Novo Nordisk breached ABPI Code over Saxenda materials at fertility conference lacking prominent pregnancy warnings (AUTH/3299/1/20)

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Key facts

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Case	AUTH/3299/1/20
Company	Novo Nordisk
Product	Saxenda (liraglutide)
Setting	British Fertility Conference (Fertility 2020), Edinburgh
Issue focus	Insufficiently clear/prominent pregnancy/trying-to-conceive warnings in materials used at a fertility conference; lack of written certified rep briefing record
Applicable Code year	2019
Complaint received	19 January 2020
Case completed	15 July 2020
Breach clauses	2, 7.2, 9.1, 15.1, 15.9, 26.2
No breach clauses	2, 3.2, 4.1, 7.3, 7.4, 7.9, 9.1, 14.1, 14.3, 14.5, 15.2, 16.1, 18.1, 18.2, 29
Sanctions	Undertaking received; Additional sanctions: Advertisement
Materials referenced	Patient brochure (UK/SA/0616/0068); Women’s health leavepiece (UK19SX00080)

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

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A named individual complained about Novo Nordisk’s promotion of Saxenda (liraglutide) at the British Fertility Conference (January 2020).
Saxenda’s SPC (Section 4.6) stated it should not be used during pregnancy/breastfeeding and should be discontinued if pregnancy occurs or if a patient wishes to become pregnant; SPC Section 5.3 included preclinical reproductive toxicity information.
Novo Nordisk exhibited with a table-top stand and two representatives; two printed items were available: a patient brochure (ref UK/SA/0616/0068) and a women’s health leavepiece (ref UK19SX00080).
The complainant alleged the representative promoted Saxenda in a way that implied helping women get pregnant, without stating relevant pregnancy/trying-to-conceive warnings, and raised concerns about patient materials being available at a fertility meeting.
The Panel accepted it was not necessarily unacceptable to promote Saxenda at a fertility conference, but found the materials were general and not tailored to the audience and relied too heavily on prescribing information for highly relevant pregnancy warnings.
On appeal, the Appeal Board focused on the need for very clear guidance on pregnancy/trying-to-conceive risks given the fertility setting, and on the lack of written certified briefing records for representatives in this new conference area for the company.

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Breach found: Clauses 2, 7.2, 9.1, 15.1, 15.9, 26.2.
No breach found: Clauses 3.2, 4.1, 7.3, 7.4, 7.9, 14.1, 14.3, 14.5, 15.2, 16.1, 18.1, 18.2, 29.
The Appeal Board upheld the Panel’s view that relying on prescribing information alone was insufficient in this context and that delegates should be in no doubt about use prior to fertility treatment.
The Appeal Board ruled the patient brochure and women’s health leavepiece were misleading because they did not clearly reflect the relevant SPC warnings (even though the leavepiece included the warning in prescribing information, it was not clear/prominent enough for the fertility context).
The Appeal Board ruled Novo Nordisk could not show representatives were adequately trained/briefed for this new setting because no written certified record of the verbal briefing was provided.

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