Boehringer Ingelheim & Lilly: Trajenta “Control and care matter” leavepiece – no breach (AUTH/2449/11/11, AUTH/2450/11/11)

What happened

• A general practitioner complained about a six-page, gate-folded Trajenta (linagliptin) promotional leavepiece titled “Control and care matter” (ref UK/TJR/00031).
• Trajenta was co-marketed by Boehringer Ingelheim and Lilly for type 2 diabetes mellitus to improve glycaemic control in adults (monotherapy or combination therapy).
• The leavepiece used the headline “Glycaemic control … with a difference …” and included claims such as:
  • “the first DPP-4 inhibitor excreted primarily via the bile”
  • “5% of the Trajenta dose is excreted via the kidney”
  • “No dose adjustment”
  • “No additional treatment-related renal monitoring required”
  • “Appropriate for adult patients with type 2 diabetes at high risk of declining renal function”
  • “Prescribe Trajenta 5mg once daily”
  • “Can be taken with or without food”
• The back page included a table comparing dosage recommendations for available DPP-4 inhibitors by degree of renal impairment, using wording from SPCs.
• The complainant alleged the campaign relied on misleading, unbalanced/selective, unsubstantiable and exaggerated/distorted material, including implied comparisons with other DPP-4 inhibitors (notably saxagliptin) and potentially unsafe implications about renal monitoring.
• The companies responded jointly, stating the claims were supported by the Trajenta SPC and that “additional” renal monitoring meant monitoring specifically required as a consequence of initiating Trajenta (not routine diabetes care monitoring).

Outcome

• Panel: No breach of the Code in relation to the challenged claims and overall presentation.
• Appeal: The complainant appealed aspects of the rulings (including interpretation of “No dose adjustment”, “Can be taken with or without food”, and high standards). The Appeal Board upheld the Panel’s decisions; the appeal was unsuccessful.
• Final result: No breach of Clauses 2, 7.2, 7.4, 7.9, 7.10 and 9.1.

Clauses considered

• Clause 2
• Clause 7.2
• Clause 7.4
• Clause 7.9
• Clause 7.10
• Clause 9.1

Sanctions

• None (no breach case).

ABPI signatory lens

• Why this matters: “Difference” positioning and class comparisons are high-risk. Even when claims are ultimately upheld, complaints can escalate to appeal and consume significant time and resource—especially where layout could be read as implying superiority over competitors.
• Where teams slip up:
  • Using broad, unqualified “difference” headlines that can be read as comparative across a class.
  • Relying on page layout/visual separation to manage interpretation (e.g., practical dosing bullets appearing under a “difference” banner).
  • Using “no monitoring required” style language without explicitly anchoring it to “additional monitoring due to initiating this medicine”.
  • Including competitor information (e.g., SPC-derived tables) that may be perceived as selective, even if factually accurate.
• Control that would have prevented it: A structured “comparative claims and implied comparison” review at sign-off (medical + compliance) that stress-tests: (1) headline-to-body linkage, (2) whether any statement could be read as a class advantage, and (3) whether “no monitoring/dose adjustment” claims need explicit qualifiers to avoid misinterpretation.

What I’d check in an audit

• Whether “difference” messaging is supported by the SPC and whether the scope of “difference” is clear (what exactly is different, and from what).
• Evidence pack for each key claim (SPC sections cited; any supporting publications used for pharmacokinetics/excretion rationale).
• Whether “No dose adjustment” is appropriately scoped (e.g., renal impairment, hepatic impairment, elderly) and consistent with the SPC.
• Whether “No additional treatment-related renal monitoring required” is clearly defined as “additional due to initiating Trajenta” and does not undermine routine monitoring expectations.
• Competitor comparison table governance: source control (SPC versions/date), exact wording, and internal review notes confirming accuracy.
• Layout risk assessment: whether visual design could cause readers to associate non-differentiating claims (e.g., “with or without food”) with comparative headings.
• Distribution controls and recall documentation (the companies stated ~11,000 copies distributed; recalled the following month).

What the sanctions tell you

• No sanctions were applied because the Panel and Appeal Board found no breach.
• Even without sanctions, the case shows that “implied comparison” arguments can be tested heavily—especially where competitor products are named and SPC comparisons are included.

3 questions to ask your team this week

• When we say “different”, have we defined exactly what is different and ensured the design doesn’t imply broader superiority than intended?
• Do any “no monitoring” or “no dose adjustment” statements need clarifying language (e.g., “no additional monitoring required as a consequence of initiating [product]”) to avoid unsafe interpretations?
• If we include competitor SPC information, do we have a documented process to ensure it is current, complete for the stated purpose, and presented in a way that won’t be seen as selective?

Key facts

Download the full case report (PDF)

Reviewed by Dr Anzal Qurbain (FFPM) — ABPI Final Signatory