Shionogi Europe: LinkedIn posts about Fetcroja ruled pre-licence promotion and public promotion of a POM

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Key facts

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Case	AUTH/3343/5/20
Company	Shionogi Europe
Product	Fetcroja (cefiderocol)
Channel	LinkedIn (Shionogi EU LinkedIn account)
Issue	Pre-licence promotion (CHMP update) and promotion of a prescription only medicine to the public (marketing authorisation update)
Complainant	Concerned UK health professional
Complaint received	4 May 2020
Case completed	24 July 2020
Applicable Code year	2019
No breach	Clause(s) 26.1, 26.2 (Post 1 only, narrow technical point)
Breach	Clause(s) 2, 3.1, 9.1, 26.1, 26.2
Sanctions	Undertaking received; Additional sanctions; Advertisement
Appeal	No appeal

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

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A UK health professional complained about two Shionogi Europe posts on LinkedIn referring positively to Fetcroja (cefiderocol).
Post 1 ("CHMP update") said: “Great news for patients…” and “Fetcroja Pending EC decision - European Medicines Agency”, with hashtags (eg healthcare, patients, antibiotics, antimicrobial resistance) that increased reach beyond followers.
Post 2 ("marketing authorisation update") said: “Fantastic news! … Fetcroja … has received a marketing authorization…”, again with broad hashtags (eg antibiotic resistance, infection, bacteria).
Shionogi said the EU LinkedIn account was originally intended for employer branding/recruitment; a limited number of staff had admin rights.
The employee who posted had permission to represent the company on LinkedIn and discussed the posts with their line manager, but Shionogi stated neither considered the ABPI Code requirements.
On notification of the complaint, Shionogi deleted the posts the same day and issued a company-wide communication; it also found some staff had liked/shared the posts.
Shionogi retrained relevant staff on social media and Code requirements (May 2020) and planned to review/revise its social media policy with knowledge validation.

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No breach of Clause(s) 26.1 and 26.2 in relation to the first (pre-authorisation) post, on a narrow technical point: at that time Fetcroja was not licensed and therefore not classified as a prescription only medicine, so Clauses 26.1/26.2 did not apply.
Breach of Clause(s) 3.1 (pre-licence promotion) for the CHMP update post.
Breach of Clause(s) 26.1 and 26.2 for the marketing authorisation update post (promotion of a POM to the public and encouragement to ask a health professional to prescribe).
Breach of Clause(s) 9.1 (high standards not maintained).
Breach of Clause(s) 2 (bringing discredit upon and reducing confidence in the industry), given the posts were made with company knowledge/authority and there appeared to be a lack of awareness/understanding of the Code.
No appeal.

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