Home E-Weekly April 29, 2014

FDA Attempting to Ease Drug Shortages

Published: April 28, 2014

The FDA is assuring healthcare executives that it "will take every action within its authority" to address shortages of saline and other drugs, but reminding them that it doesn't have the authority to direct manufacturers' business decisions.

Responding to a letter from American Hospital Association Executive Vice President Rick Pollock, FDA Commissioner Margaret Hamburg says what the agency can do, among other measures, is work with current manufacturers to better understand and alleviate the quality-related disruptions in production that can lead to shortages, and expedite inspections of additional manufacturers that are interested in starting new production of products that have been in short supply.

The AHA had asked the FDA to "do even more to end this shortage by pushing current manufacturers to not only continue to produce these products at their maximum capacity but also to make investments to ensure an increasing supply for the future."

The 4 companies currently manufacturing IV saline — Baxter Healthcare, B. Braun, Hospira and Fresenius Medical Care — are working to restore the supply of IV saline and other saline solutions, says Ms. Hamburg.

Jim Burger

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