Sanofi Twitter post about Epilim and the IMMDS safety review: public-facing content ruled misleading and an advert to the public (AUTH/3166/2/19)

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Key facts

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Case	AUTH/3166/2/19
Company	Sanofi
Complainant	Concerned UK health professional
Medicine	Epilim (sodium valproate)
Channel	Twitter (Sanofi UK account)
Issue	Tweet about co-operation with the IMMDS safety review; named a POM and its use; lacked safety context/balance; not certified
Complaint received	27 February 2019
Tweet date	18 January 2019
Case completed	11 June 2019
Published	May 2020 Code of Practice Review
Applicable Code year	2016 (per PMCPA case page)
Breach clauses	9.1, 14.5, 26.1, 26.2
No breach clauses	2, 4.1, 4.2, 4.3, 4.4, 4.9, 9.9, 11.1, 12.1, 14.1, 16.1, 28.1, 28.6
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 a tweet from Sanofi UK (18 Jan 2019) referencing Epilim (sodium valproate) and the Independent Medicines and Medical Devices Safety (IMMDS) Review.
The tweet stated Sanofi had spoken to @IMMDSReview and was assisting the Review team on the “complex issue” of using Epilim to treat women and girls of child-bearing potential with epilepsy.
The complainant alleged the tweet was promotional, highlighted Epilim’s black triangle status, and cited a wide range of clauses.
Sanofi argued the tweet was a factual, non-promotional announcement on a matter of public interest (co-operation with a government-directed safety review), and therefore largely outside the promotional requirements alleged.
The Panel considered the tweet was available to the public (not restricted), and that Twitter content can be rapidly disseminated widely.

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Breach of Clause 14.5 (tweet should have been certified as material for the public).
Breach of Clause 26.2 (tweet was not balanced and was misleading about the safety review and use of the medicine; could raise unfounded hopes).
Breach of Clause 26.1 (on balance, advertising a prescription only medicine to the public).
Breach of Clause 9.1 (high standards not maintained).
No breach of Clauses 2, 4.1, 4.2, 4.3, 4.4, 4.9, 9.9, 11.1, 12.1, 14.1, 16.1, 28.1, 28.6.
No appeal.

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