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  • Regulatory NewsRegulatory News

    Legislators Want to Exempt Much of FDA's Funding from Future Budget Cuts

    New legislation introduced in Congress would exempt nearly half of the US Food and Drug Administration's (FDA) budget from austerity measures meant to help balance the federal budget. Background The bill, the FDA Safety Over Sequestration (FDA SOS) Act would specifically exempt FDA's user fees from the effects of future budget sequestration . The user fees, which come from the pharmaceutical and medical device industries, are meant to help fund FDA's regulatory...
  • 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...
  • Legislators to OMB: Sequestration of FDA User Fees Wrong, Should be Reversed

    Legislators in the House of Representatives seem to have a consistent message for the White House's Office of Management and Budget (OMB), the office which effectively sets and enforces policy within the executive branch: Stop holding the US Food and Drug Administration's (FDA) user fees hostage. Background FDA's funding comes from a variety of different streams. While it receives a substantial amount of funding from the congressional appropriations process, it also rec...
  • White House Jumps to Defense of FDA, Other Agencies, over Proposed Budget Cuts

    White House officials are backing up a number of allegations made by several industry watchers regarding the effects of budget sequestration on the US Food and Drug Administration (FDA), noting that, among other things, the cuts could negatively impact drug review times and regulatory science. On 1 March 2013, federal agencies are scheduled to run into the effects of budget sequestration, which calls for annualized budget cuts of approximately 8% for all domestic non-def...
  • Politico: FDA, Other Domestic Agencies Unable to Freely Talk about Sequestration

    If federal agencies, including the US Food and Drug Administration (FDA), seem to be approaching the looming threat of fiscal devastation rather quietly, it's not by accident, reports Politico . That's because Cabinet-level officials, including Kathleen Sebelius, secretary of the Department of Health and Human Services and FDA Commissioner Margaret Hamburg's boss, have been under a virtual gag order from executive branch officials, said Politico . Any remarks they...
  • As FDA Avoids Fiscal Cliff, Trouble Looms on Horizon

    US legislators have passed a measure aimed at averting the so-called "fiscal cliff" for at least two months, giving both them and federal employees-including the US Food and Drug Administration (FDA)-a reprieve from potentially massive budget cuts. The proposed deal, passed in both chambers of Congress and awaiting President Barack Obama's signature, contains a number of tax-related and other provisions mostly aimed at raising revenues while preserving lower tax ra...
  • With Cuts to FDA Looming, Congress Prepares to Adjourn--Again

    Federal programs, including those of the US Food and Drug Administration (FDA), are under seige. Under the combined terms of a proposed budget resolution and budget sequestration, FDA stands to lose hundreds of millions of dollars in both congressionally appropriated and user fee-generated funding during the 2013 fiscal year. And, with just three months left in which to restore funding to FDA, Congress is preparing to adjourn-again. The Hill reports that the Senate...
  • More than $110 Million in FDA User Fees to be Seized Under Sequestration

    The US Food and Drug Administration (FDA) stands to lose more than $300 million in funding and industry-paid user fees under a budget sequestration process scheduled to come into effect in January 2013, according to a new report released by the Office of Management and Budget. The report, " OMB Report Pursuant to the Sequestration Transparency Act (STA) of 2012 ," came in response to legislators' demands that the executive branch release more information regarding th...
  • 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...
  • 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...