Novartis’ Entresto team has earned the ire of the PMCPA. For the third time in 12 months, the U.K. drug promotion watchdog has found the Swiss drugmaker’s actions have brought discredit upon the pharma industry.
The case centers on two third-party documents that physicians could download from a Novartis portal. Neither text was written by Novartis. The panel was most concerned about a treatment algorithm from the Journal of the American College of Cardiology that lacked the most up-to-date Entresto prescribing information.
The outdated information lacked a recommendation against splitting and crushing tablets and a warning about the risk of psychiatric events such as hallucinations. Novartis told the PMCPA it didn’t feel the lack of the recommendation against splitting would put the majority of Entresto patients at risk.
That conclusion went down badly with the PMCPA panel, which was “very concerned about Novartis’ view of the clinical significance of the changes.” The panel had a different take on the materials.
“In the panel’s view, the omission of information about not splitting or crushing tablets, the wording about psychiatric disorders, and the interactions information relating to lithium and diuretics from the prescribing information present in [the treatment algorithm] had the potential to impact patient safety,” the PMCPA said.
Novartis’ claim that human error was to blame for the failure to update the information didn’t lessen the seriousness of the matter, the panel said, and the length of time the offending document was available was “particularly” concerning. Those factors led the panel to conclude Novartis had brought discredit on the industry. A spokesperson for Novartis commented on the case.
"We hold ourselves accountable for maintaining the highest ethical standards and regret the breach established by PMCPA case AUTH/3725/1/23. We continually review internal policies across our organization to ensure adherence to U.K. compliance regulations and remain committed to being a responsible partner for patients and the healthcare system," the spokesperson said.
The panel also looked at another document with out-of-date Entresto information. While the panel found the material breached the code, the differences between the old and new information were limited to updates required as part of the Brexit process.