Novartis, Roche, Croma Pharma, Daiichi Sankyo, AstraZeneca and AbbVie named in advertisements for breaches of the ABPI Code

Novartis – Case AUTH/3633/4/22

For providing some, but not all, the relevant information in relation to renal and hepatic impairment in the body of a webpage which was intended to advise health professionals on considerations when using  Entresto (sacubitril/valsartan) which was misleading, Novartis 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

Novartis – Case AUTH/3635/4/22

For use of a claim in an Entresto (sacubitril/valsartan) podcast, in the absence of any qualification, which downplayed the importance of renal function and was thereby misleading and incapable of substantiation Novartis 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       - Making a claim incapable of substantiation

Clause 14.4      - Implying that a medicine has some special merit, quality or property

Roche – Case AUTH/3639/4/22

For providing some, but not all, of the important information in relation to the administration of Polivy (polatuzumab vedotin), within a section of the promotional website that was intended to advise health professionals on the appropriate administration of the medicine and for not highlighting to the reader, on the dosing webpage, that additional important information in relation to dose modifications was within the safety webpage of the website, Roche 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

Croma Pharma – Cases AUTH/3644/5/22 and AUTH/3694/10/22

For the poor impression created by the arrangements of a Letybo (botulinum toxin type A) launch symposium held in Monaco which was such that hospitality, including the venue, did not appear to be secondary to the main purpose of the event, which was compounded by signage at the event and noting that hospitality provided, in particular at international meetings, attracted public scrutiny, Croma Pharma 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 10.1      - Providing inappropriate hospitality

Roche – Case AUTH/3646/5/22

For omitting important safety information from the dosing webpage of the Rozlytrek (entrectinib) promotional website that a health professional would expect to have been made aware of on such a webpage, Roche 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 

Daiichi Sankyo – Case AUTH/3649/5/22

For failing to make immediately apparent to health professionals in the body of promotional material which referred to the therapeutic use of Nilemdo (bempedoic acid) or Nustendi (bempedoic acid and ezetimibe) in combination with a statin that there was a contraindication regarding concomitant use with simvastatin >40mg daily, and for failing to comply with its undertaking provided in Case AUTH/3504/2/21, 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 3.3        - Failing to comply with an undertaking

Clause 5.1        - Failing to maintain high standards

Clause 6.1        - Misleading impression provided

Novartis – Case AUTH/3655/6/22

For referring to Mayzent initiation in patients with a history of myocardial infarction and heart failure without making apparent the absolute contra-indication in patients with a history of myocardial infarction or heart failure in the previous 6 months, except on a separate webpage and within the prescribing information which, in the Panel’s view, was insufficient to negate this immediate misleading impression, Novartis 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        - Misleading impression provided

Clause 6.2        - Misleading impression incapable of substantiation

AstraZeneca – Case AUTH/3678/8/22

For failing to include on the page of the printed journal advertisement where the prescribing information was not visible, reference to where it could be found; and because the advertisement misleadingly implied that all strengths of Symbicort could be prescribed for MART [maintenance and reliever therapy] when Symbicort 400/12 should be used as maintenance therapy only, and the points in small font at the very bottom of the page in question were wholly insufficient to qualify the misleading impression given and use of the higher Symbicort dose (400/12) for reliever therapy had the potential to impact patient safety, 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         - Making a misleading claim

Clause 6.2         - Making an unsubstantiated claim

Clause 11.2      - Promotion inconsistent with the SPC

Clause 12.7       - Failing to include on the pages of a printed journal advertisement where the prescribing information was not visible, reference to where it could be found

AbbVie – Case AUTH/3712/11/22

For the use of the imagery of a young female surfing that did not reflect the typical patient with moderate to severe psoriatic arthritis and could not be substantiated and for the use of imagery of a young female in relation to Rinvoq (upadacitinib), a product with a known risk of foetal harm without highlighting that there were restrictions on use in this population which had the potential to impact patient safety, AbbVie 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        - Failing to ensure material was sufficiently complete and not misleading

Clause 6.2       - Making an unsubstantiated claim

Clause 6.3       - Failing to ensure artwork conformed to the letter and spirit of the Code

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

Ends

Notes to Editors:
[1] The advertisements will appear in the British Medical Journal on 21 October and the Nursing Standard on 1 November.

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

About the Prescription Medicines Code of Practice Authority (PMCPA)
The 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.