The Proposed Federal ‘Right-To-Try’ Law Is Not The Answer For Critically Ill Patients

Currently, patients have two main options to access experimental therapies that may treat their conditions but that have not yet been approved by the Food and Drug Administration (FDA): enrolling in a clinical trial or applying to FDA’s expanded access (also known as compassionate use) program. But because FDA’s expanded access program has been viewed as cumbersome and overly restrictive, 31 states have passed “Right-To-Try” laws in the past two years. Based on model legislation created by the Goldwater Institute, a public policy think tank, right-to-try laws are intended to authorize use of experimental, not-yet-approved treatments for patients with advanced illness; prohibit sanctions of health care providers for providing experimental treatment; and clarify health insurers’ roles. In May, the Trickett Wendler Right to Try Act of 2016, a companion to a House bill introduced in 2015, was introduced in the Senate. But right-to-try laws, while currently popular, are controversial. In California, Governor Jerry Brown recently vetoed a right-to-try law, saying the FDA’s revised expanded access program should be given a chance to work. A 2015 article in The New England Journal of Medicine provides a legal and ethical critique of expanded access and use of investigational drugs, noting that right-to-try laws “will have limited effect” because “they do not compel manufacturers and insurers to supply and pay for experimental therapies.” I am a survivor of advanc...
Source: Health Affairs Blog - Category: Health Management Authors: Tags: Drugs and Medical Technology Featured Health Professionals Narrative Matters Quality clinical trials Compassionate Use right-to-try laws Trickett Wendler Right to Try Act Source Type: blogs