US HB7953

Establishes reciprocal marketing approval allowing drugs approved by trusted international regulators (European Medicines Agency, UK MHRA, Health Canada) for immediately life-threatening conditions to receive FDA approval within 30 days of application

Applies only to drugs intended for diagnosis, treatment, or mitigation of immediately life-threatening diseases or conditions that are not already FDA-approved and have not had prior FDA approval withdrawn for safety concerns

Authorizes reciprocal allowance for clinical trials, permitting manufacturers to conduct U.S. trials based on authorization from trusted international regulators with FDA decision required within 30 days

Grants FDA authority to withdraw or suspend reciprocal approval if new evidence shows unreasonable risk of serious adverse events or if the originating international authority rescinds its approval

Requires HHS Secretary to submit a comprehensive report to Congress within 5 years evaluating program effectiveness, number of approvals granted/denied, patient safety impact, and recommendations for continuation or modification