Novo Nordisk, Moderna, Otsuka, AstraZeneca and Daiichi Sankyo named in advertisements for breaches of the ABPI Code

Novo Nordisk – Case AUTH/3717/12/22

For its involvement in an article published in The Sunday Times in 2022, where a statement made by a global senior leader promoted a prescription only medicine to the public in a way that was misleading, Novo Nordisk was ruled in breach of the following clauses of the 2021 Code:

Clause 2 - Bringing discredit upon, and reducing confidence in, the pharmaceutical industry

Clause 5.1 - Failing to maintain high standards

Clause 6.1 - Providing misleading information

Clause 26.1 - Promoting a prescription only medicine to the public

Clause 26.2 - Providing unbalanced information and encouraging members of the 

public to ask their health professional for a specific prescription only medicine

Moderna – Case AUTH/3746/2/23

For promoting Spikevax (COVID-19 vaccine) in a manner that was inconsistent with its summary of product characteristics, Moderna was ruled in breach of the following clauses of the 2021 Code:

Clause 2 - Bringing discredit upon, and reducing confidence in, the pharmaceutical industry

Clause 5.1 - Failing to maintain high standards

Clause 11.2 - Promoting a medicine in a manner that was inconsistent with its summary of product characteristics

Otsuka Pharmaceuticals UK Ltd – Case AUTH/3751/3/23

For failure to include important information in a healthcare professionals educational guide, that treatment with Jinarc (tolvaptan) should be discontinued if renal insufficiency progresses to CKD stage 5, which could potentially impact patient safety, Otsuka was ruled in breach of the following clauses of the 2021 Code:

Clause 2 - Bringing discredit upon, and reducing confidence in, the pharmaceutical industry

Clause 5.1 - Failing to maintain high standards

Clause 6.1 - Providing misleading information

AstraZeneca – Case AUTH/3769/5/23

For failure to comply with the undertaking and assurance given in Case AUTH/3488/3/21, due to the omission of Symbicort (budesonide, formoterol fumarate dihydrate) prescribing information in Case AUTH/3585/11/21, AstraZeneca was ruled in breach of the following clauses of the 2021 Code:

Clause 2 - Bringing discredit upon, and reducing confidence in, the pharmaceutical industry

Clause 3.3 - Failing to comply with an undertaking

Clause 5.1 - Failing to maintain high standards 

Daiichi Sankyo – Case AUTH/3770/5/23

For failing to state a Nustendi (bempedoic acid, ezetimibe) contraindication regarding coadministration with a statin in patients with active liver disease or unexplained persistent elevations in serum transaminases, within the tolerability section of a promotional website, which could potentially impact patient safety, Daiichi Sankyo was ruled in breach of the following clauses of the 2021 Code: 

Clause 2 - Bringing discredit upon, and reducing confidence in, the pharmaceutical industry

Clause 5.1 - Failing to maintain high standards

Clause 6.1 - Providing misleading information

Clause 6.2 - Providing misleading information that was incapable of substantiation

Novo Nordisk – Case AUTH/3821/9/23

For inappropriate sponsorship arrangements that amounted to an inducement and a failure to disclose transfers of value Novo Nordisk was ruled in breach of the following clauses of the 2021 and 2019 Codes:

2021 Code: 

Clause 2 - Bringing discredit upon, and reducing confidence in, the pharmaceutical industry

Clause 5.1 - Failing to maintain high standards

Clause 28.1 - Failing to document and publicly disclose certain transfers of value

2019 Code: 

Clause 2 - Bringing discredit upon, and reducing confidence in, the pharmaceutical industry

Clause 9.1 - Failing to maintain high standards 

Moderna – Case AUTH/3886/3/24

For failure to ensure only approved clinical trial recruitment materials were used, leading to a WhatsApp message being sent by a third party that contained an unapproved and inappropriately high financial incentive to encourage the recruitment of children, Moderna was ruled in breach of the following clauses of the 2021 Code:

Clause 2 - Bringing discredit upon, and reducing confidence in, the pharmaceutical industry

Clause 5.1 - Failing to maintain high standards 

The case reports are available at www.pmcpa.org.uk. 

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