Leo, Janssen, Teva, Lundbeck, Otsuka Europe, Daiichi-Sankyo, and Roche named in advertisements for breaches of the ABPI Code
Seven companies have been named in advertisements for bringing discredit upon, and reducing confidence in, the pharmaceutical industry. In addition, Janssen was publicly reprimanded.
LEO Pharma
For LEO Pharma UK employees’ engagement with a number of posts on the global LinkedIn page, which resulted in multiple breaches of the Code including promoting a medicine prior to the grant of its marketing authorisation, promotion of Enstilar (betamethasone dipropionate/calcipotriol monohydrate) which was inconsistent with its marketing authorisation and misleading with respect to the safety of the medicine, LEO Pharma was ruled in breach of the clauses of the 2019 Code.
Janssen
Janssen voluntarily admitted that it had failed to maintain oversight and high standards in relation to a nurse-led Stelara (ustekinumab) homecare service and was ruled in breach of the clauses of the 2019 Code. In addition, the Code of Practice Appeal Board required Janssen to be publicly reprimanded for its failure to have oversight or control of a patient-facing service for 28 months and for its delay in making its voluntary admission once the errors had come to the company’s attention; the company was also required to be audited and re-audited.
Teva
For failing to include an adverse event reporting statement within the content of promotional webpages themselves in relation to five respiratory products, failing to include such a statement anywhere in the materials for Tymbrineb (tobramycin) and Qvar (beclometasone dipropionate) and for only including the relevant statement within the prescribing information for Cinqaero (reslizumab) when it was subject to additional monitoring, Teva was ruled in breach of the clauses of the 2019 Code.
Lundbeck
For an article which promoted Abilify Maintena (aripiprazole) in a manner which was not in accordance with its marketing authorisation, used inaccurate efficacy and safety claims which were not capable of substantiation, did not include prescribing information and other mandatory information and was considered to be disguised promotion, Lundbeck was ruled in breach of the 2019 Code.
Otsuka Europe
For voluntarily admitting a failure to promptly notify affiliates of changes to the summary of product characteristics for Samsca (tolvaptan) and to promptly provide the updated prescribing information which meant that it had breached the undertaking given in a previous case, Otsuka Europe was ruled in breach of the 2019 Code.
Daiichi-Sankyo
For using claims which misleadingly implied that Nilemdo (bempedoic acid) and Nustendi (bempedoic acid, ezetimibe) could be added to any existing oral lipid lowering treatments and were generally well tolerated when they were contraindicated with simvastatin >40mg daily (information in this regard was provided in a footnote in the material at issue) and Nustendi co-administered with a statin was contraindicated in patients with active liver disease or certain elevations in serum transaminases and were thus not capable of substantiation and had the potential to adversely affect safety in patients for which each medicine was contraindicated, for implying that both medicines could be taken at any time which was not so (information in this regard was provided in a footnote) and as the non-proprietary names were not readily readable, Daiichi-Sankyo was ruled in breach of the clauses of the 2019 Code.
Roche
Roche voluntarily admitted a typographical dosing error in a Gazyvaro (obinutuzumab) leavepiece for nurses. As the dosing error could have led to patient safety issues, particularly as it related to the first dose of the medicine, Roche was ruled in breach of theclauses of the 2021 Code.
The advertisements will appear in the British Medical Journal on 30 April 2022 and the Nursing Standard on 5 May.
25 April 2022
