Off-label requests on social media and how to respond?
Unsolicited requests on social channels can come from physicians, HCPs, patients, etc. through private messaging or on public social platforms. With the expansion of social media marketing in pharma we see that this is becoming an increasing concern for companies wanting to utilize these communication channels. However, FDA’s position on this issue has not changed much since 1982. In recent years, FDA has restated:
“that firms can respond to unsolicited requests for information about FDA-regulated medical products by providing truthful, balanced, non-misleading, and non-promotional scientific or medical information that is responsive to the specific request, even if responding to the request requires a firm to provide information on unapproved or uncleared indications or conditions of use.
Regardless of whether the initial unsolicited request for off-label information was made in a non-public or public forum, a firm that chooses to respond should provide the final response containing the requested off-label information about its product only to the specific individual who requested the information as a private, one-on-one communication.”
How do we put this into practice? Responding to public off-label requests on social media platforms:
For those unfamiliar with social media, there are generally two methods of communication on every platform: 1. direct messaging (private 1-to-1 communication) and 2. public posts on a timeline, comment thread, newsfeed etc.
If the public request asks about off-label usage of a specific company’s product by name, the company of that product may choose to respond; for example:
“Hi, Company X. Can your drug, Drug Y, be used for Indication Z?” YES
“What drug/device can be used for Indication Z?” NO
However, because this is a public forum and more than one person has potential to see this information, the response on the public forum must include:
- Disclosure of involvement with firm—should not contain promotional tone
- That the request contains unapproved usage of the product
- Please contact the medical/scientific representative or medical affairs department for further information
- List contact information
What if they contact us through social media on direct message? Can we respond then?
Responses to unsolicited requests should be done by medical or scientific personnel and should not come from sales and marketing teams. Unless the people that are monitoring your social media accounts are also from the medical affairs department, the answer is no.
What type of information can we provide through private communication?
Your response can address ONLY the indication in question and must also include benefits and risks associated with the drug/device and the indication. Any other associated risks must also be included.
With your response, you must include:
- FDA-required labeling for the product (i.e. package insert, patient labeling)
- Statement that FDA has not approved usage for the product for these purposes
- Disclosure of approved indications or product
- Safety information (including boxed warnings)
- Complete list of references for supporting information (i.e. medical journals)
Please maintain documentation of this interaction.
For more information regarding this topic please refer to FDA’s draft guidance found here.
