GSK employee complaint: Revolade IFR email implied off‑licence use; internal brand-plan email referenced off‑licence presurgery use (AUTH/2474/1/12)

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Key facts

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Case number	AUTH/2474/1/12
Parties	GlaxoSmithKline employee v GlaxoSmithKline
Company	GlaxoSmithKline (GSK)
Medicines	Revolade (eltrombopag); Seretide (fluticasone/salmeterol); ReQuip XL (ropinirole)
Main issues	Implied off-licence promotion via IFR appointment email; internal email disseminating unqualified off-licence reference; allegations about training/test conduct
Complaint received	25 January 2012
Case completed	6 September 2012
Applicable Code year	2011
Breach clauses	3.2, 9.1, 15.2
No breach clauses	2, 9.1, 15.1, 15.9
Sanctions	Undertaking received
Appeal	No appeal

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

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What happened

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A GSK employee complained about promotion and/or staff training relating to Revolade (eltrombopag), Seretide (fluticasone/salmeterol) and ReQuip XL (ropinirole).
Revolade IFR email: A representative emailed a hospital consultant (via the consultant’s secretary) with the subject line: “Request for an appointment re an IFr submission for a patient with Myeloid Firosis [sic]”, proposing a meeting to “discuss putting together the IFR for your patient with Myeloid Fibrosis”.
Revolade’s licensed indication was for adult chronic immune (idiopathic) thrombocytopenic purpura (ITP) in specified circumstances; the complainant alleged the email promoted unlicensed use for myeloid fibrosis/myelofibrosis.
GSK said the consultant wanted support for an IFR for chronic ITP (patient also had myelofibrosis) and separately requested information on myelodysplastic syndrome/bone marrow failure syndromes; that unsolicited request was routed to Medical Information.
Brand plan email: An internal covering email sharing a global tactical brand plan “for background reading only” also reproduced outputs from a UK brand plan day, including: “Explore data to cover use in presurgery – off licence but reported to team”. It was sent beyond the UK brand planning team to, among others, a hospital healthcare business manager (HHBM) in a field-based role.
Training allegations: The complainant alleged HHBMs falsified a Seretide product knowledge test and a pilot annual product knowledge review (answers allegedly read out; questions/answers allegedly texted in advance), and alleged broader inadequate training and unethical internal practices. These allegations were not upheld on the evidence provided.

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Outcome

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Breach found: Clause 3.2 (Revolade IFR email implied off-licence promotion).
Breach found: Clause 15.2 (high standards not maintained by the representative in relation to the Revolade email subject line/impression created).
Breach found: Clause 9.1 (high standards not maintained due to the unqualified off-licence reference in the internal brand-plan covering email being disseminated to an HHBM outside the brand planning team).
No breach: Clause 2 (no “particular censure” warranted in the circumstances considered).
No breach: Clause 15.1 (training allegations about Seretide test, pilot product knowledge review, and broader training standards were not proven on the balance of probabilities).
No breach: Clause 15.9 (allegation relating to an email listing investigators using Revolade under a named patient programme was not established as unacceptable under the Code).
No appeal.

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