A stream of breaches of the Association of the British Pharmaceutical Industry’s Code of Practice has seen five pharmaceutical companies – AstraZeneca, Gruenenthal, Janssen-Cilag, Boehringer Ingelheim and Eli Lilly – named and shamed in the British medical press.
AstraZeneca was reprimanded for facilitating the use by independent speakers of uncertified presentations, which the ABPI’s policing arm the Prescription Medicines Code of Practice Authority (PMCPA) ruled were misleading as to the licensed indication for Duaklir Genuair (formoterol/aclidinium).
Consequently, the drug giant was ruled in breach of four clauses of the Code, including being misleading as to the licensed indications of medicines, and implying a use for a medicine which was inconsistent with its summary of product characteristics.
Gruenenthal was in the dock for failing to comply with a previous undertaking, failing to brief its representatives correctly regarding call rates and failing to agree written contracts in advance of engaging health professionals. Its actions breached seven clauses, the PMCPA noted, in producing representatives’ briefing material that was likely to lead to them breaching the Code and failing to be sufficiently clear to representatives about the differences between call and contact rates, for example.
For distributing a letter regarding diabetes drug Jardiance (empagliflozin) that prepared the market for an anticipated licence extension, Boehringer Ingelheim and Lilly were ruled in breach of four clauses of the Code, including Clause 3.2, for using material that was inconsistent with the summary of product characteristics and promoting and unlicensed indication, and Clause 12.1, disguising promotional materials.
Lastly, for material sent by Janssen Europe to UK health professionals that promoted Stelara (ustekinumab) for an unlicensed indication and failing to certify such material, Janssen voluntarily admitted it had fallen foul of the Code by promoting a medicine in a manner inconsistent with its summary of product characteristics, failing to maintain high standards, and failing to certify promotional material.
All drugmakers had brought discredit upon, and reduced confidence in, the pharmaceutical industry, thereby breaking a key Clause of the Code. Details of their Code breaches will be included in advertisements to appear in the Nursing Standard on 14 December 2016 and the Pharmaceutical Journal and British Medical Journal on 17 December 2016.
More information on the cases can be found on the PMCPA’s website.
