• FDA to Get Access to New Funding, Sequestered User Fees Under New Spending Bill

    The holiday season may technically be over, but the US Congress is poised to give the US Food and Drug Administration (FDA) a long-sought and large gift in the coming weeks: Access to approximately $85 million in sequestered user fee funding and more than $90 million in new funding. Background: Sequestered User Fees FDA was authorized to collect the funds under the 2012 Food and Drug Administration Safety and Innovation Act (FDASIA) , but its authority to spend the fun...
  • Hearing on FDA Appropriations Finds Usual Supporters Voting Against the Agency's Budget

    The US Food and Drug Administration (FDA) is, first and foremost, a regulatory agency charged with overseeing the safety, efficacy and quality of healthcare and other consumer products. But it is also an agency that frequently finds itself at the nexus of political battles, such as this week when its appropriations were put to a vote in the US House of Representatives, leading to a bizarre political debate. Background The US government has been "shut down" since 1 Octob...
  • FDA Funding Set to Increase in 2014 after Year of Cutbacks

    US healthcare product regulators stand to get a sizable boost in their funding during the next fiscal year if the House Appropriations Committee gets its way. The Committee's Agriculture Appropriations Subcommittee, which has budget authority over the US Food and Drug Administration, met on 5 June 2013 to mark-up the Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations bill, which would set FDA's funding for the 2014 fiscal ...
  • New Funding Required to Allow FDA to Face 'Brave New World' of Global Supply Chains, Says Hamburg

    US Food and Drug Administration (FDA) Commissioner Margaret Hamburg has found herself in front of a congressional hearing for the second time this week, this time under far more favorable circumstances explaining why the agency deserves the funding it receives and-hopefully-more of it. Globalization In prepared testimony delivered on 18 April 2013 to the Senate Committee on Appropriations, the congressional panel with principal authority over FDA's budget, Hamburg obser...
  • 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...
  • 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...
  • House Budget Draft Eliminates Comparative Effectiveness Research Agencies

    • 18 July 2012
    Two federal agencies charged with controlling costs by conducting non-binding comparative effectiveness research stand to be eliminated under the latest draft of an appropriations bill in the House of Representatives. AHRQ to be 'Terminated' The Agency for Healthcare Research and Quality (AHRQ) is, like the US Food and Drug Administration (FDA), contained under the umbrella of the US Department of Health and Human Services, and is run by longtime-Director Carolyn Clan...
  • 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...
  • FDA Receives Small Funding Boost In Senate Appropriations Bill

    The US Food and Drug Administration (FDA) could see an addition $24 million in funding under a bill cleared by the Senate Appropriations Committee on 26 April. The bill, The Agriculture, Rural Development, Food and Drug Administration and Related Agencies Appropriations Act of 2013 , would increase overall FDA appropriations to $2.54 billion, or a 1% increase over its Fiscal Year 2012 appropriated amount. BioCentury notes the increase is greater than the amoun...
  • Hamburg: FDA Now Approving More Drugs During First-Round Than Ever Before

    US Food and Drug Administration (FDA) Commissioner Margaret Hamburg appeared before the House Committee on Appropriations 29 February 2012 to argue on behalf of FDA's Fiscal Year 2013 budget request. Hamburg made a number of notable regulatory assertions in her testimony to the committee. Among them: "FDA now has the highest first action approval rate for new drugs we have ever had." "We lead the world in the number and speed of drug approvals: of the 57 novel drugs...
  • Report: Obama Budget Unlikely to Contain Funds for FDA White Oak Campus

    Reporting by the Federal Times on 10 February indicates that the US Food and Drug Administration (FDA) is unlikely to see new funds for their White Oak, MD consolidated campus project during fiscal year 2013. Sens. Ben Cardin (D-MD) and Barbara Mikulski (D-MD) joined Reps. Steny Hoyer (D-MD), Chris Van Hollen (D-MD) and Donna Edwards (D-MD) in writing a letter to President Obama on 31 January to call for the restoration of the funds. "We understand that the FY 2013 ...