There are practices that become inappropriate through sales conduct alone, without any distortion of evidence. Advising physicians to prescribe double doses to sidestep a new drug's one-year duration limit. Using a joint product presentation as cover for implicit off-label endorsement. Running a sponsored lecture while the speaker's slides have never passed through the company's supervisory review unit. Distributing materials that still carry a package insert format invalidated in 2024. None of these involve factual error. All of them are failures of process and attitude. This article documents every such case recorded across seven years of Ministry of Health, Labour and Welfare surveillance reports — none omitted.

So What / So Why — The Core of This Category

"Other improper sales practices" refers to conduct where the problem lies not in the content of information but in how it is delivered, what procedures are skipped, or how a setting is exploited. This is a dimension separate from factual accuracy, yet it strikes at the foundations of regulatory and industry-wide norms.

Consider the prescription duration limit on new drugs — in principle, no more than 14 days per prescription during the first year post-approval. This limit exists to contain the risk of long-term patient exposure before sufficient post-marketing safety data has accumulated. When a medical representative teaches a physician to circumvent that limit through a double-dose prescription, the rule becomes a dead letter. If the physician complies without understanding the implication, patients face long-term use during a period when safety has not yet been confirmed.

The same structural problem underlies undisclosed conflicts of interest (COI) and the omission of pre-use speaker slide review. Presenting a lecture as "objective" scientific information while concealing that the speaker received funding from the sponsoring company strips the audience of the context they need to assess what they are hearing. A sponsor that allows a lecture to proceed without reviewing the speaker's slides has, in effect, declined to take responsibility for the accuracy of information about its own product.

The continued use of old-format package inserts may look like a minor technicality, but the 2019 revision to the prescribing information format — which clarified the urgent safety information section and the warning section, among other changes — was a regulatory update designed to reduce the risk of misreading in clinical settings. Distributing materials carrying the old format after the five-year transition period ended in March 2024 obstructs healthcare professionals' ability to accurately grasp current safety information.

What / Where / Why / How — Which Guidelines Were Violated and How

What (what actually happens)

Where (in which settings and channels)

Verbal explanations by MRs (outside examination rooms, in pharmacy departments); company-organized in-hospital study sessions and training events; web seminars and online lectures; product introduction videos on healthcare professional websites; product promotional materials (brochures, slides); commercial discussions with pharmaceutical wholesaler sales staff.

Why (four deep-structure drivers)

① Motivated reasoning — "This is a good drug, so teaching doctors how to prescribe more of it benefits patients" — the conclusion comes first. ② Local rationalization — "That explanation came from the other company's rep at a joint session, so it's not our responsibility" or "The speaker said it, so the company isn't liable" — responsibility is sliced into pieces. ③ Omission bias — COI timing is left to the speaker, slide review is left to whoever happens to be in charge, and no one confirms either was done. ④ Externalization of responsibility — "We weren't aware the transition period had ended" or "My manager was present too" — blame is assigned to the organization or the environment.

How (which guideline provisions are breached)

The Ministry of Health, Labour and Welfare's Guidelines on Sales Information Activities for Prescription Drugs (September 2019) prohibit, under the duty to avoid improper or erroneous use, "recommending methods of use other than the approved indications, dosage, and administration." Circumventing prescription duration limits falls squarely within this prohibition. On COI, the guidelines require that "where a person who has received payment in connection with sales information activities makes a presentation, this fact must be clearly disclosed." On pre-use review of materials, the guidelines state explicitly: "Materials used in sales information activities must, before use, undergo review in advance by the sales information activities supervisory unit" — speaker materials are not exempt. Continued use of the old-format package insert violates the requirement that materials "be updated and corrected as appropriate when the latest findings become available." The wholesaler sales representative's promotion of unapproved indications conflicts with the intent of Article 68 of the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices (prohibition on advertising unapproved drugs) and with the standards under the Japan Pharmaceutical Manufacturers Association Code of Practice, which applies to pharmaceutical wholesalers as well.

