Novartis is in hot water with the U.K.’s drug marketing rule maker the PMCPA after it was found to have breached three of its rules, including its most serious: Clause 2.
The issue centers around a website for Novartis’ heart drug Entresto, specifically the “Starting and Monitoring Entresto” page of the Entresto promotional website, for not properly showing the med’s potential safety risks.
The PMCPA, which polices the ABPI Code and its clauses, found that by “providing some, but not all” of the drug’s safety risks for liver and kidney damage in a section that was set up to advise health professionals on considerations when using the medicine “was misleading.”
The PMCPA found three rule violations: breach of Clause 6.1, which is “Providing misleading information,” as well as a breach of Clause 5.1, which is “Failing to maintain high standards," and Clause 2, “Bringing discredit upon and reducing confidence in the pharmaceutical industry.”
The body ruled that any health professional reading the site should be able to find all the information on how the drug could stop the liver from working properly, but that “was not so” and therefore a breach of Clause 6.1.
The situation was similar regarding the drug's potential risk of impairing kidney function. Once again, the PMCPA determined that Novartis failed to adequately present all the necessary information on the page intended for healthcare professionals, despite the obligation to do so since healthcare professionals would be prescribing the medication. This violation also constituted a breach of Clause 6.1.
As a result of those two violations, another breach occurred. Since the issues pertained to patient safety, the PMCPA concluded that Novartis had failed to uphold high standards, thereby ruling a breach of Clause 5.1.
These rule violations were so severe that they also constituted a breach of the most serious rule. "Clause 2 was designated for such instances of significant censure," stated the PMCPA in its ruling.
According to the ruling panel, healthcare professionals expect company-produced materials to be comprehensive and clear, particularly in matters of patient safety. However, in Novartis' case, they only provided partial information concerning renal and hepatic impairment within the body of a webpage intended to guide healthcare professionals on the use of the medicine.
The PMCPA said that as a result, Novartis “had reduced confidence in, and brought discredit upon, the industry and a breach of Clause 2 was ruled.”