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  • FDA: Budget Sequestration Could Lead to 'Loss of Whole User Fee Programs'

    The current congressional budget environment is leading to a situation in which the US Food and Drug Administration (FDA) could face the loss of "whole user fee programs" and hundreds of millions of dollars, FDA recently told Bloomberg Businessweek . The agency remarks were in response to recent reports indicating that industry-paid user fees set to flow to the agency under the recently passed FDA Safety and Innovation Act (FDASIA) legislation are at risk of bei...
  • Report: US Budget Sequestration Could Seize Portion of FDA User Fees

    A planned 7.8% across-the-board budget cut for all federal agencies passed into law in 2011 could ultimately effect the US Food and Drug Administration's (FDA) user fees, reports a prominent agency advocate. The cut, otherwise known as budget sequestration, came as the result of the Budget Control Act  of 2011 , which stated that if Democrats and Republicans were unable to come up with substantial, voluntary cuts to federal expenditures, an automatic trigger w...
  • FDA Could Soon Have Better Information to Plan for Massive Budget Cuts

    Officials at the US Food and Drug Administration (FDA) may soon have a better sense of the impact of an upcoming budget sequestration measure thanks to a new piece of legislation signed into law 7 August by President Barack Obama. The bill, the Sequestration Transparency Act of 2012 , comes as partisan wrangling over the impact of the Budget Control Act of 2011 comes to a head. The act was the culmination of a tense budget standoff between congressional Demo...
  • OMB to Federal Agencies: Begin Planning for Massive Budget Cuts

    The White House Office of Management and Budget (OMB) wants federal agencies, including the US Food and Drug Administration (FDA), to remember that on 1 January 2013, all agencies may lose nearly a tenth of their appropriated budget unless Congress acts to override a budget trigger passed into law in 2011. The 2011 action, known as the Budget Control Act (BCA) of 2011 , instituted a trigger procedure known as budget sequestration. Under the procedure, if Congress is...
  • As House Prepares to Appropriate FDA Funding, Sequestration Process Looms Large

    On Wednesday, 6 June the US House of Representatives will begin to markup a piece of proposed legislation which would fund the US Food and Drug Administration (FDA) below levels proposed in a similar bill being considered by the US Senate. The as-yet-unnumbered House bill , which would fund FDA and agriculture agencies, calls for $3.84 billion in funding, with $712.8 million of that to come from prescription drug user fees, $69.7 million to come from medical device use...