Roche again found guilty of most serious marketing breach, this time for omitting safety information

Roche has received a dressing-down for omitting important safety information from a cancer drug dosing webpage. A U.K. self-regulatory body concluded Roche brought discredit upon, and reduced confidence in, the pharmaceutical industry by failing to provide information that is important to patient safety.

The case centers on a webpage for Roche’s Rozlytrek, a drug used to treat ROS1-positive non-small cell lung cancer and NTRK fusion-positive solid tumors. After viewing Roche’s U.K. resources website, an anonymous person complained to the Prescription Medicines Code of Practice Authority (PMCPA) that the content was misleading and not fair or balanced because it omitted critical information.

According to the complainant, the webpage lacked “relevant and exact information,” as per the summary of product characteristics (SPC), on monitoring changes to the heart, liver, central nervous system, blood and bones and adjusting treatment based on the data. 

In the complainant's view, the lack of “specific advice from the SPC around dosage reductions and discontinuation for a black triangle product, demonstrated the lack of understanding by Roche around patient safety.” The complaint questioned “who had approved this content for release considering the danger to patients of such content missing important information.”

Roche took a very different view in its response, expressing disappointment at receiving a complaint that it believed had no basis. The Swiss drugmaker noted that the website contained prominent links to the prescribing information and directed readers to the SPC for further information on modifying the dose of Rozlytrek in response to adverse reactions.

According to Roche, the information was “accurate, balanced, fair, objective and unambiguous, reflected the SPC, did not mislead the health professional and enabled them to form their own opinion of the medicine.” That view underpinned the company’s belief that it had maintained the standards expected of the industry.

The PMCPA sided with the complainant on three of the five potential breaches. Importantly, the three wins for the complainant included the accusation that Roche breached Clause 2, which covers issues that bring discredit on the pharma industry. Roche has now breached the clause three times in two years, with the latest decision following earlier rulings on a Gazyvaro leave piece and a Polivy website.

In explaining its latest conclusion, the PMCPA said “prejudicing patient safety” is one of the ways companies can breach Clause 2. Noting 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 breached the clause.