Q（Question）

May a company provide information on off-label use or unapproved dosage regimens to a physician who has experience using the drug in that manner, even when the physician has not requested such information?

A（MHLW answer）

Unless a physician has made a request, providing information on off-label drugs or unapproved dosage regimens is not permitted.

Items requiring particular attention: (3)

So what (meaning): Even if the physician has prior off-label use experience, the company may not initiate the information provision without a request from that physician.

So why (rationale): Prior use experience does not substitute for a formal request; the request-driven principle (item 3) applies without exception.

Commentary — background, application, practical notes

This question addresses the intuitive field-level assumption that a physician with prior off-label use experience need not formally request information before receiving it. The answer is unequivocally no. The guideline makes a healthcare professional's explicit request an absolute prerequisite for providing information on unapproved or off-label drugs, and that requirement is not relaxed by the physician's personal history or attributes.

A typical scenario involves a medical representative who knows that a physician in a particular department regularly uses a drug off-label for a specific condition, and reasons that proactively sharing new evidence would be useful. Even in that situation, no unapproved-use information may be initiated by the company unless the physician personally requests it.

A common boundary error occurs when a representative opens a conversation by mentioning the physician's known off-label use practice—for example, 'I understand your department uses this drug for that condition.' That opening itself may constitute a regulated promotional approach. The physician's usage history cannot serve as a company's justification for off-label information provision, and leveraging that knowledge to prompt or steer a request is itself a compliance risk.