Right to Try Act: Should Terminally Ill Patients be Able to Try Experimental Treatments? (H.R. 2368)
Do you support or oppose this bill?
What is H.R. 2368?
(Updated May 24, 2018)
This bill — known as the Right to Try Act — would allow the use of experimental drugs, biological products, and devices that haven’t been approved by the Food and Drug Administration (FDA) by patients diagnosed with a terminal illness in accordance with state laws.
A physician would be required to make several certifications before a patient could receive experimental drugs, including:
That the physician is in good standing with professional certifying organizations and has personally examined the patient.
That there is no reason to conclude the experimental treatment poses an unreasonable and significant risk of danger to the patient.
That the patient has been diagnosed with a terminal illness and doesn’t have treatment options that are comparable to the experimental treatment and are approved by the FDA.
That the probable risk to the patient from the treatment isn’t greater than the probable risk from the patient’s disease or condition.
That the physician has provided the patient with a written statement and oral explanation of the medical treatment.
The patient would also have to acknowledge that the physician has disclosed:
The treatment is experimental or non-conventional.
That the treatment hasn’t been approved by the FDA.
The material risks generally recognized by a reasonably prudent physician of the medical treatment’s side effects.
An explanation of the medical treatment, including the expected frequency and duration of the treatment.
No producer, manufacturer, distributor, prescriber, dispenser, possessor, or user of an experimental treatment could be held liable for providing or using the treatment. No outcome of the treatment could be used by a federal agency reviewing the treatment to delay or otherwise adversely impact the review or approval of the experimental treatment.
Argument in favor
This bill would give families and individuals access to potentially lifesaving treatments that haven’t been approved by the FDA when they have no alternative. If the patient and physician understand the risks, they should have the right to try experimental treatments.
Argument opposed
This bill is too risky because the FDA and clinical trial process exist to prevent unsafe treatments from being used. Besides, insurers may not pay for it and drug companies may not allow the experimental treatment to be used.
Impact
Terminally ill patients and their physicians; drug companies and insurers; states; and the FDA.
Cost of H.R. 2368
A CBO cost estimate is unavailable.
Additional Info
In-Depth: Sponsoring Rep. Brian Fitzpatrick (R-PA) introduced this bill to give terminally ill patients the ability to use experimental treatments when they have no other alternative:
“Each day, families across the country receive the devastating news of a terminal diagnosis. Even with the amazing work done in American medical research and development, for too many, access to these potentially lifesaving treatments will come too late, or not at all. The Right to Try Act opens the opportunity to trial-stage care and establishes the freedom for patients and their doctors to try therapies where the benefits far outweigh the risks. Americans — our constituents — should have every opportunity to fight for their life, or the life of their loved one. Whether it’s a father courageously battling ALS or a brave child living with Duchene Muscular Dystrophy, they deserve the right to try.”
Detractors say that going outside the FDA approval process poses serious risks for patients, as Dr. R. Adams Dudley told NPR:
“We know some people try to take advantage of our desperation when we’re ill. If we take the FDA out of it, how do we protect people from physicians or drug companies that will want to sell them things and will want to prey their desperation? If you say there’s a path that’s not through the FDA, then there are billions of dollars to be made by skipping the important steps that we’ve developed.”
This legislation has the support of four bipartisan cosponsors, including three Republicans and one Democrat.
Of Note: According to the National Conference of State Legislatures, a total of 31 states have enacted right to try laws.
Media:
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Sponsoring Rep. Brian Fitzpatrick (R-PA) Press Release
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Newsworks
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NPR
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People
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Philly.com
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FreedomWorks (In Favor)
Summary by Eric Revell
(Photo Credit: Bill Branson / Public Domain)
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