Teva and Daiichi Sankyo named in advertisements for breaches of the ABPI Code

Teva – Case AUTH/3656/6/22

Teva was ruled in breach of the following clauses of the 2019 Code for failing to include the black triangle for Ajovy in an article which, in the Panel’s view, Teva was responsible for and was promotional, which was compounded by a failure to include an adverse event reporting statement; for failing to include prescribing information for Ajovy and Copaxone; for failing to certify the article; for describing Copaxone as ‘new’ when it had been available for more than 12 months in the UK, and including a statement in the article which implied that Copaxone was licensed for all types of multiple sclerosis which was not so:

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

Clause 3.2        - Promoting a medicine in a manner that was inconsistent with the particulars listed in its summary of product characteristics

Clause 4.1        - Failing to include prescribing information

Clause 4.9        - Failing to include the prominent adverse event reporting statement

Clause 4.10      - Failing to include a black triangle

Clause 7.11      - Referring to a product as ‘new’ when it has generally been available for more than 12 months in the UK

Clause 9.1        - Failing to maintain high standards

Clause 14.1      - Failing to certify promotional material

 

Daiichi Sankyo – Case AUTH/3673/7/22

For using a claim which misleadingly implied that Nilemdo (bempedoic acid) could be used therapeutically in combination with any oral lipid lowering treatment without making the contraindication with simvastatin >40mg daily immediately apparent which might prejudice patient safety and was such as to reduce confidence in, and bring discredit upon, the pharmaceutical industry Daiichi Sankyo was ruled in breach of the following clauses of the 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/3677/7/22

In referring to the therapeutic use of Nilemdo (bempedoic acid) and Nustendi (bempedoic acid and ezetimibe) in combination with a statin/other lipid lowering therapies, without sufficiently mentioning that they were contraindicated with simvastatin>40mg in two sales aids, two leavepieces and two briefing materials for representatives, particularly given that simvastatin was a commonly prescribed statin, meant that there was a risk that some patients on simvastatin >40mg daily might be inappropriately treated with Nilemdo or Nustendi and for the repeated failure to comply with the Code on this matter which was particularly serious and might prejudice 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      - Misleading impression provided

Clause 6.2      - Misleading impression incapable of substantiation

 

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

 

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