Hearing: Examining FDA’s Generic Drug and Biosimilar User Fee Programs

Subcommittee on Health (Committee on Energy and Commerce)

Thursday, March 2, 2017 (10:00 AM)

2123 RHOB
Washington, D.C.

Witnesses

Panel one

Dr. Janet Woodcock M.D.
Director, Food and Drug Administration, Center for Drug Evaluation and Research

Added 02/28/2017 at 06:20 PM
  • Witness Statement [PDF] Added 03/01/2017 at 03:47 PM
  • Truth in Testimony and CV [PDF] Added 03/01/2017 at 05:36 PM

Panel two

Mr. Allan Coukell
Senior Director, The Pew Charitable Trusts, Health Programs

Added 02/28/2017 at 06:20 PM
  • Witness Statement [PDF] Added 03/01/2017 at 03:47 PM
  • Truth in Testimony and CV [PDF] Added 03/01/2017 at 04:12 PM

Mr. David Gaugh
Senior Vice President of Sciences and Regulatory Sciences, Association for Accessible Medicines

Added 02/28/2017 at 06:20 PM
  • Witness Statement [PDF] Added 03/01/2017 at 03:47 PM
  • Truth in Testimony and CV [PDF] Added 03/01/2017 at 04:12 PM

Ms. Kay Holcombe
Senior Vice President of Science Policy, Biotechnology Industry Organization

Added 02/28/2017 at 06:20 PM
  • Witness Statement [PDF] Added 03/01/2017 at 05:33 PM
  • Truth in Testimony and CV [PDF] Added 03/01/2017 at 04:12 PM

Mr. Bruce A. Leicher
Chair, a Division of the Association for Accessible Medicines, The Biosimilars Council

Added 02/28/2017 at 06:20 PM
  • Witness Statement [PDF] Added 03/01/2017 at 03:47 PM
  • Truth in Testimony and CV [PDF] Added 03/01/2017 at 04:12 PM

Ms. Juliana Reed
Immediate Past President, The Biosimilars Forum

Added 02/28/2017 at 06:20 PM
  • Witness Statement [PDF] Added 03/02/2017 at 09:41 AM
  • Truth in Testimony and CV [PDF] Added 03/01/2017 at 04:12 PM

Text of Legislation

  • H.R. 749, Lower Drug Costs through Competition Act [PDF] Added 02/28/2017 at 10:07 AM

Support Documents

  • Hearing Notice [PDF] Added 02/23/2017 at 03:23 PM
  • Background Memo [PDF] Added 02/28/2017 at 09:51 AM
  • Hearing Attendance [PDF] Added 03/13/2017 at 12:40 PM
  • Document for the Record - Rep. Long - FTC Article [PDF] Added 05/19/2017 at 05:35 PM

Member Statements

  • Opening Statement - Full Committee Chairman Greg Walden [PDF] Added 03/13/2017 at 12:40 PM
  • Opening Statement - Health Subcommittee Chairman Michael C. Burgess [PDF] Added 03/13/2017 at 12:40 PM
  • Opening Statement - Full Committee Ranking Member Frank Pallone, Jr. [PDF] Added 03/16/2017 at 05:31 PM

Hearing Record

  • Preliminary Transcript [PDF] Added 03/16/2017 at 05:31 PM

First Published: February 23, 2017 at 03:20 PM
Last Updated: May 19, 2017 at 05:35 PM


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