The maker of weight loss drugs Ozempic and Wegovy broke rules around the advertising and marketing of its medication to healthcare workers over three years, the medicines watchdog has found.
The Health Products Regulatory Authority (HPRA), the medicines regulator, said pharmaceutical company Novo Nordisk had complied with regulations during an inspection in May 2023, but there were also “a significant number of non-compliances”.
Grouping these together into one “overall major deficiency”, the HPRA said this “should be addressed as a matter of urgency”.
In a report, the authority said it is “possible” other non-compliances exist at the site that were not identified during the inspection.
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The report is part of the HPRA’s routine surveillance activities looking at the years 2021 to 2023 and was obtained under the Freedom of Information Act by James Larkin, a postdoctoral researcher in the Royal College of Surgeons in Ireland (RCSI) who examines conflicts of interest.
The HPRA criticised the level of control and governance for educational activities and promotional material, describing them as “deficient”.
According to the inspection, Novo Nordisk ran a pilot training course for 13 healthcare professionals – eight GPs and five practice nurses – in April 2022, where the design and contents were “inappropriate”, with some aspects being “promotional in nature”.
The report highlighted issues with how six trainee healthcare professionals shadowed a trainer for three hours in private sessions with patients.
The HPRA said there was “no evidence” Novo Nordisk had considered whether this was appropriate given that the trainer had been paid by the company to run the sessions and might prescribe its products in front of the trainees.
Furthermore, a presentation comparing Novo Nordisk products with other medications at a medical education meeting on November 5th, 2021, was “unbalanced”, they said.
A teaching guide aimed at healthcare workers, approved in May 2021, did not comply with regulations as it did not feature statements on adverse reactions, precautions and contraindications, the HPRA said.
The company recently launched a new advertising campaign in Ireland proclaiming: “It’s about my health, not just my weight”.
The campaign, which can be seen on buses, bus stops, billboards and in broadcast media, is being reviewed by the HPRA and Advertising Standards Authority following the receipt of complaints.
The company has described it as a “disease awareness campaign”. It does not mention any drugs, but does contain the company logo.
[ As a cardiologist, here is what I tell my patients about OzempicOpens in new window ]
Last July, Novo Nordisk was reprimanded by UK regulators for breaking rules around advertising its products.
A spokeswoman said the company “addressed the findings to ensure compliance with industry regulation and this was completed to the HPRA’s satisfaction immediately following the inspection”.
“Our focus remains on meeting the needs of patients, healthcare professionals and partners, and we are committed to improving the lives of people living with chronic disease in Ireland.”
