Ferring v Pharmasure: Meriofert detail aid ruled misleading on comparative efficacy and safety presentation

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Key facts

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Case number	AUTH/3227/7/19
Complainant	Ferring Pharmaceuticals Ltd
Respondent	Pharmasure Limited
Product	Meriofert (menotrophin)
Comparator referenced	Menopur (menotrophin for injection)
Material	Detail aid/leavepiece (ref UK/201809/00001/01); similar claims noted on Pharmasure UK website (UK/201810/00005/01)
Main issues	Misleading comparative efficacy/superiority implication; insufficient substantiation/context; unclear/extrapolated scientific tables; safety data not fairly balanced
Key studies cited	Lockwood et al (2017); Alviggi et al (2013); Birken et al (1996) (two papers discussed); Lombardi et al (2013); Cole et al (year not stated)
Complaint received	19 July 2019
Case completed	18 June 2020
Applicable Code year	2019
Breach clauses	7.2, 7.4, 7.8, 7.9
No breach	Clause 7.8 (narrow allegation re page 4 graphic in isolation)
Sanctions	Undertaking received
Appeal	No appeal

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

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Ferring complained about a Pharmasure Meriofert (menotrophin) detail aid (ref UK/201809/00001/01) and noted similar claims on the Pharmasure UK website (UK/201810/00005/01).
The material compared Meriofert with Menopur (Ferring’s product) in the IVF setting and sought to differentiate Meriofert (including by emphasising “predominantly placental hCG”).
Claims relied mainly on two non-inferiority studies: Lockwood et al (2017) and Alviggi et al (2013).
The Panel considered that the way secondary endpoints, context, and study design limitations were presented created an overall impression of clinical superiority that was not adequately supported or fairly balanced.
Page 7 safety tables were criticised for implying differences without appropriate statistical/contextual explanation and for not adequately reflecting significant hot flush differences.
A narrow allegation that a specific graphic (considered in isolation) was misleading was not upheld.

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Breach rulings: Clauses 7.2, 7.4, 7.8, 7.9.
No breach ruling: Clause 7.8 (for the very narrow allegation that the graphic on page 4, in isolation, was misleading).
Sanctions applied: Undertaking received.
Appeal: No appeal.

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