Britannia, AstraZeneca, Allergan, GlaxoSmithKline and Sanofi named in advertisements for breaches of the ABPI Code

Britannia Pharmaceuticals Ltd – Case AUTH/3355/5/20

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 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      - Failure to approve and supervise non interventional studies

 

In addition the Code of Practice Appeal Board required Britannia to be audited. 

 

AstraZeneca UK Limited – Case AUTH/3430/11/20

For promoting an unlicensed vaccine, including to members of the UK public on LinkedIn, AstraZeneca 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 Limited – Case AUTH/3431/11/20

For promoting Botox (botulinum toxin type A), a prescription only medicine to the public, on social media, 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 9.1        - Failing to maintain high standards

Clause 26.1      - Promoting a prescription only medicine to the public

 

In addition, the Code of Practice Appeal Board required Allergan to be publicly reprimanded for its widespread use of social media which promoted a prescription only medicine to the public.

 

GlaxoSmithKline UK Limited – Case AUTH/3432/12/20

GlaxoSmithKline was ruled in breach of the following clauses of the 2019 Code in relation to the promotion of its respiratory medicines, Trelegy (fluticasone/umeclidinium/vilanterol), Anoro (umeclidinium/vilanterol), Incruse (umeclidinium) and Relvar (fluticasone/vilanterol):

 

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

Clause 3.2        - Promotion inconsistent with the summary of product characteristics (SPC)

Clause 4.3        - Failing to include the non-proprietary names next to the most prominent display of the brand name

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

Clause 4.10      - Failing to include an inverted black triangle for relevant products

Clause 9.1        - Failing to maintain high standards

Clause 14.1      - Failing to certify the final form of promotional material

Clause 26.3      - Failing to include information about how to report adverse events on material for patients

 

Sanofi – Case AUTH/3487/3/21

For a misleading email to existing customers about the reimbursement of its flu vaccine and another email to an NHS manager which disparaged the opinion of health professionals and appeared to call into question official NHS guidance, Sanofi was ruled in breach of the following clauses of the 2019 Code:

 

Clause 2           - Bringing discredit upon the pharmaceutical industry

Clause 8.2        - Disparaging the professional opinion of health professionals

Clause 9.1        - Failing to maintain high standards

Clause 9.2        - Failing to recognise the professional standing of the audience

Clause 15.2      - Employee failing to maintain a high standard of ethical conduct

 

GlaxoSmithKline UK Limited – Case AUTH/3515/5/21

For referring to three medicines (Trelegy (fluticasone/vilanterol/umeclidinium), Anoro (vilanterol/umeclidinium) and Incruse (umeclidinium)) licensed for chronic obstructive pulmonary disease (COPD) but not asthma on a registration page for an asthma-focussed webinar, within a list of medicines which were indicated for use in asthma, which implied that the medicines could be used in asthma when their summaries of product characteristics stated that they should not be used in patients with asthma and was a matter of patient safety, GlaxoSmithKline 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 (SPC)

Clause 9.1        - Failing to maintain high standards

 

 

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