Hearing: “The Future of Medicine: Legislation to Encourage Innovation and Improve Oversight”

Subcommittee on Health (Committee on Energy and Commerce)

Thursday, March 17, 2022 (10:30 AM)

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

Dr. Jeff Allen
President and CEO, Friends of Cancer Research

Added 03/15/2022 at 01:27 PM
  • Witness Statement [PDF] Added 03/15/2022 at 04:12 PM
  • Response to Questions for the Record [PDF] Added 06/13/2022 at 02:25 PM
  • Witness Truth in Testimony [PDF] Added 03/15/2022 at 04:12 PM
  • Witness Biography [PDF] Added 03/15/2022 at 04:12 PM

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

Added 03/15/2022 at 01:27 PM
  • Witness Statement [PDF] Added 03/15/2022 at 04:12 PM
  • Response to Questions for the Record [PDF] Added 06/13/2022 at 02:25 PM
  • Witness Truth in Testimony [PDF] Added 03/15/2022 at 04:12 PM
  • Witness Biography [PDF] Added 03/15/2022 at 04:12 PM

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

Added 03/15/2022 at 01:27 PM
  • Witness Statement [PDF] Added 03/15/2022 at 04:12 PM
  • Witness Truth in Testimony [PDF] Added 03/15/2022 at 04:12 PM
  • Witness Biography [PDF] Added 03/15/2022 at 04:12 PM

Dr. Ruben Mesa
Executive Director, Mays Cancer Center, UT Health San Antonio MD Anderson

Added 03/15/2022 at 01:27 PM
  • Witness Statement [PDF] Added 03/15/2022 at 04:12 PM
  • Witness Truth in Testimony [PDF] Added 03/15/2022 at 04:12 PM
  • Witness Biography [PDF] Added 03/15/2022 at 04:12 PM

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

Added 03/15/2022 at 01:27 PM
  • Witness Statement [PDF] Added 03/16/2022 at 09:24 AM
  • Response to Questions for the Record [PDF] Added 06/13/2022 at 02:25 PM
  • Witness Truth in Testimony [PDF] Added 03/16/2022 at 09:24 AM

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

Added 03/15/2022 at 01:27 PM
  • Witness Statement [PDF] Added 03/15/2022 at 04:12 PM
  • Response to Questions for the Record [PDF] Added 06/13/2022 at 02:25 PM
  • Witness Truth in Testimony [PDF] Added 03/15/2022 at 04:12 PM
  • Witness Biography [PDF] Added 03/15/2022 at 04:12 PM

Text of Legislation

  • H.R. 1730, the “Speeding Therapy Access Today Act of 2021” [PDF]
  • H.R. 2565, the “FDA Modernization Act of 2021” [PDF]
  • H.R. 3085, the “Equity in Neuroscience and Alzheimer’s Clinical Trials Act of 2021” or the “ENACT Act of 2021” [PDF]
  • H.R. 3927, the “Manufacturing API, Drugs, and Excipients in America Act” or the “MADE in America Act” [PDF]
  • H.R. 4472, the “Better Empowerment Now to Enhance Framework and Improve Treatments Act of 2021” or the “BENEFIT Act of 2021” [PDF]
  • H.R. 4511, the “FDA Advancing Collection of Transformative Science Act” or the “FACTS Act” [PDF]
  • H.R. 5030, the “Diversifying Investigations Via Equitable Research Studies for Everyone Trials Act” or the “DIVERSE Trials Act” [PDF]
  • H.R. 5566, the “Finding Orphan-disease Remedies With Antifungal Research and Development Act of 2021” or the “FORWARD Act of 2021” [PDF]
  • H.R. 5585, the “Advanced Research Project Agency–Health Act” or the “ARPA-H Act” [PDF]
  • H.R. 6000, the “Cures 2.0 Act” [PDF]
  • H.R. 6584, the “Diverse and Equitable Participation in Clinical Trials Act” or the “DEPICT Act” [PDF]
  • H.R. 6888, the “Helping Experts Accelerate Rare Treatments Act of 2022” [PDF]
  • H.R. 6963, the “Accelerated Approval Integrity Act of 2022” [PDF]
  • H.R. 6972, the “Give Kids a Chance Act” [PDF]
  • H.R. 6973, the “Enhanced Access to Affordable Medicines Act” [PDF]
  • H.R. 6988, the “Drug Manufacturing Innovation Act” [PDF]
  • H.R. 6996, the “Accelerating Access for Patients Act” [PDF]
  • H.R. 7006, the “Improving the Nation’s Safe Pharmaceuticals and Excipients by Creating Tools for Inspecting and Overseeing Needed Supplies Act” or the “INSPECTIONS Act” [PDF]
  • H.R. 7008, the “Pre-Approval Information Exchange Act” [PDF]
  • H.R. 7032, the “Increasing Transparency in Generic Drug Applications Act” [PDF]
  • H.R. 7035, the “Biologics Market Transparency Act” [PDF]
  • H.R. 7047, a bill to amend title III of the Public Health Service Act with respect to the determination by the Secretary regarding certain biosimilar application elements, and for other purposes [PDF]

