Allergan marketing breaches discredited industry
pharmafile | March 22, 2011 | News story | Medical Communications |Â Â Allergan, Cephalon, PMCPAÂ
Allergan, the manufacturer of Botox, has been censured for several breaches of the ABPI Code of Practice.
The PMCPA watchdog ruled that Allergan had failed to maintain high standards, and had brought discredit upon and reduced confidence in the pharma industry. Moreover, it had failed to comply with an undertaking based on an earlier breach.
The seriousness of the breaches mean the ruling will be advertised in the pharma, medical and nursing press.
The PMCPA considered two cases against the company, which hinged on Allergan using data in presentations in ways which had already been ruled misleading by the watchdog.
Both were prompted by complaints from Merz, manufacturer of Xeomin/Bocouture, a rival brand to Botox/Vistabel.
The cases were dealt with separately because the breaches took place at different events but the central point in both was that Allergan effectively ignored what the PMCPA ruled in an earlier case (AUTH/2183/11/08).
In that instance, Allergan’s use of data deriving from research (by Hunt et al) implied a difference in potencies between Xeomin and Botox in favour of Botox (the products are both botulinum toxin).
However, the PMCPA panel found this was inconsistent with the summaries of product characteristics (SPCs), which showed similar dosing regimens for the two brands.
While some animal data possibly showed a difference, the Code says this cannot be extrapolated to clinical situations without data to show it is of direct relevance.
That case has a direct bearing on the two new cases, because Allergan still appeared to be using the Hunt et al data in a way which would make the audience think Botox was superior.
The PMCPA panel is particularly keen to enforce undertakings by companies it has censured, seeing it as vital for the reputation of the industry – and the Code’s credibility.
In the first new case (AUTH/2335/7/10), Merz alleged that an Allergan presentation at the FACE (facial aesthetic conference and exhibition) congress in July 2010 used the Hunt et al data in a similar way to AUTH/2183/11/08.
The second case (AUTH/2346/8/10) brought by Merz was for a meeting the same month at which Merz and Allergan had been invited to present to a group of health professionals trying to decide which botulinum to purchase – and again, the Hunt et al data was used.
The Panel considered that it was difficult to view Allergan’s presentations as anything other than promotional.
In each case (although only after an appeal by Merz each time), the PMCPA panel found Allergan guilty of failing to maintain high standards (clause 9.1) and the more serious charges of bringing discredit upon and reducing confidence in the pharma industry (clause 2) and failing to comply with an undertaking (clause 25).
In the same round of censure adverts, Cephalon was pulled up for half a dozen Code breaches for hospitality which the PMCPA deemed excessive.
Adam Hill
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