• User Fee Acts: The Current State of Play
  • May 2, 2012 | Author: Libby L. Baney
  • Law Firm: Faegre Baker Daniels - Washington Office
  • The debate over the UFAs went into full swing last week, as the congressional committees responsible for FDA oversight released "Manager's Amendment" draft text and the Senate HELP Committee completed markup.

    Throughout D.C.'s health and life sciences community, there is buzz about the 112th Congress' passage of the User Fee Acts (aka "UFAs"): the Prescription Drug User Fee Act (PDUFA), the Medical Device User Fee Act (MDUFA), the Generic Drug User Fee Act (GDUFA), and the Biosimilar User Fee Act (BsUFA)). What reforms to the U.S. Food and Drug Administration (FDA) will be included in the UFAs? Why will these reforms be included?  How will the FDA regulatory landscape change for industry and consumers?

    Clarity Could Be Coming

    The debate over the UFAs went into full swing last week, as the congressional committees responsible for FDA oversight released their "discussion drafts."  In addition to industry-FDA agreements on user fees, discussion drafts contained additional, non-controversial provisions proposed by members of Congress. These provisions touch on diverse topics, including Internet promotion, drug shortages, device approvals, third-party inspections and antibiotics development.

    We're in the Game

    Faegre Baker Daniels' advisory and advocacy division, FaegreBD Consulting, is working on pushing two legislative reforms as the UFAs move forward: (1) establishing a federal lot-level drug traceability system to improve the safety and integrity of the U.S. pharmaceutical distribution chain; and (2) amending the Federal Food Drug and Cosmetic Act to ensure prescription drugs are dispensed in accordance with a defined "valid prescription" requirement in order to enhance federal enforcement efforts against illegal online drug sellers (aka "online pharmacies") who sell prescription medications without a valid prescription. These two reforms have strong bipartisan, bi-cameral backing on the Hill and are actively supported by diverse group of companies and organizations. FaegreBD Consulting anticipates that these reforms will be discussed in upcoming committee markups and, potentially, on the Senate and/or House floor.  FaegreBD Consulting has also been instrumental on behalf of the 510(k) Coalition in adding and modifying provisions to improve the FDA's regulation of medical devices, particularly in such areas as rescission authority, the least burdensome requirement, expanding the use of experts, and the de novo process.  

    Going Forward

    The Senate Health, Education, Labor and Pensions (HELP) Committee's UFA discussion draft was marked up on April 25 and the House Energy and Commerce Committee will hold a markup on May 8.  Both committees seek to have a full committee vote on the UFAs sometime in May, with the measure going before the full chamber thereafter. Current thinking is that Congress will seek to have the UFAs signed into law before the August recess, in advance of election season and before PDUFA and MDUFA expire at the end of September.