Exaggerated and Misleading Expressions

"Ultimate," "the only one," "superior" — 28 cases where words not supported by approval review found their way into promotional materials and slides. The underlying data was not falsified. Yet a choice of headline, a single adjective, or one leap of logic gave the audience an impression that exceeded the actual evidence. Results without statistical significance were described as effective; adverse-event headings were softened to "mild"; a single institution's treatment policy was presented as if it were a guideline. Expression problems tend to be dismissed as matters of nuance, but the cumulative effect distorts prescribing decisions. This is the core of what PMD Act Article 66 prohibits as exaggerated advertising.

Mio"Yui, read case 04-19. The antimicrobial agent. What did the representative say?"

Yui"It says they used the phrase 'ultimate' to describe antibacterial activity. But... isn't that a matter of wording? The numbers were accurate, weren't they?"

Mio"Stop right there. The moment you think 'it's just wording,' you've lost sight of what this category is really about. Using an unsupported superlative within the approved indication range is itself exaggerated advertising under PMD Act Article 66. Even if the numbers are correct, when the expression goes beyond the evidence, it's a violation."

Yui"In case 04-05, the data showed no significant difference, yet the title actively promoted efficacy. That's not a numbers problem — it's a titling problem?"

Mio"Precisely — it's both. Choosing to present non-significant data at all is an evidence problem. Framing it as a positive result in the title is an expression problem. Reviewers need to be able to identify and articulate both layers."

Yui"Case 04-10 caught my attention. 'Exaggerated safety through a leap of logic,' it says. A single institution's treatment policy was presented as if it were a guideline."

Mio"Imagine how a physician reading that would respond. They might decide to prescribe on the assumption it's a guideline recommendation. The question with misleading expressions isn't about the data — it starts with what happens to the recipient's decision-making."

Yui"Case 04-23 involves exaggerated expressions in patient-facing materials. Is the standard different from materials for healthcare professionals?"

Mio"The regulatory framework is the same. But the information asymmetry is greater with patients. Writing 'highly effective' for someone who has no basis for evaluating a drug has a far larger impact than writing it for a physician. Whether you, as a reviewer, keep that in mind is exactly what's being tested."

Yui"Case 04-27 used results from a secondary endpoint to call this drug 'the only' treatment. Would it have been acceptable if the primary endpoint had shown significance?"

Mio"Even with a proven primary endpoint, 'the only' requires a full comparison with every other available therapy. There is always a gap between what approval review has established and what a promotional material claims. The force trying to close that gap is what generates these cases."

Yui"So the common thread in this category is that the expression exceeds what the evidence can actually support."

Mio"Exactly. That's what separates this from Category 03, where the data itself was altered. Here, the numbers were not touched. But the words stepped outside the evidence. As a reviewer, you will be asked to draw that line every single time."

28 real cases from the reports