Testimonials – The Pitfalls

People like to get information from people they trust. Moreover, a hallmark of digital communications has been a turning away from large, institutionalized sources for information and turning instead to hear from individuals.

Pew Research has shown that especially for people with chronic conditions, there is a reliance on getting information and support from friends and family and one quarter say that they seek information from people who have the same health condition that they do. In other words, there appears to be good reason for the use of testimonials by patients when seeking to promote a medical product. A patient like me who has faced what I faced and now has been through the experience tells me what it is like, and I may take great stock in what they say.

But while it may make sense, there may be inherent regulatory risks in going down that path – risks that are peculiar to use of testimonials. Why?

Part of the appeal in having a patient describe their experience using a medical product is that they provide a real, first-person description of how the product worked for them and the difference it made for them with respect to their condition. That is also the drawback.

Communications about the use of a medicine are supposed to reflect the label that FDA approved for the product. Going outside of that parameter risks an FDA regulatory action like a warning or untitled letter from the Office of Prescription Drug Promotion (OPDP).

I went through my database of OPDP Warning and Untitled Letters which includes letters from 2004 through today and tracks multiple characteristics of the letters, including descriptions of the communications vehicle (brochure, video, e.g.) and of course, the violations cited. The data base profiles more than 300 letters and over 1000 violations. While not a separate field, when a testimonial has been involved it is noted in the file.

I was able to identify 12 instances in which FDA sent a letter regarding a communication that involved a patient testimonial – in 3 of those instances the patient was also a celebrity spokesperson.

It is noteworthy that the most common violation cited in OPDP letters generally is the minimization or omission of risk information – by far. However, when it comes specifically to patient testimonials, the most common violation was the overstatement of efficacy, involving 11 of the 12 letters.

The basis for that is likely that when a person describes in subjective terms their experience with a medication, it usually includes a reference to the impact the use had on their lives. Phrases such as it “literally changed my life” and “restored my confidence” or describing in personal terms the use of the medication for which evidence does not exist to demonstrate that everyone would have such an experience.

Almost all of the communications vehicles involved video, but it also involved some print.

It also bears reminding that OPDP usually looks not only to an individual statement or action (though that can suffice) but also the entirety of the presentation.

This is not to say that testimonials are bad or should not be attempted, but it does say that one should take care to examine the presentation carefully, with particular sensitivity to the issue of overstatement of efficacy and to take note of historical examples where FDA has acted.

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Weekly Roundup 3.11.16

The chives have poked their way up through the winter refuse of leaves and dried stems letting me know it is time to get the garden beds all ready again for Spring and to even be so optimistic as to begin some cautious planting. I fully believe that one day I will have my little farm that I want, but in the meantime, a small back yard that despite its size still overwhelms me, will have to do. In any case, welcome Spring!

And as we prepare ourselves for outdoor labors, here is some of what happened indoors that was interesting this week:

  • FDA Settles “Off-Label” Lawsuit – A long-standing lawsuit regarding corporate speech and off-label discussion of products made the news this week when FDA and the company involved arrived at a settlement. The lawsuit involved a company aiming to use truthful and accurate communication to discuss its product even where the discussion involved an off-label use. A lower court had ruled that FDA could not prohibit such communication. In the settlement it was reported that FDA agreed to circumstances whereby the company could promote an off-label use where the promotion was truthful and not misleading. Despite the fact that the settlement only applies to the company in the lawsuit, it does necessarily beg the questions whether the agency will eventually reconsider its approach to this issue. You can read media coverage of this here.
  • Another DTC StudyLast week it was noted in The Weekly Roundup that FDA was seeking input on a study that the agency would undertake regarding the impact of the use of animation in DTC ads. This week there is another chapter, indicating a broader assessment of DTC advertising, as FDA announced that it was also seeking input into the use of superimposed text and its impact on consumer comprehension. On a related note, all the study would be for naught if Senator Al Franken gets his way – having introduced legislation this week to deny the tax deduction available to companies engaged in RX DTC advertising.

Off to the garden beds!  Have a great weekend everyone.

