PMCPA Case Analysis

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All Cases PMCPA Case of the Week PMCPA Cases

Showing 1914 cases

2019
CASE
AUTH/3199/5/19 Vifor Pharma

Vifor Pharma: breach of undertaking over Ferinject vs Monofer safety comparisons and medical information email (AUTH/3199/5/19)

PMCPA ruled Vifor breached undertakings by using materials and a medical information email that misleadingly compared Ferinject vs Monofer on hypersensitivity/ADRs, and…

2019
CASE
AUTH/3289/12/19 Bristol-Myers Squibb

Bristol Myers Squibb and Pfizer: Eliquis prescribing information in promotional email (AUTH/3289/12/19 & AUTH/3290/12/19)

Eliquis promotional email used July 2019 prescribing information after an Oct 2019 SPC update on reversal agent/overdose. Panel found PI content sufficient…

2019
CASE
Teva

Teva breached Clause 4.1 after DuoResp Spiromax prescribing information was hard to read in sponsored webinar

A UK health professional said DuoResp Spiromax prescribing information in a Teva-commissioned webinar was difficult to read. The Panel ruled the line…

2020
CASE
AUTH/3367/7/20 GlaxoSmithKline

GSK Duac banner ad on Pulse Today: complaint about missing prescribing information (AUTH/3367/7/20)

A UK health professional said a Duac online banner appeared static and lacked a one-click link to prescribing information. Panel found PI…

2020
CASE
AUTH/3332/4/20 Swedish Orphan Biovitrum ⭐ Case of the Week

AUTH/3332/4/20: Anonymous v Sobi β€” unsolicited MSL β€œmaking contact” email during COVID-19 (No breach)

Anonymous complaint about an unsolicited MSL email to an NHS address during COVID-19. Panel found the email was non-promotional, mirrored an approved…

2020
CASE
AUTH/3344/5/20 Britannia Pharmaceuticals

Britannia Pharmaceuticals: promotional email sent without consent and no robust unsubscribe process (AUTH/3344/5/20)

A health professional received a promotional Parkinson’s magazine by email despite asking to be removed from mailing lists. PMCPA found breaches for…

2019
CASE
Sanofi

Sanofi: Praluent website banner claim about reducing CV risk further ruled not misleading (no breach)

A UK health professional alleged a Praluent website banner broadened the licence and promoted off-label. The PMCPA Panel found the claim aligned…

2020
CASE
AUTH/3394/10/20 Novartis Pharmaceuticals UK

Novartis disease awareness melanoma booklet: breach over ambiguous patient organisation involvement wording (AUTH/3394/10/20)

A melanoma patient booklet was found balanced on treatment/testing, but breached the Code because β€œin association with” Melanoma UK was ambiguous and…

2020
CASE
AUTH/3372/8/20 Bristol-Myers Squibb Pharmaceuticals

Bristol-Myers Squibb: UK employees’ LinkedIn β€˜likes’ brought US Opdivo post into scope (AUTH/3372/8/20)

UK employees β€˜liked’ a US colleague’s LinkedIn post about positive Opdivo Phase 3 data in upper GI cancers. The Panel said this…

2020
CASE
AUTH/3425/11/20 Bristol-Myers Squibb ⭐ Case of the Week

AUTH/3425/11/20 & AUTH/3426/11/20: RCGP Overdiagnosis Group complaint about Eliquis AF pulse-check email (No breach)

RCGP Overdiagnosis Group challenged a Pfizer/BMS Eliquis email promoting AF pulse checks at flu clinics for over-65s, alleging omission of UK NSC…

2020
CASE
AUTH/3421/11/20 Novartis Pharmaceuticals UK

Novartis: employee β€˜liked’ Cosentyx study post on LinkedIn, triggering POM promotion and certification breaches (AUTH/3421/11/20)

A Novartis employee β€˜liked’ a Cosentyx study headline on LinkedIn. PMCPA ruled POM promotion to the public plus missing INN and certification…

2021
CASE
AUTH/3474/2/21 Britannia Pharmaceuticals

AUTH/3474/2/21: Ever Pharma v Britannia β€” 0844 technical support line for APO-go (No breach)

Ever Pharma challenged Britannia’s use of an 0844 business-rate number for APO-go support. Panel found the helpline was in scope but ruled…

2021
CASE
AUTH/3488/3/21 AstraZeneca

AstraZeneca breached Code over Trixeo website mobile display and missing comparator prescribing information (AUTH/3488/3/21)

PMCPA found breaches on Trixeo HCP website: generic name too small on mobile, PI not one-click on mobile, site not certified for…

2021
CASE
AUTH/3499/4/21 Daiichi-Sankyo UK

AUTH/3499/4/21: Daiichi-Sankyo website page promoted Efient and Lixiana to the public and breached a prior undertaking

A corporate website page about Efient and Lixiana was accidentally left externally accessible via site search. PMCPA ruled promotion of POMs to…

2021
CASE
AUTH/3527/6/21 Leo Pharma ⭐ Case of the Week

LEO Pharma voluntary admission: undisclosed 2019 transfers of value to patient organisations (AUTH/3527/6/21)

LEO discovered four cross-border transfers of value involving three UK patient organisations. Three 2019 payments were disclosed late and two agreements weren’t…

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