Takeda v Merck Sharp & Dohme: outdated leavepiece used after withdrawal undertaking (black triangle error)

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Key facts

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Case	AUTH/3125/11/18
Complainant	Takeda UK Ltd
Respondent	Merck Sharp & Dohme Ltd
Products	Vipidia (alogliptin); Januvia (sitagliptin)
Issue	Outdated promotional leavepiece used after undertaking to withdraw materials incorrectly associating alogliptin with the inverted black triangle
Material(s)	“Sitagliptin Information Pack” (DIAB-1107051-0014; Aug 2017); Januvia leavepiece (DIAB-1248337-0000; Mar 2018)
Key dates	Black triangle removed from SPC: 18 June 2018; undertaking to withdraw by end Aug 2018 (agreed 2 Aug 2018); item seen at conference: Oct 2018
Applicable Code year	2016
Clause(s) breached	9.1
Complaint received	23 November 2018
Case completed	9 January 2019
Appeal	No appeal
Sanction(s)	Undertaking received

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

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Takeda (Vipidia/alogliptin) raised inter-company dialogue with Merck Sharp & Dohme (Januvia/sitagliptin) about a “Sitagliptin Information Pack” that mentioned alogliptin and displayed the inverted black triangle on every page mentioning it.
The black triangle for alogliptin had been removed from the SPC on 18 June 2018.
In agreed inter-company dialogue minutes, Merck Sharp & Dohme gave an undertaking to withdraw all materials associating alogliptin with the black triangle by end of August 2018.
Takeda later saw a Januvia leavepiece on an MSD promotional stand at a diabetes conference in October 2018 that still associated alogliptin with the black triangle.
MSD investigated and said the leavepiece (DIAB-1248337-0000; March 2018) had been included by a representative who had confirmed destruction but had not destroyed it.
The Panel also noted concern that a number of representatives appeared to have completed the withdrawal late (“completed late” on a spreadsheet), in addition to those on long-term sick leave whose responses were not documented.

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Breach found: Clause 9.1.
The Panel held that the material used in October was not up-to-date and that high standards had not been maintained.
The Panel emphasised that while inter-company undertakings are not covered by the Code, it is important companies comply with them; failure may indicate inter-company dialogue was ultimately unsuccessful.

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