Sunovion Pharmaceuticals Europe Ltd, Bayer plc, Astellas UK Limited, Astellas Pharma Europe Limited and A Menarini Pharma UK SRL have been named in advertisements(1) following breaches of the ABPI Code of Practice and Sunovion was publicly reprimanded.

All have brought discredit upon, and reduced confidence in, the pharmaceutical industry. In addition, Sunovion has been publicly reprimanded.

Sunovion - Case AUTH/2935/2/17

For one of its managers encouraging staff at a regional sales meeting to suggest to customers that if they did not consider Latuda (lurasidone) as part of a patient review there might be legal consequences, Sunovion was ruled in breach of the following clauses of the Code:

Clause 15.2  -  Failing to maintain a high standard of ethical conduct in the field force.
Clause 15.9 ​ - Providing verbal direction that advocated a course of action that would be likely to lead to a breach of the Code.

The Code of Practice Appeal Board(2) subsequently decided to publicly reprimand Sunovion for providing inaccurate and misleading information to the PMCPA Panel and the Appeal Board. The Appeal Board considered that self-regulation relied, inter alia, upon the provision of complete and accurate information. The Appeal Board also required Sunovion to be audited.

The case report is on the PMCPA website, and the public reprimand appears on the front cover of the PMCPA November 2017 Code of Practice Review.

Bayer – Case AUTH/2943/3/17

For producing representatives' training and briefing material which suggested an unlicensed use for Xarelto (rivaroxaban), Bayer 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 15.9 - Producing representatives' briefing material that advocated a course of action likely to lead to a breach of the Code.

Astellas UK - Case AUTH/2957/5/17

​Astellas UK voluntarily admitted that, over a long period of time, a large number of its promotional materials which referred to two medicines failed to include the prescribing information for both of those medicines. Prescribing information was omitted for Vesicare (solifenacin) and Prograf (tacrolimus). The company further admitted that it did not act immediately once the problem was discovered and it was 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.

Astellas Pharma Europe - Case AUTH/2958/5/17

Astellas Pharma Europe voluntarily admitted that an electronic advertisement for Xtandi (enzalutamide), which incorrectly referred to an indication and a publication as new, had not been certified; additionally the company had not followed its withdrawal process and it was ruled in breach of the following clauses of the Code:

Clause 2     - Bringing discredit upon, and reducing confidence in, the pharmaceutical industry.
Clause 7.11- Referring to an indication approved more than 12 months ago as new.
Clause 9.1  - Failing to maintain high standards.
Clause 14.1- Failing to certify promotional material.

A Menarini – Case AUTH/2960/6/17

For failing to initially certify and subsequently recertify its website which provided information to the public and to patients and for failing to act quickly when a link to an adverse event reporting site was missing, A Menarini 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 14.3 - Failing to certify material for the public or patients.
Clause 14.5 - Failing to recertify in-use material at an interval of not more than 2 years.
Clause 14.6 - Failing to preserve certificates.

The full case reports were published in the PMCPA November 2017 Code of Practice Review and are available at www.pmcpa.org.uk.