The Reality of Change: An Analysis of the November 12-13 FDA Public Hearings
By Christopher M. Schroeder, CEO, HealthCentral | Email Chris | Follow Chris on Twitter

“Few will have the greatness to bend history itself; but each of us can work to change a small portion of events, and in the total of all those acts will be written the history of this generation.” Robert Kennedy

“Part of courage is simple consistency.” Peggy Noonan

Nearly 1,000 people sought fewer than 300 available seats – while thousands more watched online – to witness, of all things, otherwise quietly held regulatory hearings. Last week the FDA gathered for the first time in a decade to discuss how both regulators and pharma and medical device makers can best leverage interactive tools and social media to promote user safety. In all the brouhaha here in Washington on health care reform more broadly, these hearings brought the first direct attention to the simple and clear proposition that the American conversation about health has moved online. Interactive technology has forever altered how health seekers inform themselves and connect with one another as they take control of their health decision-making.

The speakers at these hearings came from all walks of life, each with their own agendas. All, however, were united in two clear beliefs: First, what the FDA has done to date to help keep health seekers aware and safe is inadequate to the unleashing of patient interactive behavior. Second, the extraordinary power of the Internet and social media offers an unprecedented opportunity for regulators and marketers to engage greater collections of individuals, with highly specific health concerns, on their terms in language they can understand, to promote health literacy.

The near-universal reaction of people I spoke with, and much of the coverage, lamented “how repetitive” all the testimonies were. But I have been in Washington twenty years, have served in government. Rarely does one see such consensus on anything. And it is in the unanimity of such consistency where the foundation of change is laid.

Example after example in the presentations at the hearings underscored how Americans are exponentially seeking information and having conversations on the Internet to take control of their health decision-making. Beyond the sheer size of consumer health activity online, is the unprecedented specificity of highly-targeted, condition-related engagements across hundreds of thousands of searches and social networks each day. Millions of engagements and conversations are happening regardless. The only question must be how to engage in them usefully to make the safest, best informed decisions with their doctors.

Equally clearly articulated was that marketers empowered to safely engage online and in social media are part of the answer. In fact, pharma, medical device and health marketers not only possess unique knowledge and expertise about their products and services, they are the ONLY regulated contributors to these conversations. The FDA must be clear on what marketers can and cannot do, so that marketers can engage.

For health marketers – in fact, I have long argued for ALL marketers – the watchword is transparency. The test is quite simple – at no point should a user have any confusion as to the source of the information that he or she is considering at any time in their information gathering experiences.

For regulators, at the same time, marketers cannot be held accountable for interactive conversations or any third-party content differently than they are in any media – it would be, for example, like holding them accountable for the comment of an interviewee on a TV show where their ads run.

There is a great opportunity for a partnership of responsibility between regulators and marketers whose result would be a profound improvement in America's health literacy.

There is also a shared understanding upon which both marketers and regulators must come to terms.

The universal message, and with great passion, to regulators and marketers alike in these hearings was the plea of “health seeker first!” Users don't read the back of DTC magazine ads written for doctors because it isn't in language they understand and the presentation is intimidating. Few listen to the ends of television ads because few find value in them and most don't watch television ads AT ALL. Real users search, research, ask questions, compare stories, prepare to talk with their doctors – all in their own language and on their terms. Those who ignore this are, themselves, ignored.

Starting your marketing campaign by thinking solely of getting people to do what YOU want for YOUR outcome, creating regulations geared towards medical professionals, in legalese, trying to control health seekers to protect what YOU think works best for health safety, is a form of consistency too. Such consistency has utterly predictable outcomes, and no one benefits in the end.

Health-seeker focused change comes not only by regulators embracing the fact that the Internet has become an increasingly essential tool for consumers in managing their health, and crafting guidance that empowers marketers to get off the side lines. It requires marketers to change as well.

All that transpired last week may seem like small, repetitive, even obvious steps. And, I assure you all that any change in these worlds will take longer than we may hope. But the past is rarely prologue. We are in the midst of very new times, very new policies and policy-makers, empowered by profound shifts in technologies and communications. Individuals can now, and will, vote with their feet. The burden is on all of us to engage them on their terms, and create innovative ways to educate them and protect their best interests in safety.

Read Chris Schroeder's FDA testimony here.

 

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