The U.K. drug marketing body, the Prescription Medicines Code of Practice Authority (PMCPA), is once again taking action against Novartis' U.K. business, which has become a repeat offender in terms of "bringing discredit upon, and reducing confidence in, the pharmaceutical industry."
This time, the PMCPA, responsible for policing drug marketing rules in the U.K. as outlined in the Association of the British Pharmaceutical Industry Code, identified significant concerns related to a Novartis website promoting its multiple sclerosis (MS) drug Mayzent.
On the drug's official website, an anonymous healthcare professional complained to the PMCPA that Novartis had not adequately demonstrated its drug could not be used in patients who had experienced a heart attack or heart failure within the past six months, among other concerns.
The PMCPA noted in its ruling that the website recommended starting treatment with Mayzent in patients with a history of myocardial infarction and heart failure “without making apparent the absolute contra-indication in patients with a history of myocardial infarction or heart failure in the previous 6 months." This was only mentioned on separate webpages and within the prescribing information, and the PMCPA said that was “insufficient” and “did not negate the misleading immediate impression given that Mayzent could be initiated in any patient with a recent history of MI or heart failure.”
It added that not having this important information “might potentially prejudice patient safety.”
Due to the gravity of this safety concern, the PMCPA determined that Novartis had violated Clause 2 of the code, which is the most severe breach and involves a company "bringing discredit upon, and reducing confidence in, the pharmaceutical industry."
The healthcare professional went one step further, saying Novartis’ compliance culture was poor and that there were “huge errors around compliance” and that a “lack of experienced signatories was [detrimental] to a safe compliance speak up culture.”
Novartis argued against this accusation in its case to the PMCPA, and the panel did not factor this into its ruling.
But Novartis has been on the PMCPA’s naughty list many times this year, including now three times for breaching Clause 2, which is only reserved for the most serious of cases.
This includes a similar case involving its heart drug Entresto, where, earlier this year, Novartis was found in breach for failing to provide all of the drug's safety risks on a website intended for healthcare professionals.
Novartis also received a reprimand for another Clause 2 breach, once again related to Entresto. This time, the issue concerned a podcast titled "Heart to Heart," developed specifically for heart failure specialist nurses. In one of the episodes, Novartis presented a series of efficacy claims and, even more significantly, safety claims that landed it in hot water.
In addition to this breach, Novartis received several other separate and less serious rulings from the PMCPA. This includes yet another for Entresto, where it was found in breach of six clauses, as well as for a promotional webpage for Kesimpta, another MS drug, which fell afoul of three breaches, and another three breaches for promotional messaging on a webpage for its respiratory therapy Xolair.