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ill side effect information ever be one click away?

After years of mulling over social media uses, the Food and Drug Administration plans to study the whether a tweet promoting a prescription drug with a link to risk information is an acceptable way to reach consumers.

The plan is the latest in an ongoing, but drawn-out, effort by the agency to provide the pharmaceutical industry with guidelines for using social media to promote medicines. The FDA, in fact, two years ago issued a draft guidance about the use of social media platforms, such as Twitter, but never actually addressed if drug makers could employ links to convey important side effect data.

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The study, which the agency disclosed in a Federal Register notice on Tuesday, may eventually mean that companies will find it easier to promote their medicines, since both risk and benefit information must be provided to consumers in any material. The failure of the FDA to offer more guidance on this topic has, instead, caused confusion, especially since the agency has dissuaded the use of links.

In fact, companies had been using links until April 2009, when the FDA unexpectedly issued 14 letters to different companies warning against links that contained risk information. As a result, this ended the one-click rule, although there was never any official rule of that sort, explained Mark Senak, a senior vice president and partner at the FleishmanHillard public relations firm and who writes the Eye On FDA blog.

Since then, however, the pharmaceutical industry has shied away from using links over concerns that the agency may issue violations. Drug makers and their marketing partners argue the FDA social media policies have failed to keep up with technology, such as character limitations, and, as a result, are restrictive.

The question now is whether this planned study signals a renewed interest on the part of the FDA to revisit social media usage by drug makers and if the agency is growing more comfortable with ways to convey side effect information, specifically.

Senak noted in a blog post Wednesday that drug makers collectively have at least 300 Twitter feeds, although the “overwhelming majority” are not about specific products, but instead are geared toward corporate news, patient recruitment for clinical trials, and advocacy issues.

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“The digital milieu is where patients learn about health care. It’s one of primary places where they go,” he told us. If the FDA was to allow companies to use links to provide risk information — the one-click scenario, in other words — “it would free up the environment in which companies communicate about products. But it would have taken them seven years to get to that point.”

Indeed, at this point, he questioned whether the agency effort is worth it. In his view, the FDA would be better off addressing some of the gaps noted in the social media guidance two years ago, such reporting side effects or using links to third-party sites that contain still more information.

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