STAT+: Want high-quality generic drugs? One expert has ideas on how consumers can trust their supply

Kevin Schulman, a professor at Stanford University School of Medicine, has proposed a method to enhance consumer trust in generic drugs by leveraging independent laboratory testing. Generic drugs constitute approximately 90% of prescriptions in the United States due to their affordability, but concerns regarding inconsistent quality have led to shortages, with over 60% of these shortages attributed to quality issues, according to the U.S. Food and Drug Administration (FDA). Many manufacturers, particularly those in India, have faced citations for violating manufacturing protocols, resulting in product recalls and import bans. Schulman, who previously collaborated with Valisure, an independent lab that identified impurities in common medications, advocates for the FDA to promote testing by accredited, third-party laboratories. This approach aims to provide a more reliable assessment of drug quality, thereby bolstering consumer confidence in the generic pharmaceutical supply chain. The proposal addresses the long-standing issue of quality control in generic drug manufacturing, which has historically been a significant challenge.