• 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 ...
  • FDA Says Hurricane Sandy Will Affect Review Target Dates, Regulated Industry

    Hurricane Sandy left much of the US' eastern seaboard battered and flooded after coming ashore in late October, and the damage and delays it caused are having regulatory implications, the US Food and Drug Administration (FDA) said in an announcement. In a 1 November 2012 statement , FDA Commissioner Margaret Hamburg said her agency was heavily focused on the storm and its potential to affect regulated industry. "We often think of major storms like Sandy in terms of th...
  • Budget Passes Senate, Leaving User Fees at 2012 Levels

    Both chambers of Congress have now passed a continuing resolution that would keep the government's-and the US Food and Drug Administration's (FDA)-budget at existing fiscal year 2012 levels, averting a government shutdown but also leaving in limbo several important FDA programs. Legislators scrambled on 21 September to pass a legislative fix for the establishment of fees for generic drug products, but did not establish similar exemptions for prescription drug, medica...
  • Budget Bill Passes House, Leaving FDA User Fees to Languish

    A budget bill passed in the US House of Representatives would, in its current form, deprive the US Food and Drug Administration (FDA) of tens of millions of dollars in funding promised to it in legislation passed earlier this year. The bill, also known as a continuing resolution (CR), would fund the government at fiscal year 2012 levels, essentially keeping in place the exact same budget that existed last year. The bill passed the House on 13 September in a 329-91 vote...
  • User Fees Expected to Save Taxpayers $358M Over Next Ten Years

    • 14 May 2012
    The US Senate's Food and Drug Administration Safety and Innovation Act (FDASIA) is a expected to save taxpayers $358 million over the coming decade, with $71 million in savings in the next five years according to an analysis conducted by the Congressional Budget Office (CBO). The bill, whose primary purpose is to reauthorize a variety of user fee programs used to fund the US Food and Drug Administration (FDA), contains a number of reforms and adjustments that would imp...
  • As User Fee Bill Sails Through House Committee Vote, a Focus on Industry Efforts

    The House Energy and Commerce Committee advanced the Food and Drug Administration (FDA) Reform Act of 2012 , a package of proposals to both fund and reform the agency, by a unanimous vote involving 46 members of the House of Representatives. "The legislation ensures continuation of various FDA programs, including the Prescription Drug User Fee Act and Medical Device User Fee Act , and authorizes new user fee programs, the Generic Drug User Fee Act and Biosimilar...
  • House Committee to Vote on User Fee Bill, Aiming for Passage in July

    The US House of Representatives' Energy and Commerce Committee is set to hold a vote on Thursday, 10 May on a collection of user fee legislation being dubbed the Food and Drug Administration (FDA) Reform Act of 2012 . The bill would reauthorize the Prescription Drug User Fee Act and the Medical Device User Fee Act , authorize the Generic Drug User Fee Act and the Biosimilars and Interchangeable Products User Fee Act , and make a number of reforms to FDA's review...
  • House Subcommittee Passes User Fee Reauthorization Legislation

    • 09 May 2012
    The US House Energy and Commerce Subcommittee on Health completed its markup process for a package of user fee programs including the Prescription Drug User Fee Act (PDUFA), the Medical Device User Fee Act (MDUFA) and the Generic Drugs User Fee Act (GDUFA) , easily passing the legislation unanimously via a voice vote. The entire markup process was remarkably quick, taking just under a half hour to complete -a stark contrast in a Congress sturggling to pass any piec...
  • User Fee Act Passes Senate Panel While Tensions Escalate in the House

    • 26 April 2012
    The Senate's Health, Education, Labor and Pensions (HELP) Committee passed a collection of user fee acts in a piece of legislation known as the Food and Drug Administration Safety and Innovation Act (FDASIA) , advancing the bill for an eventual  vote before the entire Senate. The 25 April HELP Committee markup process for FDASIA saw a flurry of activity in both the House and Senate. Regulatory Focus summarizes that activity for you here: The Hill : The Sen...
  • Report: Fight Over FDA User Fee Bills Threatening To Derail Legislation

    Riders and add-ons in legislation intended to help fund the US Food and Drug Administration (FDA) through industry-paid user fees are threatening to derail the entire legislation, reports  Politico . A number of user fee bills, including the Prescription Drug User Fee Act, the Medical Device User Fee Act , the Generic Drug User Fee Act and the Biosimilars and Interchangeable Products User Fee Act are all being wrapped up into a single piece of legislation ins...
  • Report: User Fees Could Be In Peril in Partisan Congress

    A Bloomberg Government study claims a partisan Congress seeking to make changes to the US Food and Drug Administration (FDA) and the user fee legislation that funds it could put the entire package of user fee legislation in jeopardy. The pieces of user fee legislation currently before Congress included the Prescription Drug User Fee Act (PDUFA), the Medical Device User Fee Act (MDUFA), the Generic Drugs User Fee Act (GDUFA), and the Biosimilar and Interchangeab...
  • User Fee Legislation for Generics and Biosimilars Released Ahead of Hearing

    Legislation establishing the user fee programs for generic drugs and biosimilar products was introduced in the House of Representatives on 9 February . The bill, To amend the Federal Food, Drug, and Cosmetic Act to establish user-fee programs for generic drugs and biosimilars (H.R. 3988) , now goes before the House Energy and Commerce Committee for markup. The Committee is set to meet on 9 February to hear testimony from numerous government and industry officials, incl...