Case Records — Every One of Them

FY2019 (Heisei 31)

Channel / Therapeutic area: Glaucoma and ocular hypertension treatment / verbal explanation by company representative

What happened: When a physician said a new drug with a 14-day prescription limit was hard to adopt because visit intervals didn't align, the representative responded: "One bottle covers a full month of use, so monthly visit intervals work fine."

Violation: The representative recommended a use pattern contrary to the prescription duration limit (no more than 14 days per prescription in the first year post-approval).

Original statement (translated): "One bottle covers a full month of use, so monthly visit intervals work fine."

Channel / Therapeutic area: Chronic constipation treatment / company-organized study session (verbal)

What happened: When asked about the prescription duration limit, the representative stated: "Because the dose can be increased, adjusting accordingly makes long-term prescribing possible." The same representative also said that the drug was "a useful agent with few side effects in pediatric populations" and urged the physician to recommend it, while omitting the condition specified at the time of drug price listing — that use is restricted to patients for whom other constipation treatments have proven insufficient.

Violation: The representative both encouraged circumvention of the prescription duration limit and provided selectively incomplete safety information.

Original statement (translated): "Because the dose can be increased, adjusting accordingly makes long-term prescribing possible."

Channel / Therapeutic area: Analgesic / product introduction video on a healthcare professional website

What happened: A video cited a clinical paper to support the drug's safety profile, but the lead author of that paper was receiving compensation as a "medical expert advisor" to the marketing authorization holder. This relationship was not disclosed anywhere in the video.

Violation: The conflict of interest in the original paper was not disclosed.

Channel / Therapeutic area: Diuretic / presentation slides at an in-hospital briefing

What happened: A paper cited in slides to support the drug's efficacy involved a COI, but no disclosure of this was included in the slides.

Violation: The COI in the cited paper was not disclosed in the presentation slides.

FY2020 (Reiwa 2)

Channel / Therapeutic area: Tissue adhesive / joint product presentation by a pharmaceutical company and a medical device company

What happened: At a joint session covering a tissue adhesive (indicated only when body fluid leakage from sutured or joined tissue occurs and no other appropriate treatment is available) and an absorbable tissue reinforcement material, a representative from the medical device company presented detailed photographic lecture materials on off-label use following tongue cancer resection surgery — a procedure where suturing can achieve tissue closure. The pharmaceutical company's representative made no objection to this explanation.

Violation: Off-label use was explained in detail at a joint session, and the pharmaceutical company tacitly accepted it. The guidelines prohibit recommending methods of use outside approved indications and dosage, and silent acquiescence carries the same weight as active endorsement.

Channel / Therapeutic area: Sleep-onset medication / web-based training session

What happened: A physician speaker with a COI relationship with the organizing company displayed a COI disclosure slide at the opening, but the display time was so short it "disappeared in the blink of an eye," leaving attendees unable to read its contents.

Violation: Formal compliance with the COI disclosure requirement means nothing if attendees are given no time to absorb the content. Disclosure must be substantive, not merely nominal.

Original statement (translated): "The COI slide was displayed for such a short time — it disappeared in the blink of an eye — that the content could not be read."

Channel / Therapeutic area: Analgesic / verbal explanation by MR

What happened: For a drug still within its first post-approval year and therefore subject to duration limits, the MR advised a physician: "Prescribing double the dose means you can effectively prescribe more than 14 days' worth in a single visit."

Violation: This was a deliberate proposal to route around the prescription duration limit — whose purpose is to secure an adequate post-marketing safety surveillance window — and gutted the rule in practice.

Original statement (translated): "Prescribing double the dose means you can effectively prescribe more than 14 days' worth in a single visit."

Channel / Therapeutic area: Infusion products generally (no specific product) / company-organized training session

What happened: At a company-sponsored lecture, the speaker promoted the organizing company's products to an excessive degree.

Violation: The guidelines require that "promotional activities such as lectures organized, co-organized, or sponsored by a company be managed under that company's responsibility to ensure they are conducted appropriately." The speaker's statements fall within the scope of the organizing company's responsibility.

