PMCPA Case Analysis

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All Cases PMCPA Case of the Week PMCPA Cases

Showing 1914 cases

2019
CASE
Napp ⭐ Case of the Week

Napp: Invokana renal outcomes discussion at conference stand; internal CREDENCE training slides ruled to breach

Anonymous pharmacist alleged off-licence CKD promotion of Invokana at a diabetes conference. Panel couldn’t prove what was said (no breach), but ruled…

2019
CASE
AUTH/3212/6/19 Otsuka

Otsuka UK/Otsuka Europe: UK-circulated press release found to promote unlicensed ASTX727 and mislead on evidence and decitabine indication (AUTH/3212/6/19, AUTH/3262/6/19)

A UK-circulated press release about investigational ASTX727 made unsubstantiated benefit/safety claims and implied an incorrect indication for decitabine. Breaches: 3.1, 3.2, 7.9,…

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…

2019
CASE
Amgen

Amgen: sponsored osteoporosis therapy review service challenged over third-party email linking β€œclient product/therapy priorities” (No breach)

Anonymous group alleged a third-party therapy review provider’s internal email showed commercial bias and disguised promotion in Amgen-funded osteoporosis reviews. Panel and…

2019
CASE
Takeda

Takeda breached Clause 7.11 by calling Takhzyro β€œnew” more than 12 months after promotion began

A BMJ-hosted ad described Takhzyro as β€œa new preventative treatment”. PMCPA ruled Takhzyro had been promoted from 1 April 2019, so β€œnew”…

2019
CASE
Chugai ⭐ Case of the Week

Roche and Chugai: complaint about allegedly out-of-date RoActemra prescribing information (no breach)

A UK health professional alleged RoActemra prescribing information in a Guidelines in Practice product review was out of date vs SPC updates.…

2020
CASE
AUTH/3388/9/20 Daiichi-Sankyo UK

Daiichi-Sankyo: congress programme listed product-linked symposia without mandatory info or clear sponsorship declaration (AUTH/3388/9/20)

A patient-organisation congress website listed Daiichi-Sankyo symposia agendas naming Lixiana, Nilemdo and Nustendi with indications but omitted mandatory prescribing/AE/black triangle info and…

2019
CASE
Sanofi

Sanofi voluntary admission: Dupixent website resource not certified (Clause 14.1)

Sanofi self-reported that a downloadable NICE technology appraisal resource on dupixent.co.uk for HCPs was live without certification during a system transition. PMCPA…

2020
CASE
AUTH/3404/10/20 Camurus

AUTH/3404/10/20: Indivior v Camurus β€” Buvidal guidelines and webinars treated as promotional; public access and missing safety info

Camurus-funded Buvidal β€œclinical guidelines” and webinars were ruled promotional, lacked PI/AE reporting and INN, were not certified, and one webinar was publicly…

2021
CASE
AUTH/3526/6/21 Leo Pharma

Leo Pharma voluntary admission: broken prescribing information links in Innohep promotional emails (AUTH/3526/6/21)

Leo Pharma UK admitted six promotional emails for Innohep were sent with broken single-click prescribing information links after a website merge. PMCPA…

2021
CASE
AUTH/3464/1/21 Novartis Pharmaceuticals UK ⭐ Case of the Week

Novartis breached ABPI Code after edited Beovu HCP video omitted safety caution (AUTH/3464/1/21)

PMCPA ruled Novartis’ edited Beovu β€œfirst experience” HCP video was misleading because it retained positive case outcomes but omitted the presenter’s caution…

2020
CASE
AUTH/3418/11/20 Leo Pharma

Leo Pharma: missing clinical trial signposting and late patient organisation disclosure (AUTH/3418/11/20)

Leo’s UK homepage lacked signposting to clinical trial results and it disclosed 2019 patient organisation support over 5 months late. Breaches of…

2021
CASE
AUTH/3504/4/21 Daiichi-Sankyo UK

Daiichi-Sankyo: Nilemdo/Nustendi HCP website claims and safety caveats relegated to footnotes (AUTH/3504/4/21)

PMCPA found breaches where Nilemdo/Nustendi web claims implied add-on use with any lipid-lowering therapy, while key contraindications/caveats (eg simvastatin >40mg; bile acid…

2021
CASE
AUTH/3449/1/21 Small Pharma

AUTH/3449/1/21: Small Pharmaβ€”misleading lay press quote about DMT’s effects on depression

A Guardian article quoted a Small Pharma employee making strong, unqualified claims about DMT β€˜undoing’ depressive thoughts. The Panel found the claim…

2021
CASE
AUTH/3542/7/21 Daiichi-Sankyo UK

Daiichi-Sankyo: β€˜Add on’ cholesterol ad misleading due to simvastatin contraindication buried in footnote (AUTH/3542/7/21)

A Nilemdo/Nustendi journal ad implied add-on use without clearly flagging simvastatin >40mg contraindication. PMCPA found the claim misleading with potential patient safety…

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