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.

Brand-name prescription drug manufacturers use various strategies to extend their market exclusivity periods by delaying generic or biosimilar competition. Recent Congressional legislation has targeted four such tactics. We analyze these proposals and assess their likely effect on competition in the U.S. drug market.

The COVID-19 pandemic has revealed the vulnerability of the US generic drug supply chain to foreign production. Many policies have been proposed to mitigate this vulnerability. In this article, we argue that nonprofit drug manufacturers have the potential to make important contributions.