Rx Import Legislation: One Step Forward, Two Steps Back – And Odd Dance Partners
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.
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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.
Newly proposed pathway to allow states to pursue wholesale importation of drugs from Canada is extremely narrow and restrictive, at least in draft form. It is still a terrible precedent for industry – one that can be easily expanded if it takes effect.