Q（Question）

When a physician or pharmacist at an exhibition booth at an academic conference requests information on off-label drugs or unapproved dosage regimens, may the company provide such information?

A（MHLW answer）

Providing information that the company has determined complies with this guideline is permissible, in accordance with the conditions of this guideline.

However, because information provision at a conference exhibition booth is generally considered part of a sales promotional activity, in such situations the company must clearly indicate that the information concerns unapproved indications, dosages, or regimens, and must provide the information in a more deliberate manner, clearly separated from the promotional activity.

Items requiring particular attention: (1), (3), (7)

So what (meaning): Booth responses to off-label requests are allowed, but because booths are inherently promotional spaces, the representative must explicitly flag the information as unapproved and visibly separate the exchange from any concurrent promotional messaging.

So why (rationale): A conference booth is presumed to be a promotional setting; without explicit labeling and separation, sharing off-label data in that context would conflate promotion and scientific information, violating items (1), (3), and (7).

Commentary — background, application, practical notes

Academic conference exhibition booths are inherently promotional settings designed to raise product awareness, meaning the entire booth environment is contextually framed as a sales information activity. This question confirms that responding to a request for off-label information in a booth is permissible, while establishing the additional procedural requirements of explicit declaration and clear separation from the promotional activity.

A typical scenario: a representative is explaining an approved product at a booth when a physician stops by and asks whether the drug can be used for an off-label condition. If the company has determined that a response is appropriate under the guideline, the representative may answer, but must explicitly state—verbally or in writing—that the information concerns an unapproved indication, and must conduct this exchange in a manner that is clearly distinguished from the ongoing promotional interaction.

Common compliance failures include booth promotional materials that inadvertently incorporate off-label data, or situations where off-label information is naturally absorbed into the promotional flow. Additionally, because conference booths are open spaces where multiple attendees may be listening, the multi-recipient issues from Q20 and Q21 can arise simultaneously. Practical mitigation strategies include conducting off-label discussions in a separate area of the booth, designating a distinct representative for such exchanges, or providing the response in writing, thereby achieving physical as well as contextual separation.