Faster Drug Access and Importation to Combat Shortages and Low Competition.
This bill aims to increase the availability of prescription drugs by speeding up generic approvals and allowing temporary importation. It establishes mechanisms to quickly bring drugs from abroad during shortages or when the market lacks sufficient competition. Citizens can expect improved access to essential therapies and potentially lower costs.
Key points
Temporary Drug Importation: The FDA can authorize importing drugs from trusted countries for up to 3 years if a shortage exists in the US.
Boosting Competition: Markets with low competition (fewer than 5 available drugs, expired patents) will be treated like shortage markets, accelerating generic approvals.
Expedited Generic Review: For markets identified as marginally competitive, the review and inspection process for new generic drug applications will be fast-tracked.
Status:
Expired
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