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Hearing on "Examining FDA’s Generic Drug and Biosimilar User Fee Programs," Subcommittee on Health (March 2, 2017)

Thursday, March 2, 2017 - 10:00am
2123 Rayburn House Office Building

The Subcommittee on Health held a hearing on Thursday, March 2, 2017, at 10:00 a.m. in 2123 Rayburn House Office Building.  The hearing is entitled “Examining FDA’s Generic Drug and Biosimilar User Fee Programs.”  




Key Documents

Memorandum from Ranking Member Pallone to the Subcommittee on Health

Opening Statement of Ranking Member Pallone as prepared for delivery

Preliminary Transcript


Panel I:

Janet Woodcock, M.D.
Director, Center for Drug Evaluation and Research
U.S. Food and Drug Administration
Panel II:
David Gaugh
Senior Vice President of Sciences and Regulatory Sciences
Association for Accessible Medicines
Bruce A. Leicher
Senior Vice President and General Counsel
Momenta Pharmaceuticals, Inc.
Chair, The Biosimilars Council, a Division of the Association for Accessible Medicines
Juliana Reed
Vice President of Government Affairs
Coherus BioSciences
Immediate Past President, The Biosimilars Forum
Kay Holcombe
Senior Vice President of Science Policy
Biotechnology Industry Organization
Allan Coukell
Senior Director, Health Programs
The Pew Charitable Trusts