Pharmaceutical Industry In Turmoil, Four Companies Found Guilty Of Code Violations
Novartis, Pfizer, Otsuka, and Novo Nordisk reprimanded by PMCPA for ABPI code violations.
Breaking News
Jul 08, 2024
Mrudula Kulkarni

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.