• Regulatory NewsRegulatory News

    FDA’s FY22 budget priorities: boost inspections, surveillance; avert device shortages

    The US Food and Drug Administration’s FY 2022 budget request to Congress indicates the agency’s wishes to catch up on the backlog of inspections that have been delayed due to COVID-19, improve its drug surveillance efforts to detect possible shortages, and avert shortages for such medical devices as personal protective equipment (PPE).   Many of these requests have been driven by the need to combat device and drug shortages wrought by the pandemic.   The request al...
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    Biden’s first budget request seeks $6.5 billion for FDA

    The US Food and Drug Administration (FDA) is seeking $6.5 billion in funding for FY2022 under President Joe Biden’s $6 trillion budget proposal announced on Friday, an overall increase of $477 million (8%) over the agency’s FY2021 budget.   In a news release, the agency said the $6.5 billion budget would be used for “investments in critical public health infrastructure, core food safety and medical product safety programs and other vital public health programs,” which ...
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    House committee proposes $500M in COVID funding for FDA

    The House Energy and Commerce Committee will convene Thursday to markup its portions of the budget reconciliation bill that will contain President Joe Biden’s proposed $1.9 trillion COVID-19 relief package.   The budget reconciliation process was created under the Congressional Budget Act of 1974 and enables Congress to fast-track legislation related to taxes, spending and debt limits. Democrats have opted to use the process to allow them to pass the stimulus package...
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    Trump’s 2020 Budget Seeks FDA Tweaks to Increase Generic Competition

    With Democrats controlling the House, the specifics of President Donald Trump’s Fiscal 2020 budget, released on Monday, may not matter much, but it does feature new attempts to alter US Food and Drug Administration (FDA) processes in order to increase generic drug competition. Similarly to last year’s budget , the 2020 budget looks to save more than $1 billion in Medicare and Medicaid funds by stopping some generic drug applicants, who file first and win tentative appr...
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    Update: Appropriations Bill Would Give FDA $269M Boost Over FY2018 Budget

    The House and Senate passed a seven-bill spending package on Thursday to fund large portions of the federal government through FY2019. And President Donald Trump has said he will sign the bill.   The spending package comes near the end of a three-week stopgap funding measure to allow the government to reopen after a record 35-day partial government shutdown that began on 22 December 2018 after President Donald Trump refused to sign a short-term spending bill over his...
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    Senate Appropriations Bill Maintains FDA Funding for 2018

    The Senate Appropriations Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies on Tuesday voted to advance its draft FY2018 appropriations bill, which includes $2.8 billion in discretionary funding for the US Food and Drug Administration (FDA). The full Appropriations Committee is scheduled to meet Thursday to mark up the bill before voting to advance it to the Senate for consideration. While the funding levels in the bill d...
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    House Drafts FY 2018 FDA Budget With Same Appropriation Levels as 2017

    The House Appropriations Committee on Tuesday released the fiscal year 2018 Agriculture Appropriations bill, which would enact a total of $2.8 billion in discretionary funding for the US Food and Drug Administration (FDA). That level of appropriations, which stands in stark contrast to President Donald Trump’s call to eliminate appropriations for FDA and run the agency entirely on industry user fees, would continue FDA’s budget authority (BA) appropriations at the...
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    FDA Commissioner Vows to Eliminate Backlog of Orphan Drug Designation Requests

    At a Senate hearing on President Donald Trump's FY2018 budget request for the US Food and Drug Administration (FDA), Commissioner Scott Gottlieb vowed to eliminate the backlog of orphan drug designation requests and said he will soon release "modern and risk-based" tools for assessing new treatments, especially for rare diseases and conditions with no effective treatments. "Right now we have a backlog of about 200 orphan drug designation requests where we haven't respond...
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    Gottlieb: FDA Hiring Freeze Lifted, Plans for Increased Generic Competition Coming

    US Food and Drug Administration (FDA) commissioner Scott Gottlieb was in the hot seat on Thursday to defend President Donald Trump's budget plan to the House appropriations subcommittee, though the conversation quickly dovetailed away from the billion-dollar user fee increase proposed, and revealed that FDA as of Thursday is no longer subject to a federal hiring freeze. While Gottlieb noted that he "wasn't involved in the formulation of the budget," as he's only bee...
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    Trump’s 2018 Budget Seeks Last-Minute Renegotiation of FDA User Fee Deals

    President Donald Trump's FY 2018 budget proposal for the US Food and Drug Administration (FDA), leaked late Monday, seeks a last-minute renegotiation of user fee deals forged over the last two years to make up for about a 30% decrease in the agency’s budget. The call for more than $1 billion in new user fees to replace appropriations comes as both the House and Senate have advanced their versions of the user fees reauthorization legislation with the previously negoti...
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    Senate Democrats to Trump: HHS Cuts Will Impede 'Cures' Implementation

    Eleven Senate democrats sent a letter to President Donald Trump on Tuesday explaining how his proposed cuts in the FY 2018 budget for the Department of Health and Human Services (HHS) will make implementation of the bipartisan 21st Century Cures Act much more difficult. "We urge you to listen to both sides of the aisle and drop any attempts to implement the damaging proposed cuts at HHS laid out in your budget," they wrote. Trump’s budget blueprint for 2018 ...
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    Government Spending Bill Would Boost FDA Funds by Almost $40M

    The US House and Senate appropriations committees on Monday released government spending bills through the end of this fiscal year, offering the US Food and Drug Administration (FDA) a boost in discretionary spending and user fee revenues. In total, the agreement on spending through 30 September 2017 contains $153.4 billion in discretionary and mandatory funding, which is $16.3 billion below President Donald Trump’s FY2017 budget request and $12.5 billion above the FY20...