Four drugmakers found to have breached ABPI code

Novartis, Pfizer, Otsuka and Novo Nordisk have been called out by the UK’s Prescription Medicines Code of Practice Authority (PMCPA) for breaching the Association of the British Pharmaceutical Industry’s (ABPI) code of practice.

Novo Nordisk was also in line for a public reprimand from the PMCPA, just over a year after the UK unit of the Danish drugmaker was suspended from membership of the ABPI for two years after being found to have committed serious breaches of the code. The new breaches stemmed from further investigation of the earlier case.

The latest infraction revolves around Novo Nordisk’s failure to disclose ‘transfers of value’ of approximately £7.8 million (around $10 million) – payments to more than 150 different health professionals (HCPs) and healthcare organisations (HCOs), over a three-year period between 2020 and 2022.

The public reprimand was required because the breaches amounted to failures to disclose payments in its voluntary reporting over a sustained period, according to the PMCPA.

Novo Nordisk has agreed to put a full-time staffer in its HCP payment office in charge of overseeing the “planning, tracking, and reporting” stages of the payment process as part of its response to the breaches.

Pfizer’s transgression was to have promoted an unlicensed vaccine to members of the public via Twitter (now X), with a message tweeted by a US employee of Pfizer (now retired) and subsequently re-tweeted by a “very senior member” of Pfizer UK. The prompt was a Pfizer/BioNTech press release about their COVID-19 vaccine.

The text of the tweet read: “Our vaccine candidate is 95% effective in preventing COVID-19, and 94% effective in people over 65 years old. We will file all of our data with health authorities within days. Thank you to every volunteer in our trial, and to all who are tirelessly fighting this pandemic.”

The complainant alleged the tweet included relative efficacy rates without any information about absolute efficacy rates and that no safety data or safety information was provided, and therefore that Pfizer had misleadingly and illegally promoted its COVID-19 vaccine. The ABPI included social media in its code of practice in early 2023.

Novartis has been upbraided for failing to update and recertify two documents hosted on one of its websites to include up-to-date prescribing information for Entresto (sacubitril/valsartan), its drug for heart failure with reduced ejection fraction (HFrEF), which had “the potential to impact patient safety,” according to the PMCPA. The case was prompted by an HCP complaint.

Finally, Otsuka was found to have breached the code for failing to disclose relevant information in its response to a previous case concerning the conduct of a senior Otsuka employee following the dinner at a British clinical group meeting.

Interviewees had not been given the opportunity to see or sign the statements submitted to the PMCPA in connection with that case, according to the complaint, which was filed by an ex-Otsuka employee. It also claimed three employees were forced out of the business because they were whistleblowers, but, without any formal finding of unfair dismissal, the PMCPA ruled the complainant had not been able to prove this had been the case.