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/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,…

2023
CASE
AUTH/3757/3/23 Otsuka

Otsuka criticised for lack of transparency in PMCPA submission about earlier case (AUTH/3757/3/23)

Ex-employee alleged Otsuka withheld relevant facts and used unsigned witness statements in a 2015 PMCPA case response. Panel found breaches of Clauses…

2022
CASE
AUTH/3717/12/22 Novo Nordisk ⭐ Case of the Week

AUTH/3717/12/22: Public complaint about weight-loss media coverage – Novo Nordisk (Sunday Times interview led to breaches)

Five weight-loss media articles were complained about. Novo Nordisk was not responsible for four. One Sunday Times interview quote was ruled promotional…

Ask questions about any PMCPA case

Anzal, our PMCPA rulings expert, has knowledge of over 2,000 published cases β€” ask about precedents, clauses, and how they apply to your situation.

⭐ Flagship Programme

AQP Flagship Path — the complete UK ABPI signatory programme

12 modules. 12 weeks. Final Signatory readiness. The industry standard for ABPI Code signatories — £995 + VAT.

Enrol — AQP Path Learn more

📰 Weekly PMCPA Case Breakdown

One real case. One key lesson. Every week β€” free.

Subscribe Free
🎓 AQP Training