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Drug Importation in Times of Need

The HHS announced a work group to evaluate policies for importing certain drugs in short supply domestically. But one industry group has supply chain security concerns.

Part of the FDA’s mission is to monitor the pharmaceutical supply chain to support patient access to necessary drugs.

Late last week, the Department of Health and Human Services announced plans to create a work group to examine prescription drug importation policies. 

In a statement, Commissioner Scott Gottlieb noted that “for certain critical medicines, where there are no blocking patents or exclusivities associated with the drugs, but where there is only a single manufacturer (sole-source); conditions may develop that create significant barriers to, and ultimately threaten, patient access.”

Conditions for importation

Gottlieb explained, “Conditions could include dislocations in the supply chain or sudden, significant price increases that close off channels of availability. These circumstances can leave patients without access to drugs they need. These could be situations where there’s only one U.S. approved and marketed version of an old drug that’s not commonly used, but is still medically important. Many of these cases involve generic medicines. These disruptions can create public health consequences that are similar to the occurrence of a drug shortage.”

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Break out of the ordinary: see what’s new in life sciences packaging