AstraZeneca and Organon have been found in serious breach of the U.K.’s pharma code, with a watchdog ruling both companies brought discredit on the industry.
The Prescription Medicines Code Of Practice Authority (PMCPA) case against AstraZeneca centers on a claim the company made on a website for Symbicort. The website said U.K. guidelines recommend all newly diagnosed asthma patients aged 12 years and up should receive a certain regimen. However, a complainant noted that another regimen is recommended for some patients. Symbicort is approved in both populations.
AstraZeneca accepted that it made “an unintentional error” by failing to accurately reflect the full U.K. guidelines. Yet the drugmaker denied that the error constituted a patient safety risk, arguing that there was no theoretical risk of an overdose. That view underpinned AstraZeneca’s argument that it neither failed to maintain high standards nor brought discredit on the industry.
The PMCPA panel reached a different conclusion, questioning the robustness of the review and approval process for the webpage and determining that the shortcomings represented a failure to maintain high standards. Believing the materials raised a “genuine patient safety concern,” the panel concluded that AstraZeneca brought discredit on the industry.
In the case of Organon, the PMCPA contacted the drugmaker after receiving a complaint about a webinar the company sponsored. A healthcare organization held the webinar to discuss teenage pregnancies and the importance of long-acting reversible contraception (LARC). A promotional video for Organon’s LARC, Nexplanon, ran before the webinar.
The complainant alleged that the webinar constituted off-label promotion of Nexplanon, which isn’t licensed for use in people aged under 18 years in the U.K. Organon denied it breached any clauses of the code. The argument rested on the belief that the video complied with the code and that Organon wasn’t accountable for the content of the webinar.
Organon’s provision of the promotional video undermined that argument in the eyes of the PMCPA panel. The video meant Organon had influenced the balance and scope of the webinar, the panel said. While the parties intended to form an arm’s length arrangement, the panel ruled that the influence of the video implicated Organon in the content of the webinar.
That finding unraveled Organon’s defense. Having ruled that Organon was liable for the content of the webinar, the panel determined that the company had breached the rules on making misleading and unsubstantiated claims. That led the panel to conclude that Organon had failed to maintain high standards and had brought discredit on the industry.