Grünenthal breaches Code with off-label promotion
pharmafile | September 28, 2010 | News story | Medical Communications | Code of Practice, Grunenthal, PMCPA, Versatis
Grünenthal has been severely criticised in two rulings by UK pharma’s self-regulatory body the PMCPA for promoting off-label use of its drugs.
The judgments relate to printed materials for the German pharma company’s pain relief brand Versatis – some of the material was distributed at a meeting of the British Pain Society (BPS).
An anonymous source alerted the PMCPA, which oversees the ABPI Code of Practice, to copy on both a poster and handout.
This read: “Versatis has an ‘off-label’ use for the symptomatic relief of localised neuropathic pain, and could provide a substantial saving to the local health-economy”.
But Versatis is only indicated for the symptomatic relief of neuropathic pain associated with previous herpes zoster infection (post-herpetic neuralgia, PHN).
In a scathing judgment, the PMCPA panel said a cost comparison on the poster between Versatis and other products was “inaccurate and misleading”.
The PMCPA ruled Grünenthal breached clauses 2 of the Code (which deals with discrediting, and reducing confidence in, pharma) and 3.2 (promotion must be in accordance with a medicine’s marketing authorisation).
The company was also found to have contravened clause 9.1, which states that “high standards must be maintained at all times”.
In the second ruling, the company was deemed again to have breached Code clauses 2 and 9.1 – as well as 7.2, which deals with misleading information, claims and comparisons.
One of the poster’s authors was a Grünenthal employee – a fact that the panel said had not been clearly stated.
Given that Grünenthal had paid for the printing of the poster and had helped with its submission to the BPS, the panel dismissed the company’s statement that it had not had editorial control.
The PMCPA was “especially concerned that the company had certified the promotional item which referred to an unlicensed indication knowing that it would appear as part of a peer-reviewed poster presentation at a scientific conference”.
The PMCPA has yet to confirm what sanctions it will take against Grünenthal, but past breaches of clause 2 of the Code have merited ‘naming and shaming’ adverts in the medical, pharmaceutical and nursing press.
Adam Hill
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