Highlights of the 11/2009 FDA Hearing on Healthcare and Social Media

Tom Abrams summed up two days of FDA hearings in one word: “Wow.”

Abrams, director of the FDA’s Division of Drug Marketing, Advertising and Communications, was reacting to the conclusion of roughly 16 hours of presentations by 69 speakers over two days. As reported in my last blog, the FDA called the hearings Nov. 12-13 to find out more about how healthcare and pharma companies are using online promotion and education methods to inform patients, and to hear ideas on whether social media use by such companies should be addressed in FDA guidance or regulations.

After the hearings concluded, there were two words healthcare marketers and agency executives used to sum up their sentiments: “What now?”

That’s the big question for everyone, which even Abrams acknowledged will be challenging for the agency to address. He didn’t provide a timetable for FDA’s expected next steps, other than to note the docket for the hearing will remain open until Feb. 28, 2010. “We will do this carefully so we get this right,” Abrams said in his wrap-up discussing how FDA will proceed in reviewing the data and presentations. “It’s too important of an area not to do it right, as we want the best information about medical products [to be available] for consumers and healthcare professionals.”

The takeaways from the hearing were fairly clear: the Internet and social media are quite different than traditional print and broadcast advertising. Also, it is evident that the few critics of healthcare promotion who presented at the hearings want the FDA to raise the bar on fair balance presentation using new media and agency executives, while many DTC advocates are full of ideas for making the Internet more user-friendly for health-seeking searchers.

A few highlights from the hearings:

  • Pfizer chief medical officer, Dr. Freda Lewis-Hall, noted in her second-day testimony, “We’ve clearly seen from our experience that social media is a different animal. It does not operate in the same way as other traditional communication channels. Based on our research with physicians….. We now know that doctors expect transparency, speed, convenience and custom-tailored approaches in answering even the most complex medical questions. They don’t want to be TALKED AT…they want to engage in a dialogue, but they want to initiate that dialogue and keep control over it.”
  • Google representatives suggested a new, custom ad format for FDA-approved products which would include an extra line of text to clearly state risks and also link to more information for consumers. “We think this new format will help set a clear standard for advertisers and give users important information,” Google managing policy counsel, Pablo Chavez, wrote on the search company’s blog last week.
  • Ogilvy 360 Digital Influence offered a solution. It is based on the concept of the “3 C’s Rule” of accountability for brands and online content. The gist of the Ogilvy proposal is that brands should be held accountable for content if they created it or if they collaborated with or compensated the creator in some way. “The real significance of our presentation, however, and several others throughout the day was that they are clear signs from people within the industry raising their hands and saying, ‘We want regulation to help us define right and wrong,’” Ogilvy’s Rohit Bhargava wrote on his blog. “The tone is not one of resistance, but of participation. Guidelines help all of us, and we want to see them as soon as we can.”

While the presentations tilted in favor of finding a way to put the full power of the Internet in the hands of both healthcare companies and patients, the questions asked by FDA staff did not provide a real sense of the agency’s thinking on the issue. It would be hard for anyone, however, to argue with the statement that technology has changed the playing field for anyone in the healthcare system, be it patients, doctors or marketers and agency executives.

Only time will tell how the FDA responds, but in the interim the wheel that is social media keeps turning - - creating new opportunities for healthcare companies and patients to collaborate.  Regardless of FDA direction, like other industries, social media has forever changed healthcare and pharma marketing.

About The Author

Ken Brooks

Other posts byKen Brooks

Wayfinderhttp://wayfindersf.com

06

01 2010

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