Novartis Criticized as Panel Finds Issues with Entresto Files

A PMCPA panel has expressed significant concerns regarding Novartis' stance on the clinical relevance of certain changes to its prescribing information. Novartis’ Entresto team has faced criticism for the third time in a year from the U.K. drug promotion watchdog, which has judged that the Swiss pharmaceutical company's actions have tarnished the industry’s reputation.

The controversy revolves around two third-party documents accessible to physicians through a Novartis portal. Although Novartis did not author these documents, the panel's primary issue was with a treatment algorithm from the Journal of the American College of Cardiology that contained outdated prescribing information for Entresto.

The outdated information omitted crucial recommendations, including advice against splitting and crushing tablets, as well as warnings regarding psychiatric risks like hallucinations. Novartis defended itself by stating that it did not believe the absence of such recommendations would significantly endanger most Entresto patients.

However, this defense was not well-received by the PMCPA panel. The panel expressed strong concerns over Novartis’ perception of the clinical importance of these missing details. The panel asserted that omitting advice on splitting or crushing tablets, psychiatric disorder warnings, and interaction information with medications like lithium and diuretics could potentially compromise patient safety.

The PMCPA did not consider Novartis' explanation—that the failure to update the information was due to human error—as mitigating the severity of the issue. The panel was particularly troubled by the duration for which the erroneous document was available, leading to the conclusion that Novartis had indeed discredited the pharmaceutical industry.

A Novartis spokesperson responded to the situation by emphasizing the company’s commitment to ethical standards and compliance with U.K. regulations. The spokesperson acknowledged the breach identified by PMCPA case AUTH/3725/1/23 and assured that Novartis continuously reviews its internal policies to maintain high ethical standards and regulatory adherence.

Additionally, the panel examined another document that also contained out-of-date Entresto information. Although this document was also found to violate the code, the discrepancies between the outdated and current information were largely related to updates necessitated by the Brexit process.

In summary, the PMCPA panel's ruling highlighted serious concerns about outdated prescribing information for Entresto and its potential impact on patient safety. Novartis’ explanations and claims of human error did not alleviate the seriousness of the issue, resulting in the company being criticized for bringing discredit to the pharmaceutical industry. Novartis has committed to reviewing its policies to ensure compliance and ethical integrity in the future.