FDA Issues Draft guidance On Off-Label Inquiries Through Social Media
The FDA has been mulling over several issues on social media since the Section 15 Hearings in 2009. It has, at long last, issued Draft Guidance on Off-label Inquiries conveyed through social media. Significantly, a company’s response that follows the Draft Guidance, if the Guidance is finalized as is, will not be considered proof of promotion of off-label uses.
The key questions are whether the company solicited the inquiry and whether it was conveyed through on a public non-public site. The Draft Guidance focuses on unsolicited requests, as requests solicited by the company may be considered as evidence of a firm’s intent that a product be used for promotion of off-label uses, a fertile ground for investigations and resulting large fines.
Responses to unsolicited requests regarding potential off-label use conveyed in a non-public electronic forum should narrowly tailored to the product that is the subject of the inquiry, and should include the FDA labeling (i.e., the package insert), any pertinent safety information (boxed warnings), and applicable scientific references, such as peer-reviewed journals.
Responses to non-solicited inquiries through pubic social media are significantly more restricted. Such inquires may not contain any off-label product use information and must indicate that the use in the inquiry has not been approved or cleared by the FDA. The response must refer the person making the inquiry to the appropriate medical or scientific personnel (not sales or detail personnel). On an additional cautionary note to those responsible for social media at pharmaceutical and biotech companies, the response may not be “promotional in nature or tone,” and may not contain links to promotional, product or company websites.