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FDA issues draft social media guidance for off-label information

Two years after its public hearing the US regulator issues its first social media guidance

The US Food and Drug Administration (FDA) has finally issued some guidance on the pharma industry's use of social media channels like Twitter and YouTube.

It comes more than two years after the regulator held, with much fanfare, a two-day public hearing on the area, but the new guidelines are likely to disappoint many.

Instead of legally enforceable rights or responsibilities they take the form of draft recommendations, and then only address certain types of information requests.

The FDA says its new draft guidance is intended to present its current thinking on how pharma and medical device companies can respond to unsolicited requests for information about off-label use.

Such requests include those that come from “emerging electronic media”, a term that covers a range of online channels including social media.

But the FDA recommends pharma adopts a very limited policy when it comes to requests that come through channels such as social media sites.

It suggests public responses to public unsolicited requests for off-label information about a company's named product should be restricted “to providing the firm's contact information and should not include any off-label information”.

“Regardless of the fact that the original, unsolicited off-label question may have been available to a very broad audience, the firm should not make its detailed response with off-label information publicly available within the same forum.”

There is more scope for private, one-to-one, communications between companies and individuals about off-label use information.

However, this does not apply to sales and marketing personnel, who the FDA describe as “focused by training and experience on promoting a firm's products”.

The agency says this group should have no input on the content of responses to unsolicited questions or requests for off-label information.

Instead the regulator recommends questions or requests about off-label uses be referred to a firm's medical or scientific representative or department.

Off-label promotion is illegal and cases have led to large fines for pharma companies, consequently the regulator's new guidance does not cover solicited requests for off-label information.

“Such solicited requests may be considered evidence of a firm's intent that a drug or medical device be used for a use other than that specifically approved or cleared by FDA,” the guidance warns.

It cites two social media examples of these types of requests. The first is using a microblogging service like Twitter to announce study results that suggest an off-label use of a product is safe and effective.

The second example is where a company encourages users to post videos about their own uses of its product to third-party video-sharing sites like YouTube, which may result in video postings about an off-label use of the product.

Still at the draft stage, the FDA's recommendations are further limited to a narrow set of circumstances. The guidance doesn't apply to requests for information about drugs' approved indications or for information on medicines that have yet to be approved for any indication.

The FDA's 15-page draft guidance requires close reading for its implications for US pharma marketers, but former FDA commissioner Peter Pitts says it holds valuable lessons.

Writing on Medical Marketing & Media he said: “The giant regulatory bugaboo, not only of social media but of regulated speech writ large, is off-label communications. So those who are complaining this document isn't 'comprehensive enough' don't understand what it has to offer.”

Whatever limitations industry – or its agencies – may find in the document it remains noteworthy for being the first time the US regulator has addressed social media - and as such was welcomed by AstraZeneca.

Writing on the AZ Health Connections blog, the pharma company's external communications manager Tom Hushen said it was an important step that showed the FDA is paying attention to “these changing mediums”.

“These channels help us listen to and participate in important conversations about health care in the United States. Therefore, we applaud the FDA for providing guidance and look forward to the evolution of health care conversation in digital media,” he said.

• Read the full Guidance for Industry Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices

5th January 2012

From: Marketing

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