The Fast-tracking Approval for Innovative Rare disease therapies Act, or FAIR ACT, seeks to address significant delays United States patients face in accessing innovative medicines and participating in cutting-edge clinical trials. Congress finds that the lengthy regulatory process at the Food and Drug Administration (FDA) contributes to clinical trials moving abroad, potentially threatening U.S. leadership in biomedical innovation. The bill establishes a reciprocal marketing approval mechanism for certain drugs intended for immediately life-threatening diseases or conditions. Under this system, a product can be deemed approved in the U.S. if it is lawfully marketed in a foreign country by a trusted international regulatory authority , provided there are no U.S. or foreign safety concerns. The Secretary of Health and Human Services must grant or deny such approval within 30 days of a request, also finalizing labeling and post-market requirements during this period. The Secretary can withdraw reciprocal marketing approval if new evidence shows an unreasonable risk or if the foreign authority rescinds its approval. The bill also introduces a reciprocal allowance for clinical investigations , permitting manufacturers to conduct clinical trials in the U.S. if they have authorization from a trusted international regulatory authority for the same investigation. The Secretary must treat such applications as meeting U.S. criteria and respond within 30 days. Key trusted international regulatory authorities explicitly named include the European Medicines Agency Medicines and Healthcare Products Regulatory Agency of the United Kingdom Health Canada , with the Secretary having the power to designate others. The bill mandates a comprehensive report within five years to assess the program's effectiveness, impact on patient safety, and provide recommendations for its future.