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?

Chair on Fire

The move by the US FDA and the Department of Health and Human Services (HHS) to explore the creation of a temporary, narrow drug importation program targeting sole-source products that are off-patent and off-exclusivity generates questions both practical and philosophical for drug sponsors.

According to a July 19 statement from HHS, Secretary Alex Azar has directed FDA Commissioner Scott Gottlieb to form a...

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