Roche, mirroring Novartis, guilty of most serious marketing breach for Polivy website

For the second time this month, the U.K.'s drug marketing body, the PMCPA, has found a Switzerland-based Big Pharma to be in significant violation of its rules. The breach in question falls under Clause 2, which pertains to "bringing discredit upon, and reducing confidence in, the pharmaceutical industry."

Earlier this month, the PMCPA, responsible for enforcing drug marketing rules in the U.K., criticized Novartis for significant safety omissions on its heart drug Entresto's product website. Novartis was found guilty of three breaches, including the serious Clause 2, which is the most severe violation a pharmaceutical company can face.

Now, a similar error has been discovered at Roche, where a drug website intended for healthcare professionals was found to have omitted essential information. However, unlike the previous case involving safety risks, this breach primarily relates to Roche's discussion of the administration of its diffuse large B-cell lymphoma cancer drug Polivy. Although indirectly tied to safety, it raises concerns as incorrect administration could potentially endanger patients' health.

During its investigation, the PMCPA discovered that the dosing page of Polivy's promotional website, primarily aimed at healthcare professionals, lacked crucial administration instructions necessary for ensuring patient safety.

Specifically, the PMCPA found that Roche created a misleading impression by suggesting all essential information for administering Polivy was provided. However, this was not the case concerning specific instructions related to infusion lines and dose modifications in the event of an infusion-related reaction.

As a result, the marketing watchdog determined that Roche violated Clause 6.1 (providing misleading information) as well as Clause 5.1 (failing to maintain high standards) and the most severe violation, Clause 2, which brings discredit upon and reduces confidence in the pharmaceutical industry.

Interestingly, these are the exact same breaches the PMCPA found Novartis guilty of on its Entresto website.