• Regulatory NewsRegulatory News

    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...
  • Group Calls for Changes to User Fee Bill After Transparency Concerns Emerge

    A group of 20 public interest organizations has written the US Congress to express their displeasure with a measure which would purportedly allow the US Food and Drug Administration (FDA) to hide health and safety inspection information from the public. The group is most concerned about Section 812 of the FDA Reform Act (FDARA) , which they say "allows the FDA to deny the public access to information relating to drugs obtained from a federal, state, local or foreign gov...
  • Congressional Research Service Releases Side-by-side Analysis of User Fee Bills

    • 01 June 2012
    The Congressional Research Service, the House and Senate's semi-private think tank, has released what it is calling a side-by-side comparison of the Senate's Food and Drug Administration Safety and Innovation Act (FDASIA) and the House's Food and Drug Administration Reform Act (FDARA) . The report contains brief summaries of both bills' titles and provisions and how they relate to and alter current laws, particularly the Federal Food, Drug and Cosmetic Act (FD&C ...
  • House Overwhelmingly Passes User Fee Legislation

    • 31 May 2012
    The House of Representatives voted overwhelmingly to support the Food and Drug Administration Reform Act (FDARA) , sending the bill to a conference committee for an ultimate merger with the Senate's  Food and Drug Administration Safety and Innovation Act (FDASIA) . House members voted 387 to 5 in support of the legislation, which would institute a package of reforms to the US Food and Drug Administration (FDA) and renew and create a series of industry-paid user fee...
  • House Version of user Fee Legislation Gets Major Boost from CBO

    What a difference a week and some amendments make. The Congressional Budget Office (CBO) has re-scored the House's amended version of the Food and Drug Administration Reform Act (FDARA) and has found that instead of costing taxpayers $250 million, it will now save taxpayers $370 million. The distinction is important, and not just because of the fiscal implications for taxpayers. Under legislation commonly known as PAYGO , any normal legislation found to add to the def...
  • Report: Lobbying Pushes Bioavailability Testing Provisions Into House User Fee Bill

    • 30 May 2012
    A well-connected pharmaceutical company has succeeded in inserting a provision into the House's marked-up version of pending user fee legislation to require some fees go toward research to determine whether a generic is as safe and effective as the product to which it is compared, reports The New York Times . The Times reports Endo Pharmaceuticals, soon to be renamed Endo health Solutions, hired a former Congressman and a former House staff member to lobby members of ...
  • House to Vote on User Fee Reauthorization, Medical Device Tax Repeal Bills

    The US House of Representatives is moving quickly to vote on a package of reforms and user fee proposals similar to one approved on 24 May by the US Senate, with House leadership confirming a bill containing the provisions will be brought to a vote on 30 May. The bill, the Food and Drug Administration Reform Act (FDARA) , would renew and expand user fee provisions required of industry and used to fund the US Food and Drug Administration (FDA), which would also see a n...
  • Senate Easily Clears Amended User Fee Bill

    The US Senate passed the Food and Drug Administration (FDA) Safety and Innovation Act (FDASIA) on 24 May, advancing the bill for an eventual merger with the House of Representatives' parallel legislation. The bill, which would fund FDA through a series of user fee agreements between FDA and regulated industry, was approved with near-unanimous consent. Only Sen. Bernie Sanders (I-VT) voted against the legislation. The Congressional Budget Office (CBO) provided a boos...
  • White House Throws Support Behind Senate User Fee Bill

    • 17 May 2012
    The Obama Administration has indicated it "strongly supports passage" of user fee legislation currently in the US Senate, saying it will "help speed safe and effective drugs, medical devices and biosimilar biological products to patients." The support of the White House-long expected but until now unannounced-comes as both chambers of the US Congress prepare to meet to vote on their respective versions of user fee legislation. The Senate is scheduled to vote on 17 May on...