Leo, Janssen, Teva, Lundbeck, Otsuka Europe, Daiichi-Sankyo, and Roche named in advertisements for breaches of the ABPI Code

LEO Pharma – Case AUTH/3428/11/20

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 following clauses of the 2019 Code:

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

Clause 3.1        - Promoting an unlicensed medicine

Clause 3.2        - Promotion inconsistent with the summary of product characteristics

Clause 4.1        - Failing to include prescribing information

Clause 4.8        - Failing to include the date on which the promotional material was drawn up or last revised.

Clause 7.2        - Making a misleading claim

Clause 7.9        - Making claims that did not reflect the available evidence regarding possible adverse reactions

Clause 9.1        - Failing to maintain high standards

Clause 14.1      - Failing to certify promotional material

Clause 14.3      - Failing to certify educational material for the public

Clause 26.1      - Promoting a prescription only medicine to the public

 

Janssen-Cilag Ltd – Case AUTH/3436/12/20

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 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

 

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 – Case AUTH/3451/1/21

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 following clauses of the 2019 Code:

 

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

Clause 3.2        - Promoting a medicine for an unlicensed indication

Clause 4.1        - Failing to include prescribing information

Clause 4.6        - Failing to include a clear, prominent statement as to where prescribing information could be found

Clause 4.9        - Failing to include information about how to report adverse events

Clause 9.1        - Failing to maintain high standards

Clause 28.1      - Failing to clearly separate sections for each target audience on a website and identifying the intended audience at the outset

 

Lundbeck – Case AUTH/3452/1/21

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 following clauses of the 2019 Code:

 

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

Clause 3.2        - Promotion inconsistent with the summary of product characteristics

Clause 4.1        - Failing to include up-to-date prescribing information

Clause 4.6        - Failing to include a clear, prominent statement as to where prescribing information could be found

Clause 4.9        - Failing to include information about how to report adverse events

Clause 7.2        - Making a misleading claim

Clause 7.4        - Making an unsubstantiated claim

Clause 7.9        - Making claims that did not reflect the available evidence regarding possible adverse reactions

Clause 9.1        - Failing to maintain high standards

Clause 12.1      - Disguising promotional material

 

Otsuka Europe – Case AUTH/3489/3/21

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 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

Clause 29         - Failing to comply with an undertaking

 

Daiichi-Sankyo – Case AUTH/3504/4/21

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 following clauses of the 2019 Code:

 

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

Clause 4.3        - Legibility of generic names

Clause 7.2        - Making a misleading claim

Clause 7.4        - Making an unsubstantiated claim

Clause 9.1        - Failing to maintain high standards

 

Leo Pharma – Case AUTH/3527/6/21

For failures in relation to disclosure of payments made to patient organisations in 2019 and its lack of oversight of overseas affiliate’s interactions with UK based patient organisations, Leo Pharma 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

Clause 14.3      - Failing to certify

Clause 27.7      - Failing to disclose an accurate list of patient organisations to which it provided financial support and/or significant indirect/non-financial support

 

Roche – Case AUTH/3568/10/21

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 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 inaccurate and misleading information

 

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