It’s never much fun when parents receive a letter from the principal alerting them to the mischief that their young darling has been causing at school.
It’s a whole lot worse when the letter is to pharmaceutical company management, it’s from the American Food & Drug Administration (FDA) and the message is clear: cease and desist.
Drugmaker Novartis found itself in that extremely unpleasant situation last month, when the FDA demanded that the company remove a “Facebook Share” widget on the website for its leukemia drug Tasigna.
What? These widgets are at the heart of the new social web. Sharing via Facebook is virtually guaranteed by the American Constitution (or, if not, it should be). What’s going on here?
What this incident illustrates is one of the perils of today’s technology, especially if you’re in a closely regulated industry such as pharmaceuticals or (any day now) financial services.
As ReadWriteWeb pointed out, the “Share This” tool drew its content (the words that were shared with Facebook users) not from the material displayed on the Tasigna page but from its metadata, the content designed for search engines and not usually visible to human visitors to the web page.
Unfortunately that metadata just didn’t comply with FDA requirements. As the FDA’s letter points out:
The shared content is misleading because it makes representations about the efficacy of Tasigna but fails to communicate any risk information associated with the use of this drug. In addition, the shared content inadequately communicates Tasigna’s FDA-approved indication and implies superiority over other products. Thus, the shared content for Tasigna misbrands the drug in violation of the Federal Food, Drug, and Cosmetic Act and FDA implementing regulations.
Oh, is that all?
Well, no. The FDA also dinged Novartis for failure to submit the Facebook Share widget for approval as is required for pharmaceutical promotional materials.
Novartis removed the Facebook Share widget after the FDA’s request, but it also made another change. The company edited the description in the metadata of each page to conform to FDA rules.
The Bigger Picture
Pharmaceutical marketers around the world are facing some tough challenges, of which the “Facebook Share” incident is just a recent example.
In today’s always-connected world, consumers are turning to the web and each other (through social networks) for information on symptoms, diseases and treatments — self-diagnosing before they even visit a doctor. There’s a high risk of misdiagnosis and desperate need for expert advice.
Unfortunately, this cyberchondria is likely to go unchecked, at least in terms of input from the pharmaceutical companies. Their hands are tied by regulators, usually for the very good reason that typical advertising behaviour (puffery, unsubstantiated claims, unfettered performance promises) can have somewhat terminal side-effects in this particular industry.
As we noted when we last discussed the problem (in October last year, just before an FDA hearing to consider social media and the pharmaceutical industry):
Exactly how do you provide the usual slab of “prescribing information” (often hundreds of words outlining the risks associated with a given remedy) in an environment such as Twitter (140 characters) or even Google Adwords (12 words)? Must any ‘fans’ of a pharmaceutical product provide written disclaimers before going viral with their endorsements?
In its presentation to the FDA hearing, Ogilvy’s 360 Digital Influence arm made these comments:
1. How can marketers fulfill regulatory requirements with space-limited social media?
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The space and real time limitations of social media make it unreasonable in some online communications such as Twitter to include full fair balance, Important Safety Information alongside any branded message.
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Including fair balance, Important Safety Information that is the online equivalent of a “turn of a page” is reasonable.
The Suggested Solution:
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The FDA should enforce the “1-click rule” – in effect ensuring the full fair balance, Important Safety Information is AT MOST one click away from any branded message.
2. What parameters should apply to posting corrective information on third party sites?
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Marketers should not be responsible for policing any content that anyone posts online that relates to their products or brand that has not been developed by company.
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The exception to this rule is if the content meets any of the “3 C’s Rule” noted below.
The Suggested Solution:
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Marketers are not responsible for posting corrective information unless they are deemed accountable for that content under the “3 C’s Rule.”
3. What online communications should marketers be accountable for?
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There should be a simple and consistent way for determining accountability for any content online.
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Marketers should not be held accountable for content that is not under their control or influence.
The Suggested Solution:
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Implement “The 3 ‘s Rule” — marketers should be held accountable if the answer to any of the 3 “C” questions below is yes:
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Creation
Did the marketer create the content and has it not been altered or excerpted in any way by a third party? -
Collaboration
Did the marketer work directly or indirectly with any third party to create the message? -
Compensation
Did the marketer fund the creation of the message or compensate the creator in any way?
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The Health Professionals You See Most Often
The jury’s still out on the vexed issue of whether pharmaceutical companies should be allowed keys to the social kingdom. In the meantime, however, another industry sector has stepped up to the bat: pharmacy.
Earlier this month, two of America’s largest pharmacy chains, Walgreens and Rite-Aid, rolled out programmes in which their customers can use Internet chat to talk with pharmacists about medical advice 24×7. However the two chains have taken significantly different approaches.
Walgreens has given its pharmacist-chat-teams full access to its medical databases on patients across the country while competitor Rite-Aid took the more conservative route of limiting chatters to generic advice based on nothing more than what consumers choose to share.
As retail technologist Evan Schuman remarked:
Walgreens’ more daring approach has some huge potential benefits. For example, what if a consumer asks about a particular drug interaction with an over-the-counter (OTC) sleep aid but forgets to mention a long-term prescription? With the ability to see that consumer’s full list of medications, the pharmacist could spot a problem and potentially prevent a life-threatening combination. How much consumer loyalty is earned by a chat that proactively saves a patient’s life?
The ability to add in OTC drug questions and information to consumers’ databases is also medically valuable. It would allow their personal pharmacist in their local branch to flag OTC interactions, which those pharmacists otherwise would have little way of knowing (unless an eagle-eyed cashier happened to notice).
In our view, pharmacy does have a valuable role to play in social media, providing (as it does in the real world) a buffer between pharmaceutical companies and the public at large. There is the usual problem of “where’s the money?” — who pays for pharmacists to dispense free advice online? Government? Pharmaceutical companies? Users?
Resolution remains somewhere beyond the horizon …
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