FDA has released a new draft guidance that offers recommendations to companies wishing to respond to unsolicited requests for off-label information, including requests made via social media websites. The guidance is entitled Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices and will be available for comment for 90 days from the date of publication.
According to the guidance, many firms encounter requests for off-label information about their products through websites, discussion boards, chat rooms or other electronic forums, and the FDA recognizes that firms are capable of responding to such requests in a “truthful, nonmisleading, and accurate manner.” The guidance states, “Furthermore, as these firms are regulated by the FDA and have their own robust and current information about their products, FDA recognizes that it can be in the best interest of public health for a firm to respond to unsolicited requests for information about off-label uses of the firm’s products that are addressed to a public forum, as other participants... may not provide or have access to the most accurate and up to date information...”
The guidance describes how to determine whether a request is unsolicited or solicited (solicited requests may be considered evidence of a firm’s intent that a drug be used for off-label purposes), and provides recommendations on responding to non-public requests, such as a one-on-one email or telephone call where the request is not made available to the public, and public requests, such as a request on a public internet forum.
With regards to public requests, however, the FDA is concerned that firms may post detailed public responses to questions about off-label uses of their products in a way that are communicating unapproved information to those who have not asked for it. The FDA recommends that firms only respond to public requests that pertain specifically to its own named product. Caution should also be taken when responding to more general questions. For example, for a question such as “What drug/device can be used for Condition Y?”, the firm should not respond if its product has not been FDA-approved or cleared for the mentioned condition. Meanwhile, a company wishing to respond to a more specific question such as “Can Drug/Device X be used for Condition Y?”, where X is a named product of the company, should limit its reply to providing the firm’s contact information and shout not include any off-label information. Further information and recommendations are detailed in the guidance.
If a firm responds to unsolicited requests for off-label information in the manner described in the draft guidance, the FDA said that it will not use such responses as evidence of a firm’s intent that the product be used for unapproved or cleared uses.