Pfizer and Bristol-Myers Squibb: Eliquis promotion on Pulse email and microsite found misleading and missing prescribing information

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Key facts

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Case number	AUTH/3246/9/19 and AUTH/3247/9/19
Case reference	Promotion of Eliquis
Complainant	Concerned UK health professional
Respondent/company	Pfizer Limited and Bristol-Myers Squibb Pharmaceuticals Limited (BMS/Pfizer Alliance)
Product(s)	Eliquis (apixaban)
Material/channel	Promotional email and Alliance-sponsored VTE webpages/microsite on Pulse (Pulsetoday.co.uk)
Key issue	Email deemed promotional but lacked prescribing information; “No dose adjustments… regardless of… renal function” claim/heading ruled misleading with critical renal impairment information relegated to smaller text
Dates (received/completed if stated)	Complaint received 27 September 2019; Case completed 13 May 2020
Appeal	Yes; Alliance appeal unsuccessful and Panel rulings upheld
Code year	Not stated
Breaches/clauses	Clauses 4.1, 7.2, 7.4, 9.1 and 2 (breaches upheld on appeal); Clause 7.3 raised but no ruling
Sanctions	No explicit additional sanctions stated beyond the required undertaking/corrective actions described in the report

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

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A concerned UK health professional complained about promotion of Eliquis (apixaban) by Pfizer Limited and Bristol-Myers Squibb Pharmaceuticals Limited (the Alliance).
The material appeared on the Pulse website (Pulsetoday.co.uk) and included a promotional email with the subject heading “Clot Busting – DVT/PE management at your fingertips [BMS/Pfizer Alliance funded content]”.
The complainant said the email did not indicate what medicine was at issue and contained no prescribing information.
The complainant said the linked webpage was accessible without preventing non-health professionals from seeing it.
The complainant challenged the claim: “Eliquis can be used in a broad range of patients with VTE with no dose adjustments regardless of age, weight or renal function*”, where the asterisk text stated Eliquis should be used with caution in severe renal impairment (CrCl 15–29 ml/min) and was not recommended in CrCl<15 ml/min or dialysis.
The Panel considered the email promotional and said it should be capable of standing alone; it should have included prescribing information or a clear and prominent direct single-click route to it.
The Panel and Appeal Board considered the “No dose adjustments” heading and “regardless of… renal function” claim could be read without the qualifying text/table being seen (including due to continuous scrolling), and that relying on a footnote/qualifying text was not acceptable to ensure compliance.

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The Panel ruled breaches of Clause 4.1 (email lacked prescribing information), Clause 7.2 (misleading claim), Clause 7.4 (incapable of substantiation), Clause 9.1 (did not encourage rational use / high standards), and Clause 2 (bringing discredit due to patient safety concerns).
The Alliance appealed the rulings under Clauses 4.1, 7.2, 7.4, 9.1 and 2.
The Appeal Board upheld all the Panel’s rulings; the appeal was unsuccessful on all points.
Key Appeal Board concern included the use of the word “regardless” implying Eliquis could be prescribed regardless of renal function, creating risk of inappropriate use (including in end stage renal failure), and that critical safety information was relegated to smaller text below the headline claim.

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Clause 4.1 – Breach ruled (email promotional and did not include prescribing information or a clear prominent direct single-click route to it); upheld on appeal.
Clause 7.2 – Breach ruled (misleading “No dose adjustments”/“regardless of… renal function” claim); upheld on appeal.
Clause 7.4 – Breach ruled (misleading claim/heading incapable of substantiation); upheld on appeal.
Clause 9.1 – Breach ruled (did not encourage rational use / failure to maintain high standards); upheld on appeal.
Clause 2 – Breach ruled (patient safety information relegated to smaller text; brought discredit upon and reduced confidence in the industry); upheld on appeal.
Clause 7.3 – Raised by case preparation manager but no ruling (Panel did not consider the complainant made an allegation under 7.3).

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