No Comparative Data, Rumor-Driven Fear — How Disparagement of Competing Products Actually Happens

Channel / Product Area: MR oral information provision / Oncology (originator biologic)

What happened: With no inquiry from the medical institution, the responsible MR proactively and broadly provided unfavorable information about biosimilars to multiple monitored sites that were considering switching. The content covered: ① "Not approved overseas (though details were reportedly unavailable)"; ② emphasis on the limited clinical trials and use of extrapolation for indication approval; ③ repeated insistence that "biosimilars are equivalent/similar, not identical"; ④ the claim that "patients already on the originator biologic cannot switch to a biosimilar" (in fact, no such prohibition exists); ⑤ statements about a separate biosimilar product unrelated to the drug being discussed — specifically that "its efficacy is questionable" and "its purification is poor."

Why it is a violation: Unsolicited information provision combined with scientifically unfounded negative characterizations. Meets the guideline criteria for "disparaging or defaming competing products" and "arbitrarily inducing without scientific basis."

Direct quotation: "Statements about a biosimilar of a separate product unrelated to the drug in question — specifically that 'its efficacy is questionable' and 'its purification is poor.'" (FY2019 Report)

Channel / Product Area: MR oral information provision / Pruritus treatment (branded drug)

What happened: After a medical institution had already decided to switch to a generic drug, the branded manufacturer's MR visited not only the hospital but surrounding dispensing pharmacies to explain: "The generic lacks the full set of approved indications and has been subject to insurance-based payment adjustments in other prefectures. Please reconsider the switch."

Why it is a violation: Proactive and broad provision of information unfavorable to a generic drug. The multi-site campaign following a completed switch decision raises the possibility of organized conduct.

Direct quotation: "The generic drug lacks the full set of approved indications and has been subject to insurance-based payment adjustments in other prefectures. Please reconsider the switch." (FY2020 Report)

Channel / Product Area: MR oral information provision / Oncology

What happened: To a medical institution considering switching to a competing drug, the responsible MR provided the information that "other facilities adopted [the competing drug] but switched back to the original product due to adverse events including vascular pain." No details about the investigation behind that information were mentioned at all.

Why it is a violation: Use of unverified rumor-level information to obstruct a switch to a competing product. Meets the guideline criteria for "arbitrarily inducing without scientific basis."

Direct quotation: "Other facilities adopted [the competing drug] but switched back to the original product due to adverse events including vascular pain." (FY2020 Report)

Channel / Product Area: MR oral explanation / Parkinson's disease treatment (transdermal patch)

What happened: The MR referenced a competing drug in the same class and explained that their product was superior to the competitor's in terms of feel during application — despite the absence of any comparative data.

Why it is a violation: Superiority claim without comparative data. Meets the guideline criteria for "arbitrarily inducing without scientific basis" and conflicts with the comparative advertising provisions of the Standards for Appropriate Drug Advertising.

Direct quotation: "Provided an explanation that their product was superior to the competing drug despite the absence of comparative data." (FY2020 Report)

Channel / Product Area: Company representative explanation in an online group meeting / Antibacterial drug

What happened: Although the slide materials identified competing products by active ingredient name only, the verbal explanation repeatedly named the competing products by brand name in comparisons with the company's own drug.

Why it is a violation: Concealing product names in written materials while naming them verbally is a classic method of maintaining documentary respectability while effectively disparaging competitors. Meets the guideline criteria for "disparaging or defaming competing products."

Direct quotation: "While the slide materials listed only active ingredient names without specific product names, the verbal explanation repeatedly used competitors' brand names — not ingredient names — in comparisons with the company's own drug." (FY2021 Report)

Channel / Product Area: MR hospital visit / Renal anemia treatment

What happened: After the MR explained a characteristic of their product — "only our drug produces enhanced iron utilization at the same dose" — they added: "a characteristic no competing company has been able to achieve." The product characteristic itself was supported by clinical trial data; it was the reference to competing companies that constituted disparagement.

Why it is a violation: Embedding a phrase that negates competitors within an otherwise factual product description creates a perception of superiority in the physician's mind. Meets the guideline criteria for "disparaging or defaming competing products."

