(Reuters) -AstraZeneca has breached the UK pharmaceutical industry's code of practice, an industry self-regulatory body ruled on Friday, after incorrect claims related to the drugmaker's asthma
AstraZeneca Found in Violation of UK Code Over Symbicort Claims
AstraZeneca's Breach of Marketing Code
(Reuters) -AstraZeneca has breached the UK pharmaceutical industry's code of practice, an industry self-regulatory body ruled on Friday, after incorrect claims related to the drugmaker's asthma treatment Symbicort.
Details of the Breach
The Prescription Medicines Code of Practice Authority (PMCPA) said a website incorrectly stated that all newly diagnosed asthma patients aged 12 and above should receive AstraZeneca's Symbicort as an "as-needed" reliever therapy.
Response from AstraZeneca
That claim did not reflect national guidelines, it said, which recommend that highly symptomatic patients or those with severe exacerbations should instead be prescribed a different treatment involving regular daily dosing plus as-needed use.
Implications for Patient Safety
"We take PMCPA findings extremely seriously and our processes are regularly reviewed to ensure compliance with the Code," an AstraZeneca spokesperson said in an emailed statement to Reuters.
The drugmaker was found in breach of four clauses of the code set by the Association of the British Pharmaceutical Industry, including making misleading claims about Symbicort. PMCPA is a division of the association.
Symbicort, one of AstraZeneca's most well-known and lucrative drugs, is a combination inhaler used to treat asthma and chronic obstructive pulmonary disease. It made the company nearly $3 billion in revenue last year.
In a response to the industry regulator, the company accepted that the claim was misleading, but disputed that patient safety was jeopardised.
The watchdog said the breach raised genuine patient safety concerns as highly symptomatic patients could be inadvertently prescribed unsuitable treatment, potentially resulting in poor symptom control or persistent exacerbations.
AstraZeneca argued that both treatment approaches use the same maximum daily dose and the website included links to full prescribing information and national guidelines, though it updated the web page immediately after receiving the complaint.
(Reporting by Yamini Kalia in Bengaluru; Editing by Rashmi Aich and Janane Venkatraman)
