Roche fined for serious breach of marketing code by failing to disclose safety data

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Roche, a prominent pharmaceutical company, is under scrutiny for omitting vital safety details from a webpage dedicated to dosing information for one of its cancer drugs. The Prescription Medicines Code of Practice Authority (PMCPA), a self-regulatory body in the UK, has determined that Roche’s actions have cast a shadow on the pharmaceutical industry’s reputation and eroded confidence by neglecting to provide crucial information essential for patient safety.

The controversy revolves around a webpage dedicated to Roche’s Rozlytrek, a drug designed to combat ROS1-positive non-small cell lung cancer and NTRK fusion-positive solid tumors. An anonymous individual, after perusing Roche’s UK resources website, filed a complaint with the PMCPA, alleging that the content was deceptive and lacked fairness and balance due to the omission of critical information.

According to the complainant, the webpage failed to present “relevant and precise information,” as stipulated in the summary of product characteristics (SPC). This information pertained to monitoring changes in the heart, liver, central nervous system, blood, and bones, as well as making treatment adjustments based on data.

The complainant further asserted that the absence of “specific advice from the SPC regarding dosage reductions and discontinuation for a black triangle product” highlighted Roche’s lack of comprehension concerning patient safety. This raised questions about the approval process for releasing content that omitted such crucial information, given the potential risks to patients.

In response, Roche expressed its disappointment, maintaining that the complaint lacked a solid foundation. The Swiss pharmaceutical company argued that the website prominently featured links to prescribing information and directed readers to the SPC for additional details on modifying Rozlytrek dosages in response to adverse reactions.

According to Roche, the provided information was “accurate, balanced, fair, objective, and unambiguous,” aligned with the SPC, did not mislead healthcare professionals, and enabled them to form their own judgments about the medication. Roche contended that it had upheld the industry’s expected standards.

However, the PMCPA ruled in favor of the complainant on three out of five potential breaches. Most notably, these wins included the accusation that Roche had violated Clause 2, which addresses issues that tarnish the pharmaceutical industry’s reputation. This marks the third time in two years that Roche has breached this clause, following previous rulings concerning a Gazyvaro leave piece and a Polivy website.

In its latest decision, the PMCPA pointed out that “prejudicing patient safety” is one of the ways in which companies can breach Clause 2. Given that “Rozlytrek was a black triangle medicinal product subject to additional monitoring, and that important safety information was omitted from the dosing webpage,” the PMCPA panel concluded that Roche had indeed breached the clause. This decision underscores the importance of transparency and comprehensive information dissemination in the pharmaceutical industry, particularly concerning patient safety.

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