Examining Patient Access to Investigational Drugs, Hearing Before the Subcommittee on Health of the Committee on Energy and Commerce, House of Representatives, One Hundred Fifteenth Congress, First Session, October 3, 2017 [open pdf - 8MB]
This is the October 3, 2017 hearing titled "Examining Patient Access to Investigational Drugs" before the House Subcommittee on Health of the Committee on Energy and Commerce. From the opening statement of Michael C. Burgess: "Currently, the United States Food and Drug Administration conducts an expanded access program aimed at helping these patients who do not qualify for clinical trials to help them gain access to therapies that are unapproved by the FDA [Food and Drug Administration]. I understand the feelings and the passions of individuals who believe these therapies have the potential to save their life or offer them a chance to alter the course of their illness. I also recognize that the Food and Drug Administration must strike the right balance between ensuring public safety and granting access to new treatments. [...] The subcommittee will also examine several pieces of Federal legislation--S. 204, the Trickett Wendler Right to Try Act of 2017 authored by Senator Ron Johnson of Wisconsin; Representatives Biggs' and Fitzpatrick's House companion bills; and H.R. 1020, the Compassionate Freedom of Choice Act of 2017, introduced by our fellow Health Subcommittee member, Morgan Griffith of Virginia." Statements, letters, and materials submitted for the record include those of the following: Brian K. Fitzpatrick, Andy Biggs, Scott Gottlieb, John E. Dicken, Naomi Lopez Bauman, Matthew Bellina, Kenneth I. Moch, Alison Bateman-House, and Ellen V. Sigal.
Serial No. 115-60
Government Publishing Office: http://www.gpo.gov/