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Pharmaceutical Industry In Turmoil, Four Companies Found Guilty Of Code Violations

Novartis, Pfizer, Otsuka, and Novo Nordisk reprimanded by PMCPA for ABPI code violations.

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  • Jul 08, 2024

  • Mrudula Kulkarni

Pharmaceutical Industry In Turmoil, Four Companies Found Guilty Of Code Violations

Novartis, Pfizer, Otsuka, and Novo Nordisk have been reprimanded by the UK’s Prescription Medicines Code of Practice Authority (PMCPA) for violating the Association of the British Pharmaceutical Industry’s (ABPI) code of practice. Novo Nordisk, in particular, faces a public reprimand from the PMCPA. This comes just over a year after the Danish pharmaceutical company’s UK branch was suspended from the ABPI for two years due to severe code violations. The new breaches were uncovered during a further investigation of the previous case.

The recent violation involves Novo Nordisk’s failure to disclose approximately £7.8 million (around $10 million) in ‘transfers of value’ to over 150 health professionals (HCPs) and healthcare organizations (HCOs) between 2020 and 2022. According to the PMCPA, a public reprimand was warranted because the breaches represented a failure to report these payments voluntarily and consistently over an extended period.

Novo Nordisk has decided to assign a dedicated full-time staff member to its HCP payment office to oversee the "planning, tracking, and reporting" stages of the payment process, addressing recent compliance issues. Pfizer's violation involved promoting an unlicensed vaccine to the public on Twitter (now X). The initial tweet was posted by a retired US Pfizer employee and later re-tweeted by a senior Pfizer UK member, following a Pfizer/BioNTech press release about their COVID-19 vaccine.

The tweet stated: "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." A complaint was made, alleging that the tweet provided relative efficacy rates without including absolute efficacy rates and lacked safety data or information, thereby misleadingly and illegally promoting the COVID-19 vaccine. The ABPI incorporated social media into its code of practice in early 2023.

Novartis has faced criticism for not updating and recertifying two documents on one of its websites to include current prescribing information for Entresto (sacubitril/valsartan), a medication for heart failure with reduced ejection fraction (HFrEF). The Prescription Medicines Code of Practice Authority (PMCPA) highlighted that this oversight could potentially impact patient safety. This issue came to light following a complaint from a healthcare professional.

In a separate case, Otsuka was found to have violated the code by failing to provide pertinent information in its response to a previous inquiry regarding the behavior of a senior employee at a British clinical group dinner. According to a complaint from a former Otsuka employee, interviewees were not allowed to review or sign the statements submitted to the PMCPA related to that case. The complaint also alleged that three employees were forced out of the company for being whistleblowers. However, the PMCPA concluded there was no formal evidence of unfair dismissal, and the complainant could not substantiate this claim.

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