FY2021 (Reiwa 3)

Channel / Therapeutic area: Anti-influenza drug / verbal explanation by pharmaceutical wholesaler sales representative

What happened: A wholesaler sales representative urged a medical institution to stock the drug, stating that an unapproved indication expansion was "expected to be approved."

Violation: The scope of the guidelines covers "sales information activities conducted by marketing authorization holders, their contractors and partners, and pharmaceutical wholesalers." Soliciting purchase on the basis of an unapproved indication conflicts with the intent of Article 68 of the Pharmaceuticals and Medical Devices Act (prohibition on advertising unapproved drugs).

Original statement (translated): "Approval is expected for the indication expansion — do you really not want to stock this product?"

Channel / Therapeutic area: (No specific product) / manufacturer-organized web seminar

What happened: At a manufacturer-organized web seminar, none of the presenters disclosed COI. When asked, the presenters said it was because "the manufacturer never asked us to."

Violation: The responsibility to require and manage COI disclosure rests with the sponsoring company. The company's failure to ask resulted in a situation where every presenter disclosed nothing.

Original statement (translated): "None of the presenters disclosed COI. According to the presenters, they did not display COI information because the manufacturer had not requested it."

Channel / Therapeutic area: Insomnia treatment / verbal explanation by company representative

What happened: As a workaround for prescription duration limits on a newly launched drug, the representative advised a physician: "By prescribing two tablets of half the maximum approved daily dose for 14 days, you can effectively hand the patient 28 days' worth in a single visit."

Violation: The representative taught a specific technique for delivering the equivalent of 28 days' supply in one prescription — a direct and explicit negation of the purpose behind the prescription duration limit.

Original statement (translated): "By prescribing two tablets of half the maximum approved daily dose for 14 days, you can effectively hand the patient 28 days' worth in a single visit."

FY2022 (Reiwa 4)

Case classifications in FY2022 covered categories ① through ⑥ (unapproved indications, data manipulation, absence of evidence, exaggerated claims, denigration of competing products, underemphasis of safety risks). No cases were reported under "undisclosed COI" or "other improper sales practices" in that year.

FY2023 (Reiwa 5)

Channel / Therapeutic area: Osteoporosis treatment / in-hospital presentation by company representative (in person)

What happened: While seeking pharmacy department permission to conduct in-hospital promotion, a representative showed a conceptual diagram from a review paper and stated: "This drug has a better anabolic window than competitor **, and because it does not cause excessive bone resorption, it is superior." On investigation, the diagram was found to be a conceptual illustration of the duration over which bone metabolism effects occur — not clinical outcome data.

Violation: A claim of superiority over a competing product was made using only a conceptual diagram, without any clinical efficacy data. The guidelines prohibit explanations based on information of insufficient reliability or accuracy.

Original statement (translated): "This drug has a better anabolic window than competitor **, and because it does not cause excessive bone resorption, it is superior."

FY2024 (Reiwa 6)

Case classifications in FY2024 covered categories ① through ⑦ (unapproved indications, data manipulation, absence of evidence, factual misrepresentation, emphasis on efficacy only, denigration of competing products). No cases were reported in a category specific to "other improper sales practices" that year.

FY2025 (Reiwa 7)

Channel / Therapeutic area: Kampo preparation / product promotional materials at an in-hospital product presentation

What happened: At an in-hospital product presentation held in the second half of 2024, the responsible MR distributed product promotional materials containing a package insert in the old format. The prescribing information format for prescription drugs was revised on April 1, 2019, with a five-year transition period. That transition period ended on March 31, 2024.

Violation: The guidelines require that "materials used in sales information activities be prepared in compliance with relevant laws and this guideline, and be updated and corrected as appropriate when the latest findings become available." Continuing to use old-format materials after the transition period ended violates this requirement.

