Today, in response to President Obama's Executive Order of Oct. 31,
2011, the Obama Administration has issued an interim final rule that
will help prevent prescription drug shortages, according to a new release from the Health and Human Services Department.
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 FDA's
current work to ensure Americans have access to the medicine they need.
"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."
"Shortages delay or deny needed care for patients and FDA is committed
to making sure that patients and health professionals have the drugs
they need when they need them, said FDA Commissioner Margaret Hamburg,
M.D. "We will continue to take steps such as issuing this interim final
rule to prevent and reduce current and future disruptions in the supply
of lifesaving medicines."
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