Drug Importation Can Be Triggered By 'Excessive' Price Increases; Now US FDA Has To Decide What That Means
Did FDA Commissioner Scott Gottlieb and HHS Secretary Alex Azar have a change of heart on importation? Or are they being pressured from above?
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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.
There are rumblings a drug importation proposal is coming, but there are no signs that the HHS/FDA working group has been active in the year since it was created.
In JAMA editorial, former FDA chief supports drug importation under narrow circumstances as a way to reduce drug prices, marking a shift from his previous stance on the issue and that of other past agency heads. Essay, co-authored by former CMS Acting Administrator Andy Slavitt, calls importation "a workaround born of desperation."