PMCPA reprimands Chiesi for multiple breaches
Chiesi has been publicly reprimanded by the PMCPA part for promoting its asthma drug Fostair off-label.
The embarrassing slapdown from the PMCPA, which enforces the ABPI Code, comes after the company provided misleading information over what turned out to be multiple breaches of the Code – including failure to follow a previous ruling by the watchdog.
In an unusual move, the PMCPA’s investigating panel reported Chiesi to the Appeal Board for it to consider whether further sanctions should be taken – a decision which is still pending since an audit of Chiesi’s procedures was found to be ‘not satisfactory’.
This means Chiesi may yet have more punishment to come.
The case began when GlaxoSmithKline alerted the authorities to Chiesi’s promotion of Fostair as a treatment for chronic obstructive pulmonary disease (COPD) at the American Thoracic Society (ATS) in May 2011.
During Chiesi’s symposium, a UK health professional presented the results from a Phase III study on Fostair demonstrating equivalence with AstraZeneca’s established COPD treatment Symbicort – but did not state that Fostair was not licensed in this indication.
In an earlier case (AUTH/2379/1/11) Chiesi was ruled in breach for distributing an issue of the journal Respiratory Disease in Practice – deemed to promote Fostair for COPD – from a British conference stand and agreed to cease using the journal and any similar material.
The panel considered that the content of the ATS symposium meant that this undertaking had not been complied with.
Chiesi also initially told the PMCPA that UK health professionals attending its ATS symposium had done so at their own volition and not through any Chiesi activity.
However, Chiesi subsequently submitted that its staff had been instructed by bosses to tell UK doctors at the conference about the symposium.
Breaches of the Code
It was deemed that the firm had invited UK health professionals to a symposium at which information on the use of Fostair in an unlicensed indication was presented – meaning high standards had not been maintained (clause 9.1).
Although Fostair is licensed for use in COPD in Turkey, the PMCPA said the presentation promoted the use of Fostair in COPD and was not in accordance with the terms of its marketing authorisation (clause 3.2).
An article in another edition of Respiratory Disease in Practice – sponsored by Chiesi, and for which the company had suggested an author – again implied that a COPD marketing authorisation was already in place for Fostair.
Bringing discredit to the industry
This ignored the undertaking that Chiesi gave to the PMCPA in case AUTH/2379/1/11 and therefore the panel ruled that ‘high standards had not been maintained’ (clause 9.1) and Chiesi had “brought discredit upon and reduced confidence in the pharmaceutical industry” (clause 2).
Some of the PMCPA’s strongest language is reserved for the fact that it “had to ask Chiesi three times for information before it got all of the facts needed to make its rulings”.
Apart from the muddle over whether Chiesi had asked doctors to attend the symposium or not, the PMCPA had to ask twice about the controversial article in Respiratory Disease in Practice before Chiesi admitted it had suggested the author.
“This was unacceptable,” the PMCPA said. “Self regulation relied upon a full and frank disclosure of the facts at the outset.”
Since the Appeal Board is going to make another audit of Chiesi’s procedures in September, this can only be an interim case report at present, the PMCPA says.
Chiesi “accepted that it had made errors and that it had taken action to improve its processes to avoid similar errors” – but the Appeal Board still decided that Chiesi should be publicly reprimanded.
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