Novo Nordisk was recently suspended as a member of the Association of the British Pharmaceutical Industry (ABPI) for two years, as a result of significant breaches of the ABPI Code of Practice. According to the ABPI, the Prescription Medicines Code of Practice Authority (PMCPA) investigated Novo Nordisk’s actions and found the company to be in breach of the Code of Practice, including Clause 2 which deals with actions that are “likely to bring discredit on, or reduce confidence in, the pharmaceutical industry.”
The Behavior
According to the PMCPA, Novo Nordisk failed to clearly disclose its sponsorship of a weight loss training course of health care professionals. The course was promoted on LinkedIn and was portrayed as a third party training provider with “arm’s length” support from Novo Nordisk.
The advertisement included a picture of “what appeared to be an overweight female” with the following words: ‘With #obesity affecting around 1 in 4 #adults in the #UK, is your #pharmacy offering a #weight management service? We have funding to get you started if not! Join us Sunday morning for a FREE #webinar to start your journey. Our #nurse will guide you all the way so you are not alone in your setting up. We will #walkthewalk with you [link]?’
The link led to the training provider’s website with the heading “Free Weight Management Course.” The website also noted Novo Nordisk had reviewed all of the materials for accuracy, but neither the LinkedIn post nor the website where the material was held seemed to indicate that they were approved by Novo Nordisk.
What really prompted the attention of the PMCPA, however, was that the training referenced GLP1-RA in the treatment of obesity. At the time, Novo Nordisk was the only company that had a GLP-RA available for the treatment of obesity. The LinkedIn post, however, did not “make clear Novo Nordisk’s involvement,” nor did it say “whether it was a promotional or non-promotional meeting” but that considering that Novo Nordisk was involved in, and ultimately gave, a patient group direction to ensure that even non-prescribers could indirectly prescribe its product, it appeared to be promotional.
The patient group direction was part of what Novo Nordisk was offering healthcare professionals through the LinkedIn ad. It was being given “to individuals for their own personal benefit to run private clinics which was bribing health professionals with an inducement to prescribe.” Additionally, since the course had been run several times previously, there was a large number of health professionals who received the offer from Novo Nordisk.
Novo Nordisk Response
Novo Nordisk responded, saying in part that the content of the training course was created by and owned by the training provider and that the patient group direction for the drug was prepared by another third party, a company that provided clinical services to pharmacists, but was offered by the training provider.
Novo Nordisk also noted that it had provided sponsorship from February 2020 to December 2021 to the training provider to support the cost per attendee for a training course for health professionals about obesity and providing a “how to provide a weight management service” as a webinar or e-learning module and to support the cost of providing a patient group direction to prescribe the Novo Nordisk drug Saxenda to those health professionals who completed the course and who wanted to offer the drug as part of their weight management service.
Novo Nordisk contended that it supported both activities at an arm’s length and had no influence on the content of the training other than to check the accuracy of the information in the appropriate part of the training slides, but the content of the training course was created by, and owned, by the training provider.
The company also noted that the training provider made the LinkedIn post regarding the training and that they were not involved in the post, or even aware of it. Novo Nordisk was unable to provide a copy of the post beyond the one that was provided by the complainant.
The Sanctions
It seems one of the reasons for the stiff penalty was that according to the contract that Novo Nordisk signed, it would be recognized as the “official sponsor” of the weight management course, and in fact seemed to be the only sponsor. The Panel also noted that the contract stipulated that Novo Nordisk had reviewed the training materials used on the course for medical and factual accuracy, and that the company, therefore, would have had a “clear idea of what would be covered before deciding whether or not to fund the project,” therefore having an understanding that its drug Saxenda would be “covered positively within the course, including being the primary medicinal treatment discussed.” The panel ultimately found that the course was “in effect, promotional material for Saxenda for which Novo Nordisk was responsible.”
This is only the eighth time in the past 40 years that the ABPI issued such a significant sanction. During the suspension, Novo Nordisk is still subject to the ABPI Code and jurisdiction of the PMCPA, it will be unable to access ABPI membership benefits. Novo Nordisk will be removed from all ABPI groups, including the ABPI board, and any information and briefing put forth by ABPI.
Novo Nordisk will be subject to PMCPA audits in 2023 and 2024, where it will need to show “clear, significant, and then sustained improvement to industry standards” to be considered to be re-admitted to ABPI after the suspension. The ABPI Board has also requested quarterly updates from Novo Nordisk, outlining the company’s views on the progress it is making against the improvement plan. The ABPI Board has reserved the right to take further action after the review of the audit reports.
“While we are disappointed with this outcome, we accept the decision. We will remain committed to following the ABPI Code of Practice and maintaining the highest possible ethical standards required by the pharmaceutical industry,” a Novo Nordisk spokesperson said.
Social Media Guides
In January 2023, the PMCPA published new social media guidance for pharmaceutical companies to understand and apply the Code of Practice standards to all online communications channels.
Social Media guidance from the United States Food and Drug Administration (FDA) can be found here.