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

2019
CASE
Otsuka

Otsuka UK/Otsuka Europe: UK-circulated press releases about unlicensed ASTX727 found to breach high standards and substantiation rules

Two online press releases about investigational ASTX727 were circulated to UK outlets. Panel found misleading, unsubstantiated study claims and failure to maintain…

2020
CASE
AUTH/3347/5/20 Strides Pharma UK ⭐ Case of the Week

Strides Pharma: LinkedIn comment promoted POM Strivit D3 to the public (AUTH/3347/5/20)

A senior employee’s LinkedIn comment praising Strivit D3 (β€œlicensed, prescribed, kosher and halal”) was ruled to be public promotion of a prescription-only…

2020
CASE
AUTH/3333/4/20 Novo Nordisk

Novo Nordisk: Saxenda exhibition stand at medical aesthetics conference found to breach high standards (AUTH/3333/4/20)

Complaint about Saxenda promotion at a medical aesthetics exhibition. Appeal Board ruled no public promotion (Clause 26.1) and no Clause 2 breach,…

2020
CASE
AUTH/3336/4/20 Bio Products Laboratory

AUTH/3336/4/20: Anonymous v Bio Products Laboratory β€” lay press coverage of unlicensed β€˜hyperimmune’ Covid-19 shots (No breach)

Anonymous NHS intensivist challenged BPL comments in Daily Mail/Telegraph and LinkedIn about unlicensed β€˜hyperimmune’ Covid-19 shots. Panel found no breach (narrowly, no…

2020
CASE
AUTH/3324/3/20 Gedeon Richter

Gedeon Richter: internal training and cycle-meeting slides used outside approval/certification (AUTH/3324/3/20)

Employee complaint alleged data concealment and other issues. Panel found breaches only for using two training items outside approval dates and an…

2019
CASE
Novartis Pharmaceuticals UK

Novartis voluntary admission: representative discussions about Piqray (alpelisib) pre-licence ruled promotional

Novartis self-reported after a representative discussed CHMP wording for unlicensed Piqray with two clinicians. Panel ruled this was pre-authorisation promotion and a…

2020
CASE
AUTH/3445/12/20 Novo Nordisk ⭐ Case of the Week

AUTH/3445/12/20: Novo Nordisk Ozempic email alleged off-label promotion to under-18s (No breach)

Complaint said an Ozempic promotional email implied use in all type 2 diabetes patients because β€œadults” appeared later in small text. Panel…

2021
CASE
AUTH/3460/1/21 Novartis Pharmaceuticals UK

AUTH/3460/1/21: Complainant v Novartis β€” Beovu journal ad and safety information (No breach)

A health professional complained a Beovu journal ad lacked safety information given post-marketing retinal vasculitis/occlusion concerns. Panel found prescribing info covered key…

2021
CASE
AUTH/3454/1/21 Sanofi

Sanofi Toujeo Coach webinar invite briefing: copy/paste template and tracking invites (AUTH/3454/1/21)

Employee complaint about Toujeo Coach webinar invite emails (copy/paste template, tracking numbers sent, alleged reminder emails). Panel found no evidence of non-compliance…

2021
CASE
AUTH/3458/1/21 Napp Pharmaceuticals

AUTH/3458/1/21: Anonymous health professional v Napp (Invokana) – off-licence promotion allegations dismissed on appeal (no breach)

Complaint alleged off-licence promotion and inadequate safety info in an Invokana CREDENCE webinar/video. Panel initially found a misleading dosing slide, but Appeal…

2021
CASE
AUTH/3486/3/21 Sanofi

Sanofi: complaint about alleged off-licence promotion of Suliqua via APC formulary listing (AUTH/3486/3/21) – No breach

Anonymous HCP alleged off-licence promotion after an APC formulary listed Suliqua for use with basal insulin. Panel found no evidence Sanofi influenced…

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…

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