According to the guidance, many firms encounter requests for off-label information about their products through websites, discussion boards, and other electronic forums, and FDA recognizes that firms are capable of responding to such requests in a "truthful, non-misleading, and accurate manner." Indeed, FDA acknowledges that it can be in the best interest of public health for companies to reply to these requests because other participants in the discussion may not be able to provide accurate information.
The guidance discusses responses to both non-public information requests, such as a one-on-one email or telephone call, and public requests, such as a request on an online forum. The latter type is more complicated because firms must ensure that their response does not communicate unapproved information to those who have not asked for it.If a firm responds to unsolicited requests for off-label information in the manner described in the draft guidance, FDA said it will not use such responses as evidence of a firm's intent that the product be used for unapproved or cleared uses.
Stephanie Sutton is an associate editor of Pharmaceutical Technology.