Hearing: “FDA User Fee Reauthorization: Ensuring Safe and Effective Drugs and Biologics”

Subcommittee on Health (Committee on Energy and Commerce)

Thursday, February 3, 2022 (10:00 AM)

Meeting was rescheduled to the time and date listed above.
2123 RHOB
Washington, D.C.
This will be a hybrid hearing held in 2123 Rayburn House Office Building, as well as remotely on the Committee's Cisco Webex Platform. The hearing will be live streamed on the Committee's website at https://energycommerce.house.gov.

Witnesses

Panel one

Dr. Patricia Cavazzoni
Director, Center for Evaluation and Research, U.S. Food and Drug Administration

Added 02/01/2022 at 11:51 AM
  • Witness Statement [PDF] Added 02/01/2022 at 04:16 PM
  • Response to Questions for the Record [PDF] Added 09/23/2022 at 01:45 PM
  • Witness Truth in Testimony [PDF] Added 02/01/2022 at 04:16 PM
  • Witness Biography [PDF] Added 02/01/2022 at 04:16 PM

Dr. Peter Marks
Director, Center for Biologics Evaluation and Research, U.S. Food and Drug Administration

Added 02/01/2022 at 11:51 AM
  • Witness Statement [PDF] Added 02/01/2022 at 04:16 PM
  • Response to Questions for the Record [PDF] Added 09/23/2022 at 01:45 PM
  • Witness Truth in Testimony [PDF] Added 02/01/2022 at 04:16 PM
  • Witness Biography [PDF] Added 02/01/2022 at 04:16 PM

Panel two

Dr. Cartier Esham
Chief Scientific Officer, Executive Vice President, Emerging Companies, Biotechnology Innovation Organization

Added 02/01/2022 at 11:51 AM
  • Witness Statement [PDF] Added 02/01/2022 at 01:18 PM
  • Response to Questions for the Record [PDF] Added 06/13/2022 at 02:15 PM
  • Witness Truth in Testimony [PDF] Added 02/01/2022 at 01:18 PM
  • Witness Biography [PDF] Added 02/01/2022 at 04:18 PM

David Gaugh
Senior Vice President, Sciences and Regulatory Affairs, Association for Accessible Medicines

Added 02/01/2022 at 11:51 AM
  • Witness Statement [PDF] Added 02/01/2022 at 01:57 PM
  • Response to Questions for the Record [PDF] Added 06/13/2022 at 02:15 PM
  • Witness Truth in Testimony [PDF] Added 02/01/2022 at 01:57 PM
  • Witness Biography [PDF] Added 02/01/2022 at 01:57 PM

Dr. Reshma Ramachandran
Physician-Fellow, Yale National Clinician Scholars Program, Chair, Doctors for America FDA Task Force

Added 02/01/2022 at 11:51 AM
  • Witness Statement [PDF] Added 02/01/2022 at 01:18 PM
  • Response to Questions for the Record [PDF] Added 06/13/2022 at 02:15 PM
  • Witness Truth in Testimony [PDF] Added 02/01/2022 at 01:18 PM
  • Witness Biography [PDF] Added 02/01/2022 at 01:18 PM

Juliana M. Reed
Executive Director, Biosimilars Forum

Added 02/01/2022 at 11:51 AM
  • Witness Statement [PDF] Added 02/01/2022 at 01:27 PM
  • Response to Questions for the Record [PDF] Added 06/13/2022 at 02:15 PM
  • Witness Truth in Testimony [PDF] Added 02/01/2022 at 01:27 PM
  • Witness Biography [PDF] Added 02/01/2022 at 01:27 PM

Dr. Lucy Vereshchagina
Vice President, Science and Regulatory Advocacy, Pharmaceutical Research and Manufacturers of America

Added 02/01/2022 at 11:51 AM
  • Witness Statement [PDF] Added 02/01/2022 at 01:27 PM
  • Response to Questions for the Record [PDF] Added 06/13/2022 at 02:15 PM
  • Witness Truth in Testimony [PDF] Added 02/01/2022 at 01:27 PM
  • Witness Biography [PDF] Added 02/01/2022 at 01:27 PM

Text of Legislation

  • H.R. ____, the "Biosimilar User Fee Amendments of 2022" [PDF]
  • H.R. ____, "Generic Drug User Fee Amendments of 2022" [PDF]
  • H.R. ____, the "Prescription Drug User Fee Amendments of 2022" [PDF]

Support Documents

  • Hearing Notice [PDF]
  • Briefing Memo [PDF] Added 02/01/2022 at 11:51 AM
  • Hearing Notice - Time Change [PDF] Added 02/02/2022 at 12:58 PM
  • Document for the Record - A JAMA Oncology article published on January 20, 2022, entitled, “Accelerated Approval Is Not Conditional Approval: Insights From International Expedited Approval Programs” [PDF] Added 02/11/2022 at 01:10 PM
  • Document for the Record - A table comparing international expedited approval programs from JAMA Oncology article [PDF] Added 02/11/2022 at 01:10 PM
  • Document for the Record - A January 27, 2022, article from Endpoint News entitled “Scott Gottlieb criticizes CMS in feud over Aduhelm coverage, calls out their lack of expertise” [PDF] Added 02/11/2022 at 01:10 PM
  • Document for the Record - A statement from the National Health Council [PDF] Added 02/11/2022 at 01:10 PM
  • Document for the Record - A statement from the Alzheimer’s Association and Alzheimer’s Impact Movement [PDF] Added 02/11/2022 at 01:10 PM
  • Document for the Record - A statement from the American College of Physicians [PDF] Added 02/11/2022 at 01:10 PM

Member Statements

  • Opening Statement of Rep. Anna G. Eshoo, Chairwoman of the Subcommittee on Health [PDF] Added 02/11/2022 at 01:10 PM
  • Opening Statement of Rep. Brett Guthrie, Ranking Member of the Subcommittee on Health [PDF] Added 02/11/2022 at 01:10 PM
  • Opening Statement of Rep. Frank Pallone, Jr., Chairman of the Full Committee [PDF] Added 02/11/2022 at 01:10 PM
  • Opening Statement of Rep. Cathy McMorris Rodgers, Ranking Member of the Full Committee [PDF] Added 02/11/2022 at 01:10 PM

Hearing Record

  • Member Attendance [PDF] Added 02/11/2022 at 01:10 PM

First Published: January 27, 2022 at 06:01 PM
Last Updated: September 23, 2022 at 01:45 PM


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