Novo Nordisk breached ABPI Code over Ozempic formulary guide omitting retinopathy risk (AUTH/3258/10/19)

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Key facts

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Case number	AUTH/3258/10/19
Company	Novo Nordisk Limited
Medicine	Ozempic (semaglutide)
Issue area	Formulary decision guide content; omission of diabetic retinopathy discussion beyond prescribing information
Key material cited	Ozempic Formulary Decision Guide (UK/SM/0818/0304)
Complaint received	10 October 2019
Case completed	18 May 2020
Applicable Code year	2019
Appeal	No appeal
Breach clauses	Clause 7.9; Clause 9.1
Sanctions	Undertaking received; Additional sanctions: Not stated

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

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A contactable complainant (later joined by an ex-employee) complained about the promotion of Ozempic (semaglutide) by Novo Nordisk.
Allegations included: company staff helping to write local formulary applications; staff being incentivised/paid commission for formulary acceptance; inability to distinguish medical staff from sales representatives; omission of key safety information (diabetic retinopathy risk) from a formulary decision guide (UK/SM/0818/0304); failure to provide an SPC or detailed retinopathy explanation on request; misleading cost information; promotion before product supply; and alleged off-licence switching advice from a named employee.
The Panel assessed multiple strands but noted the complainant did not name most individuals involved and provided limited supporting evidence for several allegations.
The key upheld issue related to the content of the Ozempic Formulary Decision Guide (UK/SM/0818/0304): it did not specifically refer to diabetic retinopathy other than via prescribing information.

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Breach found: the Ozempic Formulary Decision Guide (UK/SM/0818/0304) failed to mention diabetic retinopathy risk in the body of the document; the Panel considered it had to be capable of standing alone and not rely on prescribing information for key safety issues.
No breach found for allegations about staff writing formulary applications, disguised promotion, incentivisation of medical staff, failure to provide SPC, misleading cost information, promotion prior to availability, alleged conversations/off-licence switching advice, and delayed medical information response (insufficient evidence provided).
No breach of Clause 2 (including cumulative effect): the circumstances did not warrant the particular censure reserved for Clause 2.

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