Drug Importation Can Be Triggered By 'Excessive' Price Increases; Now US FDA Has To Decide What That Means

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...