Azar directs FDA to establish working group on drug importation

HHS Secretary Alex Azar has asked FDA Commissioner Scott Gottlieb to set up a working group to investigate how to safely import prescription medications from other countries.

HHS Secretary Alex Azar has asked FDA Commissioner Scott Gottlieb to set up a working group to investigate how to safely import prescription medications from other countries. The move aims to safeguard against a situation in which there is a significant price hike for a drug produced by just one manufacturer and not protected by exclusivities or patents. "We look forward to working with Commissioner Gottlieb and the FDA to explore how importation could help address price hikes and supply disruptions that are harming American patients," said Azar. "We have seen a number of both branded and generic examples in recent years where a single manufacturer dramatically hikes the price for a drug unprotected by patent or exclusivities." Compared with other importation proposals to import a wide range of drugs, "this working group will examine the potential to promote competition for drugs that are off-patent or off-exclusivity and produced by one manufacturer," HHS said. The agency also noted that any importation from other countries will be limited to instances in which medications can be "imported with adequate assurances of safety and effectiveness."