Latest news with #PMCPA
Russia Today
28-04-2025
- Business
- Russia Today
Moderna risks UK suspension over cash and toys offered to kids
US 'big pharma' company Moderna could be suspended or expelled from a UK trade body after breaches of industry rules, including offering children cash and teddy bears to take part in Covid vaccine trials, The Telegraph reported. Moderna, which joined the Association of the British Pharmaceutical Industry (ABPI) in 2023, now faces an audit that could result in its suspension or expulsion. A new ruling is expected to be published in the coming days, according to The Telegraph. If sanctioned, it would become the tenth firm to face suspension from the ABPI in the past 40 years, the newspaper UK's drug watchdog, the Prescription Medicines Code of Practice Authority (PMCPA), said Moderna's lack of transparency was "unacceptable" and damaged the industry's October 2024, Moderna was fined £14,000 ($17,850) after a WhatsApp message offered £1,500 ($1,872) to minors to join the NextCOVE Covid booster trial. Although the company later reduced the payment to £185 ($231), at least one site continued promoting the original offer. The PMCPA said the payment was 'much higher than would be considered a reasonable reimbursement' and ruled that it discredited the pharmaceutical industry. In a separate case, Moderna was fined nearly £44,000 ($56,000) after Britain's pharmaceutical watchdog found it had damaged the industry's reputation. In 2023, Bradford Teaching Hospitals NHS Foundation Trust published adverts aimed at children aged 12 and over, offering 'a lovely certificate and a 'be part of the research' teddy bear.' Two online articles also promoted recruitment.A senior Moderna employee co-authored promotional articles, including one with former vaccines minister Nadhim Zahawi, without disclosing his affiliation, the Telegraph reported. The employee also sent promotional tweets without revealing his PMCPA said Moderna 'misled regulators' about when it learned of the breaches. While the company claimed it acted promptly after being informed in January 2024, evidence showed executives had been alerted by UsForThem in August findings showed 'how readily [Moderna] put profit ahead of the health and safety of children' and 'laid bare just how little regard it has had for the regulatory system that was supposed to keep it honest,' Molly Kingsley, founder of UsForThem, told the vaccines, including Moderna's Spikevax, may lead to side effects in minors, such as pain at the injection site, fatigue, headache, fever, and, in rare cases, myocarditis or pericarditis, according to health authorities.
Telegraph
26-04-2025
- Business
- Telegraph
Moderna faces suspension over Covid jab breaches
Moderna could face suspension from Britain's pharmaceutical trade body following a string of breaches of the regulatory code. The Covid vaccine maker is due to be audited by the Prescription Medicines Code of Practice Authority (PMCPA) over 'unacceptable' practices that brought discredit upon the industry. If found to be lacking adequate compliance systems, Moderna could ultimately be suspended or expelled from the Association of the British Pharmaceutical Industry (APBI). It follows several code breaches, including representatives of the company offering children £1,500 and teddy bears to take part in Covid vaccine trials. In a fresh ruling, which is expected to be published in the coming days, the company was also found to have misled regulators about when it first became aware of the financial incentives to children. Moderna claimed it had taken action as soon as it was notified about the cash offer by the Health Research Agency in January 2024, but it has now emerged that senior executives were informed in August 2023 by the campaign group UsForThem, yet failed to take action. Under the Medicines for Human Use (Clinical Trials) regulations, it is prohibited for incentives or financial inducements to be given to children or their parents. The PMCPA ruled the company had shown a lack of transparency that was 'completely unacceptable' and brought discredit upon the industry. A senior employee was also found to have co-authored three articles, including one with Nadhim Zahawi, the former vaccines minister, which promoted Moderna's Covid vaccine without disclosing he worked for the company. He also sent promotional tweets from a personal account without revealing his role. The PMCPA said the article and tweets amounted to advertising the vaccine, and viewed the failure to inform readers of links to Moderna as unacceptable. Molly Kingsley, the founder of UsForThem, said: 'Many of the previous judgments against Moderna have revealed how readily it put profit ahead of the health and safety of children. 'Now it has also laid bare just how little regard it has had for the regulatory system that was supposed to keep it honest. 