Direct quotation: "A characteristic no competing company has been able to achieve." (FY2022 Report)

Channel / Product Area: Company representative explanation in an online meeting / Migraine prevention

What happened: The representative noted that a competing drug in the same class requires a loading dose (high-dose initial administration) at the first injection, while their product does not, then stated without any basis that their product is "clinically superior." Whether or not a loading dose is required does not, in itself, indicate clinical utility.

Why it is a violation: Connecting a difference in formulation design to a claimed clinical advantage without scientific basis. Meets the guideline criteria for "arbitrarily inducing without scientific basis."

Direct quotation: "The competing product requires a loading dose at first administration, whereas our product does not, and there was a statement that our product is 'clinically superior.'" (FY2022 Report)

Channel / Product Area: Online meeting with supervisor of company representative also present / Migraine prevention

What happened: After sharing a screen showing a comparison table of three products in the same class, the representative — without being asked — stated that "Drug A requires double the initial dose" and "Drug B causes a lot of constipation," disparaging two competing products by name and advocating for their own product's superiority. The supervisor's presence on the call strongly suggests organizational involvement.

Why it is a violation: Named enumeration of competitor faults is a textbook case of guideline-prohibited disparagement. The supervisor's presence implies the conduct was organizational rather than individual.

Direct quotation: "The representative stated that Drug A [a competing product] requires double the initial dose and Drug B causes a lot of constipation, disparaging competing products while advocating for their own product's superiority. The representative's supervisor was also present on the call, suggesting the possibility that this type of explanation was being conducted on an organizational basis." (FY2022 Report)

Channel / Product Area: Company representative explanation in an online meeting / Other respiratory drugs

What happened: Without being asked, the representative named a competing product and explained: "The competing product is designed for once-daily dosing and maintains a high blood concentration, which means more [redacted], and as a result more adverse events. Our product, through its drug delivery technology, uses smaller amounts at more frequent intervals, so blood concentration peaks are lower and adverse events are less likely — or so a physician at a certain university hospital told me." The representative did caveat the claim with "I don't have data so this is just for reference," but the underlying explanation had no evidentiary basis.

Why it is a violation: Using a university hospital physician's attributed remark as a shield to imply, without evidence, that the competitor's product causes more adverse events. Meets the guideline criteria for "disparaging or defaming competing products" and "arbitrarily inducing without scientific basis."

Direct quotation: "The competing product is designed for once-daily dosing and maintains a high blood concentration, which means more [redacted], and as a result more adverse events, whereas our product uses drug delivery technology to achieve smaller amounts at more frequent intervals, so blood concentration peaks are lower and adverse events are less likely — or so a physician at a certain university hospital told me." (FY2023 Report)

Channel / Product Area: Company representative explanation in an online meeting / Other oncology drugs

What happened: The representative named a competing product and asked the physician: "The clinical trial results for [competing product] did not reach data at this level [meaning their own product's figures], but Doctor, what is your view on that point?" No data or graphs for the competing product were shown at any point.

Why it is a violation: Rather than making the disparaging statement directly, the representative attempted to elicit it from the physician through a leading question. The tactic was structured to avoid the appearance of guideline-prohibited disparagement, but was nonetheless determined to constitute a violation.

Direct quotation: "The clinical trial results for [competing product] did not reach data at this level [own product's figures], but Doctor, what is your view on that point?" (FY2023 Report)

Channel / Product Area: Company-hosted web product briefing / Diabetes treatment

What happened: Following a web lecture, a healthcare professional asked: "The competing drug has a CKD indication — what about your product?" The representative answered: "The competing drug's trial did not include cases of nephrosclerosis, but ours did, making ours closer to real-world CKD." When asked about the rate of kidney biopsy performance, the representative responded "I don't know that level of detail." The statement criticized the competitor's trial quality without sufficient basis.

Why it is a violation: Taking the form of a good-faith response to a legitimate physician question while disparaging the competitor's trial quality on insufficient evidence. Meets the guideline criteria for "arbitrarily inducing without scientific basis" and "disparaging or defaming competing products."

