GP v Pfizer and Bristol-Myers Squibb: Eliquis leavepiece renal dosing table found misleading

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Key facts

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Case number	AUTH/3215/6/19 and AUTH/3216/6/19
Case reference	GP v Pfizer and Bristol-Myers Squibb
Complainant	General practitioner
Respondent/company	Pfizer Limited and Bristol-Myers Squibb Pharmaceuticals Limited (the Alliance)
Product(s)	Eliquis (apixaban)
Material/channel	Six-page, landscape, gatefold leavepiece (ref PP-ELI-GBR-4453), intended for distribution by representatives and from exhibition stands
Key issue	Headline/table implied no Eliquis dose adjustment was needed in all NVAF patients with mild/moderate renal impairment; insufficient qualification; misleading comparison versus other NOACs; SPC inconsistency; patient safety concerns
Dates (received/completed if stated)	Complaint received 21 June 2019; Case completed 13 May 2020
Appeal	Yes. Alliance appealed Clause 9.1 and Clause 2; Appeal Board upheld both. Alliance accepted breaches of Clauses 3.2, 7.2 and 7.3.
Code year	Not stated
Breaches/clauses	Clauses 2, 3.2, 7.2, 7.3, 9.1
Sanctions	No explicit additional sanctions stated beyond the required undertaking/corrective actions described in the report

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

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What happened

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A general practitioner complained about a page from a six-page, landscape, gatefold leavepiece promoting Eliquis (apixaban) (ref PP-ELI-GBR-4453) issued by Pfizer Limited and Bristol-Myers Squibb Pharmaceuticals Limited.
The page headline stated: “Eliquis is the only factor Xa inhibitor that does not require a dose adjustment in patients with NVAF who have mild or moderate renal impairment*”.
The page included a table comparing renal-impairment dose adjustment for Eliquis versus rivaroxaban, edoxaban and dabigatran, using colour shading.
The table stated “no dose adjustment” for Eliquis in normal renal function and mild/moderate renal impairment, with an asterisk leading to a small-font footnote describing Eliquis dose-reduction criteria (age, weight, serum creatinine) and severe renal impairment dosing.
The complainant alleged the presentation was misleading and could lead to patient harm if clinicians missed the asterisk/footnote and failed to adjust dose according to the licence.
The complainant also alleged the page was designed to give unfair advantage over competitor medicines.
The Alliance said the leavepiece was designed to be read in a specific sequence and included prominent dosing criteria on another panel; it also stated the leavepiece had been withdrawn in June 2019 due to a prescribing information update and a revised version was later approved.
The Panel considered there was no evidence about the order recipients would read the leavepiece and reiterated the principle that each page must be able to stand alone for Code compliance and could not rely on qualification on another page or in a footnote.

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Outcome

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The Panel ruled the table and headline implied no Eliquis dose adjustment was needed in all NVAF patients with mild to moderate renal impairment, which was not so, and found the immediate impression misleading; the small-font footnote and dosing information on another page were insufficient to qualify it.
The Panel ruled the dosing information and headline did not accurately reflect the Eliquis SPC for NVAF patients with normal renal function or mild/moderate renal impairment and was inconsistent with the SPC.
The Panel ruled the comparison misleading because it implied Eliquis was the only NOAC not requiring dose adjustment in moderate renal impairment, which was not so.
The Panel ruled failures to maintain high standards and that the matter brought discredit upon and reduced confidence in the industry due to patient safety implications.
On appeal, the Alliance accepted breaches of Clauses 3.2, 7.2 and 7.3, but appealed Clause 9.1 and Clause 2.
The Appeal Board upheld the Panel’s rulings for Clause 9.1 (high standards) and Clause 2 (discredit), noting busy health professionals might scan and focus on the traffic-light table and that the page was insufficient when viewed in isolation for appropriate prescribing decisions.
Complaint received: 21 June 2019. Case completed: 13 May 2020.

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Clauses

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Clause 7.2: Breach ruled (misleading impression; insufficient qualification by small footnote/other page).
Clause 3.2: Breach ruled (promotion inconsistent with the Eliquis SPC dosing recommendations).
Clause 7.3: Breach ruled (misleading comparison implying Eliquis uniquely required no adjustment in moderate renal impairment).
Clause 9.1: Breach ruled (failure to maintain high standards); upheld on appeal.
Clause 2: Breach ruled (brought discredit upon and reduced confidence in the industry due to patient safety implications); upheld on appeal.

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Key facts

What happened

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