Abstract

Certification marks are a type of trademark used to show that a product or service meets specific standards or qualities set by an independent organization (not by the manufacturer or seller). Certification marks could enhance the quality perception and oversight of generic drugs. Despite the FDA’s rigorous regulatory framework, skepticism about generic drug quality persists among patients and prescribers, partly due to the FDA’s limited ability to inspect manufacturing facilities. Independent certification marks — similar to USDA Organic or Energy Star labels — could help communicate drug quality information more effectively to consumers, incentivize manufacturers to exceed baseline standards, and bolster trust in generics. Such a system could operate without legislative changes and offer a cost-effective supplement to existing FDA inspections, particularly given the challenges posed by an increasingly globalized drug supply chain and current FDA resource constraints.