Pharma Awaits Next Steps from FDA on Social Media
Expert Analysis by Mark Tosh, Editor-in-Chief, DTC Perspectives

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 last week to the conclusion of roughly 16 hours of presentations by 69 speakers over two days. The FDA called the hearings Nov. 12-13 to find out more about how pharma companies are using online promotion and education methods to inform patients and to hear ideas on whether social media use by pharmaceutical companies should be addressed in FDA guidance or regulations. The industry would like new guidance – or something that provides clarity around new media – that would provide drug companies wider latitude to use the new media tools to advertise on Web sites, search engines and social media sites.

After the hearings concluded, there were two words pharma 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, and the FDA deserves some praise for finally getting these issues out into an open forum. It also seemed evident that the few critics of pharma 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.

As 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.”

The impetus for FDA to call this hearing was strong industry reaction to 14 notice of violation letters issued in late March that cited pharmaceutical companies' use of sponsored links on search results pages. The ads were deemed violative because they included benefit information without the corresponding risk details (which was due to the space constraints of the sponsored-link format).

At the hearing, 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.

Another solution was offered by the agency Ogilvy 360 Digital Influence. 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.”

On the other side of this debate, however, are consumer advocates who see the Internet as a medium that could be too easily abused by pharma. “Drug companies should not be engaged in promotion of their products via e-mail, text messaging or social-network sites,” noted Steven Findlay, senior health policy analyst for the advocacy group Consumers Union. “It should be done on their own site.” He added that the FDA's existing print ad guidelines, which require detailed explanations of the risks associated with prescription drugs, should also apply to online advertising, where, he noted, “space is not an issue.”

While the presentations tilted in favor of finding a way to put the full power of the Internet in the hands of both pharma 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.

“It all comes back to this big question,” Pfizer's Lewis-Hall noted. “How do we meet the health information needs of consumers, patients and professionals in a new environment that is changing literally by the hour?” She added, “I ask that you sustain the momentum and continue to listen to a range of expert voices, such as industry, agency, technology partners, patient advocates and thought-leaders…. I see some common themes. This space is nothing like what we have seen in the offline world and requires specific guidance for the online space.”

Only time will tell how the FDA responds.

 

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