SOURCE: Cutting Edge Information

Cutting Edge Information

June 16, 2011 12:07 ET

Making Sense of Social Media in a Regulatory Vacuum

While FDA Delays Social Media Guidance, European Group Weighs In With First Doctrine

RESEARCH TRIANGLE PARK, NC--(Marketwire - Jun 16, 2011) - The Food and Drug Administration recently announced yet another delay for the release of its highly anticipated guidance on social media, but a European trade association has now published a groundbreaking directive of its own. The guidelines provide long-awaited insights into the future acceptable use of social media by pharmaceutical and biotechnology companies.

British Trade Association First to Weigh In on Pharmaceutical Social Media

"Marketing and medical affairs executives in the U.S. have been looking to the Food and Drug Administration for direction on using social media correctly," said Jason Richardson, president of Cutting Edge Information. "The European guidance offers a potential glimpse into what the FDA's own guidance will contain."

A new executive briefing, 'Making Sense of Social Media in a Regulatory Vacuum,' examines the pharmaceutical industry's efforts to navigate unclear and delayed regulatory guidelines for social media. U.S. trade association PhRMA has indicated the organization intends to wait on the FDA before setting its own doctrine for companies' social media usage.

FDA has repeatedly missed its self-imposed deadlines to release guidelines. The growing sentiment among pharmaceutical marketing professionals is that official guidance is still some time off. Moreover, FDA leaders have indicated the body will take a piecemeal approach, issuing multiple guidance documents each aimed at a specific question about usage.

The Association of the British Pharmaceutical Industry (ABPI) has jumped out of the regulatory vacuum by publishing a set of guidelines instructing its member organizations how to use social media and online communication in ways that keep them compliant with ABPI's overall code of conduct.

Reading the Tea Leaves

"Companies are wary of venturing into unknown territory, but they are also aware of the great potential of social media," Richardson said. "The industry is eager for any information that may hold clues for negotiating the social media landscape."

The ABPI guidance tackles adverse event reporting, blog sponsorship and link sharing, among other hot-button issues. The guidance avoids platform-specific recommendations on social media channels such as Twitter and Facebook, instead focusing on acceptable communication practices.

For more information about pharmaceutical social media strategy, contact Cutting Edge Information at +1 919-403-6583.

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    Eric Bolesh and Casey Ferrell