US FDA’s Narrow Path For Imports: Beware The 'SIP'-pery Slope
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.
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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.
The very public attempt by the state of Florida to question FDA’s decision on COVID monoclonal antibodies is the latest example of how the politics of COVID is roiling the agency’s reputation. But is it really so different than Florida’s pre-pandemic plans to import drugs from Canada?
Proposed rule allowing states to import certain drugs from Canada would require tight supply chain, extensive security and reporting responsibilities. The potential costs and rigor involved in implementing the program could impede its uptake.