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

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Key facts

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Case number	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 for locally advanced/metastatic disease)
Main issue	Risk-minimisation claim implied direct evidence and universal benefit; substantiation concerns; email permission/unsubscribe concerns
Applicable Code year	2016
Complaint received	19 October 2017
Case completed	4 June 2018
Appeal	No appeal
Breach clauses	7.2, 7.4
No breach clauses	9.9
Sanctions	Undertaking received; Additional sanctions: Not stated
Source	https://www.pmcpa.org.uk/cases/completed-cases/auth29851017-pharmacist-v-sun-pharma

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 article 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 was misleading because the product was licensed in only 5 of 8 dose bands (stated as no RTA solution for 30% of patients), so the “minimise risk” impression could be overstated.
A further concern was that the email was sent via a database agency and recipients could not unsubscribe from Sun Pharma alone; opting out appeared to 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 established benefits for RTA gemcitabine and for all patients, which 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 previously opted in to receive promotional emails via the database agency, and the email explained how to unsubscribe.
No appeal.

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