'Never before has a company so new to the pharmaceutical industry been rebuked in this way.' In two new rulings, Moderna was found to have made ten new breaches of the code. UsforThem said it was particularly worrying as they related to three senior executives at the company. The PMCPA said that an audit was now necessary to look at whether Moderna's culture, governance and framework were operating effectively, and said the Appeal Board would then consider whether further sanctions were needed after auditors had reported back. Suspension of expulsion The Appeal Board can report a company to the APBI board, which can suspend or expel them from the APBI. Suspension or expulsion would be a blow for Moderna, which only joined in 2023. The APBI has taken the measure just nine times in the past 40 years. The last company to be suspended was Novo Nordisk in 2023. The company manufactures the high-profile weight loss drugs Saxenda and Wegovy, and type 2 diabetes drug Ozempic. Its membership was restored in March. In the past year, Moderna has been ordered to pay thousands for breaches of the regulations, including for using off-label data to promote its Spikevax vaccine at the European congress of clinical microbiology and infectious diseases in April 2022. But critics argue the company's revenue is nearly £7 billion in 2023, so with such small sums it has no incentive to stick to the rules, while being suspended from the APBI only brings reputational damage.
Yahoo
17-02-2025
- Business
- Yahoo
Novo Nordisk reprimanded for allegedly failing to disclose payments
The manufacturer of the weight loss jab Wegovy has been reprimanded for allegedly failing to disclose or accurately report payments to healthcare and patient organisations. Novo Nordisk breached clauses under the Association of the British Pharmaceutical Industry (ABPI) code of practice, according to the Prescription Medicines Code Of Practice Authority (PMCPA). The company said it is taking the issue 'extremely seriously' and 'is dedicated to working transparently and ethically'. The complaint was made by three individuals, who were colleagues at two separate universities, regarding the alleged failure to report payments to two healthcare organisations. Following an 'in-depth investigation', the complainants claimed Novo Nordisk allegedly failed to report, inaccurately reported, and misreported payments to healthcare organisations and patient organisations between 2015 and 2022. The probe alleged 30 organisations were missed from the company's disclosures and claims Novo Nordisk misreported 65 payments. The PMCPA said Novo Nordisk accepted breaches of clauses 24.1, 24.4, 24.5, 27.7, 9.1 and 2 of the 2019 code and clauses 28.1, 29.1, 29.2, 31.1, 31.2, 5.1 and 2 of the 2021 code. These clauses include failing to document and publicly disclose annually certain payments made directly or indirectly to health professionals, other relevant decision-makers and healthcare organisations, failing to make publicly available a list of patient organisations which it supports, and failing to make disclosures annually in respect of each calendar year in the first six months after the end of the calendar year in which the payments were made. It added that its panel 'decided on balance not to report Novo Nordisk to the code of practice appeal board for it to decide whether the imposition of further sanctions was appropriate'. It noted that the company 'had been the subject of several cases in relation to the failure to appropriately disclose transfers of value,' adding that 'additional sanctions had been imposed and that Novo Nordisk was already the subject of the audit process at the request of the code of practice appeal board'. It said the 'matters raised in this case were closely similar to matters already before the appeal board both in terms of the nature of the matters considered and that the amount undisclosed was significant'. Novo Nordisk has its headquarters in Bagsvaerd in Denmark, and was founded in 1923. Among its products is semaglutide, sold under the brand names Ozempic and Wegovy, the latter of which has been approved to treat obesity on the NHS. A Novo Nordisk spokesman said: 'Novo Nordisk is dedicated to working transparently and ethically, taking the reporting of these historical transfers of value extremely seriously. 'In fact, most of the missed disclosures included in this case were already part of our self-reported voluntary admission in November 2023 to the PMCPA. 'For those that were not included in that admission, these have been captured through our improved processes and have been accurately disclosed. 'All transfers of value related to this case were related to legitimate activities, in line with the UK pharmaceutical industry's code of practice. 'We continue to strengthen our compliance framework in the UK and remain committed to adhering to the ABPI code of practice and maintaining the highest possible ethical standards required by the pharmaceutical industry.'
