Bayer: Xarelto training quiz confusion over licensed indications led to Clause 2 breach (AUTH/2943/3/17)

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Key facts

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Case	AUTH/2943/3/17
Company	Bayer plc
Complainant	Ex-employee of a service provider to Bayer
Product	Xarelto (rivaroxaban) (10mg; 15mg and 20mg referenced)
Main issue	Alleged encouragement to promote for unlicensed indication; unclear training/assessment materials about licensed indications; certification concerns
Unlicensed use discussed	Prevention of VTE following hip fracture surgery
Panel findings	No evidence of off-label promotion to health professionals; training/briefing materials and assessment unclear; high standards not maintained; discredit to industry
Breach clauses	Clause(s) 2, 9.1, 15.9
No breach clauses	Clause(s) 3.2, 8.2, 9.1, 15.2
Sanction	Undertaking received
Complaint received	08 March 2017 (case page) / 10 March 2017 (report text)
Case completed	21 July 2017
Applicable Code year	2016
Appeal	No appeal

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

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An ex-employee of a service provider complained about a named Bayer employee’s conduct during an initial 2017 training course for contract sales representatives on Xarelto.
The complaint alleged trainees were encouraged to promote Xarelto for an unlicensed indication (prevention of VTE/DVT following hip fracture surgery) and that clinicians were spoken about disrespectfully.
A revision quiz and a written assessment included a question on licensed indications; the marking/answer sheet contained an error (it highlighted the wrong option as “NOT an indication”).
The Panel found the training and validation materials were unclear about Xarelto’s licensed indications and that discussion of off-label use added confusion.
Bayer’s investigation found some internal training materials/quizzes used were not appropriately certified per its SOP; Bayer subsequently certified/recertified materials and introduced additional controls (eg training log, field force validation).

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No breach of Clause 3.2 (no evidence that an unlicensed indication was promoted to health professionals).
Breach of Clause 15.9 (briefing/training materials not clear regarding licensed indications).
Breach of Clause 9.1 (high standards not maintained, linked to unclear training/assessment and certification concerns).
Breach of Clause 2 (circumstances brought discredit upon and reduced confidence in the pharmaceutical industry; “particular censure”).
No breach of Clause 8.2 (no disparagement of clinicians ruled).
No breach of Clause 15.2 (Panel did not consider the employee was a representative as such, so clause did not apply).
No breach of Clause 9.1 in relation to the alleged disrespectful attitude (not established on balance of probabilities).

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