MSD voluntary admission: Keytruda congress pillar ad lacked prescribing information and wasn’t certified (AUTH/3127/12/18)

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Key facts

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Case number	AUTH/3127/12/18
Company	Merck Sharp & Dohme
Product	Keytruda (pembrolizumab)
Issue	Printed congress placement of a digital app advertisement without prescribing information; material not certified for printed use
Setting	Scientific congress in the UK (global melanoma scientific congress), registration area pillar
How identified	Voluntary admission by MSD; error noticed on-site by an employee
Key timing	Error noticed 14:30 (day 2); removed/destroyed by 14:45
Complaint received	30 November 2018
Case completed	21 February 2019
Applicable Code year	2016
Breach clauses	Clause 4.1; Clause 14.1
No breach clauses	Clause 9.1
Sanctions	Undertaking received; Additional sanctions: Not stated
Appeal	No appeal
PMCPA publication	May 2019 Code of Practice Review

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

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Merck Sharp & Dohme (MSD) voluntarily admitted an advertisement for Keytruda (pembrolizumab) did not contain prescribing information.
The material was created and certified for use in a congress programme mobile app (digital format), where prescribing information would be accessible via a link.
As part of the sponsorship package, MSD was also offered placement of its company logo on a pillar in the registration area.
Congress organisers inadvertently printed the digital app advertisement instead of printing the MSD logo and placed it on the pillar near registration (before the exhibition area).
The printed version included wording such as “tap here for prescribing information”, but in print the link could not be accessed, so full prescribing information was not provided.
An MSD employee noticed the error at 14:30 on the second day and requested immediate removal and destruction; this was completed by 14:45.
The organisers confirmed removal/destruction and acknowledged responsibility for the incorrect printing.
The Panel noted the principle that companies are responsible for acts/omissions of agents or third parties, so MSD remained responsible for the placement.

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Breach of Clause 4.1 (prescribing information not included on the printed advertisement).
Breach of Clause 14.1 (advertisement not certified for the printed use/format).
No breach of Clause 9.1 (high standards): the Panel considered MSD had been badly let down by the organisers and acted promptly once aware.
No appeal.

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