WASHINGTON, DC – The Subcommittee on Health, chaired by Rep. Michael C. Burgess, M.D. (R-TX), announced a hearing for Thursday, March 2, 2017, at 10 a.m. in room 2123 of the Rayburn House Office Building. The hearing is entitled, “Examining FDA’s Generic Drug and Biosimilar User Fee Programs.”
Both the Generic Drug User Fee Amendments of 2012 (GDUFA) and the Biosimilar User Fee Act of 2012 (BsUFA) expire in September 2017, and must be reauthorized for the Fiscal Years 2018-2022. GDUFA was enacted with the goal of significantly improving the timeliness and consistency of the generic drug review process and clearing the growing backlog of applications pending at FDA. BsUFA was enacted to support the Food and Drug Administration’s (FDA) ability to work with companies in the nascent biosimilar industry and ultimately bring these important products to market in a safe and expeditious manner.
The FDA and other relevant stakeholders will provide testimony on how the programs have been implemented to date and present recommendations pertaining to their reauthorization. The subcommittee will also consider H.R. 749, the Lower Drug Costs Through Competition Act, bipartisan legislation to increase competition in the pharmaceutical industry.
“Next week’s hearing on user fee agreements will be an important discussion as we continue to work toward facilitating review and approval of life-saving and life-improving drugs, while also promoting innovation and job creation,” said Chairman Burgess. “These initiatives, as well as ensuring patients are able to receive quality, affordable, and timely care are a top priority for this Congress.”
The Majority Memorandum, witness list, and witness testimony for the hearing will be available here as they are posted.