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White House claims success in tackling prescription drug shortage

By Julian Pecquet - 02/21/12 11:52 AM ET

The Obama administration took credit Tuesday for averting some drug shortages and called on Congress to take action.

The president signed an executive order last fall that gives federal regulators more power to track drug shortages, quickly approve replacement manufacturing sites and punish price gougers. Since then, White House Deputy Chief of Staff Nancy-Ann DeParle wrote on the White House blog, the Food and Drug Administration has been able to prevent 114 drug shortages.

"In part, this resulted from the administration's call for voluntary notification to the FDA of potential shortages," she wrote. "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."

Congress now needs to step up and make FDA notification of potential shortages mandatory in more cases. Bipartisan legislation championed by Reps. Tom Rooney (R-Fla.) and Diana DeGette (D-Colo.) and by Sens. Amy Klobuchar (D-Minn.) and Susan Collins (R-Maine) has lingered in both chambers.

DeParle goes on to detail actions the agency has taken to preserve access to two cancer drugs: 

"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."

In addition, the agency released draft guidance Tuesday regarding mandatory and voluntary notification to FDA of issues that could result in a drug shortage.

"Today's announcement shows that we're making a difference and protecting the health of the American people," DeParle wrote. "And we'll continue our aggressive efforts to prevent drug shortages and ensure patients get the medicines they need."


Source:
http://thehill.com/blogs/healthwatch/medical-devices-and-prescription-drug-policy-/211729-white-house-claims-success-in-tackling-prescription-drug-shortage

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