Q（Question）

When a physician or pharmacist requests information on indications or dosages whose approval was revoked as a result of re-evaluation, what information may be provided?

A（MHLW answer）

There is no objection to providing information on the fact that approval was revoked as a result of re-evaluation and the reasons for the revocation.

Items requiring particular attention: (6)

So what (meaning): Companies may inform healthcare professionals that approval was revoked and explain the reasons. They must not promote the revoked indication itself, and must comply with safety-related provision (6).

So why (rationale): Knowledge that an indication was revoked is necessary for patient safety, but providing the revoked indication itself as usable information would constitute promotion of disapproved content — hence the limitation to the fact and reason of revocation.

Commentary — background, application, practical notes

Japan's re-evaluation system re-examines previously approved drugs against current scientific standards; when an approved indication or dosage fails to meet updated requirements, the approval is revoked. Such revocation signals a regulatory judgment that the use in question should no longer continue. To prevent physicians from unknowingly prescribing for a revoked indication, providing information about the fact of revocation and the reasons for it is permissible — and from a patient-safety perspective, proactively doing so when a physician is about to rely on a revoked indication may be appropriate.

A typical scenario is a physician asking about a specific use of a long-established drug whose approval for that indication was revoked after re-evaluation, in a setting where awareness of the revocation has not yet spread throughout the clinical community. In this case, the company representative may and should convey that the indication was revoked as a result of re-evaluation and explain the regulatory grounds for that decision.

The critical boundary is the distinction between conveying the fact and reason of revocation versus providing information about the revoked indication in a way that presents it as a usable option. Even if academic publications continue to report some efficacy for the revoked indication, proactively providing such literature in a context that suggests the indication may still be viable is prohibited. Citing the trial data that led to revocation as part of explaining the decision is acceptable; providing additional publications beyond that scope in a manner implying clinical applicability is not.