Overview
HBW Insight Pharma Intelligence quoted Steptoe partner Dennis Raglin in a March 20, 2023 article titled “California Prop 65 Complaints Against OTC Generics? Ranitidine Could Be First And Last Target.”
On March 9, the California First Appellate District published a ruling upholding a 2021 dismissal by the Alameda Superior Court of a Proposition 65 litigation that alleged over-the-counter (OTC) generic brand ranitidine antacid should have had label warnings for exposure to a potential carcinogenic. In this article, Raglin notes that Prop 65 complaints challenging labeling, rather than alleging harm, cast doubts on OTC generic products’ safety despite the products meeting stringent safety standards before being marketed. Having worked on behalf of the generic drug firms named as defendants in the ranitidine-related complaint, Raglin was quoted as saying the state superior and appellate court rulings are “very good news for generic drug manufacturers.” He further stated, “If the Supreme Court refuses to hear the case, I expect that to be the end of the road for OTC generic drug Prop65 actions…. These companies - and brands - are heavily regulated by FDA and test products frequently to ensure they meet applicable laws and FDA requirements, and their manufacturing processes must meet stringent requirements.”
The full article can be read at HBW Insight Pharma Intelligence (subscription required).
