E&C Announces Health Legislative Hearing on PDUFA, GDUFA, and BsUFA Reauthorization
Energy and Commerce Chairman Frank Pallone, Jr. (D-NJ) and Health Subcommittee Chairwoman Anna G. Eshoo (D-CA) announced today that the Health Subcommittee will hold a legislative hearing on Thursday, February 3, at 10 a.m. (EST) in the John D. Dingell Room, 2123 of the Rayburn House Office Building on reauthorization of the Prescription Drug User Fee Act (PDUFA), the Generic Drug User Fee Act (GDUFA), and the Biosimilar User Fee Act (BsUFA). The hearing is entitled, “FDA User Fee Reauthorization: Ensuring Safe and Effective Drugs and Biologics.”
“The Food and Drug Administration’s user fee agreements allow the agency to fulfill its mission to review and approve the medications that Americans rely on,” Pallone and Eshoo said. “As we continue to face the COVID-19 pandemic, adequate funding and staffing levels at FDA are more important than ever. Patients rely on FDA’s gold standard of safety and efficacy, and the American people are relying on us to ensure the agency has the resources it needs to improve development, review applications, and monitor drug safety in a timely manner. We look forward to hearing from top officials at FDA and stakeholders next week as we begin the important work of reauthorizing the prescription drug, generic drug, and biosimilar user fees.”
This will be a hybrid hearing that includes both in person and remote member attendance via Cisco Webex video conferencing. Members of the public may view the hearing via live webcast accessible on the Energy and Commerce Committee’s website. Please note the webcast will not be available until the hearing begins.
The Committee strongly recommends that members of the media view the proceedings remotely. The Capitol and House Office Buildings currently have restricted access. Seating in the Committee room for credentialed media is very limited. Media must RSVP to their respective press gallery no later than 5 p.m. on Wednesday, February 2.
House Radio/TV Gallery:
House Periodical Gallery:
House Daily Press Gallery:
Information for this hearing, including the Committee Memorandum, the legislation to be discussed, witnesses, testimony, and a live webcast will be posted HERE as they become available.