Novo Nordisk, Daiichi-Sankyo, Lundbeck, AstraZeneca, UCB and Biogen named in advertisements for breaches of the ABPI Code

 

Novo Nordisk has breached the ABPI Code of Practice for the Pharmaceutical Industry and brought discredit upon, and reduced confidence in, the pharmaceutical industry. The company was also publicly reprimanded and reported to the ABPI Board.

Novo Nordisk – Case AUTH/3525/6/21

 

For arrangements regarding Novo Nordisk’s involvement in the provision of a service by a third party training provider, including in relation to the payment of Patient Group Direction’s (PGDs) for individual health professionals, which brought discredit upon, and reduced confidence in, the pharmaceutical industry, Novo Nordisk was ruled in breach of the following clauses of the 2019 Code:

 

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

Clause 9.1        - Failing to maintain high standards and secondly for failing to certify promotional material

Clause 4.1        - Failing to include prescribing information

Clause 9.10      - Failing to indicate, at the outset, that the training and offer of PGDs  was sponsored by Novo Nordisk

Clause 12.1      - Disguised promotion

Clause 18.1      - Offering a benefit to individual health professionals that did not meet the requirements of the Code and was considered an inducement to prescribe, supply, administer and/or recommend Saxenda

Clause 22.4      - Failing to disclose, at the outset, in all of the papers relating to the meetings that the training had been sponsored by Novo Nordisk

 

The Appeal Board publicly reprimanded Novo Nordisk and reported the company to the ABPI Board which required that the company undergo an audit.  On consideration of the report of the audit and Novo Nordisk’s comments upon it, the ABPI Board would then decide whether any further action was required.

 

Daiichi-Sankyo – Case AUTH/3542/7/21

 

For a misleading claim for Nilemdo (bempedoic acid) and Nustendi (bempedoic acid and ezetimibe) which did not clearly state their contraindications with the concomitant use with certain doses of simvastatin (information in this regard was provided in a footnote), was not capable of substantiation and potentially adversely affected 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        - Making a misleading claim

Clause 6.2        - Making an unsubstantiated claim

 

Lundbeck – Case AUTH/3550/7/21                                                                                                                

 

For promoting a pipeline product at a symposium session, and for that session to be available on demand on a third party website (without the pharmaceutical company’s permission), Lundbeck was ruled in breach of the following clauses of the 2019 Code:

 

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

Clause 3.1        - Promoting a medicine prior to its marketing authorisation

Clause 9.1        - Failing to maintain high standards

Clause 9.10      - Failing to be sufficiently clear as to the company’s role and involvement

 

UCB – Case AUTH/3554/8/21

 

For promotion of Bimzelx (bimekizumab) to the public on LinkedIn, UCB was ruled in breach of the following clauses of the 2021 Code:

 

Clause 2           - Reducing confidence in the pharmaceutical industry

Clause 5.1        - Failing to maintain high standards

Clause 26.1      - Promoting a prescription only medicine to the public

 

AstraZeneca UK Limited – Case AUTH/3561/9/21

 

For AstraZeneca providing an uncertified post to be posted by a senior employee on his/her personal LinkedIn account and failing to recognise the promotional nature of the post; for failing to appropriately brief a very senior employee for a press interview; for failing to ensure that a press release dealing with a sensitive subject complied with relevant requirements of the Code and for failing to notify a newspaper about the potential implications of quotes given the sensitivity of the subject matter, 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 5.1        - Failing to maintain high standards

Clause 6.1        - Including exaggerated and misleading information

Clause 8.1       - Failing to certify promotional material

Clause 11.2      - Promoting an unlicensed indication

Clause 26.1      - Promoting a prescription only medicine to the public

Clause 26.2      - Encouraging members of the public to ask for a specific prescription   only medicine

 

Biogen Idec – Case AUTH/3575/11/21

 

For a local senior leader, who had since left Biogen Idec, sending an email to a broad internal audience in 2018, which linked a fundraising activity with the work that the recipient charities were doing with Biogen Idec in relation to Spinraza (nusinersen sodium), Biogen Idec was ruled in breach of the following clauses of the 2016 Code:

 

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

Clause 9.1        - Failing to maintain high standards

 

 

The case reports, interim case report and public reprimand are available at www.pmcpa.org.uk. 

 

For more information contact Alex Fell  afell@pmcpa.org.uk 0207 7478878

 

Notes to Editors:

 

• The advertisements will appear in the British Medical Journal 24 December 2022 and the Nursing Standard on 4 January 2023.

 

The Prescription Medicines Code of Practice Authority (PMCPA) was established by The Association of the British Pharmaceutical Industry (ABPI) to operate the ABPI Code of Practice for the Pharmaceutical Industry independently of the ABPI.  The PMCPA is a division of the ABPI.  The Code covers the promotion of medicines for prescribing to health professionals and the provision of information to the public about prescription only medicines.  If you have any concerns about the activities of pharmaceutical companies in this regard, please contact the PMCPA at 2nd Floor Goldings House, Hay’s Galleria, 2 Hay’s Lane, London, SE1 2HB or email: complaints@pmcpa.org.uk.  The Code and other information, including details about ongoing cases, can be found on the PMCPA website:www.pmcpa.org.uk.

 

The PMCPA is a division of the ABPI which is a company limited by guarantee registered in England & Wales no 09826787.  Registered office 2nd Floor Goldings House, Hay’s Galleria, 2 Hay’s Lane, London, SE1 2HB.