Pharma companies fall foul of ABPI’s Code of Practice

Sunovion Pharmaceuticals Europe, Bayer, Astellas UK, Astellas Europe and Menarini Pharma UK SRL have been named in adverts for breaching of the ABPI’s Code of Practice.

According to the Association’s policing arm, the Prescription Medicines Code of Practice Authority, all have brought discredit upon, and reduced confidence in, the pharmaceutical industry.

Sunovion was reprimanded after one of its managers encouraged 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.

As such, the firm was ruled in breach of Clause 15.2 - failing to maintain a high standard of ethical conduct in the field force, and Clause 15.9 – providing verbal direction that advocated a course of action that would be likely to lead to a breach of the Code.

For producing training and briefing materials for representatives which suggested an unlicensed use for blood thinner 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; and Clause 15.9, producing representatives’ briefing material that advocated a course of action likely to lead to a Code breach.

Astellas UK failed to include prescribing information on Vesicare (solifenacin) and Prograf (tacrolimus) in a large number of its promotional materials over a lengthy time frame. It also admitted that it did not act immediately once the problem was discovered.

Consequently, the PMCPA ruled that the company had brought discredit upon and reduced confidence in the pharmaceutical industry (Clause 2), provided incomplete prescribing information (Clause 4.1) and also failed to maintain high standards (Clause 9.1).

Astellas Pharma Europe used an uncertified electronic advertisement for Xtandi (enzalutamide) that incorrectly referred to an indication and a publication as new, and also did not subsequently follow its own withdrawal process.

As well as breaching Clause 2 and Clause 9.1 of the Code, it also broke Clauses 7.1, referring to an indication approved more than 12 months ago as new, and 14.1, failing to certify promotional material.

The PMCPA also ruled that A. Menarini breached a stream of Code Clauses 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.

As well as Clauses 2 and 9.1, the company failed to certify material for the public or patients (14.3), failed to recertify in-use material at an interval of not more than two years (14.5) and failed to preserve certificates (14.6).

Adverts detailing the breaches will appear in the British Medical Journal, the Nursing Standard, and the Pharmaceutical Journal this month, the PMCPA said.