Channel / Therapeutic area: Allergy medication / slides at a company-sponsored lecture (simultaneously falling under multiple categories ① through ⑥)

What happened: At a pharmaceutical company-sponsored lecture, the physician speaker repeatedly described "short-duration administration" and "low-dose long-term use" — both differing from the approved dosage and administration. The speaker described a competing product B by saying, without evidence, "Product A and Product B are exactly the same thing, so switching is safe." The final slide read: "Product A is safe, simple, and of great benefit to patients." The materials the speaker had prepared were distributed to attendees who requested them without having passed through review by the company's sales information activities supervisory unit. Even after the problem came to light, no correction activity targeting all attendees was carried out.

Violation: The guidelines require that "materials used in sales information activities, before use, undergo review in advance by the sales information activities supervisory unit." The slides simultaneously contained promotion of unapproved dosing methods, denigration of a competing product, underemphasis of safety risks, and exaggerated claims — yet the last line of defense, review, never functioned.

Original statements (translated): "The physician speaker repeatedly described, for Product A, methods of administration that differ from the approved dosage — including short-duration administration and low-dose long-term use." "[The materials] were distributed to attendees who requested them without having passed through advance review by the sales information activities supervisory unit."

Learning from Past Incidents ── Map of 9 chapters

  1. Part 1: Data Misuse and Manipulation That Risk Factual Misrepresentation
  2. Part 2: Selective Data Extraction, Manipulation, and Presentation
  3. Part 3: Claims Without Evidence / Unreliable Data
  4. Part 4: Presenting Unapproved Indications and Dosage Regimens
  5. Part 5: Exaggerated Claims
  6. Part 6: Efficacy-Only Promotion / Safety Information Neglect
  7. Part 7: Disparagement of Competing Products
  8. Part 8: COI Non-Disclosure
  9. Part 9 (this chapter): Other Improper Sales Practices
Key Points
  1. Circumventing prescription duration limits hollows out the regulatory system. A proposal to "prescribe double the dose and effectively hand over 28 days' supply" exploits a loophole to neutralize drug law — and in doing so, destroys the very purpose the rule was designed to serve: post-marketing safety surveillance.
  2. Responsibility for speakers and materials belongs to the company. Neither undisclosed COI nor speaker slides that bypassed the supervisory review unit are excused by the fact that "the speaker said it" — both fall squarely within the liability of the sponsoring company.
  3. Procedural failures carry the same weight as factual errors. Continued use of an invalidated package insert format, silence when off-label use is described at a joint presentation, a wholesaler passing along unapproved indication claims — none of these are excused by the argument that "the content might have been correct."
References
  1. Ministry of Health, Labour and Welfare, "Report on the Surveillance Project for Sales Information Activities for Prescription Drugs," FY2019 (March 2019)
  2. Ministry of Health, Labour and Welfare, "Report on the Surveillance Project for Sales Information Activities for Prescription Drugs," FY2020 (March 2021)
  3. Ministry of Health, Labour and Welfare, "Report on the Surveillance Project for Sales Information Activities for Prescription Drugs," FY2021 (March 2022)
  4. Ministry of Health, Labour and Welfare, "Report on the Surveillance Project for Sales Information Activities for Prescription Drugs," FY2022 (March 2023)
  5. Ministry of Health, Labour and Welfare, "Report on the Surveillance Project for Sales Information Activities for Prescription Drugs," FY2023 (March 2024)
  6. Ministry of Health, Labour and Welfare, "Report on the Surveillance Project for Sales Information Activities for Prescription Drugs," FY2024 (March 2025)
  7. Ministry of Health, Labour and Welfare, "Report on the Surveillance Project for Sales Information Activities for Prescription Drugs," FY2025 (March 2026)
  8. Ministry of Health, Labour and Welfare, "Guidelines on Sales Information Activities for Prescription Drugs" (September 25, 2019)
  9. Japan Pharmaceutical Manufacturers Association, "Code of Practice on Sales Information Activities for Prescription Drugs"
  10. Ministry of Health, Labour and Welfare, "Guidelines for Preparation of Product Information Summaries for Prescription Drugs"