The Fast-tracking Approval for Innovative Rare disease therapies Act would allow certain life-saving medicines approved by trusted international regulators—including the European Medicines Agency, UK Medicines and Healthcare Products Regulatory Agency, and Health Canada—to be automatically approved for use in the United States without going through the full FDA approval process. The bill also permits clinical trials authorized by these same international regulators to proceed in the United States if the drug treats a life-threatening disease. The FDA would have just 30 days to decide whether to grant reciprocal approval and could still withdraw approval if safety concerns emerge or if the international authority rescinds its own approval. Within five years, the FDA must report to Congress on whether the program successfully accelerated patient access to medicines, how many products were approved, and what impact it had on patient safety.
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