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Socializing Medicine – FDA Enforcement Involving Social Media

Have you ever had a conversation with someone who said pharma needs to stay away from social media because it is too risky? Even today, some hold that opinion. When social media, used primarily by individuals in its nascent stage, began to migrate into use by institutions, highly regulated industries were necessarily wary. In particular, the pharmaceutical and biotech industry had reason to be concerned given all of the oversight over promotional speech in print and broadcast. Add to that the slow and often confusing efforts by FDA’s Office of Prescription Drug Promotion (OPDP) to enunciate regulatory positions and what resulted for many was a genuine reluctance to engage.

Today, however, most companies are involved in social media platforms, some more than others, and do so across a spectrum – from career recruitment on Twitter to corporate communications and even a small amount of product-specific efforts. There are hundreds of industry sponsored Twitter feeds, Facebook pages, YouTube channels, Pintrest pages and on Periscope. However, there are still some who believe that digital communications in general, and social media in particular, is a riskier communications adventure than traditional communications vehicles.

In 2013, I tried to address that somewhat by issuing a white paper that compared OPDP enforcement actions as represented by the issuance of Warning or Untitled Letters. Measuring the period when institutional adoption of social media was in its ascendancy – 2008-2012 – the results demonstrated that not only did traditional communications vehicles such as print ads, brochures and sales aids garner the bulk of violations, there was no increase occurring among digital media when you looked at it on a year by by year basis. That analysis was recently updated in a blog posting that again showed no increase in regulatory actions aimed at digital properties.

But that is digital broadly, where have the pitfalls been when it comes to social media?Looking through my warning letter data base which tracks enforcement through a range of characteristics, I came across only six OPDP letters involving a social media communications vehicle. Here is a brief overview:

  • 3 involved YouTube
  • 2 involved Facebook
  • 1 involved Instagram (with subsequent Facebook posting, also deemed violative)
  • It is perhaps notable that no violations occurred involving Twitter, despite the fact that Twitter is likely more heavily utilized by industry in number of outlets, number of updates and number of followers than any other social media platform
  • All in all, with the Instagram posting to Facebook, there were a total of seven social media encounters in the six letters occurring between the years 2008 and 2016 (this year’s only letter so far did involve a YouTube video)
  • Two of the letters involved situations involving the use of patient testimonials
  • Two of the letters were Warning Letters, the rest were Untitled
  • Of these seven, six of the violations had nothing to do whatever with the fact that the communication occurred via social media. In other words, had the same communication been carried in a written brochure, the material still would have been in violation
  • The single violation that did relate to the social media platform was the situation involving a Facebook Share widget whereby the risk information did not convey when shared;
  • In fact, the common thread through all of the social media-related violations was the minimization or omission of risk information

So while not to suggest that social media is risk-free (any communication carries risk), 6 letters involving social media over 6 years is not bad considering the migration of communication by both industry and patients into social media and health.By contrast, looking at the same time period, there were 22 letters citing brochures for violations. While not definitive, it certainly gives you something to respond with next time someone says that social media is too risky for industry.


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Weekly Roundup 3.4.15

2016 is speeding by. We are over two-thirds of the way through the first quarter. Mother Nature continues to taunt us. Daffodils were blooming this week, only to have snow accumulating around the blossoms today. Election fever runs rampant as does a never-ending flow of commentary. At FDA, the enforcement page once again displays very little going on - with only a single OPDP letter issued so far this year.

There was actually a lot going on at the agency this week, but in the interest of brevity, here are a few things that caught my eye.  There is a lot about Zika this week and given the outbreak and the approaching summer, that is a trend likely to continue.

