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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...
  • Analysis: As Sequester Looms Large, Experts Say Four Options Likely for FDA Cuts

    Starting 1 March 2013, the US Food and Drug Administration (FDA) has a tough job ahead of it. Thanks to the effects of mandatory budget sequestration, it will have to cut 5.1% out of its budget by the end of the year. The good news, as reported by the Philadelphia Inquirer on Wednesday, is that FDA staff appears to be safe from furloughs. The bad news: FDA still has to cut $210 million from its budget. But how? The answer to that question is simultaneously simple and c...
  • If Sequester Takes Effect, Could Top FDA Brass Be Furloughed?

    How, exactly, would budget sequestration affect some of the US Food and Drug Administration's (FDA) most senior officials? If a new report from The Washington Post is correct, some of FDA's most senior center leaders could be subject to the same furloughs as the rest of the regulatory agency. The 22 February 2013 report from The Post notes that when it comes to equal application of budget sequestration, some workers might be lucky enough to escape furloughs. But ...
  • Sebelius Writes to Congress, Reminding Them of Sequester's Impact on User Fees

    US Department of Health and Human Services (DHHS) Secretary Kathleen Sebelius has quietly confirmed what many in the industry have long known: User fees paid to the US Food and Drug Administration (FDA) under various legislative vehicles and agency programs are at risk under the sequester. Background On 1 March 2013, without intervention from Congress, all federal agencies (with the exception of the Department of Defense) will be subjected to an annualized 8% reduction ...
  • 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...
  • As Deadline Looms for Budget Cuts, FDA Faces Loss of $318 Million and Many Employees

    A critical deadline is fast approaching for US legislators to act to avoid the effects of the budget sequestration process, set to come into effect on 2 January 2013 unless Congress can find at least $1.2 trillion in budget cuts over the coming decade. First, the background: In 2011, Congress passed the Budget Control Act (BCA) , which stipulated that the government's debt-driven spending was propelling it toward an unsustainable future and needed to be reigned in. Whil...
  • 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...