Direct quotation: "The competing drug's trial did not include nephrosclerosis cases, but our drug's trial did, making ours closer to the real-world CKD patient population." (FY2023 Report)

Channel / Product Area: Company representative explanation (online) / Iron-deficiency anemia treatment

What happened: During an in-hospital product hearing, the responsible MR stated — as part of an adverse event explanation — "Our drug has lower immunogenicity than [competing product] Drug X. Because immunogenicity is lower, our drug causes hypersensitivity reactions less frequently than Drug X." When the monitoring institution subsequently requested documentation of the comparative immunogenicity study, the company responded: "No such material exists; we have not conducted an immunogenicity study comparing the two drugs."

Why it is a violation: The MR named a competing product and asserted superiority in immunogenicity and hypersensitivity rates when no comparative data existed — a point the company itself later confirmed. Meets the guideline criteria for "disparaging or defaming competing products" and "arbitrarily inducing without scientific basis."

Direct quotation: "Our drug has lower immunogenicity than [competing product] Drug X. Because immunogenicity is lower, our drug causes hypersensitivity reactions less frequently than Drug X." (FY2024 Report)

Channel / Product Area: Company representative explanation (online) / Otolaryngology (ENT) drug

What happened: During a new drug hearing, the responsible MR explained: "In this antibacterial drug class, switching to high-dose formulations has been advancing in oral and ophthalmic applications. In the ENT field too, resistance among causative organisms is progressing, and the same concern exists for the competing product Drug X." When asked whether ENT-area resistance was attributable to the conventional competing product, the MR responded: "Drug X is not included as a sensitivity-surveyed agent in the academic society's antibacterial susceptibility surveillance for the ENT field, making it difficult to accurately understand changes in Drug X's antibacterial activity over time." The MR implied a resistance risk for the competing product while having no supporting data.

Why it is a violation: Suggesting that a competing product carries a resistance concern without any evidence or surveillance data to support the claim. Meets the guideline criteria for "disparaging or defaming competing products" and "arbitrarily inducing without scientific basis."

Direct quotation: "In the ENT field too, resistance among causative organisms is progressing, and the same concern exists for the competing product Drug X." (FY2024 Report)

Channel / Product Area: Company representative explanation (in-person) / Kampo (traditional Japanese herbal medicine) preparation

What happened: During a product explanation, the responsible MR stated: "Unlike competing products, our product contains a specific ingredient and has antidepressant activity." When asked for evidence of the antidepressant activity, the MR answered: "The data comes from animal studies; there is no data demonstrating efficacy in humans." The MR had invoked the phrase "unlike competing products" to imply that competitors lack this property — relying solely on animal study data.

Why it is a violation: Framing a claimed difference from competing products as a clinical advantage on the basis of animal data alone, with no human efficacy data, creates a misleading impression of superiority. Meets the guideline criteria for "disparaging or defaming competing products" and "arbitrarily inducing without scientific basis."

Direct quotation: "Unlike competing products, our product contains a specific ingredient and has antidepressant activity." (FY2024 Report)

Channel / Product Area: Direct message email broadcast / Antiviral drug

What happened: The responsible MR sent a mass email introducing the product. The email reproduced a drug interaction table from the Japanese Society of Hepatology's "Guidelines for the Treatment of Hepatitis C (8th edition, version 2)" — but selectively: the majority of the company's own drug's interactions were omitted, while the competing drug's interactions were included. The presentation created the impression that the company's drug has few interactions and is easy to use, while the competing drug has many interactions and is difficult to use. The email also described the drug as "easy to use with few drug interactions for patients on multiple medications" without providing any scientific basis for that comparative claim.

Why it is a violation: Selectively excerpting a published guideline table to make a competitor's interaction profile appear unfavorable while concealing one's own drug's interactions. Meets the guideline criteria for "disparaging or defaming competing products" and "arbitrarily inducing without scientific basis."

