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Intouch Holds Popular Webcast on FDA Social Media Guidance With Kulkarni Law Firm and MM&M

Sarah Lacy

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The industry has been waiting on social media guidance for five years, so it was no surprise that, after draft guidance was released in January with little fanfare and more than a few gray areas, there would be a lot of questions.

Did FDA give the industry the green light for social media, or should marketers continue to go slow?

On Thursday, March 13, Intouch’s Sean Nicholson and Doug Weinbrenner joined attorney Darshan Kulkarni in an expert panel moderated by MM&M’s editor-in-chief, James Chase. The topic at hand? What FDA’s new draft guidance means for social media in pharma. Proving deep interest in the topic, some 350 people logged on live to watch, listen, and participate.

The panel began by giving an idea of what the draft guidance states. Next, they specifically discussed implications for user-generated content and for paid spokespeople. They explained what it will mean for the filing requirements for submitting marketing activities to the FDA and recommended how marketers’ workflows can be reconsidered. Finally, the panel addressed about a dozen of the over 40 specific questions that were asked.

Some highlights from the webcast:

Sean Nicholson, Intouch’s senior director of social media strategy, reminded listeners that this guidance is not the end-all, be-all. It is, rather, a part of a larger set of guidance documents that the FDA forecasted in 2009. “The FDA is aware of the issues that the Internet presents,” he pointed out, “and is slowly rolling out guidance.” He and the other panelists did reinforce the draft status of the guidance and suggested that some of the many questions they discussed, as well as many of the others that listeners have, should be submitted to the FDA in response to their request for comments on the document. Feedback from industry may help the FDA modify or clarify their guidance. Comments and suggestions regarding the draft document should be submitted by April 14; electronic comments can be submitted at http://www.regulations.gov.

Doug Weinbrenner, director of social media at Intouch, discussed user-generated content. He defined what it was — for example, it could include comments on a Facebook wall, tweets about a product, or other types of information not authored by the company — and he explained a company’s responsibilities related to it. “We are not responsible for user-generated content, but we may be held responsible for our reactions to it,” he summed up.

Darshan Kulkarni, a lawyer specializing in the pharmaceutical industry, had good news for pharma marketers. “The FDA wants you to be responsive,” he pointed out. He framed the guidance not as restrictive, but rather as a path that can make it possible for companies to interact and help patients by responding to their comments and questions.

An engaging interactive segment allowed viewers to participate in several poll questions in which hypothetical situations were presented and viewers were asked how they would “rule” on the best course of action. When the responses were tallied live, the best courses of action were disclosed and explained.

Further proving the heavy interest in the topic, more than 40 questions were posed to the panel. Questions touched on issues such as:

  • What does the “monthly review” that the FDA needs submitted look like?
  • Under what circumstances does a website count as independent from a pharma company?
  • To which types of healthcare products do these social media marketing guidelines apply?
  • When will the FDA publish final guidance, and to what extent do we have to follow this draft in the meantime?
  • When social media platforms have updates, how do brands keep up with that while remaining compliant? Must they resubmit their materials completely?
  • What are the implications for products marketed internationally on global social media platforms?

Did you miss the “Green Light or Go Slow” webcast? Listen to the archived webcast here (login may be required), and view the presentation on Slideshare here.

 

Intouch Solutions is the leader in providing social media services to pharmaceutical companies. A winner of multiple social media awards, Intouch Solutions currently provides social media services to more than 15 major pharmaceutical companies. Services range from strategic planning, education, listening, training, and governance to tactical execution and community management across multiple platforms.

Contact Sean Nicholson at sean.r.nicholson@intouchsol.com for more information on how Intouch Solutions can help your organization safely and effectively engage in the social media space.

 

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