US HHS Announces New Action Plan for Drug Importation

By Emily Forster -

August 7, 2019

The US Department of Health and Human Services (HHS) has announced that it and the US Food and Drug Administration (FDA) are publishing a Safe Importation Action Plan that outlines two potential pathways for the safe importation of certain drugs originally intended for foreign markets.

The Action Plan is part of an overall policy goal by the Trump Administration to address the cost of prescription drugs. The plan outlines the pathways the Administration intends to explore to allow safe importation of certain prescription drugs as a means to lower prices and reduce out-of-pocket costs.

The Action Plan outlines the government’s intention to pursue two pathways, a notice of proposed rulemaking and guidance, to allow safe drug importation from foreign markets.  

Through a notice of proposed rulemaking, the HHS and FDA would propose to rely on the authority under current federal law that would, when the rule is finalized, authorize pilot (or demonstration) projects developed by states, wholesales, or pharmacists and submitted for HHS review, outlining how they would import certain drugs from Canada that are versions of FDA-approved drugs that are manufactured consistently with FDA approval. The HHS says that notice of proposed rulemaking would include conditions to ensure the importation poses no additional risk to the public’s health and safety and the demonstration projects would achieve “significant” cost savings to the American consumer.

Through guidance, FDA would provide recommendations to manufacturers of FDA-approved drugs that seek to import into the US versions of those drugs they sell in foreign countries. Under this pathway, manufacturers would use a new National Drug Code for those products, thereby potentially allowing them to offer a lower price than what their current distribution contracts require. To use this process, the manufacturer or entity authorized by the manufacturer would establish with the FDA that the foreign version is the same as the US version and appropriately label the drug for sale in the US.

“This could be helpful for patients with significantly high cost prescription drugs,” said the HHS in a July 31, 2019 statement in commenting on the guidance pathway. “This would potentially include medications like insulin used to treat diabetes, as well as those used to treat rheumatoid arthritis, cardiovascular disorders and cancer.”

Further details of the Action Plan are provided here.

Source: US Department of Health and Human Services