LONDON, 9 Aug (APM) - Daiichi-Sankyo, GW Pharmaceuticals, Bayer, Proveca and Otsuka have all been called out by the UK pharma industry for misleading or inappropriate claims about their products.
The Prescription Medicines Code of Practice Authority (PMCPA) - the independent body that administers the Association of British Pharmaceutical Industry (ABPI)'s code of practice - said in a Thursday statement that all the companies "have brought discredit upon, and reduced confidence in, the pharmaceutical industry" for their marketing practices.
The body called out Daiichi Sankyo for distributing two guides for anticoagulant Lixiana (edoxaban) that it claims were "misleading" in that they failed to highlight an important patient safety consideration and therefore did not encourage the rational use of the medicine.
The Japanese firm has had to issue a corrective statement to people who received the guides.
GW breached the code for promoting Epidiolex (cannabidiol) before it received marketing authorisation. The drug was recommended for approval in the EU last month for the treatment of seizures associated with Lennox-Gastaut syndrome or Dravet syndrome, two forms of epilepsy (APMMA 63846).
The case for Bayer is related to misleading claims by the German pharma about anticoagulant Xarelto (rivaroxaban). These potentially put the safety of patients with severe renal impairment at risk, said the PMCPA.
Proveca breached the code for a letter sent to individual pharmacists about the supply of unlicensed and off-label glycopyrronium versus the use of its own product, Sialanar (glycopyrronium bromide), and which could be seen as "threatening in tone", said the PMCPA.
And Otsuka was called out for failing to communicate changes to the summaries of product characteristics (SPC) from 2017 for Jinarc (tolvaptan), Samsca (tolvaptan) and Abilify (aripiprazole); for failing to update prescribing information and relevant materials and withdraw materials in a timely manner; and for failing to communicate SPC changes or provide up-to-date prescribing information.
The PMCPA said it was very concerned that an overall failure of governance processes at Otsuka Europe and Otsuka UK to implement and update SPC changes and update materials in a timely manner had potential patient safety implications.
As a result, Otsuka Europe and Otsuka UK are required to be audited.
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