AAA website: out-of-date Northern Ireland licensing statement for Pluvicto led to Code breaches

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Key facts

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Case	AUTH/3736/2/23
Company	Advanced Accelerator Applications (AAA), a Novartis company
Product	Pluvicto (lutetium (177Lu) vipivotide tetraxetan)
Channel	Company website (“RLT Hub”) linked from a Medscape email
Main issue	Website statement said Pluvicto was not licensed in Northern Ireland after EMA approval
Complaint received	12 February 2023
Case completed	22 March 2024
Applicable Code	2021
Breach clauses	Clause 5.1; Clause 6.1
No breach clauses considered	Clause 2; Clause 5.1; Clause 6.1; Clause 12.10; Clause 26.1
Sanctions	Undertaking received; Additional sanctions: Not stated
Appeal	No appeal

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

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An anonymous, contactable health professional complained about AAA’s “RLT Hub” website accessed via a Medscape email inviting recipients to learn more about Pluvicto.
On the HCP page, a bold statement said: “This page/content is for Great Britain healthcare professionals only. Pluvicto is not licensed in Northern Ireland”.
The complainant alleged this was wrong because Pluvicto had received EMA approval in mid-December 2022 (therefore licensed in Northern Ireland).
The complainant also alleged: (a) the public-facing page (containing SPC/EPAR/PIL for Pluvicto and Lutathera) was “blatant promotion” to the public, (b) black triangles were used inconsistently, (c) no sign-in was required, and (d) the mechanism of action statement about PSMA-positive cells lacked context about non-cancerous PSMA expression.
AAA said the site used audience validation (HCP vs public), the public page was “reference information” only (SPC/EPAR/PIL), black triangles were intentionally repeated for digital accessibility, and the NI licensing statement was in the process of being updated via a third party.

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Breach: Clause 6.1 (inaccurate, out-of-date information) for the NI licensing status statement.
Breach: Clause 5.1 (high standards) due to concerns about urgency/knowledge of Code requirements and adequacy of website governance procedures.
No breach: Clause 26.1 (advertising POMs to the public) — publishing SPC/EPAR/PIL on the public page was not promotional.
No breach: Clause 12.10 (black triangle) — multiple placements were not contrary to the Code on the facts.
No breach: Clause 6.1 (misleading) regarding the PSMA statement/omission allegation (complainant did not evidence misleadingness).
No breach: Clause 5.1 regarding absence of sign-in (no Code requirement for sign-in).
No breach: Clause 2 (particular censure not warranted).
No appeal.

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Breach of Clause 5.1 Failing to maintain high standards
Breach of Clause 6.1 Providing inaccurate, out-of-date information
No Breach of Clause 2 Requirement that activities or materials 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 information must be accurate, up-to-date and not misleading
No Breach of Clause 12.10 Requirement to include the black triangle in promotional material
No Breach of Clause 26.1 Requirement not to advertise prescription only medicines to the public

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