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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.

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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

The drug industry’s lawsuit against a Trump-era US Department of Health and Human Services’ final rule permitting importation of certain lower-priced drugs from Canada is not yet ripe for judicial review and should be dismissed, Biden officials argued in a new court filing that raises questions about whether industry may ever have any reason to fear the rule.

The Pharmaceutical Researchers and Manufacturers of America cannot allege harm or potential future harm until FDA authorizes a Section 804 Importation Program (SIP) that would permit a state or other non-federal government entities to import eligible prescription drugs from Canada under the 23 September 2020 final rule, HHS lawyers wrote in a 28 May filing in the US District Court for the District of Columbia

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