PMCPA Case Analysis

Over 2,000 real rulings β€” analysed for what they mean to your team. Published every day.

All Cases PMCPA Case of the Week PMCPA Cases

Showing 1914 cases

2021
CASE
AUTH/3478/2/21 Boehringer Ingelheim

AUTH/3478/2/21: Boehringer Ingelheimβ€”employees β€˜liked’ LinkedIn post about investigational COVID-19 antibody (No breach)

Two BI employees β€˜liked’ a LinkedIn news post about an investigational SARS‑CoV‑2 neutralising antibody entering Phase 1/2a. Panel found the activity in…

2020
CASE
AUTH/3441/12/20 Allergan ⭐ Case of the Week

Allergan social media tagging of HCP/clinic Instagram accounts mentioning Botox: no breach on appeal (AUTH/3441/12/20)

Ex-employee alleged Allergan product specialists promoted Botox via Instagram tags/hashtags linking to HCP/clinic posts. Panel found breaches, but Appeal Board overturned due…

2021
CASE
AUTH/3506/4/21 Daiichi-Sankyo UK

Daiichi-Sankyo: Lixiana journal ad breached overleaf prescribing information signposting requirements (AUTH/3506/4/21)

A Lixiana (edoxaban) print journal ad was cleared on imagery and dosing allegations, but breached the Code for failing to signpost that…

2021
CASE
AUTH/3489/3/21 Otsuka

Otsuka Europe voluntary admission: delayed affiliate notification of Samsca SPC and prescribing information updates (AUTH/3489/3/21)

Otsuka Europe admitted it missed SOP timelines to notify affiliates of a Samsca SPC update and delayed updated prescribing information. PMCPA ruled…

2021
CASE
AUTH/3563/9/21 Bristol-Myers Squibb

Bristol-Myers Squibb & Pfizer: Eliquis HCP websiteβ€”β€˜Choose Eliquis’ upheld, but AE reporting statement missing (AUTH/3563/9/21 & AUTH/3564/9/21)

Eliquis HCP site banner β€˜Choose Eliquis’ was not misleading, but the adverse event reporting statement wasn’t included within the promotional pages themselvesβ€”breach…

2021
CASE
AUTH/3535/7/21 SOBI

Sobi: pressure to inflate CRM activity, unclear call vs contact briefings, contract timing failures and recertification lapse (AUTH/3535/7/21)

Employee complaint: pressure to boost activity led to guidance to log emails as calls, unclear call vs contact briefings, HCP prep work…

2021
CASE
AUTH/3593/12/21 Leo Pharma ⭐ Case of the Week

LEO Pharma UK – Undeclared transfers of value (Disclosure UK) (AUTH/3593/12/21)

LEO made a voluntary admission after five 2020 transfers of value (4 HCP, 1 HCO) were omitted from its UK Disclosure UK…

2021
CASE
AUTH/3503/4/21 Leo

LEO Pharma – Kyntheum promotional website: misleading efficacy/safety messaging, missing black triangle, and problematic testimonials (AUTH/3503/4/21)

PMCPA found multiple breaches on LEO’s Kyntheum HCP website, including misleading/exaggerated claims and unbalanced safety messaging (Clause 2 at several points). Appeals…

2022
CASE
AUTH/3630/4/22 Daiichi-Sankyo UK

Daiichi Sankyo: Lixiana HCP mobile site hid PI and AE reporting behind collapsible menu (AUTH/3630/4/22)

PMCPA found Daiichi Sankyo’s Lixiana HCP mobile homepage made prescribing info and AE reporting insufficiently prominent by placing them behind an expandable…

2022
CASE
AUTH/3639/4/22 Roche Products

Roche Products Ltd – Polivy dosing webpage omitted key administration instructions (AUTH/3639/4/22)

Polivy dosing webpage gave the impression it contained all key administration info, but omitted SPC instructions on a dedicated infusion line/filter and…

2022
CASE
AUTH/3638/4/22 Novartis Pharmaceuticals UK

Novartis breached ABPI Code over β€˜Think Symptom-free’ claim for Xolair on HCP website (AUTH/3638/4/22)

Novartis’ HCP website claim β€œTHINK Symptom-free” for Xolair in CSU was ruled misleading and unsubstantiated (Clauses 6.1, 6.2, 5.1). Other claims (β€œUNLOCK…

2022
CASE
AUTH/3706/11/22 CSL Vifor ⭐ Case of the Week

CSL Vifor: NHS IV iron service alleged to be disguised promotion for Ferinject (AUTH/3706/11/22) – No breach

Ex-employee alleged CSL Vifor’s non-promotional NHS service was targeted to Ferinject-using hospitals and amounted to disguised promotion/inducement. Panel found allegations not evidenced…

2021
CASE
Astellas Pharma

Astellas voluntary admission: transfers of value not disclosed to HCOs and patient organisations (2019–2021)

Astellas self-reported undisclosed transfers of value to two healthcare organisations and five patient organisations (2019–2021). PMCPA found multiple disclosure breaches and a…

2022
CASE
AUTH/3700/10/22 Ethypharm

Ethypharm naloxone poster on telephone booth ruled to be public advertising of a POM (AUTH/3700/10/22)

A naloxone awareness poster on a telephone booth linked to a website showing branded naloxone products. PMCPA ruled it advertised a POM…

2021
CASE
Janssen

Janssen: PAH symposium video ruled misleading (relative risk without absolute risk; mislabelled ARR; TRITON context missing)

PMCPA found Janssen breached Clauses 5.1 and 6.1 (x3) over a PAH symposium video: relative risk shown without absolute risk, ARR mislabelled,…

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