to keep in mind that any claims or statements made by patients can and will be taken literally by the viewer and FDA. Expressions that may sound perfectly normal in actual conversations can overstate a drugs efficacy or inadvertently make Quality of Life claims. Be wary of statements like, It changed my life, I had more energy, I could do more than I did before, I felt better immediately, and, My symptoms completely disappeared. These and similar statements represent prescription drug claims and would require substantial evidence in order to be used in promotion.

References
1. Federal Trade Commission. 16 CFR Part 255, Guides Concerning the Use of Endorsements and Testimonials in Advertising. http://ftc.gov/os/2009/10/091005revisedendorsementguides.pdf. Accessed 10 July 2013. 2. Food Network drops Paula Deen New York Times, 21 June 2013. The New York Times website. http://www.nytimes.com/2013/06/22/dining/paula-deen-is-a-no-show-on-today.html. Accessed 26 Aug 2013. 3. Congress to Pfizer: Why is Robert Jarvik the Lipitor Man? Wall Street Journal, 7 January 2008.Wall Street Journal website. http://blogs.wsj.com/health/2008/01/07/congress-to-pfizer-why-is-robert-jarvikthe-lipitor-man/. Accessed 10 July 2013. 4. Pfizer to End Lipitor Ads by Jarvik The New York Times, 26 February 2008. The New York Times website. http://www.nytimes.com/2008/02/26/business/26pfizer.html?_r=0. Accessed 10 July 2013. 5. Op cit 3. 6. Lipitor Pitchman Jarvik Rows Into the Sunset Wall Street Journal. 25 February 2008, Wall Street Journal website. http://blogs.wsj.com/health/2008/02/25/lipitor-pitchman-jarvik-rows-into-thesunset/tab/print/. Accessed 26 Aug 2013. 7. Congress investigates Jarvik's Lipitor ads. The Heart.Org b y Web MD. l8 January 2008. The Heart. Org website. http://www.theheart.org/article/836205/print.do. Accessed 17 July 2013. 8. Op cit 4. 9. Op cit 4. 10. Lipitor: The controversial ad proves highly effective Consumer Reports. 5 March 2008. Consumer Reports website. http://www.consumerreports.org/cro/news/2008/03/lipitor-the-controversial-adproves-highly-effective/index.htm. Accessed 10 July 2013. 11. DDMAC Adds New Consumer Group To Handle Ad Load; More Marketing Briefs, The Pink Sheet. 26

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September 2006 http://www.elsevierbi.com/publications/the-pink-sheet/68/039/ddmac-adds-newconsumer-group-to-handle-ad-load-more-marketing-briefs. Accessed 10 July 2013. 12. Pharmaceutical Research and Manufacturing Association. PhRMA Guiding Principles: Direct to Consumer Advertisements Ab out Prescription Medicines (Revised December 2008). PhRMA website. http://phrma.org/sites/default/files/631/phrmaguidingprinciplesdec08final.pdf. Accessed 17 July 2013. 13. Op cit 12. 14. Pharmaceutical Research and Manufacturers of America. PhRMA Members. http://phrma.org/about/member-companies. Accessed 26 August 2013. 15. Op cit 1. 16. Code of Federal Regulations, 21 CFR 202.1. FDA website. http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?fr=202.1. Accessed 17 July 2013. 17. Op cit 12. 18. Op cit 1. 19. Drug Information Association 2012 Annual Meeting. Draft Module 1 Update (1.15 Promotional Materials), Presentation by Marci Kiester, Associate Director, Office of Prescription Drug Promotion, http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/FormsSubmissionRequirements/ElectronicSubmissions/UCM323472.pdf. Accessed 26 August 2013. 20. FDA. Draft Guidance for IndustryDirect-to-Consumer Television AdvertisementsFDAAA DTC Television Ad Pre-Dissemination Review Program (March 2012). FDA website. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM295554.pdf. Accessed 26 August 2013.

21. FDA untitled letter. Prinivil 3/1997. FDA website. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/WarningLettersandNoticeofViolationLetterstoPharmaceuticalCompanies/ Accessed 26 August 2013.

