5 Pharma Companies Cited by Industry Group For Practice Code Violations

Recently, the Prescription Medicines Code of Practice Authority (PMCPA) announced in a press release that 5 pharmaceutical companies have breached the Association of the British Pharmaceutical Industry’s (ABPI) Code of Practice. The code reflects and extends beyond UK law, and is administered by the PMCPA as part of a self-regulatory system that covers prescription medicines.

PMCPA publicly reprimanded Sunovion Pharmaceuticals Europe LTD for allowing 1 of its managers to encourage staff to suggest to customers that they could face legal action if they did not consider lurasidone (Latuda) as part of a patient review. It was ruled that Sunovion was in breach for failing to maintain a high standard of ethical conduct in the field, and for providing verbal direction that advocated a course of action that would lead to a breach of the Code. The public reprimand appears on the front cover of the PMCPA November 2017 Code of Practice Review. Subsequently, the Code of Practice Appeal Board also required Sunovion to be audited.

Additionally, all of the following companies were cited for, among other issues, bringing discredit to and reducing confidence in the pharmaceutical industry:

• Bayer PLC. Bayer was cited for breaching 3 of the code's clauses by producing training and briefing material that suggested an unlicensed use for rivaroxaban (Xarelto).
• Astellas UK Limited. Astellas UK voluntarily admitted that, over a long period of time, a large number of its promotional materials, which referred to both solifenacin (Vesicare) and tacrolimus (Pograf), failed to include prescribing information for the 2 drugs. Astellas also admitted that it did not immediately act once the problem was discovered.
• Astellas Pharma Europe Limited. Astellas Pharma Europe voluntarily admitted that it had put out an electronic advertisement for Enzalutamide (Xtandi) that incorrectly referred to an indication and a publication as new. Additionally, the company had not followed its withdrawal process for the advertisement.
• A Menarini Pharma UK SRL. Menarini was cited for failing to 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.

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