LEO Pharma, Norgine, Daiichi-Sankyo, Novartis, Sanofi, Consilient, and Pharmasure have been named in advertisements for breaches of the ABPI Code

LEO Pharma – Case AUTH/3311/2/20

For a media advisory board for Kyntheum (brodalumab) which did not meet the Code requirements and was thus considered to be promotional, LEO Pharma was ruled in breach of the following clauses of the Code:

 

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

Clause 3.1        - Promoting an unlicensed medicine

Clause 9.1        - Failing to maintain high standards

 

Norgine – Case AUTH/3365/7/20

For an email comparing Feraccru capsules (ferric maltol) with intravenous iron, which did not have sufficient information for the reader to understand the basis and significance of the data and encouraging the use of Feraccru in all inflammatory bowel disease (IBD) patients when not all of those patients would be suitable for such therapy, Norgine was ruled in breach of the following clauses of the Code:

 

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

Clause 7.2        - Making misleading claims

Clause 7.3        - Making misleading comparisons

Clause 7.4        - Making unsubstantiated claims

Clause 9.1        - Failing to maintain high standards

 

Daiichi-Sankyo – Case AUTH/3375/8/20

For failing to publicly disclose transfers of value to healthcare organisations for three years in relation to therapy reviews, and in that regard breaching its undertaking given in Case AUTH/3285/12/19, 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 9.1        - Failing to maintain high standards

Clause 24.1      - Failing to document and publicly disclose certain transfers of value to healthcare organisations

Clause 24.4      - Failing to disclose transfers of value annually within the first six months after the end of the calendar year in which the transfers of value were made

Clause 29         - Failing to comply with an undertaking

 

Novartis – Case AUTH/3399/10/20

Novartis voluntarily admitted that one of its representatives had failed to maintain high standards with regard to discussions about the recommendation for use of Piqray (alpelisib) with two clinicians held before the medicine had been granted a marketing authorisation.  Novartis was ruled in breach of the following clauses of the Code:

 

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

Clause 3.1        - Promoting an unlicensed medicine

Clause 9.1        - Failing to maintain high standards

 

Sanofi – Case AUTH/3402/10/20

For a product website which contained inaccurate information about, and out of date prescribing information for Dupixent (dupilumab), Sanofi was ruled in breach of the following clauses of the 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 7.2        - Making a misleading statement

Clause 9.1        - Failing to maintain high standards

 

Consilient – Case AUTH/3403/10/20

For allowing members of the public to view, within an app store, promotional information for InVita D3 (colecalciferol) on an app which was intended for health professionals, and for not re-certifying promotional material within two years, Consilient was ruled in breach of the following clauses of the Code:

 

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

Clause 9.1        - Failing to maintain high standards

Clause 14.5      - Using material for more than two years without re-certification

Clause 26.1      - Advertising a prescription only medicine to the public

 

Pharmasure – Case AUTH/3407/10/20

For failing to comply with a previous undertaking and continuing to use claims for Meriofert (menotrophin) which had previously been ruled to be in breach of the Code, Pharmasure acknowledged the further following breaches of the Code:

 

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

Clause 29         - Failing to comply with an undertaking

 

Daiichi-Sankyo – Case AUTH/3409/10/20

For a Lixiana (edoxaban) promotional campaign directed to UK health professionals, conducted by Daiichi-Sankyo Europe without the UK’s involvement, which, inter alia, did not include the adverse events reporting statement and referred to an unlicensed dose for Lixiana (edoxaban), Daiichi-Sankyo UK Limited was ruled in breach of the following clauses of the 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 prescribing information

Clause 4.3        - Failing to include the non-proprietary name immediately adjacent to the most prominent display of the brand name

Clause 4.4        - Failing to provide prescribing information on digital material

Clause 4.5        - Failing to provide prescribing information on audio visual material

Clause 4.8        - Failing to state when the material was drawn up or last revised

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

Clause 7.2        - Making a misleading claim

Clause 7.3        - Making misleading comparisons

Clause 7.4        - Making an unsubstantiated claim

Clause 7.10      - Making an exaggerated claim

Clause 9.1        - Failing to maintain high standards

Clause 14.1      - Failing to certify promotional material

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