Sun Pharma email promotion of ready-to-administer gemcitabine: risk-reduction claim found misleading and unsubstantiated (AUTH/2985/10/17)

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Key facts

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Case	AUTH/2985/10/17
Complainant	Lead pharmacist (cancer)
Company	Sun Pharma
Material	Email promotion of Gemcitabine (ref SUNUK031)
Product / therapy area	Gemcitabine; cytotoxic agent; NSCLC (in combination with cisplatin as first-line treatment for locally advanced/metastatic NSCLC)
Main issue	Risk-minimisation claim in email (“minimise risk by reducing dosing errors, errors in administration and bacterial contamination”) and whether it was supported by cited evidence and presented without misleading implication
Reference cited	Pouliquen et al (2012)
Applicable Code year	2016
Complaint received	19 October 2017
Case completed	4 June 2018
Breaches	Clause 7.2; Clause 7.4
No breach	Clause 9.9
Sanction	Undertaking received
Appeal	No appeal

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

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A lead cancer pharmacist complained about an email promotion for Sun Pharma’s gemcitabine 10mg/ml ready-to-administer (RTA) infusion bags (ref SUNUK031), promoted as “The Only Licensed Ready-To-Administer Gemcitabine”.
The email included the claim: “Drugs made available as ready-to-administer doses minimise risk by reducing dosing errors, errors in administration and bacterial contamination”, referenced to Pouliquen et al (2012).
The complainant argued the cited paper related to dose standardisation (SRD), did not quantify risk reduction, did not show reduced dosing errors, and did not address administration errors or bacterial contamination.
The complainant also argued the email implied reduced risk for all patients, despite the product being licensed in only 5 of 8 dose bands (no RTA solution for ~30% of patients, per the email’s table).
A further concern was that the email was sent via a database agency and recipients could not unsubscribe from Sun Pharma specifically; the unsubscribe wording suggested opting out would stop all emails (including non-promotional) from the agency.

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Breach of Clause 7.2: the risk-minimisation claim, in context, implied benefits established for RTA gemcitabine and for all relevant patients; this was misleading.
Breach of Clause 7.4: the claim could not be substantiated by the cited reference (Pouliquen et al did not assess administration errors or bacterial contamination and did not provide direct data for gemcitabine RTA).
No breach of Clause 9.9: evidence indicated the complainant had opted in to receive promotional emails via the database agency, and the email explained how to unsubscribe (despite Panel reservations about the “unsubscribe from all emails” effect).
No appeal.

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