Drug Importation Is A High-Profile Addition To US FDA’s Regulatory Agenda
Agency is targeting January 2020 for release of controversial proposed rule to allow importation of certain types of prescription drugs from Canada; although most Rx drug-related proposed and final rules on the Fall 2019 regulatory agenda are making repeat appearances, a final rule on electronic distribution of prescribing information has fallen off the list.
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Upcoming proposed rule will create a process for third parties (notably including the state of Florida) to begin importing drugs wholesale from Canada. It will be an FDA rule – though FDA has had very little input in it.
Many of the products most commonly sighted as in need of a price break are not eligible under the legal framework described.