President Obama issued an executive order this week directing the US
Food and Drug Administration (FDA) to take specific actions to prevent
and reduce future drug shortages. Under the order, FDA will require
drugmakers to provide advance notice of manufacturing problems likely to
lead to shortages, and the agency will expedite review of new drug
suppliers, manufacturing sites and manufacturing changes in cases where
expedited review will help avoid or mitigate shortages. Under the order,
FDA will also be required to report suspected stockpiling or price
gouging of scarce drugs to the Department of Justice. Generic drugmakers
have pledged to work closely with FDA to address the shortage problem.
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