AUTH/2424/8/11 & AUTH/2425/8/11: Sponsored linagliptin article ruled disguised pre-licence promotion (Boehringer Ingelheim breach; Lilly no breach)

What happened

• A general practitioner complained about an article in Future Prescriber titled “Linagliptin: new class of DPP-4 inhibitor in the treatment of T2DM”, alleging exaggerated, misleading and disguised promotion of linagliptin before a UK marketing authorisation.
• The article stated that linagliptin was approved in the UK and “due to launch here soon”, although at the time it had only received a positive opinion from the EMA/CHMP (no marketing authorisation yet).
• The article included comparative and superiority-implying messaging (eg “new class”, and a claim that linagliptin was “safer to use” with certain concomitant medicines than saxagliptin) despite no head-to-head trials.
• The declaration of interests appeared at the end of the article (after references) and stated: “Placement of this article has been funded by Boehringer Ingelheim and Lilly… checked… for factual accuracy only… Editorial control… remains with Future Prescriber”.
• The publisher’s proposal described a “managed entry programme” to “support the product” and “prepare the market”, and Boehringer Ingelheim agreed to purchase 2,000 reprints in advance (effectively commissioning the piece).
• Boehringer Ingelheim said it tried to stop publication once it saw inaccuracies and Code issues; the publisher printed it anyway. The companies asked for it not to appear online.
• Lilly stated it had no involvement: the commissioning and reprint purchase pre-dated the alliance; Lilly was unaware until after print publication and did not review the article.

Outcome

• Boehringer Ingelheim (AUTH/2424/8/11): Breach of Clauses 2, 3.1, 7.2, 7.4, 7.9, 7.10, 9.1, 9.10 and 12.1. No breach of Clause 3.2.
• Lilly (AUTH/2425/8/11): No breach of Clauses 2, 3.1, 3.2, 7.2, 7.4, 7.9, 7.10, 9.1, 9.10 and 12.1 (Panel found Lilly not responsible in the exceptional circumstances).
• The complainant appealed the no breach ruling on a narrow point about a cost statement; the Appeal Board upheld no breach of Clause 7.2 for that cost statement.

Clauses

• Boehringer Ingelheim – Breach Clause(s): 2, 3.1, 7.2, 7.4, 7.9, 7.10, 9.1, 9.10 and 12.1
• Boehringer Ingelheim – No breach Clause(s): 3.2
• Lilly – No breach Clause(s): 2, 3.1, 3.2, 7.2, 7.4, 7.9, 7.10, 9.1, 9.10, 12.1

Sanctions

• Undertaking received
• Additional sanctions: Advertisement

ABPI signatory lens

• Why this matters: “Independent” third-party content can still be treated as company promotional material if the company is inextricably linked (eg via reprint purchase/managed entry programme) or can influence content. Pre-licence “market preparation” is high-risk and can trigger Clause 2 as well as pre-authorisation promotion breaches.
• Where teams slip up:
  • Assuming “editorial control remains with the publisher” removes Code responsibility.
  • Using reprint purchases/sponsorship as a route to seed pre-launch messages (“prepare the market”).
  • Allowing inaccurate regulatory status statements (eg “approved in the UK”) to go to print.
  • Allowing superiority/“special merit” implications (eg “new class”) without substantiation.
  • Allowing comparative safety claims (“safer to use”) without appropriate evidence (and especially without head-to-head data).
  • Placing funding disclosure where it is not prominent, creating the impression of independent editorial content.
• Control that would have prevented it:
  • A formal third-party materials governance process that treats sponsored/managed-entry content and reprints as potentially promotional and requires full medical/legal/code review before commitment.
  • Contractual controls: right to approve final copy, right to withdraw, and clear requirements for prominent sponsorship disclosure (not buried after references).
  • A hard “no pre-licence product promotion” gate, including for disease/treatment landscape pieces that are timed to launch and include product-specific messaging.
  • Evidence standards for comparative claims, with explicit prohibition on “safer than” language without robust substantiation.

What I'd check in an audit

• All agreements with publishers/third parties: proposals, invoices, purchase orders (including reprint purchases) and whether they describe “support the product/prepare the market”.
• Whether the company had (or should have had) approval rights and whether materials were certified before use/association.
• Placement and prominence of sponsorship/funding disclosure (front page vs end after references).
• Regulatory status claims (eg “approved”, “due to launch”) and evidence of sign-off against current approval status.
• Comparative/superiority language (“new class”, “safer to use”) and substantiation package, including whether head-to-head evidence exists.
• Controls for pre-launch activities: how “market preparation” is defined, approved, and monitored.
• Escalation records when a third party refuses changes or publishes against company wishes (and steps taken to limit circulation).
• Alliance governance: when joint approval processes apply, and how third-party references to partners are prevented/corrected.

What the sanctions tell you

• Advertisement indicates the PMCPA viewed the conduct as serious and of wider public/professional interest (not just a technical breach).
• Undertaking received signals the company committed to stop the activity and comply going forward, but the case still warranted additional visibility.
• The inclusion of Clause 2 (discredit) alongside pre-authorisation promotion highlights heightened concern about “managed entry/market preparation” tactics.

3 questions to ask your team this week

• Do we treat sponsored articles, supplements, advertorials, and reprint purchases as potentially promotional—and do they go through full Code certification before we commit spend?
• What is our hard-stop process to prevent any pre-licence product promotion (including “treatment landscape” pieces timed to launch that include product-specific messages)?
• Are we using any comparative language (eg “safer”, “better”, “new class/special merit”) without head-to-head evidence or robust substantiation—and who signs off those claims?

Key facts

Download the full case report (PDF)

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