US HB7693

Extends multiple drug exclusivity periods by 180 days for orphan drugs that had investigational applications submitted during the COVID-19 emergency period (December 1, 2019 through 120 days before the emergency termination date)

Affected exclusivity periods include the 12-year biologics exclusivity, 5-year new chemical entity exclusivity, 3-year clinical investigation exclusivity, and 7-year orphan drug exclusivity under federal drug law

Applies only to drugs designated for rare diseases or conditions with no approved indications for non-rare diseases, where the relevant exclusivity period has not yet expired

Takes effect immediately upon enactment without requiring the Secretary to first issue implementing guidance or regulations

Introduced February 25, 2026 by Representatives Gottheimer and Bacon and referred to the House Committee on Energy and Commerce