It seems I’m here again writing a post in response to an FDA announcement. Specifically, in response to the FDA announcing they’re delaying an announcement. And I’m honestly not surprised. As discussed in earlier posts, FDA’s delay of guidance on social media for pharma is, in some ways, understandable. In recent conversations with health digital thought leaders at SXSW, many of us are beginning to wonder if this is even FDA’s remit. Hear me out on this. The FDA is an agency founded to protect the public, and the guidelines around Rx brand communications that have been formed stem from that. We have fair balance as part of DTC communications as a protection mechanism when speaking ‘directly to’ consumers. In fact, the US is one of only two nations afforded the DTC privilege. Looking at this topic through that lens, we can possibly reframe our perspective on FDA social media guidelines.
Taking an additional step back, let’s also look at those two words: social media. A term once appropriate and fit for purpose, it now feels myopic. At Edelman we look at the landscape differently, and encourage our clients to do so as well. We are much more interested in the digital/online environment as a whole, how and when to engage online in a way that is innovative and responsible, and deciding when it makes sense to engage at all. Again, by adjusting the lens, we are able to focus on delivering fresh content in ways that are new and exciting, while remaining compliant. We continue to work with our clients in navigating this challenging environment, and we do this by staying abreast of the latest technology, knowing the ground rules of DTC communications, through building close relationships throughout the industry, and applying appropriate innovative thinking.
We acknowledge that it is a more challenging environment without formal guidelines. Would we all feel better with definitive guidelines in place? Probably. As my colleague Emily Downward, SVP digital health and a practitioner with more than a decade of experience in the space recently stated, “It makes it more of a challenge without the guidelines. The [FDA response] we’re getting is through warning letters. We equate [a lack of formal guidelines] with going through an obstacle course with a blindfold on. You don’t know what not to do until you hit the wall.” Yet in the absence of guidelines what continues to happen is evolution and continued appropriate innovation, and that’s what drives growth.
For the past several years, those of us who’ve worked in digital health have used DTC regulations as our guidepost, and applied appropriate innovation to evolve them to the digital medium. Let’s look at what we’ve been able to do without guidelines; SEO optimization and development of smart, dynamic content continue to be the foundation of well-executed campaigns. Partnerships with 3rd party platforms that communicate online with consumers and HCPs in an FDA and HIPAA compliant manner are on the rise. From this time last year, more healthcare companies have joined the online conversation, not less. And as consumers and health care practitioners continue to look for information online, and desire to engage, it follows that this trend will continue. In my mind, this is an exciting time to be in this industry and to be a part of creating solutions where none existed before.
The healthcare industry was born of, and continues to thrive through, innovation. Why should it be any different now? By continuing to focus on protecting the public, FDA is focusing their resources in ways that serve their mission. Where does it make sense for the pharmaceutical industry to focus your efforts – and what role does PR have to play in all of this? It’s your remit to communicate about your brands. It’s the job of your PR agency to place your brand top of mind in a variety of media, including digital. In PR we know content and we know conversation. At Edelman we also know technology and continue to monitor its progress – and shortcomings. As with healthcare, Edelman was founded on innovation and collaboration, and it’s those values, appropriately applied and blended, that we bring to bear for our clients and the industry as we seek to break new ground in digital health.
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