Drug Importation: Biden Response To PhRMA Suit Highlights Infeasibility Of Trump-Era Rule
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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Florida was the first of four states to submit proposals for importation of prescription drugs from Canada. PhRMA recently filed a citizen petition opposing Colorado’s proposal, which notes hurdles it is facing. Infographic compares state proposals and the drugs they plan to import.
The strange politics of prescription drug importation legislation in the US are on display again, this time in the context of the FDA user fee reauthorization bill. Including the topic in the bill is a ‘big deal’ – but probably makes imports less likely.
Canada has announced new restrictions on exports to help mitigate the impact of measures in the US to lower medicine prices there.