AstraZeneca hit by 6 Symbicort marketing rule breaches, with patient safety concerns leading the most serious violation

AstraZeneca is in hot water with the U.K.’s drug marketing watchdog, the Prescription Medicines Code of Practice Authority (PMCPA), after it ruled that the Big Pharma made some serious errors of judgement for a Symbicort ad.

The case was brought by an anonymous healthcare professional who had seen an ad for AZ’s big-selling respiratory drug Symbicort in MIMS, the leading handbook for prescription and generic drugs for patients and healthcare professionals in the U.K.

The ad irked the healthcare professional to such a degree that they made a formal complaint to the PMCPA, which polices the Association of the British Pharmaceutical Industry code that makes up Britain’s drug marketing rule book.

The PMCPA agreed with most of the complaints and found AZ guilty of six breaches of the code, which is much higher than most rule breakers, and includes the most serious in Clause 2, when a pharma does something which has “brought discredit upon, and reduced confidence in, the industry.”

The two primary issues that led to these breaches revolve around AstraZeneca's characterization of the use of its medication in the advertisement.

The first main issue was that the ad, as seen in the printed version of MIMS, failed to include reference to where the prescribing information could be found on the page, with the PMCPA ruling that it simply “was not visible.”

More seriously, it also found that the ad “misleadingly implied” that all strengths of Symbicort could be prescribed for maintenance and reliever therapy, known as MART. In fact, Symbicort 400/12 should be used as maintenance therapy only.

The PMCPA said the points in small font at the very bottom of the page in question “were wholly insufficient to qualify the misleading impression.”

The PMCPA panel noted in its ruling that the use of the higher Symbicort dose (400/12) for reliever therapy “had the potential to impact patient safety” and found AZ in breach of Clause 2 as a result.

This comes after both Roche and Novartis have also this month been reprimanded by the PMCPA for Clause 2 breaches, with both Swiss pharmas now repeat offenders in this regard.