PMCPA raps Pharmaxis
pharmafile | June 16, 2014 | News story | Manufacturing and Production, Sales and Marketing | ABPI, CML, PMCPA, pharmaxis
Pharmaxis Pharmaceuticals has been given the most severe punishment that the PMCPA can hand out following a series of breaches of the ABPI Code of Practice.
The body which enforces the Code, says that Pharmaxis has brought “discredit to, and reduced confidence in, the pharma industry”: a ruling of a breach of clause 2 “is a sign of particular censure and is reserved for such circumstances”.
The problems stemmed from the way Pharmaxis certified the materials which it put out. An anonymous complainant, who was a contractor to Pharmaxis, alleged that the firm’s first standard operating procedure (SOP) for approval of non-promotional items was only in development in summer 2013.
This meant that it had not been in place for the launch and pre-launch phases of Pharmaxis’ two medicines marketed in the UK: Bronchitol (mannitol), an add-on therapy for the treatment of cystic fibrosis (CF) and Osmohale (mannitol), a diagnostic for identifying bronchial hyper-responsiveness.
As a result the complainant said, such materials around the drugs were not subject to any medical check or approval – but the PMCPA did not believe that the complainant had shown, on the balance of probabilities, that this was the case so no breach was ruled.
However, a specific part of the complaint related to a series of journals called Current Medical Literature (CML) – updates on cystic fibrosis – which the complainant said had been incorrectly deemed ‘non-promotional’ and therefore not certified.
After looking at two volumes of the journal, the PMCPA panel agreed that CML should have been certified as a ‘medical and educational good and service’ (MEGS) – and the inclusion of Bronchitol advertisements in it rendered the journals promotional.
A key part of the problem was that Pharmaxis had not categorised the journal, at the outset, under the Code – and this meant, the PMCPA says, that “it was difficult in such circumstances to maintain compliance”.
An audit by an external consultant also revealed that before August 2013 items were not certified in their final form, despite the Code saying they should be.
The company’s activity with CML had breached clauses 14.1 and 14.3, both of which deal with the certification of promotional material. And taking everything into account, Pharmaxis was also held to have fallen foul of clause 9.1, which states that “high standards must be maintained at all times”.
The most serious breach, of clause 2, was ruled because the panel considered that “Pharmaxis’ failure to correctly categorise the cystic fibrosis CML as either promotional or non-promotional at the outset, and to thus correctly certify it, displayed a poor understanding of the Code”.
The PMCPA concludes: “That, together with the company’s failure to certify the final form of its material, reduced confidence in, and brought discredit upon, the industry.”
Adam Hill
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