Merz Pharma slammed by PMCPA
pharmafile | September 21, 2012 | News story | Medical Communications, Sales and Marketing | ABPI, Merz Pharma, PMCPA
Merz Pharma UK has been rapped over the knuckles for three of the most serious breaches it is possible to make of the ABPI Code of Practice.
The company failed to do what it said it would following misdeanours in a previous case – an offence of which the PMCPA takes a particularly dim view.
As a result, Merz was deemed to have caused discredit to, and reduced confidence in, the pharma industry (clause 2) – a sign of particular censure from the PMCPA.
It also fell foul of clause 9.1, which states high standards “must be maintained at all times” by pharma companies and clause 25, which makes clear that firms must comply with undertakings made under the Code.
The new complaint, which formed the basis of case AUTH/2516/6/12, came from Allergan, whose Botox was compared to Merz’s Bocouture in an advert issued by Merz and published in Cosmetic News in June this year.
The ad showed a vial of Bocouture next to one of Botox (both products are botulinum toxin type A) and the claim “In glabellar frown lines, clinical studies suggest Bocouture vs Botox: Equal Potency 1:1 Clinical Conversion Ratio”.
In smaller font were the words: “Unit doses recommended for Bocouture are not interchangeable with those for other preparations of botulinum toxin” – a statement referenced to the Bocouture summary of product characteristics (SPC) of June 2010, as was the claim for equal potency.
The claim for a 1:1 clinical conversion ratio was referenced to Sattler et al (2010).
Allergan’s complaint was that this breached the undertaking given by Merz in an earlier case (AUTH/2270/10/09), when an ad compared Botox to Merz’s Xeomin (the same product as Bocouture but with different indications).
Back then it was ruled by the PMCPA that the results of a non-inferiority study could not be used to claim equivalence – Merz admitted it had no data to support a claim that Xeomin was equivalent to Botox and this was still so.
On that basis, Allergan said that the implication of equivalence and the ‘1:1 Clinical Conversion Ratio’ claim between Bocouture and Botox breached the undertaking given in Case AUTH/2270/10/09.
The company’s concern was that prescribers would think Bocouture and Botox, being both botulinum toxin type A, were interchangeable in terms of potency units, delivered the same clinical results and could be converted 1:1.
However, the Bocouture 50U and Xeomin 50U SPCs were altered after Allergan highlighted to regulators potential safety concerns with the wording in both, removing any reference to equal potency.
The statement about a 1:1 dosing ratio in the Xeomin 50U SPC had also been removed and Allergan pointed out that that the information from non-inferiority studies was specifically about patients with blepharospasm or cervical dystonia.
The SPCs for Botox 50U, 100U and 200U stated: “Botulinum toxin units are not interchangeable from one product to another. Doses recommended in Allergan units are different from other botulinum toxin preparations”.
The advertisement had also been at issue in a third case – AUTH/2496/4/12 – in which Allegan had made similar allegations.
The PMCPA had ruled then that the undertaking in Case AUTH/2270/10/09 had not been breached – but this was overturned upon appeal by Allergan.
That same breach of undertaking therefore applied to the newest case – which meant that the panel ruled a breach of clause 25 and one of clause 9.1.
There was still no data upon which to base a claim that Botox and Bocouture were clinically equivalent and the PMCPA was ‘concerned to note’ that, even though the ad was withdrawn following changes to the Bocouture SPC, Cosmetic News published it in error.
Although Merz had reviewed its processes for ensuring only current and approved advertisements were used, the panel said that its actions had breached clause 2 of the Code.
Adam Hill
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