Hearing on "FDA User Fee Reauthorization: Ensuring Safe and Effective Drugs and Biologics"
The Subcommittee on Health of the Committee on Energy and Commerce held a hybrid hearing that included both in-person and remote attendance on Thursday, February 3, 2022, at 10:00 a.m. This hearing took place in the John D. Dingell Room, 2123 of the Rayburn House Office Buidling, as well as remotely using Cisco Webex online video conferencing. The hearing is entitled, "FDA User Fee Reauthorization: Ensuring Safe and Effective Drugs and Biologics."
Key Documents
Memorandum from Chairman Pallone to the Subcommittee on Health
Opening Statement from Chairman Pallone as prepared for delivery
Opening Statement from Subcommittee Chairwoman Eshoo as prepared for delivery
Livestream
Legislation
H.R.____, the "Biosimilar User Fee Amendments of 2022"
H.R.____, the "Generic Drug User Fee Amendments of 2022"
H.R.____, the "Prescription Drug User Fee Amendments of 2022"
Witnesses
Panel I
Patrizia Cavazzoni, M.D.
Director, Center for Drug Evaluation and Research
U.S. Food and Drug Administration
Peter Marks, M.D., Ph.D.
Director, Center for Biologics Evaluation and Research
U.S. Food and Drug Administration
Testimony of the U.S. Food and Drug Administration
Panel II
Cartier Esham, Ph.D.
Chief Scientific Officer
Executive Vice President, Emerging Companies
Biotechnology Innovation Organization
David Gaugh
Senior Vice President, Sciences and Regulatory Affairs
Association for Accessible Medicines
Reshma Ramachandran, M.D.
Physician-Fellow, Yale National Clinician Scholars Program
Chair, Doctors for America FDA Task Force
Juliana M. Reed
Executive Director
Biosimilars Forum
Lucy Vereshchagina, Ph.D.
Vice President, Science and Regulatory Advocacy
Pharmaceutical Research and Manufacturers of America