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PMCPA Case

AstraZeneca: UK employees’ LinkedIn ‘likes’ brought US FDA approval post into ABPI Code scope (AUTH/3707/11/22)

📅 2022 | 🖉 Dr Anzal Qurbain
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Key facts

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CaseAUTH/3707/11/22
CompanyAstraZeneca
Complaint received16 November 2022
Case completed5 March 2024
Applicable Code2021
ChannelLinkedIn (personal account post; UK employee engagement via likes/comments)
Subject matterFDA approval announcement for IMFINZI + IMJUDO + chemotherapy in Stage IV (metastatic) NSCLC; embedded video and link to AstraZeneca US press release
UK employee engagement14 UK-based employees (plus one additional like identified later)
Key compliance issuesPublic advertising of a POM; promotion of unlicensed medicine/indication; lack of certification and certificate retention; missing adverse event reporting statement
Final clause findingsNo breach Clause 2; Breach Clause 5.1 (x2), 8.1, 8.6, 12.9, 26.1
SanctionsUndertaking received; Additional sanctions: Not stated
AppealYes (by AstraZeneca). Clause 2 breach overturned; Clause 5.1 (x2) upheld.

Download the full case report (PDF)

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

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What happened

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  • A senior AstraZeneca employee working for the US affiliate posted on their personal LinkedIn about an FDA approval for a new treatment combination for Stage IV (metastatic) NSCLC, with an embedded video and a link to a US press release about IMFINZI and IMJUDO with chemotherapy.
  • Fourteen UK-based AstraZeneca employees (described as UK-based employees; the Panel noted many appeared senior) engaged with the post (likes/comments), which the Panel considered likely to proactively disseminate the content to their LinkedIn connections (including members of the public).
  • The complainant (a concerned health professional) alleged the post promoted to the public, failed to maintain high standards, was not certified, certificate not kept, and lacked a unique identifier and adverse event reporting statement.
  • AstraZeneca argued the original post was intended for a US audience, aligned with US rules and AstraZeneca US social media policy, and was outside UK Code jurisdiction; however, it accepted UK employees’ engagement disseminated the post.
  • Within one business day of receiving the complaint, AstraZeneca instructed UK-based employees to remove their likes/comments; they did so immediately. AstraZeneca later identified one additional employee who had liked the post and asked them to unlike it.
  • At the time, IMFINZI was a UK prescription-only medicine; the IMFINZI+IMJUDO+chemotherapy combination for Stage IV NSCLC was not a licensed UK indication, and IMJUDO was not indicated/licensed in the UK at the time.
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Outcome

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  • No breach of Clause 2 (the Panel’s breach ruling was overturned on appeal).
  • Breach of Clause 5.1 (x2) (upheld on appeal).
  • Breach of Clause 8.1.
  • Breach of Clause 8.6.
  • Breach of Clause 12.9.
  • Breach of Clause 26.1.
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