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HHS and FDA Release Drug Importation Action Plan

Posted in FDA

On July 31, 2019, the U.S. Department of Health and Human Services (HHS), in conjunction with the Food and Drug Administration (FDA), released an action plan for the importation of certain drugs originally intended for foreign markets, deviating from the FDA’s long history of opposing  drug importation. The action plan lays out two pathways for the safe importation of certain drugs in order to provide lower cost drugs to consumers.

The first pathway involves demonstration projects for states, wholesalers and pharmacists, whereby each would submit plans for how certain drugs could be imported from Canada at a cheaper price than the prices currently offered in the U.S.  One of the key requirements for these demonstration projects is the ability to ensure that the drug is properly labeled and can be tracked and traced.

The second pathway permits manufacturers to sell a foreign version of a FDA-approved drug in the U.S. under a different NDC number than the U.S. version.  The foreign version of the drug could then be sold in the U.S. at a lower price since the foreign version would not be subject to the same pricing requirements in the manufacturer’s current contracts with other parties in the supply chain. This pathway allows greater patient access to lower cost versions of drugs currently available in the U.S.

In a press release dated July 31, 2019, HHS Secretary Alex Azar commented “… for too long American patients have been paying exorbitantly high prices for prescription drugs that are made available to other countries at lower prices… Today’s announcement outlines the pathways the Administration intends to explore to allow safe importation of certain prescription drugs to lower prices and reduce out of pocket costs for American patients.”

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