Support Documents

  • Hearing Notice [PDF]
  • Briefing Memo [PDF] Added 03/15/2022 at 01:27 PM
  • Document for the Record - A statement from Representative Vern Buchanan of Florida [PDF] Added 04/28/2022 at 12:40 PM
  • Document for the Record - A letter from Jeffrey Brown, Science Advisor for People for the Ethical Treatment of Animals [PDF] Added 04/28/2022 at 12:40 PM
  • Document for the Record - A statement from the National Organization for Rare Disorders [PDF] Added 04/28/2022 at 12:40 PM
  • Document for the Record - A statement from Representative Elaine G. Luria of Virginia [PDF] Added 04/28/2022 at 12:40 PM
  • Document for the Record - A letter from Molly Guthrie, Senior Director of Public Policy and Advocacy for Susan G. Komen [PDF] Added 04/28/2022 at 12:40 PM
  • Document for the Record - A statement from the American Academy of Neurology [PDF] Added 04/28/2022 at 12:40 PM
  • Document for the Record - A statement from the Association of Clinical Research Organizations [PDF] Added 04/28/2022 at 12:40 PM
  • Document for the Record - A letter from pediatric cancer advocacy organizations in support of H.R. 6972 [PDF] Added 04/28/2022 at 12:40 PM
  • Document for the Record - A statement from Andrea Noda, Vice President of Health Care at Arnold Ventures [PDF] Added 04/28/2022 at 12:40 PM
  • Document for the Record - A statement from Howard “Skip” Burris, President of the Association for Clinical Oncology [PDF] Added 04/28/2022 at 12:40 PM
  • Document for the Record - A list of endorsements for H.R. 2565 submitted by the Center for a Humane Economy [PDF] Added 04/28/2022 at 12:40 PM
  • Document for the Record - A document from EveryLife Foundation for Rare Diseases entitled, “A Community Vision for a Rare Disease Center of Excellence at the FDA” [PDF] Added 04/28/2022 at 12:40 PM
  • Document for the Record - A Bloomberg op-ed entitled, “Congress Needs to Fix the FDA’s ‘Accelerated’ Drug-Approval Process” [PDF] Added 04/28/2022 at 12:40 PM
  • Document for the Record - A letter from the leading pediatric cancer clinical and preclinical consortiums endorsing H.R. 6972 [PDF] Added 04/28/2022 at 12:40 PM
  • Document for the Record - A statement from Matthew Rizzo, Chair of the American Brain Coalition [PDF] Added 04/28/2022 at 12:40 PM
  • Document for the Record - A statement from the EveryLife Foundation for Rare Diseases [PDF] Added 04/28/2022 at 12:40 PM
  • Document for the Record - Testimony from Jim Corbett, CEO of Emulate, Inc. [PDF] Added 04/28/2022 at 12:40 PM
  • Document for the Record - A letter from the Alzheimer’s Impact Movement and JDRF [PDF] Added 04/28/2022 at 12:40 PM
  • Document for the Record - A letter from stakeholders in support of H.R. 5585 [PDF] Added 04/28/2022 at 12:40 PM
  • Document for the Record - Testimony from Beyond Celiac [PDF] Added 04/28/2022 at 12:40 PM
  • Document for the Record - Testimony from the National LGBT Cancer Network [PDF] Added 04/28/2022 at 12:40 PM
  • Document for the Record - A letter from stakeholders on the Growth of Drug-Resistant Fungi Threatens Health in the U.S. [PDF] Added 04/28/2022 at 12:40 PM
  • Document for the Record - A letter from the Valley Fever Institute at Kern Medical in support of H.R. 5566 [PDF] Added 04/28/2022 at 12:40 PM
  • Document for the Record - A statement from Generation Patient [PDF] Added 04/28/2022 at 12:40 PM
  • Document for the Record - A statement from the Generics Access Project [PDF] Added 04/28/2022 at 12:40 PM
