SubHealth Reviewed Patient Access to Investigational Drugs

Posted on 09/27/2017

The Subcommittee on Health, chaired by Rep. Michael Burgess, M.D. (R-Tx), held a hearing for Tuesday Oct 3, 2017.  The hearing, entitled "Examining Patient Access to Investigational Drugs" focused on the FDA expanded access process and access to investigational drugs outside of a clinical trial.  FDA Commissioner Scott Gottlieb M.D. was amongst the numerous witnesses.  The subcommittee will also focus on legislation related to access to unapproved therapies.  

The hearing included four panels of witnesses:

Panel One: U.S. Rep. Brian Fitzpatrick (R-PA); U.S. Rep. Andy Biggs (R-AZ)

Panel Two: Scott Gottlief, M.D., Commissioner, U.S. Food and Drug Administration

Panel Three: John Dicken, Director, Health Care, U.S. Government Accountability Office (GAO)

Panel Four: Naomi Lopez-Bauman, Director of Healthcare Policy, Goldwater Institute; Lieutenant Commander Matthew Bellina, US Navy (Retired); Kenneth I. Moch, President & CEO , Cognition Therapeutics Inc; Alison Bateman-House, PhD, MPH, MA, Assistant Professor, Department of Population Health, New York University Langone Health; and Ellen V. Sigal, Chairperson and Founder, Friends of Cancer Research.

Here is the link to the live session:Live Hearing Link