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

 
• By Sarah Karlin-Smith

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.

adults hula hooping
Biden court filing indicates states will have to jump through a lot of hoops to get an importation plan approved • Source: Cultura Creative RF / Alamy Stock Photo

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