Q（Question）

When a physician or pharmacist requests off-label use information on one's own product, is it permissible to provide, in addition to the information indicated in Q1 of Q&A Part 2, the latest conference presentation data?

A（MHLW answer）

The handling of conference presentation information is the same as A4. The handling of information provision on off-label drugs, etc. must also comply with the Guidelines.

So what (meaning): Latest conference data may be added to the Q&A Part 2-Q1 information set for off-label use, but A4's requirement to disclose that the source is unpublished and not peer-reviewed, and that evidence is not established, applies; Part 4-3 conditions must also be met simultaneously.

So why (rationale): Off-label information and conference presentation data each carry distinct requirements; both sets of conditions must be applied together, not selectively.

Commentary — background, application, practical notes

Q12 confirms the simultaneous application of two separate sets of conditions. The first is the basic framework for off-label information provision established in Q&A Part 2, Q1 — responding to a request, limiting recipients, disclosing sources, and so on. The second is the requirement established in Q4 for conference presentation data — explicitly disclosing that the source is unpublished, not peer-reviewed, and that the evidence is not established. The provision of off-label information sourced from conference presentations must satisfy both sets of conditions at the same time.

A typical scenario is a physician asking to be given information on off-label use for a particular condition 'including data from recent conferences.' When adding unpublished conference presentation data to the information already permitted under Part 2 Q1 (such as data from evaluation materials used in approval review or from peer-reviewed papers), the additional data must be accompanied by the explanation that it is 'not peer-reviewed and the evidence base is not yet established.' When presenting both types of information together, it is essential to clearly indicate which information corresponds to which level of evidence.

A common practical error is interpreting Q12 to mean 'conference presentations can be provided because the request was for off-label information' and then omitting the disclosure of unpublished status. The opposite error also occurs: 'conference presentations cannot be provided as off-label information because the evidence is insufficient.' What Q12 actually establishes is 'permissible under conditions' — neither omitting the conditions nor applying blanket self-restraint. The requirement is to apply both sets of conditions accurately and simultaneously.