PMCPA Case Analysis

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All Cases PMCPA Case of the Week PMCPA Cases

Showing 1914 cases

2021
CASE
AUTH/3451/1/21 Teva ⭐ Case of the Week

Teva respiratory websites: missing PI/AE signposting online, audience separation issues, and off-label implication from guideline content (AUTH/3451/1/21)

Teva’s HCP and education websites were ruled promotional in parts. Breaches included missing prominent PI/AE signposting online, missing PI for some products,…

2019
CASE
Bristol-Myers Squibb

Bristol-Myers Squibb: UK employee β€˜liked’ US LinkedIn post linking to Opdivo/Yervoy FDA approval (public promotion and missing PI)

A senior BMS UK employee β€˜liked’ a US colleague’s LinkedIn post that linked (via Twitter) to a US press release naming Opdivo…

2020
CASE
AUTH/3427/11/20 Novo Nordisk

AUTH/3427/11/20: Lilly v Novo Nordisk β€” CVOT slide deck comparisons (No breach)

Lilly alleged Novo Nordisk’s GLP-1RA CVOT slide deck misled HCPs by inviting comparisons and omitting primary vs secondary prevention context. Panel and…

2019
CASE
AstraZeneca

AstraZeneca press releases on COVID-19 vaccine: unqualified β€œsafe” claims and relative risk without absolute risk context

Two AstraZeneca press releases described its COVID-19 vaccine as β€œsafe” and presented efficacy as relative risk reduction without absolute risk context. PMCPA…

2021
CASE
AUTH/3582/11/21 Galapagos Biotech

AUTH/3582/11/21: AbbVie v Galapagos β€” Jyseleca website claims (safety β€˜low rates’ and β€˜sustained efficacy’ summary)

AbbVie challenged Jyseleca RA website claims. Panel found β€œconsistently low rates” safety claim misleading/unsupported and β€˜At a glance’ efficacy summary misleading/incomplete. No…

2021
CASE
AUTH/3592/12/21 Janssen ⭐ Case of the Week

AUTH/3592/12/21: Bayer v Janssen (Erleada on-demand promotional video) – No breach

Bayer challenged Janssen’s Erleada promotional video alleging off-licence promotion and misleading/disparaging cross-trial safety comparisons. The PMCPA Panel ruled no breach of Clauses…

2022
CASE
AUTH/3711/11/22 Novo Nordisk

Novo Nordisk breached Clause 5.5 over unclear involvement in pharmacist obesity hub and documents (AUTH/3711/11/22)

Novo Nordisk and a pharmacist association co-developed a weight management hub. PMCPA found Novo’s exact involvement wasn’t clearly declared at the outset…

2022
CASE
AUTH/3647/5/22 Leo

Leo voluntary admission: uncertified Kyntheum website pages (AUTH/3647/5/22)

Leo admitted two Kyntheum promotional webpages went live in forms that were not UK-certified (one differed from certified content; one was a…

2022
CASE
AUTH/3655/6/22 Novartis Pharmaceuticals UK

Novartis breached Code over Mayzent web page implying initiation was suitable for patients with recent MI/heart failure (AUTH/3655/6/22)

Novartis’ Mayzent dosing webpage referenced initiation/ECG monitoring for patients with MI/heart failure history but didn’t make clear the absolute 6‑month contraindication. Breaches…

2021
CASE
UCB Pharma

Eli Lilly v UCB: Bimzelx leavepieceβ€”in vitro MOA claims implied clinical superiority

UCB’s Bimzelx leavepiece used in vitro pathway claims and cytokine level data in a way that implied clinical superiority vs IL‑17A inhibitors.…

2022
CASE
AUTH/3613/2/22 AstraZeneca ⭐ Case of the Week

AUTH/3613/2/22: Complainant v AstraZeneca β€” LinkedIn promotion allegation and alleged breach of undertaking (out of scope)

Complaint alleged LinkedIn promotion and breach of an undertaking by AstraZeneca. PMCPA concluded the matter was outwith the scope of the ABPI…

2023
CASE
AUTH/3733/1/23 GrΓΌnenthal

GrΓΌnenthal voluntary admission: failure to retain certified materials and certificates (AUTH/3733/1/23)

GrΓΌnenthal voluntarily admitted it could not locate/retain ~30 certified hard-copy items and signatures. The PMCPA ruled breaches of Clauses 5.1 and 8.6…

2023
CASE
AUTH/3725/1/23 Novartis Pharmaceuticals UK

Novartis breached Clauses 2, 5.1 and 12.1 after outdated Entresto prescribing information appeared in downloadable HCP portal documents (AUTH/3725/1/23)

Two downloadable documents on Novartis’ HCP portal contained outdated Entresto prescribing information (May 2021 and June 2020) while the webpage PI was…

2023
CASE
AUTH/3722/1/23 Otsuka

AUTH/3722/1/23: Complainant v Otsuka β€” Market research alleged to be disguised promotion (No breach after appeal)

Complaint alleged Otsuka’s Abilify Maintena tracking market research was promotional and used patient record forms like a clinical study, plus weak approvals.…

2024
CASE
AUTH/3886/3/24 Moderna

Moderna: unapproved WhatsApp trial recruitment message offered Β£1,500 to children (AUTH/3886/3/24)

A paediatrician at an NHS trial site circulated a WhatsApp recruitment message for Moderna’s NextCOVE trial offering Β£1,500 on completion. PMCPA found…

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