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Drug Importation: Biden Response To PhRMA Suit Highlights Infeasibility Of Trump-Era Rule

Executive Summary

Biden administration asks court to dismiss PhRMA’s lawsuit against Trump-era pathway for drug importation from Canada because FDA has not yet cleared any Section 804 Importation Programs (SIPs). The brief outlines the high hurdles to getting a SIP approved and Canada’s opposition to the programs. It's not clear if the Biden team plans another more feasible route to drug importation.

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