Dive Brief:
- The Association of British Pharmaceutical Industry (ABPI) sanctioned AstraZeneca and Genzyme for separate cases of marketing negligence and misinformation. The two companies' violations will be flagged in advertisements running in three high-profile medical journals this month.
- AstraZeneca was sanctioned for authorizing the distribution of a leavepiece for Forxiga which incorrectly detailed how to use a client clinical system to prescribe the medicine. An ABPI review panel concluded the misinformation could lead to inappropriate prescriptions.
- Genzyme was sanctioned for delivering a misleading presentation to a private group of experts with commissioning abilities. The case decided the company had inappropriately promoted its product, Fabrazyme, while disparaging its competition (Shire's Replagal).
Dive Insight:
The two separate cases show the importance of factual oversight while presenting detailed product information to potential clients or consumers.
In AstraZeneca's case, the review panel recognizes the company was not directly at fault for the misinformation. "The Appeal Board noted AstraZeneca had limited expertise with regard to the EMIS Web clinical system and in that regard had relied upon its agency which had let it down," the review panel wrote in the case file.
Nonetheless, since the instructions in the "leavepiece might lead to controlled patients (based on HbA1c) being identified as uncontrolled and being prescribed Forxiga," AstraZeneca was held responsible for lack of oversight and three violations of the Association's code of practice.
Genzyme's case, by contrast, resulted in 11 breaches of the code of practice, which included, among others, "bringing direct discredit upon, and reducing confidence in, the pharmaceutical industry." The review panel delivered a rather scathing indictment of the company's 22-slide presentation to the Lysosomal Storage Disorders Expert Advisory group—discrediting aspects of the presentation slide by slide.
The pivotal nuance is that members of the expert advisory group had commissioning powers, so the misleading information could inappropriately influence the market after what should have been an objective presentation.
In consequence of the code violations, the two companies were subjected to name and shame advertisements in the British Medical Journal, the Nursing Standard, and The Pharmaceutical Journal in July. Both companies also had to deliver corrective statements to all affected parties.