Britannia and Vifor (public reprimands), AbbVie, Allergan, Advanced Accelerator Applications (a Novartis company), Otsuka Europe and Otsuka UK (breaches of ABPI Code) named in advertisements

Vifor Pharma – Case AUTH/3199/5/19

 

The Appeal Board required Vifor to be audited for failing to comply with undertakings given in two previous cases in relation to the promotion of Ferinject (ferric carboxymaltose), including sending a promotional email without the prior consent of a recipient and the use of misleading claims which favourably differentiated its IV iron from a competitor on the grounds of tolerability. Vifor Pharma was previously ruled in breach of the following clauses of the 2019 Code:

 

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

Clause 29       - Failing to comply with an undertaking

 

Vifor Pharma – Case AUTH/3224/7/19

 

The Appeal Board required Vifor to be audited for making misleading and inaccurate claims which favourably differentiated Ferinject (ferric carboxymaltose) from a competitor on the grounds of tolerability. Vifor Pharma was previously ruled in breach of the following clauses of the 2019 Code:

 

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

Clause 7.2      - Making misleading and inaccurate claims

Clause 7.3       - Making misleading comparisons

Clause 8.1      - Disparaging a competitor product

Clause 9.1       - Failing to maintain high standards

 

In both cases Vifor had been previously publicly remanded (February 2021) for its failure to provide accurate and truthful information to the Code of Practice Panel and its disingenuous approach to responding to the complaints. The Appeal Board had also required an audit of Vifor’s procedures in relation to the Code and two further re-audits. At the consideration of the report of the second re-audit and Vifor’s response, the Appeal Board decided that Vifor should be publicly reprimanded for its lack of progress. The Appeal Board also decided that Vifor should be re-audited in September/October 2022.

 

Britannia – Case AUTH/3355/5/20

 

The Appeal Board required Britannia to be audited for paying health professionals for the preparation time when this was not warranted nor required as the same material or essentially the same material was reused by speakers, not having a contract for some of the engagements, not providing full information to the PMCPA about the arrangements for speakers at meetings outside the UK and arrangements for investigator led clinical trials which failed to consider patient safety and have the relevant approval processes in place.  Britannia was previously 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 13.4      - Failing to comply with the requirements for non-interventional studies

Clause 18.1      - Paying health professionals fees which did not reflect fair market value

Clause 23.1      - Engaging health professionals in other than genuine consultancy arrangements

Clause 25.2      - Failing to approve and supervise non-interventional studies

 

When considering the report of the audit and Britannia’s response, the Appeal Board decided that Britannia should be publicly reprimanded for its failure to have the necessary control of its activities with regard to compliance with the Code and its failure to provide a third party report when first requested.  The Appeal Board also decided that Britannia should be re-audited in June/July 2022.

 

AbbVie – Case AUTH/3493/3/21

 

For promoting Durysta (sustained release bimatoprost implant) on LinkedIn, prior to the grant of its marketing authorisation, AbbVie 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 9.1        - Failing to maintain high standards

 

Allergan – Case AUTH/3533/7/21

 

For various social media posts which referred to unlicensed medicines and promoted Botox (botulinum toxin type a) to the public, Allergan 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 4.1        - Failing to include prescribing information

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

Clause 9.1        - Failing to maintain high standards

Clause 14.1      - Failing to certify promotional material

Clause 26.1      - Promoting a prescription only medicine to the public

 

Advanced Accelerator Applications – Case AUTH/3528/6/21

 

For promoting an unlicensed medicine (¹⁷⁷Lu-PSMA-617) prior to the grant of the marketing authorisation, Advanced Accelerator Applications (a Novartis company) 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 9.1        - Failing to maintain high standards

 

Otsuka Pharmaceutical Europe Limited - Case AUTH/3565/10/21 and Otsuka Pharmaceuticals (UK) Limited - Case AUTH/3566/10/21

 

For omitting the frequency of dosing from prescribing information for a monthly administration of Abilify/Abilify Maintena (aripiprazole) and for breaching previous undertakings Otsuka Europe and Otsuka UK were each 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

 

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