Q（Question）

When a physician or pharmacist requests information on unapproved drugs, off-label drugs, or unapproved dosage regimens during a discussion about treatment methods, may the company provide such information?

A（MHLW answer）

Providing information that the company has determined complies with this guideline is permissible, provided the conditions of this guideline are observed.

However, if the discussion takes place as part of the continuous flow of a sales promotional activity, the provision of information on unapproved or off-label drugs or unapproved dosage regimens must be clearly separated from the sales promotional activity.

Items requiring particular attention: (1)

So what (meaning): Responding to a mid-meeting request is allowed, but if the meeting is part of a promotional visit, the off-label information exchange must be formally distinguished from the promotional activity.

So why (rationale): Mixing approved-drug promotion with off-label information creates a misleading impression; separation is required under item (1).

Commentary — background, application, practical notes

Requests for off-label information frequently arise mid-conversation during routine promotional visits. The key contribution of this question is twofold: it confirms that such requests can be honored under the guideline's conditions, while clearly establishing that when the meeting is part of an ongoing promotional interaction, the off-label information exchange must be formally separated from the promotional activity.

When a visit is structured as a sales call for an approved product, any off-label information provided within that same interaction risks being perceived as part of the promotional message. In practice, this separation can be achieved verbally—for instance, by stating 'I will now respond to your question about the unapproved indication separately from our discussion of the approved product'—or by directing the physician to a medical information service or scheduling a distinct follow-up contact.

A common error is assuming that because the physician asked the question spontaneously, no further procedural step is needed. However, compliance depends not only on the presence of a request but also on the context in which the information is delivered. When off-label information is woven into a promotional dialogue, it can create the impression that an unapproved use is being recommended, even if unintentionally. The separation requirement exists to govern the context of the communication, not just its content.