Novartis: Leqvio webinar registration page—adverse event reporting statement not sufficiently prominent (AUTH/3670/6/22)

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Key facts

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Case	AUTH/3670/6/22
Complainant	Anonymous, contactable health professional
Company	Novartis
Material	Webinar registration webpage for Leqvio (inclisiran)
Webinar title	“Introducing an innovative approach to lipid management with inclisiran (Leqvio)”
Product	Leqvio (inclisiran) (black triangle product)
Applicable Code	2021
Complaint received	30 June 2022
Case completed	14 July 2023
Appeal	No appeal
Breach clauses	Clause 5.1; Clause 12.9
Sanctions	Undertaking received; Additional sanctions: Not stated

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

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A health professional complained about a Novartis webinar registration webpage for Leqvio (inclisiran) titled: “Introducing an innovative approach to lipid management with inclisiran (Leqvio)”.
Concerns raised included: the title allegedly implying broader use than the licensed indication (including in children), use of the word “innovative”, an invitation to contact Medical Information (alleged solicitation), and that adverse event (AE) reporting information was not prominent (Leqvio is a black triangle medicine).
The Panel assessed the registration webpage itself (not the webinar content).
The AE reporting statement appeared at the bottom of the webpage in a smaller font than the main body text; although there was a link saying “Prescribing information and adverse event reporting information can be found here”, Clause 12.9 required the statement to be included prominently within the material itself.

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Breach found for the AE reporting statement not being sufficiently prominent on the webpage.
No breach found regarding alleged misleading implication of indication/paediatric use, substantiation, unlicensed promotion, “innovative” as a superlative/special merit, and alleged solicitation of medical information questions (complainant did not establish the alleged non-compliance).
No breach of Clause 2 in relation to AE reporting prominence, as the Panel considered breaches of Clauses 12.9 and 5.1 adequately covered the issue and an additional Clause 2 breach would be disproportionate.

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Breach of Clause 5.1 Failing to maintain high standards
Breach of Clause 12.9 Failing to include a prominent adverse event reporting statement
No Breach of Clause 2 Requirement that activities or material must not bring discredit upon, or reduce confidence in, the pharmaceutical industry
No Breach of Clause 5.1 Requirement to maintain high standards
No Breach of Clause 6.1 Requirement that claims must not be misleading
No Breach of Clause 6.2 Requirement that information must be capable of substantiation
No Breach of Clause 11.2 Requirement not to promote a medicine for an unlicensed indication
No Breach of Clause 14.4 Requirement that claims should not imply that a medicine or an active ingredient has some special merit, quality or property unless this can be substantiated.

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