  • Document for the Record - A statement from the National Marrow Donor Program/Be The Match [PDF] Added 04/28/2022 at 12:40 PM
  • Document for the Record - A statement from the Humane Society of the United States and Humane Society Legislative Fund [PDF] Added 04/28/2022 at 12:40 PM
  • Document for the Record - A May 2021 letter from the EveryLife Foundation for Rare Diseases [PDF] Added 04/28/2022 at 12:40 PM
  • Document for the Record - Testimony from Dr. Paul A. Locke, Associate Professor at the Johns Hopkins Bloomberg School of Public Health, Department of Environmental Health and Engineering [PDF] Added 04/28/2022 at 12:40 PM
  • Document for the Record - A statement from Representative Kevin McCarthy of California [PDF] Added 04/28/2022 at 12:40 PM
  • Document for the Record - Testimony from Dr. Gary Michelson, Founder and Co-Chair of the Michelson Center for Public Policy [PDF] Added 04/28/2022 at 12:40 PM
  • Document for the Record - A statement from the National Brain Tumor Society [PDF] Added 04/28/2022 at 12:40 PM
  • Document for the Record - Testimony from Dr. Trivia Frazier, CEO of Obatala Sciences [PDF] Added 04/28/2022 at 12:40 PM
  • Document for the Record - A letter from the Personal Care Products Council, the Humane Society Legislative Fund, and the Humane Society of the United States [PDF] Added 04/28/2022 at 12:40 PM
  • Document for the Record - A statement from Rajarshi Banerjee, CEO of Perspectum [PDF] Added 04/28/2022 at 12:40 PM
  • Document for the Record - A statement from Kristie Sullivan, Vice President of Research Policy for the Physicians Committee for Responsible Medicine [PDF] Added 04/28/2022 at 12:40 PM
  • Document for the Record - A letter from 14 stakeholder groups in support of H.R. 7008 [PDF] Added 04/28/2022 at 12:40 PM
  • Document for the Record - Testimony from Dr. Hope R. Ferdowsian, President and CEO of Phoenix Zones Initiative [PDF] Added 04/28/2022 at 12:40 PM
  • Document for the Record - A letter from Representative Nancy Mace of South Carolina [PDF] Added 04/28/2022 at 12:40 PM
  • Document for the Record - Testimony from the International Autoimmune Encephalitis Society [PDF] Added 04/28/2022 at 12:40 PM
  • Document for the Record - Testimony from Dr. J. Lowry Curley, Co-Founder and CEO of AxoSim Inc. [PDF] Added 04/28/2022 at 12:40 PM
  • Document for the Record - A statement from the Neuroscience Working Table [PDF] Added 04/28/2022 at 12:40 PM
  • Document for the Record - Testimony from the Allergy & Asthma Network [PDF] Added 12/12/2022 at 11:28 AM
  • Document for the Record - Testimony from the American Academy of Family Physicians [PDF] Added 12/12/2022 at 11:28 AM

Member Statements

  • Opening Statement of Rep. Anna G. Eshoo, Chairwoman of the Subcommittee on Health [PDF] Added 03/18/2022 at 12:30 PM
  • Opening Statement of Rep. Brett Guthrie, Ranking Member of the Subcommittee on Health [PDF] Added 03/18/2022 at 12:30 PM
  • Opening Statement of Rep. Frank Pallone, Jr., Chairman of the Full Committee [PDF] Added 03/18/2022 at 12:30 PM
  • Opening Statement of Rep. Cathy McMorris Rodgers, Ranking Member of the Full Committee [PDF] Added 03/18/2022 at 12:30 PM

Hearing Record

  • Member Attendance [PDF] Added 03/18/2022 at 12:30 PM
  • Preliminary Transcript [PDF] Added 04/28/2022 at 12:40 PM

First Published: March 10, 2022 at 04:01 PM
Last Updated: December 12, 2022 at 11:28 AM