FDA sends warning letters to Sanofi and Viatris over misleading product claims

The FDA’s Office of Prescription Drug Promotion issued untitled warning letters to Sanofi and Viatris after reviewing promotional materials that the agency deemed misleading.

The letters cite specific emails and a television advertisement in which the companies made claims about their products that were not supported by the evidence required for prescription‑drug promotion.

Both firms are required to correct the material and provide a response outlining how they will ensure future compliance with FDA advertising rules.

The action underscores the regulator’s ongoing focus on truthful communication in the pharmaceutical sector, reminding companies that inaccurate claims can trigger enforcement actions.