Q（Question）

When a physician or pharmacist requests comparative information on contraindications, specific precautions, drug interactions, specific adverse events, or adverse events in specific patient backgrounds between one's own and competing products, is it permissible to provide such information?

A（MHLW answer）

Same as A6.

So what (meaning): Comparative data on contraindications (= the patients or conditions for which the drug must not be used), interactions (= cases where taking the drug together with another drug or food makes it work too strongly or too weakly), and specific adverse events is handled the same way as A6. Even when the question is narrowed to a single item, provide the information without dropping the context of the overall safety profile (= the full picture of a drug's safety information), and state the source.

So why (rationale): Contraindications and specific adverse events are part of that safety picture. The condition required in A6 — show the full picture of safety — does not change here, so the A6 answer is applied directly to this case as well (= applied by analogy).

Commentary — background, application, practical notes

Q7 applies A6 by analogy (= taking an earlier answer with the same intent and applying it directly to this case). It confirms that even when someone requests a comparison of individual safety items — contraindications, precautions, drug interactions, and specific adverse events — the A6 duty to present the full picture (= the duty to show not just part of the safety information but the whole picture) still applies. Even if the request is focused on a specific item, that does not mean the provider may narrow the range of information they give in the same way.

A typical scenario is a physician asking, 'what is the difference in contraindications between your product and the competing product for patients with reduced kidney function?' Showing the contraindication comparison itself is fine, because it stays within the scope of the request. But suppose you show only the fact that favours your own product — your product has no contraindication while the competing product does — and say nothing about points where the competing product's specific adverse event profile (= the body of information on particular adverse events) is more favourable than yours. That way of presenting it picks only the convenient facts, which is arbitrary, selective use of information.

A frequent problem in interaction comparisons is showing only part of the interaction profile (= the body of information on interactions) for an enzyme that breaks drugs down in the body (CYP = a drug-metabolising enzyme found mainly in the liver; when it is involved, interactions with other drugs become more likely). When you stress that your product has little effect on a specific CYP pathway but deliberately leave out how it compares with the competing product on other interactions (e.g., differences in the renal elimination route by which the drug leaves the body in urine, or P-glycoprotein substrate status = how readily the drug is affected by Pgp, a transporter that pumps drugs out of cells), you distort the context of the whole safety profile. Even when the request is narrowed to a specific interaction, showing where that interaction sits within the full interaction information in the package insert is the safe practical move.