Astellas UK, Astellas Europe, Pfizer, Novartis Pharmaceuticals and Tor Generics named in advertisements(1) following breaches of the ABPI Code

Press Release 14 September 2017

Astellas UK and Astellas Europe have brought discredit upon, and reduced confidence in, the pharmaceutical industry, in addition both have been publicly reprimanded. Pfizer Ltd, Novartis Pharmaceuticals UK Ltd and Tor Generics Ltd have brought discredit upon, and reduced confidence in, the pharmaceutical industry.

Astellas UK and Astellas Europe - Cases AUTH/2939/2/17 and AUTH/2940/2/17

Each company voluntarily admitted that the prescribing information for a number of their medicines had been incomplete, by the omission of some adverse events and the like, for several years and they were ruled in breach of the following clauses of the Code:

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

Clause 4.1    - Providing incomplete prescribing information

Clause 9.1    - Failing to maintain high standards.

Pfizer and Novartis – Cases AUTH/2928/1/17 and AUTH/2929/1/17

For failing to comply with their previous undertakings, by continuing to misleadingly promote Ultibro Breezhaler (indacaterol/glycopyrronium) without setting that within the context of its licensed indication and for producing representatives' briefing material that was not sufficiently clear, Pfizer and Novartis were 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    - Making claims inconsistent with the SPC.

Clause 7.2    - Making misleading claims.

Clause 9.1    - Failing to maintain high standards.

Clause 15.9  - Producing representatives' briefing material that was likely to lead to a breach of the Code. 

Clause 29     - Failing to comply with an undertaking.

​Tor Generics – Case AUTH/2950/4/17

For promoting Tor-bac (saline solution for injection) which was not yet licensed, but was expected to be classified as a prescription only medicine, in a magazine aimed at the public, Tor Generics 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.

Notes to Editors:

(1) The advertisements will appear in the British Medical Journal on 16 September 2017, the Nursing Standard on 20 September 2017 and the Pharmaceutical Journal on 30 September 2017.

(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

The Prescription Medicines Code of Practice Authority (PMCPA) was established by The Association of the British Pharmaceutical Industry (ABPI) to operate the ABPI Code of Practice for the Pharmaceutical Industry independently of the ABPI. The PMCPA is a division of the ABPI. The Code covers the promotion of medicines for prescribing to health professionals and the provision of information to the public about prescription only medicines. If you have any concerns about the activities of pharmaceutical companies in this regard, please contact the PMCPA at 7th Floor, 105 Victoria St, London, SW1E 6QT or emailcomplaints@pmcpa.org.ukThe Code and other information, including details about ongoing cases, can be found on the PMCPA website: www.pmcpa.org.uk.