PMCPA Case Analysis

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All Cases PMCPA Case of the Week PMCPA Cases

Showing 1914 cases

2022
CASE
AUTH/3707/11/22 AstraZeneca ⭐ Case of the Week

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

A US-facing LinkedIn post about an FDA-approved lung cancer combo was liked/commented on by 14 UK-based AstraZeneca employees, triggering ABPI Code breaches…

2022
CASE
AUTH/3690/8/22 GlaxoSmithKline

GSK: Senior medical employee β€˜loved’ LinkedIn post seen as disseminating off-label promotion for Jemperli (AUTH/3690/8/22)

A senior UK-based GSK medical employee β€˜loved’ an external LinkedIn post about rectal cancer immunotherapy. Panel said this likely disseminated off-label promotion…

2023
CASE
AUTH/3762/4/23 SyriMed

AUTH/3762/4/23: Complainant v SyriMed (Thame Laboratories) β€” representative exam allegation (No breach)

Ex-employee alleged an individual promoted medicines to HCPs for 2+ years without ABPI qualification. Panel found no evidence for the 2-year claim…

2023
CASE
AUTH/3746/2/23 Moderna

Moderna: ECCMID β€œproduct theatre” presentation ruled promotional and inconsistent with Spikevax SPC (AUTH/3746/2/23)

At ECCMID 2022, a UK HCP presentation was ruled promotional for Spikevax and included booster-dose data inconsistent with the SPC. Breaches: Clauses…

2023
CASE
AUTH/3801/7/23 AstraZeneca

AUTH/3801/7/23: Complainant v AstraZeneca β€” LinkedIn β€˜About’ section alleged public promotion (No breach)

Complaint alleged a senior AstraZeneca leader’s LinkedIn β€˜About’ section promoted POMs to the public and referenced unlicensed indications/trials. Panel ruled no breach…

2023
CASE
AUTH/3839/10/23 Ipsen ⭐ Case of the Week

Ipsen voluntary admission: employee promoted to HCPs in Northern Ireland without verified ABPI representative exam (AUTH/3839/10/23)

Ipsen admitted an employee in a promotional role in Northern Ireland had no verified ABPI representative exam on file. PMCPA ruled breaches…

2023
CASE
AUTH/3803/07/23 GlaxoSmithKline

GSK press release on dostarlimab EAMS found promotional to the public and for an unlicensed indication (AUTH/3803/07/23)

PMCPA ruled GSK’s EAMS press release for dostarlimab was promotional, sent to mainstream media, and promoted an unlicensed indication. Breaches: 5.1, 11.2,…

2023
CASE
AUTH/3806/8/23 AstraZeneca

AstraZeneca breached ABPI Code over missing PI and weak PI signposting on Tagrisso HCP website pop-up (AUTH/3806/8/23)

PMCPA ruled AstraZeneca’s Tagrisso Connect HCP site breached the Code because the first promotional pop-up lacked prescribing information and didn’t clearly signpost…

2023
CASE
AUTH/3809/8/23 Bayer

AUTH/3809/8/23: Complainant v Bayer β€” Advisory board alleged to be pre-licence promotion (No breach on appeal)

Complaint alleged Bayer’s US advisory board was disguised pre-licence promotion of Eylea 8mg. Panel initially found breaches, but Appeal Board overturned them…

2024
CASE
AUTH/3892/4/24 AstraZeneca

AstraZeneca Twitter/X posts about Covid-19 vaccine: one tweet ruled promotional pre-authorisation (AUTH/3892/4/24)

PMCPA reviewed four AstraZeneca UK corporate tweets about its Covid-19 vaccine. Tweets 1–3 were non-promotional corporate updates. Tweet 4 was ruled promotional…

2024
CASE
AUTH/3923/6/24 GlaxoSmithKline ⭐ Case of the Week

AUTH/3923/6/24: Complainant v GSK β€” Trelegy sales aid alleged off-label promotion (No breach)

Anonymous health professional alleged GSK sales aids promoted Trelegy for patients inadequately treated on multiple-inhaler triple therapy (MITT). Panel ruled no breach…

2007
CASE
AUTH/2071/11/07 Takeda

AUTH/2071/11/07: GP v Takeda – Competact/Actos leavepiece and mixed use of relative vs absolute risk

A GP challenged a Takeda promotional leavepiece for pioglitazone that presented benefits as relative risk reduction but harms as absolute risk. The…

2008
CASE
AUTH/2103/3/08 Trinity-Chiesi Pharmaceuticals

AUTH/2103/3/08: Anonymous PCT medicines management team member v Trinity-Chiesi – therapeutic review service (no breach)

Anonymous complaint alleged Trinity-Chiesi sponsored a switch service to Clenil. Panel reviewed the Clinical Support Service documents and process and found no…

2008
CASE
AUTH/2152/8/08 Sanofi

AUTH/2152/8/08: Novo Nordisk v Sanofi-Aventis – Promotion of Lantus (mailer and leavepieces)

Complaint about Lantus promotional materials. Panel ruled multiple presentations of comparative dosing/weight data were misleading due to context and incomplete disclosure, breaching…

2008
CASE
AUTH/2144/7/08 Syner-Med

AUTH/2144/7/08 Nurse v Syner-Med: question at a meeting (no breach)

A nurse alleged a sponsored symposium discussion implied an EpiPen could replace cardio-pulmonary resuscitation for IV iron reactions. The Panel could not…

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