The Independent
17-02-2025
- Business
- The Independent
Novo Nordisk reprimanded for allegedly failing to disclose payments
The manufacturer of the weight loss jab Wegovy has been reprimanded for allegedly failing to disclose or accurately report payments to healthcare and patient organisations. Novo Nordisk breached clauses under the Association of the British Pharmaceutical Industry (ABPI) code of practice, according to the Prescription Medicines Code Of Practice Authority (PMCPA). The company said it is taking the issue 'extremely seriously' and 'is dedicated to working transparently and ethically'. The complaint was made by three individuals, who were colleagues at two separate universities, regarding the alleged failure to report payments to two healthcare organisations. Following an 'in-depth investigation', the complainants claimed Novo Nordisk allegedly failed to report, inaccurately reported, and misreported payments to healthcare organisations and patient organisations between 2015 and 2022. Novo Nordisk is dedicated to working transparently and ethically, taking the reporting of these historical transfers of value extremely seriously Novo Nordisk spokesman The probe alleged 30 organisations were missed from the company's disclosures and claims Novo Nordisk misreported 65 payments. The PMCPA said Novo Nordisk accepted breaches of clauses 24.1, 24.4, 24.5, 27.7, 9.1 and 2 of the 2019 code and clauses 28.1, 29.1, 29.2, 31.1, 31.2, 5.1 and 2 of the 2021 code. These clauses include failing to document and publicly disclose annually certain payments made directly or indirectly to health professionals, other relevant decision-makers and healthcare organisations, failing to make publicly available a list of patient organisations which it supports, and failing to make disclosures annually in respect of each calendar year in the first six months after the end of the calendar year in which the payments were made. It added that its panel 'decided on balance not to report Novo Nordisk to the code of practice appeal board for it to decide whether the imposition of further sanctions was appropriate'. It noted that the company 'had been the subject of several cases in relation to the failure to appropriately disclose transfers of value,' adding that 'additional sanctions had been imposed and that Novo Nordisk was already the subject of the audit process at the request of the code of practice appeal board'. It said the 'matters raised in this case were closely similar to matters already before the appeal board both in terms of the nature of the matters considered and that the amount undisclosed was significant'. Novo Nordisk has its headquarters in Bagsvaerd in Denmark, and was founded in 1923. Among its products is semaglutide, sold under the brand names Ozempic and Wegovy, the latter of which has been approved to treat obesity on the NHS. We continue to strengthen our compliance framework in the UK and remain committed to adhering to the ABPI code of practice and maintaining the highest possible ethical standards required by the pharmaceutical industry Novo Nordisk spokesman A Novo Nordisk spokesman said: 'Novo Nordisk is dedicated to working transparently and ethically, taking the reporting of these historical transfers of value extremely seriously. 'In fact, most of the missed disclosures included in this case were already part of our self-reported voluntary admission in November 2023 to the PMCPA. 'For those that were not included in that admission, these have been captured through our improved processes and have been accurately disclosed. 'All transfers of value related to this case were related to legitimate activities, in line with the UK pharmaceutical industry's code of practice. 'We continue to strengthen our compliance framework in the UK and remain committed to adhering to the ABPI code of practice and maintaining the highest possible ethical standards required by the pharmaceutical industry.'
