Sneak preview: This afternoon, the House Energy and Commerce subcommittee on Health will hear from FDA Deputy Commissioner Joshua Sharfstein and other agency officials at the first drug safety hearing since the new administration took office. We’ll have more on what Commissioner Sharfstein has to say later this afternoon.
In other FDA buzz, Mark Senak at Eye on FDA says that shifts in web referral traffic–Facebook now tops Google as the top referring site—underscores the power shift toward social media on the web:
The emergence of Facebook as a driver of traffic signals an important shift in the way that people are getting and consuming information. More than ever, the idea of referral from a contact is taking up a huge proportion of the spectrum. That means that for any message – whether it is product related, or public health related – to gain traction, you have to do more than build a Web site and wait for people to discover it. You have to have a Facebook presence.Mr. Senak, who consults industry on communications, points to some of the problems of a regulated industry participating in a space as splintered and unregulated as Facebook and Twitter, when it’s not always clear who’s doing the talking. He says FDA should be on Facebook. But it’s not clear exactly what he wants the agency to do once it gets there – serve in an ombudsman or watchdog role? or actively engage with consumers and those in the pharma community? Just avert the “Risk of Ignoring”? In a previous post, he suggests that Facebook would provide a good portal to agency resources, and that may be so, but he leaves aside the important question of how the FDA might protect public health in that space.
This is part of a larger conversation about how pharma and medical device companies operate on the internet – an act which, we note, is a form of marketing. The FDA is charged with regulating the marketing of approved prescription drugs and devices.
In November, the agency invited the public to weigh in on how the agency can uphold its mission to protect the public health as companies move more and more of their marketing resources and attentions to the internet. Community Catalyst and the Pew Prescription Project urged FDA to proceed with caution—and until there is good evidence of public health benefits and comprehension of risks in online venues, existing rules about how companies talk to consumers and what they say should not be bent or relaxed.
But Senak detracts from his call for FDA to “be there” by urging companies not to wait for rules or guidance, suggesting that those who wait to understand the parameters of online marketing do so at their peril.
And so as FDA slowly grapples with its increasingly complex task of developing some guidance around social media – an environment that is constantly evolving at breakneck speed – the agency needs to consider how people are in fact communicating today and companies need to decide if they can afford to wait for the agency to issue any parameters for operating in this environment or they forge ahead and hope for the best. At this point, you must decide if you shape the environment, or you let it shape you.It’s a worrying rallying cry, considering that these companies aren’t selling refrigerators – they’re selling life-changing and lethal substances.
–Kate Petersen, PostScript blogger