The Final State of the Union
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Summary:
President Obama's Executive Order directing action to prevent and reduce prescription drug shortages is working: The Food and Drug Administration has prevented114 drug shortages so far.
On October 31, 2011 President Obama signed an Executive Order directing the Food and Drug Administration (FDA) to take action to help further prevent and reduce prescription drug shortages, protect consumers and prevent price gouging. Nearly four months later, it’s clear that the President’s Executive Order and the good work of the FDA are making a difference for the American people.
Since President Obama signed his Executive Order, FDA has prevented 114 drug shortages. In part, this resulted from the Administration’s call for voluntarily notification to the FDA of potential shortages. Notification of a potential shortage is crucial: with enough advance warning, FDA can take action to help stop a potential drug shortage. And since President Obama signed his Executive Order, voluntary notifications have increased six-fold.
Today, the FDA is announcing the steps it has taken to end the shortage of two important drugs that fight cancer:
- To avert an impending shortage of methotrexate, a drug used to treat children with leukemia, the FDA has worked with manufacturers to help ramp up production and has approved a new application to produce the version of the drug that is most needed , which will further bolster supply and ensure patients have access to this lifesaving medicine.
- To end the shortage of the cancer drug Doxil, the FDA will allow the temporary importation of a replacement drug. This action should address patient needs and end this drug shortage.
The FDA is also responding to President Obama’s Executive Order by releasing new draft guidance for the drug industry on requirements for both mandatory and voluntary notification to FDA of issues that could result in a drug shortage.
There is more work to do to prevent drug shortages. Congress still has not acted on legislation that would make notifying the FDA of potential drug shortages mandatory in more cases. And we know that there is no one single cause of drug shortages: everyone has a role to play to prevent shortages from happening.
But today’s announcement shows that we’re making a difference and protecting the health of the American people. And we’ll continue our aggressive efforts to prevent drug shortages and ensure patients get the medicines they need.
