AstraZeneca Forxiga EMIS Web ‘9 step guide’ ruled misleading; corrective statement and public reprimand (AUTH/2793/9/15)

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Key facts

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Case number	AUTH/2793/9/15
Complainant	Clinical pharmacist
Company	AstraZeneca
Medicine	Forxiga (dapagliflozin)
Material	Leavepiece: “9 step guide to identify your uncontrolled and overweight patients with type 2 diabetes (T2D) who may be suitable for treatment with dapagliflozin EMIS Web Instructions” (ref 716.131.011)
Main issue	Misleading impression from EMIS Web search/report instructions; undue emphasis on BMI/weight; lack of clarity about output and need for clinical review; inaccurate information provided to the Panel about EMIS capability
Applicable Code year	2015
Complaint received	10 September 2015
Undertaking received	16 November 2015
Panel reconvened	24 February 2016
Appeal Board consideration	7 March 2016
Case completed	17 March 2016
Corrective statement issued	15 June 2016
Breaches	Clause 3.2; Clause 7.2; Clause 9.1
No breach	Clause 2; Clause 7.2 (narrow point re time restrictions)
Sanctions	Undertaking; Corrective statement; Public reprimand

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

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A clinical pharmacist complained about an AstraZeneca leavepiece giving EMIS Web instructions to identify “uncontrolled and overweight” type 2 diabetes patients who “may be suitable” for Forxiga (dapagliflozin) (ref 716.131.011).
The leavepiece set out a 9-step EMIS Web search/report build and used criteria including age, type 2 diabetes code, loop diuretic exclusion, BMI ≥25, HbA1c ≥58 mmol/mol and eGFR ≥60 mL/min/1.73m2.
The complainant alleged the instructions were potentially misleading because no time restriction was applied to BMI/GFR/HbA1c, meaning patients could be identified as “uncontrolled” based on historical HbA1c even if currently controlled.
The Panel found the leavepiece implied that following the guide would generate a list of uncontrolled patients suitable for Forxiga, without mentioning the need for clinical review, and with a screenshot that could mislead about the nature/completeness of the output.
The Panel also considered the emphasis on BMI (title, criteria, screenshot) risked promoting Forxiga for some patients based solely on weight, despite Forxiga not being indicated for weight loss.
After the ruling, further information showed AstraZeneca had provided inaccurate information to the Panel about EMIS Web’s ability to return latest HbA1c values; AstraZeneca later accepted it was possible and acknowledged governance and certification failings, including uncertified briefing slides.

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Breach of Clause 7.2 (misleading) in relation to the overall impression created by the leavepiece.
Breach of Clause 3.2 (promotion not in accordance with marketing authorisation/SPC) because the material promoted Forxiga for some patients based solely on weight.
Breach of Clause 9.1 (high standards not maintained).
No breach of Clause 2 (particular censure not applied).
No breach of Clause 7.2 on the narrow allegation that the absence of time restrictions (for BMI/GFR/HbA1c) was itself misleading.
Company reported to the Appeal Board under Paragraph 8.2 of the Constitution and Procedure due to governance failures and inaccurate information provided to the Panel.

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