Daiichi-Sankyo, GW Pharmaceuticals, Bayer plc, Proveca Ltd, Otsuka UK and Otsuka Europe named in advertisements for breaches of Code.

Press Release 27 July 2019

Daiichi-Sankyo, GW Pharmaceuticals, Bayer plc, Proveca Ltd, Otsuka UK and Otsuka Europe have been named in advertisements(1) following breaches of the ABPI Code of Practice for the Pharmaceutical Industry. They have brought discredit upon, and reduced confidence in, the pharmaceutical industry. In addition Daiichi-Sankyo has been required to issue a corrective statement and Otsuka Europe and Otsuka UK were publicly reprimanded.

Daiichi-Sankyo Case AUTH/3010/1/18

For distributing two Lixiana (edoxaban) guides that were misleading in that they failed to highlight an important patient safety consideration and therefore did not encourage the rational use of the medicine, Daiichi-Sankyo was ruled in breach of the following clauses:

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

Clause 9.1  - Failing to maintain high standards

Clause 7.2  - Providing misleading information

Clause 7.10- Not encouraging the rational use of a medicine

The Code of Practice Appeal Board(2) required Daiichi-Sankyo to issue a corrective statement to recipients of the items at issue.

GW Pharmaceuticals – Case AUTH/3014/1/18

For promoting Epidiolex (cannabidiol) before the grant of a marketing authorization which permits its sale or supply, GW Pharmaceuticals was ruled in breach of the following clauses:

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

 

Bayer – Case AUTH/3035/4/18

For a misleading claim about Xarelto (rivaroxaban) which potentially put the safety of patients with severe renal impairment at risk, Bayer was ruled in breach of the following clauses:

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

Clause 7.2- Making a misleading claim

Clause 7.4- Making an unsubstantiated claim

Clause 9.1- Failing to maintain high standards

 

Proveca Ltd Cases AUTH/3058/8/18 and AUTH/3060/8/18

For a letter sent to individual pharmacists about the supply of unlicensed and off-label glycopyrronium vs  the use of its own product, Sialanar (glycopyrronium bromide), and which could be seen as threatening in tone, Proveca was ruled in breach of the following clauses:

Case AUTH/3058/8/18

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

Clause 8.2- Disparaging the professional opinion of health professionals

Clause 9.1- Failing to maintain high standards

Clause 9.5- Including a reference to the MHRA when this was not specifically required

Case AUTH/3060/8/18

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

Clause 9.1   - Failing to maintain high standards

 

Otsuka Europe Cases AUTH/3041/6/18 and AUTH/3123/11/18, Otsuka UK Case AUTH/3042/6/18

For failing to communicate changes to the summaries of product characteristics (SPCs) from 2017 for Jinarc (tolvaptan), Samsca (tolvaptan) and Abilify (aripiprazole), update prescribing information and relevant materials and withdraw materials in a timely manner (Otsuka UK); and for failing to communicate SPC changes or provide up-to-date prescribing information (Otsuka Europe) each company was ruled in breach of the following clauses:

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

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

Clause 9.1    - Failing to maintain high standards

The Code of Practice Panel also had broader concerns about the governance within the two companies. In the subsequent Case AUTH/3041/6/18 Otsuka Europe was not transparent in its response as it had not disclosed relevant internal reports. 

Following reports from the Panel the Appeal Board(2) was very concerned that an overall failure of governance processes at Otsuka Europe and Otsuka UK to implement and update SPC changes and update materials in a timely manner had potential patient safety implications. Otsuka Europe and Otsuka UK were publicly reprimanded and were required to be audited. 

The public reprimand appears on the front cover of the PMCPA May 2019 Code of Practice Review.

Notes to Editors:

(1) The advertisements will appear in the British Medical Journal on 10th August, the Pharmaceutical Journal on 24th August and the Nursing Standard on 4th September 2019.

(2) The Code of Practice Appeal Board consists of an independent, legally qualified, chairman and includes independent members, as well as senior executives from pharmaceutical companies. For the consideration of any matter independent members, including the Chair, must be in a majority. Further details are available in the PMCPA Constitution and Procedure.

For more information contact Elly Button ebutton@pmcpa.org.uk  0207 7478884 or 07920863650