In a nutshell: the FDA draft guidance about responding to requests for off-label information

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 Download the full FDA draft guidance (pdf), or look at Jonathan Richman’s blog with an easy-to-read flowchart, the FDA guidance translator (pdf).

Summary:
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Draft guidance is not law.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.

Disclaimer:

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).