Leo’s Law

HR 7693, "Leo’s Law," extends existing exclusivity protections for certain orphan drugs by 180 days to address pandemic-related delays. It applies to drugs designated for rare diseases that had applications submitted during the COVID-19 emergency period (Dec 2019-March 2023), were approved under specific pathways, and have no non-rare disease indications. Key provisions extend periods like the 12-year market exclusivity under the Public Health Service Act and 5-year protections under the Federal Food, Drug, and Cosmetic Act. The bill does not create new incentives but temporarily lengthens existing protections for drug developers already navigating pandemic disruptions. This change applies only to qualifying orphan drugs meeting all specified criteria during the defined emergency period.