  • FDA Testifies on Zika Before House – FDA Chief Scientist Luciana Borio, M.D. appeared before the Subcommittee on Oversight and Investigations, House Energy and Commerce Committee this week to talk Zika, covering key areas of concern and FDA activities related thereto.  A full text of her remarks can be found here. Summarily she covered:
    • Blood and Tissue Safety – She stated that in absence of a blood screening assay, risk of transmission by blood transfusion is considered likely. To that end, FDA has issued new blood donor guidance and this week (see below) issued guidance for human cells and tissue based products. She said FDA is facilitating the development of tests for screening blood;
    • Diagnostic Testing – While there are no commercially available tests now, she stated that the agency has been reaching out to potential manufacturers to encourage and accelerate development and she said that under Emergency Use Authority that FDA had authorized the use of a test for detection of antibodies;
    • Vaccines and Therapies – She stated that there were not any treatments or vaccines in advanced development at this time;
    • Vector Control - She did state that FDA is reviewing information regarding the potential of a genetically engineered mosquito that might help suppress mosquito populations – however if approved an environmental assessment would have to be conducted and released;
    • Fraud – She stated that the agency would be actively monitoring for product claims related to Zika and will implement enforcement actions if necessary.
  • FDA Recos on Zika and Human Tissue/Cells – A few weeks ago FDA issued recommendations related to Zika and the blood supply and this week the agency followed up with Human Tissue and Cell products. In some respects, the recommendations are similar to those for blood – donors should be considered ineligible if they were diagnosed with infection or were in an area with active transmission or had sex with a male with either of those risk factors in the past six months. However, since tissue donation includes that from non-living donors the agency stated that donations should not be considered if the donor had been diagnosed within the past six months – a period chosen with limited data in mind.
  • FDA to Study Cartoon Use in RX DTC Ads – The agency published intent this week in the Federal Register to conduct a study examining the effects of using cartoons in direct-to-consumer advertising of pharmaceutical products to determine if it is a distraction for viewers when it comes to risk information. The agency is seeking public comment on this. As of this writing, no comments had been submitted, but if you are so inclined…. here is a link.

That’s it for me this week folks. Have a good and safe weekend.

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Promotion of Investigational Compound – Historical Overview

Communications regarding medicines in development – often referred to as “investigational compounds” can be particularly challenging. On the one hand, there are data milestones and advancements for the product through the regulatory cycle about which there is great interest. On the other hand, a compound that is being investigated through clinical study for possible approval by FDA should not be promoted nor should it be implied by any means that it has both safety and efficacy for a medical use for which it has not yet been approved. When does the line get crossed?

Specifically FDA regulations state that “A sponsor or investigator, or any person acting on behalf of a sponsor or investigator, shall not represent in a promotional context that an investigational new drug is safe or effective for the purposes for which it is under investigation or otherwise promote the drug. This provision is not intended to restrict the full exchange of scientific information concerning the drug, including dissemination of scientific findings in scientific or lay media. Rather, its intent is to restrict promotional claims of safety or effectiveness of the drug for a use for which it is under investigation and to preclude commercialization of the drug before it is approved for commercial distribution.” (21 CFR 312.7 (a) )

So how often has it happened that FDA has taken action when it perceives that there has been promotion of an unapproved compound and under what circumstances has it occurred?

It turns out that while the omission or minimization of risk information is the most common of all violations that have been cited by FDA over the years, promotion of an investigational compound has not been all that common. Looking back to all of the violations cited by FDA’s Office of Prescription Drug Promotion (OPDP) recently, and back when it was called the Division of Drug Marketing, Advertising, and Communications (DDMAC) through 2004, I have counted only nine letters (out of the total of 309 letters issued during that period) that addressed this particular violation.

Of the nine letters,

  • 5 involved products being investigated for use in oncology
  • A website was the communications vehicle involved in the violation in 7 out of the 9 circumstances
    • The 2 others included one brochure and one involving spoken word where an investigator gave interviews to the media that FDA deemed in violation.
  • All of the letters involved small companies.
  • While the search looked at the years 2004-2016, the first one showed up in 2008.
  • Eight of the nine letters were untitled letters – only 1 was a warning letter.
  • Finally, and perhaps most importantly, a violations cited in these letters are not predicated on a single statement. Rather the letters cite multiple statements made about the efficacy and safety together create an impression that a compound is safe and effective when cited. That is not to imply that an individual statement could not be the subject of a letter, particularly if it were brazen enough, but that the recent letters have looked at more than one statement and the totality of a presentation within the context of the communication.

And here is one interesting note – while letters from OPDP/DDMAC regularly cover more than one violation in a letter, each of the nine involving promotion of an investigational compound shared one characteristic.  They were single issue letters, meaning that the promotion was the sole reason the letter was generated.

If you are interested in seeing each one individually, here are links:

While this posting is not meant to be a tutorial, reading the letters in combination will give one a good idea of the kind of language that runs outside of regulatory parameters in the eye of FDA. Those parameters allow for the exchange of scientific information – so sticking to factual data during pre-approval is important while characterizing outcomes or position of a product in the marketplace takes you away from that.

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