Employee v Otsuka (AUTH/2988/10/17): LinkedIn posts promoted POMs to the public and included pre-licence and off-label content

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Key facts

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Case	AUTH/2988/10/17
Parties	Employee v Otsuka Pharmaceuticals (UK) Ltd
Issue	Use of LinkedIn to promote medicines
Platform	Personal LinkedIn account
Audience	300+ followers; at least some members of the public
Products/content	Tolvaptan (Jinarc) Phase 3 results link; brexpiprazole EMA review (pre-licence) link; Equelle supplement link
Key compliance themes	POM promotion to public; pre-licence promotion; licence inconsistency/misleading; missing prescribing information; lack of certification
Complaint received	31 October 2017
Case completed	31 January 2018
Applicable Code year	2016
Appeal	No appeal
Sanctions	Undertaking received; additional sanctions not stated

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

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An anonymous complainant (an Otsuka UK employee) raised concerns about a named medical science liaison (MSL) employee’s use of a personal LinkedIn account.
The employee had 300+ LinkedIn followers; Otsuka accepted at least some were members of the public.
The employee posted (May 2017) a link to a financial website article (reproducing an Otsuka global press release) highlighting positive Phase 3 data for tolvaptan (Jinarc), a prescription only medicine (POM).
The complainant alleged the tolvaptan post implied use outside the SPC (study population included ages up to 65 and CKD up to early stage 4, while the SPC stated safety/effectiveness over 50 not established and indication at initiation CKD stage 1–3).
The employee also posted a link to an article about brexpiprazole being accepted for EMA review for schizophrenia (pre-licence in the EU at the time), including brief positive clinical data.
The employee posted a link about Equelle (a non-hormonal supplement) with ordering details; Otsuka stated it was not a POM.
Otsuka stated the posts were made without its knowledge/approval, using externally sourced materials, and in contravention of internal social media policies and training.
On receipt of the complaint, Otsuka removed the posts, sought assurances no other similar posts existed, recirculated social media policies, and retrained staff (including tests and face-to-face sessions), and updated Code training to include social media.

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The Panel ruled the LinkedIn postings were within the scope of the Code because they highlighted positive/newsworthy material about Otsuka products and were proactively disseminated by an employee to followers including members of the public.
Breaches were found for promotion of POMs to the public (tolvaptan and brexpiprazole links).
Breaches were found for pre-licence promotion (brexpiprazole) and for promotion inconsistent with the licence and misleading (tolvaptan article vs SPC).
Breaches were found for missing certification and missing prescribing information for the promotional LinkedIn posting(s).
No breach was found for Clause 2 (industry disrepute) given the company had policies and training and was “badly let down” by the employee.
No breach was found for Equelle under Clause 26.1 because it was not a POM.
No breach was found for disguised promotion, declaration of sponsorship, meetings/hospitality, or Clause 1.2 (not capable of being breached per se).

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