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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A Bipartisan Case Against US FDA User Fees?
Senators Richard Burr and Bernie Sanders do not typically agree on many issues. But during consideration of the US FDA user fee reauthorization package, both expressed concern that the increasing fees contribute to higher drug prices – and both voted against moving the package forward.
User Fee Bill Clears Senate Committee With Importation, Orphan Drug Amendments
Highlighting the much-less-bipartisan atmosphere than the House, ranking member Burr votes against the package; US FDA’s advice to generic applicants could be contentious issue in reconciling the legislation between the two chambers.
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.