Direct quotation: "[The email] omitted the majority of interactions for the company's own drug and selectively reproduced interactions for the competing drug, creating the impression that the company's drug has few drug interactions and is easy to use while the competing drug has many interactions and is difficult to use." (FY2024 Report)

Channel / Product Area: MR in-person information provision / Metabolic drugs (not elsewhere classified)

What happened: The responsible MR visited a medical institution to relay the following rumor: "Two patients in this prefecture who were using Drug B [a competing product] experienced adverse events and required surgery." The MR then stated: "We believe this is an emergency situation and ask that you switch your adoption to our Drug A." Causal attribution of the adverse events to Drug B had not been established. This case was classified under both category ⑥ (disparagement) and category ⑦ (other) in the monitoring report.

Why it is a violation: Using information about adverse events with unconfirmed causality together with the emotionally charged phrase "emergency situation" to stoke physician anxiety and pressure a product switch. Meets the guideline criteria for both "appealing that one's own product is superior by disparaging or defaming competing products" and "arbitrarily inducing without scientific basis."

Direct quotation: "[The MR] visited to report receiving rumor-level information that two patients in this prefecture using Drug B [the competing product] experienced adverse events and required surgery, stating: 'We believe this is an emergency situation and ask that you switch your adoption to our Drug A.'" (FY2025 Report)

Channel / Product Area: Online group meeting (in-hospital) / Combined biological product (vaccine)

What happened: Without being asked by the healthcare professionals present, the MR — while explaining Drug A — stated: "The competing product Drug B is a combination of a vial formulation and a syringe formulation and therefore requires reconstitution at the time of use, whereas Drug A is a prefilled syringe and requires no reconstitution." The explanation did not mention that Drug A has a shorter shelf life than Drug B — an unfavorable characteristic of their own product.

Why it is a violation: The guidelines require that companies "not arbitrarily select only information that is unfavorable to competing products." When comparative information is provided, unfavorable information about the company's own product must also be disclosed. Only the competitor's disadvantage was presented.

Direct quotation: "Drug B [the competing product] is a combination of a vial formulation and a syringe formulation and therefore requires reconstitution at the time of use, whereas Drug A is a prefilled syringe and requires no reconstitution." (FY2025 Report)

Channel / Product Area: New drug presentation at a product briefing (MR in-person) / Peripheral nervous system drugs

What happened: The MR explained the incidence of sleep-related adverse events as follows: "Drug B [the competing product] is over ten percent; our Drug A is 2.4%." When the healthcare professional later checked the interview forms for both drugs, they discovered that the figure for Drug B was the incidence rate for all adverse events combined, while the figure for Drug A was the incidence rate for somnolence alone. The two figures were not measured on the same basis. The actual somnolence incidence rate for Drug B was below 1% — lower than Drug A's.

Why it is a violation: Placing figures measured on different bases side by side to create a favorable impression for one's own product. Provides information capable of causing factual misrepresentation and meets the guideline criteria for "arbitrarily inducing without scientific basis." The net effect was to create the impression that the competing product caused more adverse events.

Direct quotation: "It became clear that the incidence figure the MR cited for Drug B was the overall adverse event incidence rate, while the figure for Drug A was the somnolence-only incidence rate, and the MR was comparing these two figures. … The somnolence incidence rate for Drug B was actually below 1%, which is lower, making this an explanation that risks causing factual misrepresentation." (FY2025 Report)

Channel / Product Area: In-hospital product explanation (MR and medical affairs representative, two-person visit) / Antineoplastic agent

What happened: The medical affairs representative explained: "Our drug carries the same antibody as the competing product Drug A, but a different conjugated anticancer agent. Drug A causes severe myelosuppression and requires G-CSF. Our drug causes almost no myelosuppression." In fact, myelosuppression is listed as a serious adverse event for their own drug as well.

Why it is a violation: Stating that their own drug causes "almost no" myelosuppression — a serious adverse event that does in fact apply to it — while simultaneously emphasizing the severity of the competitor's myelosuppression, selecting only the subset of adverse event comparisons that favor their own product. Meets the guideline criteria for "disparaging or defaming competing products" and "arbitrarily inducing without scientific basis."

Direct quotation: "Drug A causes severe myelosuppression and requires G-CSF. Our drug causes almost no myelosuppression." (FY2025 Report)