Q（Question）

During a departmental briefing on a drug attended by many physicians, if one physician asks a question about the drug's efficacy, indications, or dosage approved overseas but not domestically, may the company answer in front of the other attending physicians?

A（MHLW answer）

Providing information (answering the question) in accordance with the conditions of this guideline is permissible.

However, depending on the content of the question, the company should also consider limiting information to the minimum necessary at that time and arranging individual follow-up with the questioner at a separate opportunity.

Items requiring particular attention: (2)

So what (meaning): Answering an off-label question in a group briefing is permitted under the guideline, but for complex or sensitive content, keeping the on-the-spot answer brief and scheduling a private follow-up may be the better course.

So why (rationale): Balanced and fair information provision (item 2) requires care in public group settings; individual follow-up can better ensure completeness without creating undue influence.

Commentary — background, application, practical notes

This question extends the multi-recipient issue from Q20 into a larger, more formal setting—a departmental briefing attended by many physicians. The guideline conditionally permits answering in front of the assembled group, but the caveat that the company 'should consider limiting the response to the minimum necessary and arranging individual follow-up' is the practically critical point.

A representative scenario: during a hospital departmental briefing on a drug, a physician asks about efficacy evidence for an overseas-approved indication not yet approved domestically. The company may answer within the guideline's conditions, but if the question's content is complex, requires detailed safety information, or cannot be fully addressed without risking selective emphasis, the representative should provide only a brief on-the-spot acknowledgment and schedule a private follow-up with the questioner.

The risk inherent in group responses is that they tend toward one-way information delivery, making it difficult to tailor content to the needs of individual physicians or the characteristics of their patient populations. The representative must also explicitly state in front of the group that the information concerns an unapproved indication and clearly distinguish the response from any concurrent promotional messaging. From the fairness perspective (item 2), the representative bears responsibility for assessing whether all attendees can receive balanced and complete information in that setting—and if not, individual follow-up is the compliant path.