A WhatsApp message has earned Moderna a reprimand from the UK's Prescription Medicines Code of Practice Authority (PMCPA), with Novo Nordisk, Otsuka, AstraZeneca, and Daiichi Sankyo also found to have breached the rules.
All the companies have been found in breach of the Association of the British Pharmaceutical Industry's (ABPI) code of practice, the self-regulation that sets standards for the promotion of medicines for prescribing to health professionals and other relevant decision-makers in the UK, as well as information that can be communicated to the public.
The code has been operating for more than 60 years and was updated with social media guidance in early 2023 after several drugmakers were found to have breached its tenets in posts on platforms like LinkedIn and Instagram. Moderna's reprimand is one of just a few cases that have involved WhatsApp messaging.
A complaint filed with the PMCPA on behalf of the Children's Covid Vaccines Advisory Council – which claimed Moderna used a WhatsApp message to promote the recruitment of children into a clinical trial with an "inappropriate financial inducement" of £1,500 – has been upheld.
The payment had not been cleared by the research ethics committee (REC), which is reportedly on record as concluding it was too high and could put children at risk of coercion to take part. The complainant, a health professional, said he was aware of a mother of four "who rang the trial centre after seeing this WhatsApp post, but by then the trial had stopped recruiting."
While the message was sent by a paediatrician at an NHS trial recruitment centre and not from the company itself, the PMCPA's social media guidance states that, ultimately, Moderna is responsible for it. Sponsors should be in control of this type of messaging, even if – as in this case – it is carried out on behalf of a contract research organisation (CRO), it said in its report on the case.
Moderna said the £1,500 figure was from an earlier draft of the consent form that was used in error and the final version had a reduced figure, but the PMCPA concluded it had failed to communicate the draft status properly.
The company has meanwhile also been found in breach of the code for promoting off-label information about its COVID-19 vaccine SpikeVax at a medical congress.
Other judgments
In other recent cases, Novo Nordisk has been reprimanded for an article in the Sunday Times that was concluded to have promoted the company's weight loss medications to the public, as well as for "inappropriate sponsorship arrangements" that the PMCPA said amounted to an inducement. Novo Nordisk is currently suspended from the ABPI for prior breaches of the code.
Otsuka has been rapped for failure to include information in a healthcare professionals' educational guide that treatment with autosomal dominant polycystic kidney disease (ADPKD) therapy Jinarc (tolvaptan) should be discontinued if renal insufficiency progresses to advanced chronic kidney disease (CKD), posing a patient safety issue.
Finally, AstraZeneca has been found to have omitted prescribing information for its respiratory drug Symbicort (budesonide and formoterol fumarate dihydrate) on one of its websites, while Daiichi Sankyo failed to state a contraindication with its lipid-lowering drug Nustendi (bempedoic acid and ezetimibe) on a promotional website, which the PMCPA concluded could impact patient safety.
https://pharmaphorum.com/news/whatsapp-lands-moderna-hot-water-pmcpa
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