Stiefel (GSK): Out-of-date Toctino prescribing information left live on third-party site after project cancellation

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Key facts

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Case	AUTH/3392/10/20 (PDF references AUTH/3392/9/20)
Parties	Complainant v Stiefel (GlaxoSmithKline response on behalf of Stiefel, a GSK subsidiary)
Product	Toctino (alitretinoin)
Issue	Standalone prescribing information posted on a third-party website and left live; became out-of-date and did not include black triangle when required
Third-party site	Guidelines in Practice
Key dates	PI dated June 2016; posted 18 Feb 2018; hosting page certified 23 Feb 2018; project cancelled by 8 Aug 2018; complaint received 1 Oct 2020; case completed 11 Mar 2021
Applicable Code year	2019
Breach clauses	4.1, 4.10, 9.1
No breach clauses	2
Sanctions	Undertaking received; additional sanctions not stated
Appeal	No appeal

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

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A UK health professional complained about Toctino (alitretinoin) prescribing information hosted on the Guidelines in Practice website.
The prescribing information was dated June 2016; the complainant said it appeared not to have been rechecked despite multiple SPC updates since 2016.
The complainant highlighted that the material did not include the black triangle (additional monitoring), which became required for Toctino from July 2018.
GlaxoSmithKline (for Stiefel, a GSK subsidiary) said it had commissioned a GP e-learning module in late 2017 but decided not to proceed; the project was cancelled (publisher email referenced a face-to-face cancellation meeting on 8 August 2018).
Despite the cancellation and without GSK’s knowledge (and against instructions), the publisher created and posted standalone prescribing information on 18 February 2018; the hosting page appeared to have been certified on 23 February 2018.
The prescribing information remained accessible via external search engines and stayed live until it was removed when the complaint was raised (September 2020).
Because GSK was unaware the standalone prescribing information existed on the third-party site, it was not updated to include the black triangle when that became necessary in July 2018.

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Breach of Clause 4.1.
Breach of Clause 4.10.
Breach of Clause 9.1.
No breach of Clause 2.
Panel reiterated the principle that companies are responsible for acts/omissions of third parties working on their behalf, even if inconsistent with company instructions.

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