Shield Therapeutics: corporate website promoted Feraccru to the public and promoted unlicensed pipeline products (AUTH/3037/4/18)

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Key facts

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Case number	AUTH/3037/4/18
Complainant	Anonymous “concerned UK health professional”
Company	Shield Therapeutics
Products	Feraccru (ferric maltol); PT20; PT30; PT40
Issue	Promotion of Feraccru and unlicensed medicines to the public via corporate website; lack of certification; missing prescribing information; inadequate audience separation; pre-authorisation promotion
Complaint received	26 April 2018
Case completed	24 August 2018
Applicable Code year	2016
Appeal	No appeal
No breach clauses	2; 26.1
Breach clauses	2; 3.1; 4.1; 4.6; 9.1; 14.3; 26.1; 28.1
Sanctions	Undertaking received; Advertisement

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

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An anonymous UK health professional complained about content on Shield Therapeutics’ corporate website relating to Feraccru (ferric maltol) and pipeline products PT20, PT30 and PT40.
The complainant said the site had no separate areas for prescribers vs the public, and that Feraccru content was promotional and publicly accessible without links to prescribing information.
The complainant also alleged the pipeline product pages promoted unlicensed medicines and did so before regulatory review/authorisation.
Shield said the site was intended for investors and the public and was meant to be non-promotional; it stated a contractor had changed the site without following internal procedures, making it promotional.
The Panel found the website had not been certified as required for public-facing educational material, and that parts of the site were promotional.
Feraccru content compared it favourably with other iron therapies (including IV iron), while being accessible to the public.
Pipeline pages went beyond a brief pipeline summary and included promotional-style comparative and benefit statements; PT30 and PT40 were in early clinical development.

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Breach found for: 2, 3.1, 4.1, 4.6, 9.1, 14.3, 26.1, 28.1.
No breach found for: 2, 26.1 (on a narrow technical point relating to PT20 not being classified as a prescription only medicine at the time).
No appeal.
Undertaking received; additional sanction: advertisement.

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