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Allergan reprimanded over Botox promotion

pharmafile | March 19, 2014 | News story | Medical Communications, Sales and Marketing ABPI, Allergan, Botox, Galderma, PMCPA, vistabel 

Allergan has been found guilty of breaching six clauses of the ABPI’s Code of Practice over its market research for Botox.

The complainant, and ex-Allergan employee, took exception to his old firm after they sent market research on injecting botulinum toxins to his wife, a nurse.

The complainant alleged that the material was presented as a ‘study’ but was clearly market research. He alleged that repeated use of the prescription-only medicine’s brand name within this market research by the pharma firm constituted ‘disguised promotion’. 

The ex-employee assumed that the documents had come from Galderma which markets a similar treatment called Azzalure, as the identity of the commissioning pharma company was not clear – it only later became clear once the compliant was made that the study was from Allergan.

The research was designed to promote ready-to-use neurotoxin (NTX) for aesthetics reasons, and asked 120 UK participants about their about their typical monthly activity regarding cosmetic patients.

This included which brands of NTX they were aware of (Vistabel/Botox, Neuronox, Bocouture, Azzalure, others) and whether if newer, easier to dose/use NTXs became available, they would expand their practice to treat more facial cosmetic patients. 

The Panel was concerned that when participants were asked to rate products from ‘would perform very poorly’ to ‘would perform very well’ in relation to a number of features, the first quantities listed for Vistabel/Botox ready-to-use vial and ready-to-use syringe were ‘Would have excellent overall efficacy’ and “Would be able to count on the brand to deliver patient satisfaction”. 

The corresponding question for Azzalure ready-to-use syringe listed the lower impact statements “Brand would be profitable to my practice” and “Would be a brand I trust” as the first and second statements respectively. Excellent overall efficacy and patient satisfaction were lower down the list.

The Panel noted Allergan’s late submission that, contrary to its initial statement to the PMCPA, it was not researching or developing a ready-to-use toxin, but had entered into a licensing agreement with a Korean company, Medytox to develop and – if approved – commercialise certain NTX products including a potential liquid-injectable item.

This meant that the drug did not have a licence for the treatment it was discussing.

Disguised promotion

The complainant argued that presenting the material as a ‘study’, paying the participant £65 for completing the market research and presenting arguments aiding a ‘switch’ from each of the other branded products to Botox was a ‘disguised promotion’.

The PMCPA Panel found that as the market research survey promoted Vistabel/Botox, the survey’s promotional nature was in fact disguised. A breach of the Code was ruled which was upheld on appeal by Allergan.

The Panel did not, however, consider that the material advocated a switch as alleged and ruled no breach of the Code.

But it did find that the payment of £65 was contrary to requirements of the Code and a breach was ruled which was again upheld after an appeal by Allergan.

It also found the company in breach over it sending this market research to aesthetic nurse injectors, and therefore promoted Botox/Vistabel for an unlicensed indication.

But the company was not found guilty of Clause 2 of the PMCPA Code, of bringing disrepute to the pharma industry, the most serious breach. The PMCPA did originally rule it had breached this Clause, but Allergan successfully argued against it.

Ben Adams 

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