WASHINGTON, DC - The Subcommittee on Health, chaired by Rep. Michael C. Burgess, M.D. (R-TX), announced a hearing for Wednesday, March 22, 2017, at 10:15 a.m. in room 2322 of the Rayburn House Office Building. The hearing is entitled, “Examining FDA’s Prescription Drug User Fee Program."
The Prescription Drug User Fee Act (PDUFA), which is up for reauthorization, supports the review and regulation of innovative drug products and helps ensure patients receive timely access to safe and effective new therapies. The Health Subcommittee recently held a hearing examining the Generic Drug User Fee Amendments (GDUFA) and the Biosimilar User Fee Act (BsUFA), both of which also expire in September 2017.
“Next week’s hearing on PDUFA will examine how this important user fee program has been implemented since it was reauthorized in 2012 as part of the Food and Drug Administration Safety and Innovation Act (FDASIA)," said Chairman Burgess. “I am encouraged to see that the proposed agreement between FDA and industry builds upon several key provisions in the 21st Century Cures Act, and will further streamline the development and review of innovative new drugs for patients."
The Majority Memorandum, witness list, and witness testimony for the hearing will be available here as they are posted. See Also
* Examining FDA’s Prescription Drug User Fee Program
