PMCPA Case Analysis

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All Cases PMCPA Case of the Week PMCPA Cases

Showing 1914 cases

2020
CASE
AUTH/3311/2/20 Leo Pharma Laboratories

Leo Pharma: media advisory board for Kyntheum ruled promotional and pre-licence promotion (AUTH/3311/2/20)

A paid media advisory board with journalists about brodalumab (pre-authorisation) was ruled promotional. Breaches of Clauses 3.1, 9.1 and 2; no breach…

2020
CASE
AUTH/3435/12/20 Alimera Sciences

Alimera website ruled to promote Iluvien to the public via open-access patient support downloads (AUTH/3435/12/20)

PMCPA found Iluvien site landing page allowed public access to patient treatment support booklets (for prescribed patients), amounting to public promotion. Prescribing…

2021
CASE
AUTH/3453/1/21 Pfizer

AUTH/3453/1/21: Anonymous v Pfizer β€” conduct of a representative (Xeljanz) (No breach)

Anonymous doctor alleged a Pfizer rep used different names to secure appointments during Covid-19 restrictions, promoted Xeljanz off-licence for Covid-19/IBD, and suggested…

2020
CASE
AUTH/3405/10/20 Leo

LEO: Global YouTube content, UK scope and missing mandatory information for tinzaparin symposium video (AUTH/3405/10/20)

Complaint about 60 videos on LEO’s Global YouTube. Most out of UK Code scope, but breaches found for an HCP symposium video…

2021
CASE
AUTH/3520/6/21 Sanofi ⭐ Case of the Week

AUTH/3520/6/21: NHS commissioning manager v Sanofi (flu vaccine promotion/availability) – No breach

Complaint about Sanofi’s flu vaccine ordering communications and a 30% QIVe dose reduction (with QIVr as an alternative). Panel found no evidence…

2021
CASE
AUTH/3481/3/21 Sanofi

Sanofi: internal email sharing off-licence formulary wording for Suliqua treated as briefing material (AUTH/3481/3/21)

An internal congratulatory email reproduced APC formulary wording inconsistent with Suliqua’s SPC, without an off-label warning. PMCPA ruled the email was briefing…

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

Daiichi-Sankyo: Nilemdo/Nustendi HCP website claims and readability of generic names (AUTH/3504/4/21)

PMCPA found breaches on an HCP website where generic names were not readily readable and several β€œadd-on”/dosing claims implied use with any…

2021
CASE
AUTH/3493/3/21 AbbVie

AbbVie: LinkedIn β€˜like’ ruled promotion of unlicensed Durysta (AUTH/3493/3/21)

A senior UK employee β€˜liked’ a US surgeon’s LinkedIn post naming and praising unlicensed Durysta. The PMCPA ruled this proactively disseminated pre-authorisation…

2021
CASE
Sanofi

Sanofi Lantus rebates: employee alleged anti-competitive strategy (No breach, Clause 5.1)

Employee alleged Sanofi used Lantus rebates to block biosimilar uptake and ignored internal concerns. PMCPA found no evidence of anti-competitive breach or…

2021
CASE
AUTH/3570/10/21 Stallergenes Greer ⭐ Case of the Week

Stallergenes Greer: LinkedIn post naming POM brands ruled promotion to the public (AUTH/3570/10/21)

A corporate LinkedIn post named brands and an indication for a newly authorised SLIT tablet. PMCPA ruled this was POM promotion to…

2021
CASE
AUTH/3578/11/21 AstraZeneca

AstraZeneca internal training role-plays with real HCPs: governance lapse found (AUTH/3578/11/21)

Employee alleged disguised promotion in internal training using real HCPs, including role-plays with HCPs from reps’ own territories. Panel found bona fide…

2021
CASE
Croma Pharma

Croma Pharma: Monaco Letybo launch symposium ruled to create an impression of excessive hospitality

A Monaco Letybo launch symposium at a prestigious five-star hotel, plus β€œCocktails, Meeting & Dinner” signage, led the Panel to rule hospitality/venue…

2022
CASE
AUTH/3640/5/22 Novo Nordisk

Novo Nordisk voluntary admission: GLP-1 RA supply email sent without obligatory information (AUTH/3640/5/22)

Two reps sent a certified promotional supply-update email about Ozempic/Rybelsus but omitted key obligatory items (PI links, AE reporting, date). PMCPA ruled…

2022
CASE
AUTH/3641/4/22 Teva

Teva breached ABPI Code over DuoResp Spiromax website: mobile version not separately certified and PI link hidden in hamburger menu (AUTH/3641/4/22)

PMCPA found Teva in breach for DuoResp Spiromax website when viewed on mobile: mobile/desktop final forms differed but weren’t separately certified, and…

2022
CASE
AUTH/3643/5/22 Novartis Pharmaceuticals UK ⭐ Case of the Week

Novartis breached Code over Kesimpta SMC β€œapproval” stamp and UK digital ad (missing β€˜adult’ + NI prescribing info) (AUTH/3643/5/22)

Kesimpta promo webpage implied unrestricted SMC approval (restriction not in immediate view). A UK HCP banner ad omitted β€œadult” from the licence…

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