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

Serono

Serono breached Clause 15.4 after internal call-rate document implied up to 9 unsolicited visits per year

Anonymous complaint about Serono rep call-rate targets. A typo in an β€œActivity Standards” document implied 3 calls per cycle (3 cycles/year), potentially…

2008
CASE
AUTH/2145/7/08 Guerbet

AUTH/2145/7/08: GE Healthcare v Guerbet β€” Website information found out of scope (no breach)

Intercompany complaint about information on a website. The PMCPA found the matter outwith the scope of the Code, so no breach was…

2011
CASE
AUTH/2396/3/11 Chiesi

AUTH/2396/3/11: Anonymous GP v Chiesi β€” Product standardization programme in Northern Ireland (No breach; outwith scope)

Anonymous GP complaint about a product standardization programme in Northern Ireland. Case did not go before the Panel; programme already withdrawn. No…

2016
CASE
AUTH/2858/7/16 Bayer ⭐ Case of the Week

AUTH/2858/7/16: Health Professional v Bayer β€” alleged promotion to the public (No breach; outwith scope)

A health professional alleged promotion of a prescription medicine to the public by Bayer. The PMCPA recorded no breach and found the…

2015
CASE
Alliance

Alliance Pharmaceuticals: LinkedIn launch post and press release ruled promotion of POM to the public (Xonvea)

A LinkedIn launch post and linked press release for Xonvea were found to include product claims and be disseminated to the public,…

2015
CASE
Merck Sharp & Dohme

Takeda v Merck Sharp & Dohme: outdated leavepiece used after withdrawal undertaking (black triangle error)

MSD gave an inter-company undertaking to withdraw materials wrongly showing alogliptin with a black triangle, but an outdated Januvia leavepiece was still…

2019
CASE
Otsuka

Otsuka Europe & Otsuka UK: voluntary admission over prescribing information discrepancies (Abilify, Abilify Maintena, Jinarc, Samsca)

Otsuka voluntarily admitted errors/omissions in prescribing information across four medicines. PMCPA found breaches focused on Samsca PI being inconsistent with the SPC,…

2020
CASE
AUTH/3331/4/20 GlaxoSmithKline

AUTH/3331/4/20: GlaxoSmithKline – Relvar Ellipta ad in Pulse magazine (no breach)

GSK’s Relvar Ellipta Pulse ad was challenged on generic name placement and a β€œ25% more patients improve asthma control” claim. The PMCPA…

2019
CASE
AUTH/3228/7/19 Ipsen ⭐ Case of the Week

Merz v Ipsen: Dysport β€œlong-lasting effect” campaign found misleading on appeal (AUTH/3228/7/19)

After inter-company dialogue, Ipsen’s β€œDysport – a toxin with a long-lasting effect” messaging was found to imply an unsubstantiated duration advantage. Appeal…

2019
CASE
Swedish Orphan Biovitrum

Sobi breached ABPI Code over β€˜No anaphylaxis or allergic reactions’ claim in Alprolix BMJ hosted advert

A BMJ-hosted Alprolix advert used a bold safety headline (β€œNo anaphylaxis or allergic reactions”) that was contradicted by the bullets/footnote and inconsistent…

2020
CASE
AUTH/3338/4/20 ViiV

ViiV breached ABPI Code after BMJ-hosted Dovato tile omitted generic name, PI link and black triangle (AUTH/3338/4/20)

A BMJ website β€œtile” showed the Dovato brand name but no generic name, no PI (or one-click link), no black triangle (when…

2020
CASE
AUTH/3337/4/20 Bio Products Laboratory

AUTH/3337/4/20: Anonymous v Bio Products Laboratory (LinkedIn share of Telegraph Covid-19 β€˜hyperimmune’ article) – No breach

Anonymous complaint that BPL’s LinkedIn post sharing a Telegraph article promoted an unlicensed/off-label Covid-19 therapy to the public. Panel ruled no breach…

2020
CASE
AUTH/3387/9/20 Swedish Orphan Biovitrum

Sobi webinar invite referencing NSD review: no breach (AUTH/3387/9/20)

A health professional said Sobi’s webinar title β€œBeyond the National Services Division Review” was misleading and implied NSD endorsement. The Panel found…

2019
CASE
Consilient Health ⭐ Case of the Week

Consilient app preview on Google Play ruled public advertising of POM (InVita D3)

Vitamin D Vitality app previews on Google Play showed InVita D3 and PI before download. Panel ruled this advertised a POM to…

2020
CASE
AUTH/3396/10/20 Daiichi-Sankyo UK

Daiichi-Sankyo breached ABPI Code over out-of-date competitor safety symbol in Nilemdo FOC scheme material (AUTH/3396/10/20)

Nilemdo FOC scheme material continued to show Praluent with a black triangle after it was removed from the SPC. PMCPA found the…

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