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Analyst issues sequester warning for FDA

By Elise Viebeck - 02/05/13 12:21 PM ET

Budget sequestration will severely curtail operations at the Food and Drug Administration (FDA) if cuts hit the agency March 1, analysts said Tuesday.

Consulting firm Avalere Health warned the FDA on Tuesday to prepare for the 5.1 percent automatic cut in case lawmakers do not act to stop it. The reduction would amount to $210 million in 2013, according to the White House.

"In the event of sequestration, FDA may lack the critical resources needed for the timely review of important medical products that patients depend on to address their health needs," Avalere wrote in a memo. 

"An underfunded FDA could lead to FDA review clocks being reset or delayed, which would affect a sponsor’s ability to obtain product approval — thus delaying patient access to cutting edge medical innovations."

The FDA is already operating at fiscal 2012 levels because of the continuing resolution now funding the federal government.

In the "fiscal cliff" deal, lawmakers stopped the cuts from taking effect for about two months. The sequester was triggered under the Budget Control Act of August 2011 when a congressional supercommittee failed to reach a broad deficit-reduction deal. 

President Obama will ask Congress to replace some of the sequester cuts in a speech Tuesday.

—This post was changed to correct the amount of projected cuts.


Source:
http://thehill.com/blogs/healthwatch/medical-devices-and-prescription-drug-policy-/281131-analyst-issues-sequester-warning-for-fda

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