Rep. Gene Green Opposes So-Called “Right-to-Try” Legislation
WASHINGTON, DC – Today, Congressman Gene Green (D-TX), Ranking Member of the Energy & Commerce Subcommittee, released the following statement after the House of Representatives passed S.204, a bill aimed to weaken the Federal Drug Administration’s (FDA) role in overseeing drugs for terminally ill patients:
“The so-called “Right-to-Try” legislation that the House voted on today offers false hope for patients and families. This bill establishes a dangerous and unnecessary pathway for unproven drugs, void of any FDA review or oversight, and threatens our nation’s drug approval system.”
“There is already a process for giving terminally ill patients access to experimental drugs, known as “compassionate use.” The current system works – 99% of requests are approved by the FDA. Today’s so-called “Right-to-Try” bill endangers our current system with a dangerous pathway for unproven drugs without any FDA review or oversight.”
“My daughter, an infectious disease expert at the University of Nebraska, used FDA’s Compassionate Use pathway to provide an experimental therapy for an American missionary who had contracted Ebola while in Africa in 2014. FDA approved the request for the experimental treatment over the telephone in less than 24 hours."
“The new pathway created in S. 204 is not necessary and, in fact, may well endanger the health and safety of seriously ill patients by bypassing FDA’s oversight and expertise.”