FDA releases draft guidance on requests for off-label information
FDA released draft guidance outlining how companies can respond to unsolicited requests for information on off-label use of a drug or device. FDA said off-label information should only be provided via private, one-on-one communication with the individual requester, even if the request was made through a public forum, such as product websites, online discussion boards or live presentations. FDA expressed concern that providing off-label information in a public forum may expose those who did not make the request to off-label information. The agency also is concerned that the information could remain publically available online even after the information is outdated. For a public request, the guidance recommended that companies only respond with contact details so individuals can follow up privately with the company to obtain off-label information.
The guidance noted that responses should be truthful, balanced, non-misleading and non-promotional, even if responding requires a company to provide information on unapproved indications or conditions of use. Comments on the guidance are due 90 days after publication in the Federal Register, which is expected Friday. ...