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    Regulatory Explainer: FDA User Fee Reauthorizations From 2018 to 2022

    President Donald Trump late Friday signed a bill that reauthorizes the US Food and Drug Administration (FDA) user fee programs for prescription drugs, generic drugs, biosimilars and medical devices through 2022. Taking effect 1 October, the 86-page law (the text of which can be found here ) passed the House via voice vote in July and by a vote of 94-1 in the Senate earlier this month without the addition of any controversial amendments. The law ensures the ag...
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    Trump to Sign FDA User Fee Reauthorization Bill

    Ahead of its summer recess, the US Senate on Thursday followed its House counterparts and passed a bipartisan bill to reauthorize the US Food and Drug Administration (FDA) user fee programs for prescription drugs, generic drugs, medical devices and biosimilars for the next five years. A spokesman for President Donald Trump told Focus , “The President will sign this bill, but we look forward to working with Congress to address further negotiations.” The Senate’s pas...
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    Gottlieb: FDA Will Delay Sending Layoff Notices

    In an email to agency staff on Monday, FDA Commissioner Scott Gottlieb said he will delay issuing layoff notices until after 30 September 2017, when the agency's current user fee agreements expire, if Congress has not passed legislation to reauthorize the agreements by then. Previously, FDA has said it would need to begin issuing layoff notices to thousands of employees that are funded by user fees if the agreements are not enacted by 1 August, as agencies are typically ...
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    House Passes Bill to Reauthorize FDA User Fee Programs

    In a moment of bipartisanship, the US House of Representatives on Wednesday passed a bill via voice vote to reauthorize the prescription drug, generic drug, medical device and biosimilar user fee programs through 2022. Several representatives discussed the issue of expensive medicines on the House floor Wednesday, though none of the user fee programs address the issue directly. However, speeding the review of generic drugs could lower some high-priced brand name dr...
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    House, Senate Still Aim to Pass FDA User Fee Reauthorization Bill Before Delayed August Recess

    The US House of Representatives on Wednesday will take up a bill to reauthorize the US Food and Drug Administration’s (FDA) prescription drug, generic drug, biosimilar and medical device user fee programs, and though the Senate has not yet scheduled a time to take up the bill, it is expected to before thousands of FDA employees are laid off. The bipartisan House user fee bill , which sailed through the Energy & Commerce committee unanimously last month, has be...
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    Tight Timeline to Reauthorize FDA User Fee Programs Before FDA Begins Layoffs

    The US Senate and House of Representatives have given themselves a little more than 10 working days to finish a bill to reauthorize the US Food and Drug Administration (FDA) drug, generic drug, medical device and biosimilar user fee programs and get it signed by President Donald Trump before thousands of FDA employees will receive layoff notices. In the Senate, the bill advanced through the Health, Education, Labor & Pensions Committee almost unanimously in May. T...
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    CBO Releases Cost Estimate for User Fee Bill

    The Congressional Budget Office (CBO) on Thursday released its cost estimate for the Senate's bill to reauthorize the US Food and Drug Administration's (FDA) user fee programs, saying the agency will need $1.2 billion in appropriations from 2018-2022 to implement changes brought on by the bill. The estimate is based on the version of the FDA Reauthorization Act of 2017 that was advanced by the Senate Committee on Health, Education, Labor & Pensions in May. Notably, t...
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    User Fee Reauthorization Bill Advances in the House

    The House Energy and Commerce Committee on Wednesday voted unanimously (54-0) to advance its bill to reauthorize the US Food and Drug Administration's (FDA) user fee programs for prescription and generic drugs, biosimilars and medical devices to the full House. The committee also adopted several amendments to the version of the bill, known as the FDA Reauthorization Act of 2017 , that came out of the health subcommittee on 18 May. And, in an effort to move the bill f...
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    House Subcommittee Advances User Fee Reauthorizations

    Following its Senate counterparts, the Energy & Commerce health subcommittee on Thursday advanced a bill to reauthorize the user fee agreements over the next five years for drugs, generic drugs, medical devices and biosimilars. All four amendments were agreed to, including one to increase generic drug competition and provide 180-day exclusivity for first generics where there’s a limited market, one on protecting the supply chain, one on improving the process for me...
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    Senate Committee Advances FDA User Fee Reauthorization Bill

    The Senate Committee on Health, Education, Labor & Pensions on Thursday advanced by a vote of 21-2 a bill that would reauthorize the pharmaceutical, medical device, generic drug and biosimilar user fee agreements that expire at the end of September. Two additional amendments were added to the latest version of the bill , one from Sens. Orrin Hatch (R-UT), Michael Bennet (D-CO), Richard Burr (R-NC), and Bob Casey (D-PA) on expanded access to drugs and one from Sens...
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    Senate Committee to Vote on FDA User Fee Reauthorizations

    Next Wednesday, the Senate Committee on Health, Education, Labor & Pensions will vote on the five-year reauthorization of the four US Food and Drug Administration (FDA) drug, medical device, biosimilar and generic drug user fee agreements. The current, five-year agreements are set to expire 30 September 2017, though if Congress fails to act before its summer recess, thousands of FDA employees would receive layoff notices. The proposed reauthorizations, grouped ...
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    House to Consider MDUFA Add-Ons

    With the deadline for reauthorizing the US Food and Drug Administration's (FDA) user fee programs rapidly approaching, members of the House Energy & Commerce Subcommittee on Health are considering a handful of device-related bills to include with the reauthorization package. On Tuesday, the E&C subcommittee will discuss four bills that look to make hearing aids more accessible to patients over-the-counter , overhaul FDA's inspection program for device establishments , ...