Congress could blunt sequestration effect on FDA

Congress could reduce the effect of sequestration on FDA's oversight of drugs by taking steps to make user fees available to the agency, according to the Obama administration and congressional sources. With sequestration slated to take effect Friday, attention is now shifting to the continuing resolution, a temporary budget bill that is set to expire March 27. Failure to pass a new budget bill would force a government shutdown.

The Obama administration is asking Congress to take two steps that could help FDA without increasing the deficit. First, the White House 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 PDUFA V reauthorization. Currently, the agency is collecting but is not allowed to spend fees above the amount authorized by Congress in FY12 (see BioCentury, Sept. 17, 2012). ...