RTC POVs: FDA Warning Letter for Copaxone, March 2012


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In March of 2012, the FDA released a warning letter for the drug Copaxone for its patient testimonial website. In this POV, Dii's Ruth Lim discusses the FDA's concerns and the implications for pharma companies and marketers.

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RTC POVs: FDA Warning Letter for Copaxone, March 2012

  1. 1. Highlights FDA Warning: Copaxone Teva Pharmaceuticals USA has received a warning letter from Warned for Misleading the FDA. The letter states that Teva’s branded patient Content on Branded Patient testimonial site, Team Copaxone, omits risk information Testimonial Website By: Ruth Lim, Digital Integration & Innovation and makes unsubstantiated and March 2012 misleading claims in patient testimonial content. Summary On March 15, 2012, the FDA released a warning letter to The letter says that in multiple Teva Pharmaceuticals USA instances, the site is not clear in regarding its patient testimonial indicating that the drug is meant website for Copaxone, which is a for patients diagnosed with drug for the reduction in RRMS and not for all types frequency of relapses in patients with Relapsing/Remitting of MS. Multiple Sclerosis (MS). The FDA concluded that the website The FDA warns against violates compliance testimonials that discuss use requirements by: of a drug beyond the time period that has been studied • Failing to include any ISI in the body of the website in clinical trials. • Implying that the drug treats all types of Multiple Sclerosis and not just Relapsing-Remitting MS (RRMS) This warning letter indicates that • Talking about the successful effects of drug use beyond the time the FDA takes the content period that has been studied in clinical trials presented in patient testimonials • Implying, through descriptions of a patient’s personal experience, that the drug does more than just treat RRMS very seriously — all claims in branded testimonials must be Key Information aligned with product indication According to the FDA, the Team Copaxone page as well as the patient and must be supported by testimonial pages contain suggestions that the drug is more effective clinical data. than has been demonstrated by research or clinical evidence. In particular, the Team Copaxone page overstates the efficacy of Copaxone through content that suggests that the drug reverses patients’ disability and discomfort, and enables them to “live the life they’ve dreamed of.” The FDA also pointed out the dramatization of drug efficacy in patient testimonials. Patient testimonials in the Team Copaxone site seem to imply that the drug helps patients to make a full recovery, and does not
  2. 2. just reduce the frequency of relapses (according to its indication). For instance, David Kyle’s testimonialsuggested that he was able to rapidly progress from being “partially paralyzed from the chest down” to beingable to participate in “numerous national and international triathlons” after taking Copaxone.It is important to note that while the FDA acknowledges that the patient testimonials did include an “individualresults may vary” disclaimer, they did not feel that such language is sufficient to mitigate the impression that thedrug is able to cure patients of all physical disability caused by RRMS.Likewise, the FDA also warned against the multiple suggestions that Copaxone treats all types of MS rather thanjust RRMS. Despite indicating in the body of the testimonials that patients were diagnosed with RRMS, the FDAconsiders testimonial titles such as “Taking on Multiple Sclerosis, One Step at a Time” and “Running, Swimmingand Biking Against Multiple Sclerosis” to be misleading. Another issue that the FDA found with the patienttestimonials is the indirect claim that Copaxone continue to be effective over long-term use, beyond the threeyears demonstrated by clinical evidence.Lastly, the biggest oversight on the Copaxone website is failure to include any Important Safety Information (ISI)in any of its pages. Although links to ISI were provided at the bottom of the pages, the FDA stresses that the linksare insufficient, and create a misleading impression about the importance of risk information.Implications and Action ItemsThis warning letter demonstrates the importance of making accurate and fully supported claims onpharmaceutical websites, including patient testimonial sites. As always the FDA is evaluating drug informationfor the most stringent accuracy, so it is best to:• Ensure that branded patient testimonials only illustrate behaviors that are specific to the drug’s indication. Brands must remember that patient testimonials on a branded site are also advertising and hence are subject to the same level of scrutiny as any other copy on the brand page. Therefore, brands need to ensure that all claims in branded testimonials can be backed by substantial clinical data. Brands should also be careful in the choice of words, as well as the tone of the testimonials, to avoid dramatization and exaggeration.• Be specific about the condition that the drug is indicated for. Marketers must be careful not to use the colloquial name of the condition that their drug treats, and should instead be clear in specifying full disease names.• ISI must always be present and prominent. It is important for marketers to ensure that ISI is always included in the body of every page, and is also highly accessible and readable. Marketers of black-boxed drugs must take the extra step to ensure that ISI is included anytime the brand name is mentioned.• Ensure that data is complete. Make sure that claims, associations and correlations between the drug and clinical outcomes are accurate and backed by legitimate evidence and accepted scientific methodologies.• Unbranded is better. Unbranded efforts provide a wider safety net than branded efforts. Unbranded testimonials give brands more freedom to discuss patient experience without having to tie those experiences to clinical drug data.ConclusionOverall, this warning letter indicates that the FDA subjects patient testimonials to the same level of scrutiny asother content on a branded webpage, and hence is equally intolerant of testimonials that include claims thatcannot be substantially supported by clinical data. As testimonials are a subjective recounting of patients’ RTCRM Proprietary Page 2
  3. 3. personal experiences with the drug, they often run a high risk of containing statements that cannot be clinicallysupported. Therefore, brands must put in the extra effort to thoroughly comb through the content of brandedpatient testimonials to ensure that they do not contain any unsubstantiated claims. Alternatively, brands canconsider featuring patient testimonials in unbranded sites instead, to enjoy more freedom to feature theirdesired testimonial content.To review the Copaxone warning letter, please visithttp://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/WarningLettersandNoticeofViolationLetterstoPharmaceuticalCompanies/UCM296204.pdf. For more reviews on FDA guidelinesplease visit http://www.rtcrm.com/whitepapers and http://www.rtcrm.com/blogs. FDA warning letters and FDA guidelinescan be found at http://www.fda.gov.About the Digital Integration and Innovation Team The RTC Digital Integration and Innovation team is tasked with keeping track and making sense of the ever-changing digital world. It’s our job to understand the nuances of how andwhy different types of people use technology and what that tells us about them. More importantly, it’s our jobto help our clients apply this knowledge to better communicate with their customers. We help clients translatebusiness goals into marketing campaigns that build relationships with customers. In the 21st century,understanding how and why someone uses technology is as important as understanding where they live, whatgender they are, and how old they are. That’s where we come in. From ensuring that digital behavior isconsidered in the research phase, to tactical plans that align digital, print and broadcast tactics, we work withclients and internal partners to make sure it all works.It’s not about what’s cool. It’s about what works.About RTCRTC is a full-service direct and relationship marketing agency based in Washington, D.C., in the heart ofGeorgetown, with an additional office in New York. RTC boasts more than 45 years’ worth of innovative,targeted solutions that grow its clients’ brands and help them forge lasting, valuable relationships with theircustomers. What distinguishes RTC is its unique ability to analyze data and research on both a rational andemotional level, and to leverage insights gleaned from that data to motivate customers and prospects to takeaction. RTC’s clients include AARP, Procter & Gamble and Sunovion, as well as other major brands in thepharmaceutical, financial services and telecom industries.To learn more about RTC, please visit www.rtcrm.com or follow the Twitter feed @rtcrm RTCRM Proprietary Page 3