• Regulatory NewsRegulatory News

    Senate committee proposes $3.2B budget for FDA

    The Senate Committee on Appropriations on Tuesday released draft legislation proposing $3.21 billion in discretionary funding for the US Food and Drug Administration for FY2021, closely matching the amount the agency would receive under the minibus passed in the House in July.   In total, the draft bill would set FDA’s total FY2021 funding, including user fees, at $5.88 billion.   Due to inaction on appropriations bills in the Senate before the start of the fiscal ...
  • Regulatory NewsRegulatory News

    House Appropriators Target Areas for FDA Improvement

    The House Appropriations Committee on Tuesday voted to send its FY 2020 spending bill for the US Food and Drug Administration (FDA) to the House floor, in addition to releasing a report explaining areas where FDA needs to focus its efforts. The funding bill would provide FDA with $3.26 billion in non-user fee funding, an increase of $184 million (6%) above the FY 2019 enacted level. According to the Alliance for a Stronger FDA, the bill is expected to be taken up on the...
  • Regulatory NewsRegulatory News

    House Committee Proposes 6% Increase in FDA Funding for FY 2020

    The House Appropriations Committee on Wednesday released a draft fiscal year 2020 funding bill for the US Food and Drug Administration (FDA), calling for a $184 million increase in discretionary funding over 2019’s enacted level.   Total funding for FDA, including revenue from user fees, is $5.86 billion, according to the bill. That total is slightly less than the $6.1 billion requested by the Trump Administration for FDA.   “Within this total, the Committee prov...
  • Regulatory NewsRegulatory News

    Gottlieb Testifies on Status of FDA Operations After Government Shutdown

    US Food and Drug Administration (FDA) Commissioner Scott Gottlieb testified before the House Committee on Appropriations Wednesday on the current state of agency activities. Gottlieb expressed confidence that the agency is “back on track,” despite the 35-day lapse in FDA appropriations during the longest partial government shutdown in US history. Members of the subcommittee on agriculture, rural development, FDA and related agencies questioned Gottlieb on the status of ...
  • Regulatory NewsRegulatory News

    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...
  • Regulatory NewsRegulatory News

    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...
  • Regulatory NewsRegulatory News

    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...
  • Regulatory NewsRegulatory News

    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...
  • Regulatory NewsRegulatory News

    HHS Secretary Working With Trump on a Plan to Reduce Drug Prices

    Health and Human Services Secretary Tom Price told a House appropriations subcommittee on Wednesday that his agency is working with President Donald Trump on a plan to bring down the cost of pharmaceutical drugs. Citing Trump’s numerous mentions since he took office of a plan for a new "bidding" system, Price said skyrocketing drug prices is an issue that members of Congress on both sides of the aisle are looking to target. In defending Trump’s proposed "skinny" budge...
  • Regulatory NewsRegulatory News

    Additional Funding to Combat Zika Denied in House Markup of FDA Spending Bill

    The House Appropriations Committee on Tuesday marked up the FY 2017 spending bill for the US Food and Drug Administration (FDA) and decided not to include an amendment adding $1.9 billion in additional funding requested by President Barack Obama to combat the Zika virus. Republicans argued that Obama did not provide enough specifics on where the funds will go and they voted against Rep. Nita Lowey’s (D-NY) amendment that would have attached the Administration’s additiona...
  • Regulatory NewsRegulatory News

    Updated: Congress Looks to Force FDA Into Rewriting Major Generic Drug Labeling Rule

    As Congress looks to pass a spending bill for FY 2017 by Friday, the House Appropriations Committee has released a new bill with a modest amount of new funding for the US Food and Drug Administration (FDA) and new demands on how FDA should write a controversial and major final rule on generic drug labels. The rule, which FDA has said it will finalize in July , would allow generic drug companies to update their labels with new safety information when that information bec...
  • Regulatory NewsRegulatory News

    Congressional Spending Deal Offers $132m More for FDA in 2016

    As House and Senate lawmakers race to approve a bill to fund the US government for 2016, the US Food and Drug Administration (FDA) should see a slight bump in discretionary funding of $132 million over last year. The proposed agreement, which is expected to face a vote on Friday, includes increases of $104.5 million for food safety related activities; $5 million for implementation of the Food and Drug Administration Safety and Innovation Act ( FDASIA ); $8.7 million for ...