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.

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. just reduce the frequency of relapses (according to its indication). For instance, David Kyle’s testimonial
suggested that he was able to rapidly progress from being “partially paralyzed from the chest down” to being
able 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 “individual
results may vary” disclaimer, they did not feel that such language is sufficient to mitigate the impression that the
drug 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 than
just RRMS. Despite indicating in the body of the testimonials that patients were diagnosed with RRMS, the FDA
considers testimonial titles such as “Taking on Multiple Sclerosis, One Step at a Time” and “Running, Swimming
and Biking Against Multiple Sclerosis” to be misleading. Another issue that the FDA found with the patient
testimonials is the indirect claim that Copaxone continue to be effective over long-term use, beyond the three
years 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 links
are insufficient, and create a misleading impression about the importance of risk information.
Implications and Action Items
This warning letter demonstrates the importance of making accurate and fully supported claims on
pharmaceutical websites, including patient testimonial sites. As always the FDA is evaluating drug information
for 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.
Conclusion
Overall, this warning letter indicates that the FDA subjects patient testimonials to the same level of scrutiny as
other content on a branded webpage, and hence is equally intolerant of testimonials that include claims that
cannot be substantially supported by clinical data. As testimonials are a subjective recounting of patients’
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3. personal experiences with the drug, they often run a high risk of containing statements that cannot be clinically
supported. Therefore, brands must put in the extra effort to thoroughly comb through the content of branded
patient testimonials to ensure that they do not contain any unsubstantiated claims. Alternatively, brands can
consider featuring patient testimonials in unbranded sites instead, to enjoy more freedom to feature their
desired testimonial content.
To review the Copaxone warning letter, please visit
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/WarningL
ettersandNoticeofViolationLetterstoPharmaceuticalCompanies/UCM296204.pdf. For more reviews on FDA guidelines
please visit http://www.rtcrm.com/whitepapers and http://www.rtcrm.com/blogs. FDA warning letters and FDA guidelines
can be found at http://www.fda.gov.
About the Digital Integration and Innovation Team
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About RTC
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Georgetown, 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 their
customers. What distinguishes RTC is its unique ability to analyze data and research on both a rational and
emotional level, and to leverage insights gleaned from that data to motivate customers and prospects to take
action. RTC’s clients include AARP, Procter & Gamble and Sunovion, as well as other major brands in the
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