American Society of Hematology

Obama Administration Issues Interim Final Rule to Prevent Drug Shortages

Published on: December 15, 2011

In response to ASH's advocacy calling on the Congress and Administration to take immediate action to combat shortages of life-saving medications, the Obama Administration issued an interim final rule that will help prevent prescription drug shortages.

The rule will require manufacturers that are the only producer of certain critical drugs to report to the Food and Drug Administration all interruptions in manufacturing of products. The rule builds on recommendations ASH made on the importance of early notification by manufacturers of disruptions in drug production.

In October, President Obama issued an Executive Order directing the Food and Drug Administration (FDA) and Department of Justice to take action to help reduce and prevent drug shortages, protect consumers, and prevent stockpiling and exorbitant pricing of drugs in shortage. ASH had met with Administration officials to advocate about the importance of early notification of potential drug shortages as an essential tool in helping FDA work with drug manufacturers, hospitals, doctors, and patients to prevent or mitigate a drug shortage before it becomes a crisis.

"The President made it clear that we can't wait to tackle this challenge and do all we can to prevent shortages of potentially life-saving medicines," said HHS Secretary Kathleen Sebelius. "Today's action is the latest in a series of proactive efforts we have undertaken to combat shortages of critical medicine the American people depend upon."

More information on the rule is available on the Health and Human Services website.

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