FDA Forms Work Group to Consider Short-Term Importation of Foreign Versions of Drugs
The Food and Drug Administration is forming a work group to consider allowing the importation of foreign versions of drugs in cases of U.S. supply chain disruptions, FDA Commissioner Scott Gottlieb said in a July 19 statement. For “sole-source” drugs…
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with a single manufacturer, FDA will look at allowing short-term importation of foreign versions of drugs if there are no blocking patents or exclusivities associated with those drugs, he said. Currently, supply chain disruptions related to sole source drugs can cause significant price increases that render the drugs unavailable. Short-term importation of foreign drugs may “help meet near-term patient need in the U.S. until new competition is able to enter the domestic market,” he said. The Healthcare Distribution Alliance criticized the idea in a statement. Importation of foreign versions would “threaten and destabilize” industry-government collaboration on pharmaceutical supply chain safety and security, in particular implementation of the Drug Supply Chain Security Act, HDA said.