FDA: don’t broadcast discussion on off-label uses
pharmafile | January 6, 2012 | News story | Medical Communications | FDA, Facebook, Twitter, off label, social media
The FDA has released long-awaited guidance for pharma firms about social media use.
The FDA held a two-day public hearing about pharma and social media in November 2009, and many had hoped the resulting guidance would clear up numerous legal grey areas.
A number of pharma bloggers and commentators say they are disappointed that the guidance, released with little fanfare, does not cover more contentious areas.
But it does address one central question – how pharma should respond to queries about off-label uses of their medicines.
The US regulator says unsolicited questions about off-label drug made via forums like Twitter and Facebook can be replied to, but responses must be made privately.
The FDA says pharma companies must exercise caution when answering questions about uses outside a licence in public forums, as off-label promotion of medicines is against the law.
The regulator says: “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.”
It adds: “If a firm announces results of a study via a microblogging service (e.g., Twitter) and suggests that an off-label use of its product is safe and effective, any comments and requests received as a result of the original message about the off-label use would be considered solicited requests.”
The FDA says it would consider this “evidence of a firm’s intent that a drug or other medical device be used other than that specifically approved or cleared by the FDA”.
The regulator also stipulates that personnel from the company’s medical department, and not marketers, should respond to the inquiries. It says the inherently promotional role of marketers makes them unsuitable to communicate with the public in such situations.
Read the guidance in full here
Ben Adams
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