Yahoo
12-02-2025
- Business
- Yahoo
Moderna fined for ‘luring children into Covid vaccine trials' with teddy bears
Moderna has been ordered to pay almost £44,000 after 12-year-olds were encouraged to join Covid vaccine trials with the promise of teddy bears. The US-based biotech firm was found to have discredited the industry by Britain's pharmaceutical watchdog, as well as failing to maintain high standards. The complaint related to four X adverts published by Bradford Teaching Hospitals NHS Foundation Trust in June and July 2023, which looked to recruit youngsters aged 12 and over for Moderna's updated mRNA vaccine. The adverts, which were aimed at youngsters rather than their parents, added: 'All our junior volunteers get a lovely certificate and a 'be part of the research' teddy bear.' Two separate articles published online also attempted to directly recruit children. Critics warned that the NextCOVE trial was recruiting at a time when children were deemed at low risk from Covid and were not being prioritised for jabs. Molly Kingsley, the founder of campaign group UsForThem, said: 'For any pharmaceutical company to effectively bribe children with the offer of free teddy bears to take part in a trial of a product posing a degree of risk to the child is sinister and deeply unsavoury behaviour. 'Moreover, given that by the time of this trial it was well established that Covid posed only minimal clinical risk to healthy children it is hard to see how these trials for otherwise healthy children were ever judged ethical in the first place.' Under The Medicines for Human Use (Clinical Trials) Regulations it is prohibited for incentives or financial inducements to be given to children or their parents. Pharmaceutical companies are also banned from directly advertising to children and complainants argued that the advert to test a 'new' vaccine made it appear that the jab had already been cleared by regulators. Esther McVey MP, a former member of the all-party parliamentary group on Covid-19 vaccine damage, said: 'These posts were judged to be an attempt to directly persuade children to join their Covid-19 vaccine trial. 'I think it's fair to say that this shocking behaviour sets a new low for the pharmaceutical industry. Their punishment was a fine of just £44,000 – pocket change to a company of this size. 'This latest ruling comes in a long line of cases which have found major pharmaceutical companies guilty of misleading the public about their Covid vaccine products.' Moderna was found to have breached four clauses of the Association of the British Pharmaceutical Industry (ABPI) code of practice by the Prescription Medicines Code of Practice Authority (PMCPA). The company was rebuked by regulators in October after offering children cash to test its new mRNA-1283 vaccine in the same NextCOVE trial. Moderna was ordered to pay £14,000 after it emerged that a representative had sent a WhatsApp message offering £1,500 to children, which was described by the PMCPA as 'inappropriate financial inducement.' The company was also reprimanded in September and August last year for using off label data to promote its Spikevax vaccine at the European Congress of Clinical Microbiology and Infectious Diseases in April 2022. Ben Kingsley, the head of legal affairs at UsForThem, added: 'For Moderna executives to claim that images of a smiling schoolgirl holding a teddy bear and a trial certificate were not promotions directed at children is simply disingenuous. 'This is the fourth occasion in as many months that the industry regulator has upheld a string of the most serious possible regulatory findings against Moderna, and yet there has been no meaningful consequence for the company or its executives. 'The Government must surely now ask itself whether Moderna is a suitable company to benefit from hundreds of millions of taxpayer funding for mRNA vaccine development facilities.' Moderna said it accepted the conclusions of the PMCPA review but argued that it had not approved the adverts or the article. A spokesperson said: 'The tweets and article in question, published in August 2023, were created and disseminated by third-party organisations and were not approved by Moderna. 'To prevent similar occurrences, we have reinforced our processes for oversight and communication with research sites and third parties. Moderna remains committed to maintaining the highest standards of transparency, quality, and compliance in all of its activities. 'Paediatric trials are required for regulatory approval where new medicines are researched and developed specifically for use in children, addressing their unique physiological needs.' The Telegraph has contacted Bradford Teaching Hospitals NHS Foundation Trust for comment. Broaden your horizons with award-winning British journalism. Try The Telegraph free for 1 month with unlimited access to our award-winning website, exclusive app, money-saving offers and more.
