Chiesi reprimanded again over Fostair drug
pharmafile | March 3, 2015 | News story | Manufacturing and Production, Medical Communications, Sales and Marketing | ABPI, Chiesi, PMCPA, code, formoterol/beclometason, fostair
Chiesi has been reprimanded after it breached the ABPI’s Code of Practice for its promotion of asthma inhaler Fostair.
The PMCPA notes that misleading claims regarding Fostair (formoterol/beclometason) broke clauses of the Code.
The complaint raised by AstraZeneca in 2013 accused Cheisi of unqualified and unsupported claims in its leavepiece for the asthma and chronic obstructive pulmonary disease (COPD) device.
The Cheadle-based pharma firm was publicly reprimanded for providing inaccurate information during the course of the complaint, and again during the progress of a subsequent audit.
The PMCPA panel noted that the firm’s review displayed human error and lack of attention to detail, and it considered that Chiesi’s repeated failure in this regard was completely unacceptable. Subsequently the panel concluded that Chiesi had breached Clause 7.2, making a misleading claim, plus Clause 7.4, making an unsubstantiated claim.
The original objection makes reference to content that reads ‘for an extra fine day’ on the leavepiece, and AZ suggests that the line misleads patients into thinking they’ll return to an improved pre-symptom state using the treatment.
The company said although errors had been made, it took the Code extremely seriously and was committed to making improvements.
Been here before
This wasn’t the first time the company behind Fostair has been criticised, back in 2012 wrongdoing was alerted to the authorities by GlaxoSmithKline who accused Chiesi of providing misleading information.
The panel ruled a breach of Clause 9.2 which states that high standards had not been maintained, plus Clause 2 for causing discredit upon and a reduced confidence in the pharmaceutical industry.
The PMCPA panel did not consider that in this latest instance Chiesi had failed to maintain high standards however, so no breach of Clause 9.1 was ruled.
Tom Robinson
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