22. FDA Warning Letter, Quadramet 7/2005. FDA website. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/WarningLettersandNoticeofViolationLetterstoPharmaceuticalCompanies/ Accessed 17 Aug 2013 Quadramet DTC Broadcast Radio Ad. FDA Website. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/WarningLettersandNoticeofViolationLetterstoPharmaceuticalCompanies/ Accessed 28 August 2013.

23. FDA untitled letter. Premarin 8/2010. FDA website. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/WarningLettersandNoticeofViolationLetterstoPharmaceuticalCompanies/ Accessed 17 Aug 2013.

24. FDA Warning Letter. Kaletra 7/2009. FDA website. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/WarningLettersandNoticeofViolationLetterstoPharmaceuticalCompanies/ Accessed 17 Aug 2013.

25. FDA untitled letter. Vivitrol 11/2010. FDA website. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/WarningLettersandNoticeofViolationLetterstoPharmaceuticalCom Accessed 17 August 2013. Vivitrol Patient Brochure. FDA website http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/WarningLettersandNoticeofViolationLetterstoPharmaceuticalCompanies/ Accessed 28 August 2013.

26. FDA untitled letter. Ampyra 7/2012. FDA website. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/WarningLettersandNoticeofViolationLetterstoPharmaceuticalCompanies/ . Accessed 17 August 2013. Ampyra Video Segment. FDA website http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/WarningLettersandNoticeofViolationLetterstoPharmaceuticalCompanies/ Accessed 28 August 2013 27. 2012 End of Year Summary of FDA Promotional Enforcement Activity, March 18, 2013, Covington and Burling LLP. 18 March 2013. http://www.cov.com/files/Publication/6eb09df3-add7-43d0-9fbd04876cfef0e9/Presentation/PublicationAttachment/55c9c82d-9760-41f1-840b130d76a86ce5/FDA_Enforcement_E-Alert_End_of_Year_2012.pdf. Accessed 26 August 2013

28. FDA Warning Letter. Ultram 5/2009. FDA website. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/WarningLettersandNoticeofViolationLetterstoPharmaceuticalCompanies/ Accessed 17 August 2013.

29. FDA Warning Letter. Adderall 9/2008. FDA website. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/WarningLettersandNoticeofViolationLetterstoPharmaceuticalCompanies/ . Accessed 17 August 2013.

30. FDA Warning Letter. Copaxone 3/2012. FDA website. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/WarningLettersandNoticeofViolationLetterstoPharmaceuticalCompanies/ Accessed 18 August 2013. Copaxone Exhibit Panels. FDA website. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/WarningLettersandNoticeofViolationLetterstoPharmaceuticalCompanies/ 18 August 2013.

31. FDA untitled letter. Incivek 5/2012. FDA website. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/WarningLettersandNoticeofViolationLetterstoPharmaceuticalCompanies/ Accessed 17 August 2013. Incivek Branded Story. FDA website. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/WarningLettersandNoticeofViolationLetterstoPharmaceuticalCompanies/ Accessed 17 August 2013.

32. FDA Warning Letter. Testopel 3/2010. FDA website. http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/WarningLettersandNoticeofViolationLetterstoPharmaceuticalCompanies/ucm259232 Accessed 17 August 2013. Testopel website. FDA website. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/WarningLettersandNoticeofViolationLetterstoPharmaceuticalCompanies/ Accessed 17 August 2013. 33. FDA. Draft Guidance for Industry: Presenting Risk Information in Prescription Drug and Medical Device Promotion (May 2009). FDA website. www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM155480.pdf. Accessed 26 August 2013.

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Disclosure

Use of Testimonials and Endorsements in Prescription Drug Advertisements

The opinions expressed in the article are Sullivans own and do not represent the opinions or policies of Boehringer Ingelheim Pharmaceuticals, Inc.

ABOUT THE AUTHOR(S)

Mary Sullivan is an executive director of regulatory affairs at Boehringer Ingelheim Pharmaceuticals Inc. She leads the advertising and promotion compliance group within the regulatory affairs department. Sullivan can be reached at mary.sullivan@boehringer-ingelheim.com.

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