Grünenthal and Vifor breach Code

pharmafile | July 20, 2012 | News story | Sales and Marketing ABPI, Grunenthal, PMCPA, Vifor, code, tapentadol 

Grünenthal and Vifor Pharma UK have been named and shamed for serious infringements of the ABPI Code of Practice.

Adverts detailing their offences, including breaches of clause 2: ‘Bringing discredit upon, and reducing confidence in, the pharma industry’ – have been published in the BMJ, The Pharmaceutical Journal and The Nursing Standard. 

In a case that dates back to 2010, Grünenthal has also been publicly reprimanded for its actions, which centred on the promotion of a product before it received marketing authorisation (clause 3.1). 

The Medicines and Healthcare products Regulatory Agency (MHRA) complained two years ago that Grünenthal’s team of health economic liaison managers (HELMs) was promoting its novel centrally acting analgesic tapentadol, an unlicensed medicine, to doctors. 

The HELMs talked to them about Grünenthal’s licensed products, all of which were for pain relief, but also asked questions about tapentadol or a ‘new pain drug’. 

The Prescription Medicines Code of Practice Authority (PMCPA), which enforces the Code, said this meant the HELMs were in effect raising the profile of tapentadol in an ‘unacceptable’ way. 

It ruled a breach of clause 9.1 (failure to maintain high standards) as well as clauses 2 and 3.1. The reason for the public slap on the wrist now, is that following a series of audits of procedures, firm action had still not been taken on this by Grünenthal. 

In a withering judgment, the PMCPA said: “Upon consideration of the third audit the Appeal Board was concerned that it still appeared that the company had not really understood the seriousness of the situation.” 

It also found that Grünenthal had misinformed the panel in its response to recommendations following one of the audits. 

The Vifor case, meanwhile, hinged on the company failing to follow an assurance it had made in an earlier PMCPA case.

Pharmacosmos complained that Vifor had used the claim ‘Ferinject avoids dextran-induced hypersensitivity reactions’ in two press releases. 

One described the Scottish Medicines Consortium’s approval of Ferinject to treat iron deficiency anaemia, while the other was about an MHRA nod for a simplified dosing regimen for the treatment of iron deficiency. 

But the claim – wrongly implying that Ferinject was free of such reactions – was the one which had breached the Code in the first place.

Vifor did not withdraw the releases so the PMCPA ruled it had fallen foul of clause 25 (failing to comply with an undertaking) as well as clauses 2 and 9.1. 

This time there was no public reprimand for the company.

Adam Hill 

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