As legislators and agency bureaucrats struggle to interpret and implement Sequester-mandated budget cuts, pundits and industry opinion leaders were busy speculating what the damage might be to the U.S. Food and Drug Administration’s mission. Prior to the Sequestration’s deadline passing, President Obama, asked Congress to take two steps that might help the FDA without increasing the deficit. As reported online by BioCentury February 28th, the administration asked Congress to authorize FDA to spend new and increased user fees -- including about $41 million in increased prescription drug fees and new biosimilar drug fees that were part of the PDUFA V reauthorization. Currently, the agency is collecting, but is not allowed to spend, fees above the amount authorized by Congress in FY12. The White House also asked Congress to alter sequestration so it does not apply to user fees. This would free about $36 million in PDUFA money for the rest of this fiscal year.
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