Chiesi UK has been publicly chastised for providing “inaccurate information” to the PMCPA during an audit of its processes.
The firm has been reprimanded by the PMCPA, which polices the UK’s self-regulatory code, for making a “misleading and unsubstantiated claim” about its asthma drug Fostair (beclometasone/formoterol).
Specifically, Chiesi was ruled in breach of clauses 7.2 and 7.4 of the ABPI’s Code of Conduct, ie, making a misleading claim and making an unsubstantiated claim, respectively.
But over and above this, the PMCPA said there was also a “discrepancy” between the presentation of the Fostair claim in a leavepiece provided by Chiesi, and the citation of that claim by the parties.
Before the PMCPA raised the matter with Chiesi, the company contacted the PMCPA and explained that an employee had changed the claim after certification of what should have been the final form of the leavepiece.
The company had not picked up this discrepancy until it received the outcome of the Panel’s consideration of the case. Following this admission by Chiesi, the PMCPA’s panel noted Chiesi’s further admission that in its first undertaking, the date on which the material was stated to have been withdrawn was wrong, as it was actually withdrawn two weeks later.
The panel reported Chiesi to the Code of Practice Appeal Board. In October 2013 the Appeal Board noted Chiesi’s submission that human error and lack of attention to detail led to the failure to follow the correct approval process, and to recognise the difference between the approved leavepiece and the one that was distributed, and mistakes with the date in its undertaking.
In that regard, the Appeal Board noted Chiesi had previously been censured by the PMCPA in 2013 for providing inaccurate information – again over Fostair – and it considered that Chiesi’s “repeated failure” in this regard was “completely unacceptable”.
In a statement the PMCPA said: “Self-regulation relies upon the provision of complete and accurate information. The Appeal Board was extremely concerned about Chiesi’s conduct and decided to require an audit of its procedures in relation to the Code and a subsequent re-audit.”
The first audit was conducted in March 2014 and, upon consideration of that audit report, the Appeal Board said it was “appalled” that Chiesi had stated that a standard operating procedure had been updated when in fact it had not.
The Appeal Board considered that the further provision of false information to the PMCPA was also “completely unacceptable”.
The breach will have been advertised in the BMJ, The Pharmaceutical Journal and The Nursing Standard.