Disparagement and Defamation of Competitors' Products

This category covers 28 cases spanning 2018 to 2024. The structural pattern across them is consistent: representatives claimed superiority over competitors — citing safety advantages or distinguishing features — without presenting any direct head-to-head comparison data. The tactics vary: actively disseminating unfavorable information about biosimilars and generics, asserting safety superiority based solely on differences in mechanism of action, or using alarming language about a competitor's adverse event to pressure physicians into switching. The underlying failure is the same in every instance — the comparative claim lacks evidentiary support. Unsubstantiated comparisons may constitute exaggerated advertising prohibited under Article 66 of the PMD Act, and fall squarely within Prohibition No. 5 of the seven prohibited acts listed under Principle (2) of Part 1, Section 3 of the Promotional Activities Guidelines (hereinafter, the Guidelines): 'denigrating or defaming other medicinal products with respect to their quality, efficacy, and safety.'

Mio"Yui, after going through all 28 cases, what patterns stood out to you?"

Yui"There are a lot of explanations along the lines of 'safer than competitors' or 'superior to other agents.' In almost every case, no head-to-head comparison data was actually shown. I understand intuitively why that's a problem, but I find it hard to articulate precisely."

Mio"What would make a comparison permissible, in your view?"

Yui"Evidence, I suppose — clinical trial data generated under comparable conditions."

Mio"Exactly. Accuracy is one of the four requirements under Principle (1) of the Guidelines. Even if you name the comparator, the comparison isn't accurate without supporting data. Then Prohibition No. 5 under Principle (2) explicitly bans denigrating or defaming other products. Those two provisions work together."

Yui"In case 06-18, the representative used the phrase 'a feature our competitors couldn't achieve.' Does that fall under the same problem?"

Mio"It's a textbook example. It looks like a positive claim about the company's own product, but it's functionally disparaging the competitor. Indirect defamation like that tends to slip through review. You need to develop the habit of reading the implication behind promotional language, not just the surface wording."

Yui"Case 06-27 feels a bit different — the representative described an adverse event from a competitor's product as an 'abnormal situation' and used that to push physicians toward switching. Aren't they just citing a fact?"

Mio"Using part of a fact doesn't make the framing neutral. 'Abnormal situation' was chosen specifically to provoke anxiety. If emotionally charged language is selected to drive switching rather than to inform, that's defamation regardless of the underlying fact. It also connects to the issue of exaggeration that Article 66 of the PMD Act prohibits."

Yui"The cases involving biosimilars and generics — 06-01 and 06-02 — feel qualitatively different. The motivation seems more about protecting the originator product than attacking a direct competitor."

Mio"That's a good observation. But the regulatory assessment is the same regardless of motivation. Biosimilars and generics are 'other medicinal products,' and actively disseminating unsubstantiated unfavorable information about them falls under the prohibited acts. The originator-versus-generic distinction doesn't affect how the rules apply."

Yui"So in review, whenever a comparative claim appears, the first thing to confirm is whether the material actually includes data that substantiates it."

Mio"That's the starting point. And even when data is present, check whether it's from a direct comparison trial and whether patient backgrounds are comparable. Many cases — 06-14, for instance — assert a safety difference based solely on mechanistic differences. Mechanism is not a substitute for data. That's the line every reviewer has to hold."

28 real cases from the reports