In a nutshell: the FDA draft guidance about responding to requests for off-label information

23rd January 2012 by Felix Jackson

We have summarised what the FDA guidance means to you. Download the full FDA draft guidance (pdf), or look at Jonathan Richman’s blog with an easy-to-read flowchart, the FDA guidance translator (pdf).


A company can respond to unsolicited requests for off-label information. Private communications must be responded to privately and generated by medical or scientific personnel.

They must be 1:1, tailored, high-quality, scientific and referenced.

They must include a copy of the product labeling, the approved indications, all important safety information and state that the use in question is not approved.

For an unsolicited request in a public forum that is specifically related to the product, a company can provide contact details for getting further information, eg phone or email.

There must be no off-label information provided in a public response.

The response must also indicate that the question relates to off-label use, disclose the company’s involvement and must not be promotional.

My key observations:

Importantly, this guidance only applies to the off-label use of a medicine that has a different, licensed indication. It does not apply to products in development that do not have a license (pre-license). Responding to solicited requests for off-label information could be used as evidence that a company is intending that a drug be used off-label.

Draft guidance is not law. The guidance applies to all websites, whether controlled and not controlled by the company. A requester must be completely independent of the relevant company. Companies are not being asked to remove off-label questions from a public forum, even if they are on the company’s own websites. Marketing or commercial should have no input into the responses.

My detailed observations:

You can announce the results of a study via Twitter and respond to requests for off-label information, but a response to a request related to a tweet that suggests that an off-label use of a medicine is safe and effective will be considered as a solicited response.

A browsable or searchable online product database with pre-prepared off-label information is likely to be considered as soliciting an off-label request and indicate the company’s intent is for that product to be used off-label. Please see our previous post to understand medDigital's opinion on the FDA guidance.


Follow the guidance and not our recommendations as my interpretation could be imperfect. My summary assumes you know some of the things I know (like all responses should be fair, balanced and accurate).