Bayer breached ABPI Code after US Kerendia DTC banner ads appeared on MailOnline (UK public exposure)

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Key facts

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Case number	AUTH/3684/8/22
Company	Bayer
Medicine	Kerendia (finerenone)
Channel	MailOnline (UK news website) banner advertisement with click-through to Kerendia US website
Campaign origin	US-originated Kerendia DTC National Digital Campaign (Bayer US / Bayer LLC)
Issue trigger	Geo-location settings not restricted to US-only due to operator oversight and software not defaulting to US-only
Complaint received	11 August 2022
Campaign live (as stated)	1 July to 16 August 2022
Stopped	16 August 2022
Applicable Code year	2021
Appeal	No appeal
Case completed	22 September 2023
Sanctions	Undertaking received; Additional sanctions: Not stated

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

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What happened

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A contactable complainant (healthcare communications agency employee) complained about a Kerendia (finerenone) banner advertisement appearing on MailOnline (a UK news website with a .co.uk URL).
The banner ad appeared next to a Health section article (about multiple sclerosis) and was unrelated to Kerendia’s indication (CKD associated with type 2 diabetes in adults).
The ad was part of a US-originated direct-to-consumer (DTC) national digital campaign run by Bayer US (Bayer LLC), intended for US residents only, and linked through to the Kerendia US consumer website.
Bayer’s internal investigation found the ad-buying software did not default to “US-only” geo-restriction; the operator step to set geography was overlooked, so distribution defaulted outside the US, including the UK.
The banner included prominent brand mentions and the statement “Ask your doctor how Kerendia can help”, plus a “Learn More” click-through to the Kerendia US website.
The campaign ran from 1 July to 16 August 2022 and was stopped on 16 August 2022 after PMCPA wrote to Bayer plc and Bayer UK colleagues alerted Bayer US.

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Outcome

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The Panel ruled the banner was promotional material for a prescription only medicine and was accessible to members of the public in the UK.
Breach rulings were made for advertising a POM to the public, encouraging the public to request a specific POM, and multiple compliance/format requirements for promotional material (UK PI, AE statement, certification, internet requirements, high standards).
No breach rulings were made for Clause 2, and for clauses relating to abbreviated advertisements and a patient side effects reporting statement requirement in the specific circumstances.
No appeal.

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Clauses

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Breach of Clauses 3.2 and 26.1 – Advertising a prescription only medicine to the public (Panel made one ruling which applied to both Clauses)
Breach of Clause 5.1 – Failing to maintain high standards
Breach of Clause 8.1 – Failing to certify promotional material
Breach of Clause 12.1 – Failing to include UK prescribing information
Breach of Clause 12.9 – Failing to include an adverse event reporting statement
Breach of Clause 16.1 – Producing promotional material about prescription only medicines directed to a UK audience, provided on the internet, which did not comply with all the relevant requirements of the Code
Breach of Clause 26.2 – Encouraging members of the public to ask their health professional to prescribe a specific prescription only medicine
No Breach of Clause 2 – Requirement that activities or materials must not bring discredit upon, or reduce confidence in, the pharmaceutical industry
No Breach of Clause 12.8 – Requirement that promotional material must include the date on which the promotional material was created or last revised
No Breach of Clause 13.2 – Requirement that abbreviated advertisements may only appear in professional publications
No Breach of Clause 13.6 – Requirement that abbreviated advertisements must include the prominent adverse event reporting statement
No Breach of Clause 26.4 – Requirement that any material which relates to a medicine and which is intended for patients taking that medicine must include a reporting of side effects statement

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Key facts

What happened

Outcome

Clauses

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