PMCPA Case Library

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1,930 cases found

2023
CASE
2021 Code AstraZeneca

AstraZeneca Forxiga website renal considerations complaint (AUTH/3782/6/23): no breach

Complaint alleged Forxiga ‘Prescribing & Dosing’ webpage omitted “critical” SPC warnings for moderate renal impairment (PTH increase, hypotension). Panel ruled no breach…

2023
CASE
2021 Code Novartis Pharmaceuticals Clause 2 Clause 5.1 Clause 12.1

Novartis breached Clauses 2, 5.1 and 12.1 after outdated Entresto prescribing information appeared in downloadable HCP portal documents (AUTH/3725/1/23)

Two downloadable documents on Novartis’ HCP portal contained outdated Entresto prescribing information (May 2021 and June 2020) while the webpage PI was…

2023
CASE
2021 Code Sandoz Clause 3.1 Clause 5.1 Clause 6.2

Sandoz: ABN for natalizumab biosimilar ruled promotional pre-authorisation (AUTH/3768/5/23)

ABN slide deck and summary for a natalizumab biosimilar were ruled to go beyond permitted advance budgetary notification and amount to pre-authorisation…

2021
CASE
2021 Code Tetris Pharma Clause 5.1 Clause 12.3 Clause 12.9 Clause 26.1

Tetris Pharma: LinkedIn sponsored message for Ogluo reached a non-HCP (public promotion) and lacked required safety/INN elements

A LinkedIn sponsored message promoting Ogluo (glucagon) was received by a non-HCP. The Panel found public promotion plus missing INN at first…

2021
CASE
2021 Code Advanced Accelerator Applications , a Novartis company Clause 5.1 Clause 6.1

AAA website: out-of-date Northern Ireland licensing statement for Pluvicto led to Code breaches

AAA’s RLT Hub stated Pluvicto was not licensed in Northern Ireland after EMA approval. PMCPA found the statement inaccurate/out-of-date and criticised website…

2021
CASE
2021 Code Janssen Clause 5.1 Clause 6.1

Janssen: PAH symposium video ruled misleading (relative risk without absolute risk; mislabelled ARR; TRITON context missing)

PMCPA found Janssen breached Clauses 5.1 and 6.1 (x3) over a PAH symposium video: relative risk shown without absolute risk, ARR mislabelled,…

2022
CASE
2021 Code GlaxoSmithKline

AUTH/3720/12/22: Complainant v GSK – Blenrep promotional email (no breach)

A HCP complained a Blenrep promotional email was unsolicited and imbalanced. The Panel found the recipient had opted in via a third-party…

2021
CASE
2021 Code Roche Clause 23.2 Clause 25.3

Roche: patient organisation website grant—support not clear from the outset and grant agreement missing required transparency wording

Roche funded a patient organisation website update. PMCPA found the declaration of support wasn’t apparent from the start and the written grant…

2022
CASE
2021 Code AstraZeneca Clause 5 Clause 8 Clause 12 Clause 26

AstraZeneca: UK employees’ LinkedIn ‘likes’ brought US FDA approval post into ABPI Code scope (AUTH/3707/11/22)

A US-facing LinkedIn post about an FDA-approved lung cancer combo was liked/commented on by 14 UK-based AstraZeneca employees, triggering ABPI Code breaches…

2023
CASE
2021 Code Valneva UK Clause 1 Clause 12

Valneva UK: HCP “partnership” website held promotional for JE vaccine without prescribing information (AUTH/3739/2/23)

PMCPA found Valneva’s HCP “Valneva in Partnership” site promoted its Japanese encephalitis vaccine (Ixiaro) despite no product name, and breached Clause 12.1…

2023
CASE
2021 Code Novo Nordisk

AUTH/3752/3/23: PMCPA Director/Media v Novo Nordisk (Observer articles on semaglutide/‘skinny jab’) – No breach

Five Observer articles alleged Novo Nordisk used payments, grants and PR to shape the obesity debate and influence NICE/NHS. PMCPA assessed multiple…

2023
CASE
2021 Code Pfizer Clause 5.1

Pfizer UK tweets linking to Pulse Today sponsored article: audience not stated and governance concerns (AUTH/3721/1/23)

Pfizer UK posted three public tweets linking to a Pulse Today sponsored article. Panel found the article not promotional and no POM…

2019
CASE
2019 Code Pfizer Clause 2 Clause 3.1 Clause 7.2 Clause 7.9 Clause 9.1

Pfizer: UK senior employee retweeted US post about unlicensed COVID-19 vaccine candidate on Twitter (ABPI Code 2019)

A senior UK Pfizer employee retweeted a US colleague’s tweet claiming 95% efficacy for a COVID-19 vaccine candidate before UK authorisation, with…

2023
CASE
2019 Code Novo Nordisk

AUTH/3755/3/23: Health Professional v Novo Nordisk — funding alleged to induce prescribing (No breach)

Complaint alleged Novo Nordisk funded an obesity practitioner’s salary to induce prescribing and influenced local liraglutide criteria. Panel and Appeal Board found…

2022
CASE
2021 Code AbbVie

AbbVie: Rinvoq website dosing statement ‘with or without food’ (AUTH/3705/11/22) – no breach

Complaint alleged Rinvoq dosing web copy implied it could be taken with any food (incl. grapefruit) despite SPC advice to avoid grapefruit.…

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