Last week, 12-13 November 2009, saw the FDA’s ‘Public Hearing on Promotion of FDA-Regulated Medical Products using the Internet and Social Media Tools’. This was the long-awaited opportunity that pharmaceutical marketers worldwide had been waiting for, to engage in dialogue with the FDA about how the Internet has changed medical marketing.
The FDA public hearing in Washington DC
The last time the FDA held a hearing of this nature was in 1996, and with the rate of change in the way that the Internet is used, it was clearly about time that the pharmaceutical industry and the FDA has some constructive dialogue.
Not that the hearing included much dialogue. Packed with 69 presentations over two days, the FDA panel’s comments and questions were kept to a minimum. TheFDA’s formal response is expected to come next year.
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Earlier this year, we reported on the FDA’s warning letters about Google advertising to fourteen pharmaceutical companies and analysed the impact of regulation online. This action by the FDA signalled the start of things were changing in the FDA’s approach to the Internet and sparked a call for greater clarity about how pharmaceutical companies should market themselves online. According to both Google and Yahoo! at last week’s hearing, the effectiveness of pharmaceutical keyword advertising in the USA immediately dropped after the FDA warning letters as companies felt unable to provide enough information to encourage consumers to click through.
But the big issue wasn’t simply about reducing advertising effectiveness. Pharmaceutical marketers wanted to know what they could or could not do within the boundaries of regulation. The primary concern was that the boundaries were unclear.
A US-only impact?
Now, if you are a pharmaceutical marketer outside the USA, under a different regulatory regime, you might wonder what all this has to do with you. After all, the vast majority of the rest of the world does not operate a direct to consumer (DTC) model like the USA does, so many of the pharmaceutical social media campaigns that we’ve previously covered might seem irrelevant to you.
But the important lessons so far about the FDA hearing are not really about the specifics of FDA regulation or the DTC model for marketing medicines.
After all, the primary concerns amongst pharmaceutical companies about regulatory requirements, as cited by Johnson & Johnson’s Marc Monseau in a blog post about the hearing, are around the requirement to report any side effects that people may experience whilst taking medicines (a form of ‘adverse event’), and to ensurethat they do not promote their products beyond what is covered in their approved product label (promoting ‘off-label use’). Now, if you are outside of the USA, aren’t these amongst the primary regulatory issues that affect your online marketing too?
The Internet knows no boundaries
Of course, unlike regulators the world over, the Internet rarely discriminates on the basis of geographic boundaries. So if you are outside of the USA, what the FDA allow or do not will affect health consumers in your territory too. For example, whilst you might operate in a non-DTC environment where you cannot market your medicines to patents, those same patients in your territory may be engaging with your US-based colleagues’ social media marketing campaigns and discussing medicines.
And if you think that’s a bad thing, consider the alternatives: if an Internet user searches for one of your medicines and does not find a legitimate product website anywhere in the world, what do they find? In many cases, unapproved pharmacies offering to sell potentially fake medicines without prescription to unsuspecting patients (and that’s another story altogether).
One of the biggest difficulties in establishing clear regulatory guidance is in making sure that regulators understand or are advised on the technicalities of the Internet and social media. Unless regulators understand, for example, that in online encyclopedia Wikipedia, any member of the public can edit an entry, how can they decide who should be held responsible for its content?
It was clear that all speakers over the two-day FDA hearing understood the need for regulator education, for the vast majority of time was spent elaborating on how important the Internet is for healthcare and on how social networks work. This resulted in much repetition but I would imagine that most members of the FDA panel left the hearing with at least a better understanding of social media.
Clear guidance is needed
The big challenge for the pharmaceutical industry worldwide is uncertainty about how it could and should interact using the Internet and social media. This issue was raised by many of the speakers at the hearing, including Eli Lilly’s Michele Sharp, who asked the FDA to take into account the unintended consequences of either providing no further guidance to the pharmaceutical industry or of imposing too many restrictions. Either approach, she said, would keep the industry silenced on the sidelines.
Sharp said that to date, Lilly has avoided significant interaction with healthcare professionals and patients about products in social media forums, largely because of lack of clarity in understanding the FDA’s expectations as to how Lilly could participate and comply with FDA requirements.
Accountability must rest with content creators
Not surprisingly, speakers widely agreed that creators and publishers of information should be held accountable for the information that they create, control or promote including sponsored content. More importantly, it was widely felt that companies cannot be held accountable for information that they do not have editorial control over.
In print advertising of medicines, much space is taken up in displaying important safety information required by regulation. This is one of the challenges faced in online advertising and one of the issues picked up in the FDA’s warning letters earlier in the year.
Various solutions to this were proposed, including suggestions that providing safety information just one click away should be allowed. There was, and no doubt will be for some time, much discussion about the pros and cons of this suggestion.
A new keyword ad format?
Not a company to miss a commercial opportunity, Google presented their proposal for a new ad format which it hoped would allow pharmaceutical marketers to advertise within FDA regulations.
Other ideas from presenters included FDA-approved Twitter hashtags, an FDA-approved logo, rich media advertising to allow lengthy information to be displayed in small spaces, processes for determining accountability, and a plea for a simple set of ‘can-or-cannot do’ rules.
Will anything change?
So after two days of talking, what is likely to change? The hearing may have helped the FDA gain a better understanding of the confusion pharmaceutical marketers are faced with regarding regulation and the Internet, but I have a feeling they knew something about this already.
One thing is almost certain: by the time the FDA make any ruling following the hearing, new platforms will have emerged that raise new questions and uncertainties – and of course, opportunities! Will the FDA be able to regulate in such a way as to cover any unforeseen platforms and digital media channels? I hope so, but I doubt it.
So what’s the big lesson? That nothing has changed. We’ve recently published interviews from pharmaceutical company social media communicators – Johnson & Johnson’s Marc Monseau on Twitter and Pfizer’s Bengt Mattson on his Swedish blog Ansvarsblogg – and both said that the platforms have not changed the basic rules of communication.
In my experience, there are still huge untapped opportunities for those pharmaceutical marketers around the world who will carefully take measured steps in social media and the Internet. Yet the constraints of regulation are too often used by some as an excuse for poor engagement strategies.
Whatever changes or clarification emerge from the FDA or any other regulators worldwide, one thing is certain: regulators will not tell you how to do your pharmaceutical marketing effectively. I recommend that you continue to innovate, taking well planned, strategic steps to engage stakeholders. And speak with healthcare engagement experts at Creation Interactive about how our Discovery Methodology can help you achieve success in what is destined to remain a highly regulated healthcare marketing environment.