FDA has issued its first of many draft guidance on pharmaceutical marketing on social media sites. The guidance addressed "responding to unsolicited requests for off-label information about prescription drugs and medical devices" but said it plans to issue multiple guidance’s to address different social media issues.
Unsolicited requests can be public or private requests for more information and does not include questions arising from a presentation, a sales reps mention of a product, online posting of clinical trials on unapproved uses of the drug on social media, or if the firm encourages users to post videos or blogs of their own uses of the product and questions regarding off-label use arise from those social feeds.
If a request is non-solicited but private, the firm may respond even if the response includes information about unapproved conditions or indications for use. The response, however, should only be made to the specific individual, limited to the exact questions being asked, and the information should not be publicly disseminated. The response should be informational and should not include any promotional material. Responses may also not be handled by the sales and marketing department but should be relegated to the medical or scientific personnel. The response must also include a copy of the FDA label, disclosure of the approved indications, a statement that the product is not approved as being safe and effective for the use addressed, all important safety information, and a complete list of references for all of the information disseminated.
Public unsolicited requests should not be responded to unless there is a very product specific question. If the question is specific to their product, then the firm's public response is limited to providing contact information and should not include any off-label information. Links may be attached to the products FDA label but should not include any links to promotional materials, product websites, firm websites, etc.
Cited examples present some areas of challenge, however. If a company encourages users to post videos or write blogs about their uses of the product, and they talk about off-label use of the drug resulting in questions about off-label use, this will be considered a solicited request and could be considered illegal promotion of the company.
Social media has proven to be an effective means of disseminating information, but pharma has to be very circumspect in its use of this tool since independent postings and comments might be deemed solicited and attributable to the company.