Otsuka UK: UK employee ‘like’ on LinkedIn brought US post into scope and promoted an unlicensed medicine (AUTH/3747/2/23)

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Key facts

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Case	AUTH/3747/2/23
Complainant	Anonymous, non-contactable complainant
Company	Otsuka Pharmaceuticals UK Limited
Related entity	Astex Therapeutics Limited (UK; part of wider Otsuka group)
Channel	LinkedIn (Otsuka US post; UK employee ‘like’)
Medicine	Ulotaront (SEP-363859/SEP-363856)
Issue	Promotion of an unlicensed medicine; exaggerated/unsubstantiated claim; insufficient UK ABPI social media training
Key claim cited	“a major advancement for the adjunctive treatment of major depressive disorder (MDD)”
Applicable Code year	2021
Breaches	Clause 3.1; Clause 5.1; Clause 6.1; Clause 9.1; Clause 14.4
Sanctions	Undertaking received; Additional sanctions: Not stated
Complaint received	28 February 2023
Case completed	4 June 2024
Appeal	No appeal

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

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An anonymous complainant challenged a LinkedIn post made by Otsuka US about ulotaront (SEP-363859/SEP-363856) for adjunctive treatment of major depressive disorder (MDD), calling it promotion of an unlicensed medicine and using exaggerated language (eg “a major advancement”).
The post was ‘liked’ by a senior UK employee of Astex Therapeutics Limited (part of the wider Otsuka group).
The Panel considered that ‘liking’ a post increases the likelihood it appears in connections’ feeds (eg “X likes this”) and can amount to proactive dissemination; linked content (eg a press release) was treated as part of the post.
Ulotaront had not been approved by any regulatory authorities at the time.
Otsuka UK accepted that the ‘like’ brought the material into scope of the ABPI Code and that UK-specific ABPI social media training for relevant staff was insufficient.
After the complaint, the ‘like’ was removed; Otsuka reviewed whether other UK-based employees had engaged and identified one additional Astex employee who had also engaged.
Otsuka shared its Europe social media training slides/working practice document with Astex; Astex issued training, placed materials on the intranet, and added it to induction for new staff.

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Breach of Clause 3.1 was ruled (promotion of a medicine prior to the grant of its marketing authorisation).
Breach of Clause 6.1 was ruled (misleading claim by exaggeration).
Breach of Clause 14.4 was ruled (exaggerated claim that could not be substantiated).
Breach of Clause 9.1 was ruled (staff not fully conversant with the Code and relevant laws/regulations).
Breach of Clause 5.1 was ruled (high standards not maintained).
No appeal.

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