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house Bill H.R. 2368

Right to Try Act: Should Terminally Ill Patients be Able to Try Experimental Treatments?

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.

Pamela 's Opinion
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07/29/2017
This should not involve the government. It should be a decision between the patient and doctor.
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Anna's Opinion
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07/29/2017
If you know the risks and want to try because your only other option is imminent death, then yes you should be allowed to try. This choice should be up to individuals, with the support of their families and doctors. There is no place for a politician or government official in a hospital room. Please get the government out of these personal decisions.
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Amber's Opinion
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07/29/2017
Everyone owns there own body. The government should have no say on this.
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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.

Betsy's Opinion
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07/29/2017
Terminally ill patients should be prioritized for inclusion in clinical trials, where the trial is for a treatment appropriate for their condition, but there is sadly a long history of snake-oil salesmen taking advantage of terminally ill people and loved ones with false promises of miracle cures. Untested treatments may be worthless or may be unsafe - that is precisely why FDA regulations are in place. While this bill was likely proposed with a positive intent, I worry that it could lead to unscrupulous persons taking advantage of vulnerable people.
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···
07/29/2017
The clinical trial process already exists for this, and needs as many patients as possible to produce reliable data. If we regularly let patients opt out of that process, it would greatly slow down the pace of drug trials that are beneficial to our society
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Talene's Opinion
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07/30/2017
Why do we keep having these terrible bills that are obviously meant to allow unscrupulous businesses to take advantage of vulnerable populations? No, Snake Oil Salesman should not be able to market their garbage that has not been proven to work to someone who is dying and desperate.
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bill Progress


  • Not enacted
    The President has not signed this bill
  • The senate has not voted
  • The house has not voted
      house Committees
      Constitution, Civil Rights, and Civil Liberties
      Committee on Energy and Commerce
      Health
      Committee on the Judiciary
      Crime, Terrorism and Homeland Security
    IntroducedMay 4th, 2017

What is House Bill H.R. 2368?

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.

Impact

Terminally ill patients and their physicians; drug companies and insurers; states; and the FDA.

Cost of House Bill H.R. 2368

A CBO cost estimate is unavailable.

More Information

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:

Summary by Eric Revell

(Photo Credit: Bill Branson / Public Domain)

AKA

Right to Try Act

Official Title

To authorize the use of experimental drugs, biological products, and devices by patients diagnosed with a terminal illness in accordance with State law, and for other purposes.

    This should not involve the government. It should be a decision between the patient and doctor.
    Like (167)
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    Terminally ill patients should be prioritized for inclusion in clinical trials, where the trial is for a treatment appropriate for their condition, but there is sadly a long history of snake-oil salesmen taking advantage of terminally ill people and loved ones with false promises of miracle cures. Untested treatments may be worthless or may be unsafe - that is precisely why FDA regulations are in place. While this bill was likely proposed with a positive intent, I worry that it could lead to unscrupulous persons taking advantage of vulnerable people.
    Like (87)
    Follow
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    If you know the risks and want to try because your only other option is imminent death, then yes you should be allowed to try. This choice should be up to individuals, with the support of their families and doctors. There is no place for a politician or government official in a hospital room. Please get the government out of these personal decisions.
    Like (95)
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    Everyone owns there own body. The government should have no say on this.
    Like (69)
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    Of course they should! People own themselves. Therefore a person should have the right to try anything they desire. Specifically relating to experimental drugs for treatment.
    Like (48)
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    Why does this even need to be a law? Seems to me if I was a terminally ill person and my doctor advised me of possible treatments it should be MY decision.
    Like (39)
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    The clinical trial process already exists for this, and needs as many patients as possible to produce reliable data. If we regularly let patients opt out of that process, it would greatly slow down the pace of drug trials that are beneficial to our society
    Like (32)
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    This is a shot at surviving a terrible illness or an illness that has reduced the quality of life. I believe that this should allowed. It is an option that the patient's physician feels is the best treat option. Vote yes.
    Like (28)
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    My father had ALS and lived 2 1/2 years with this horrible disease. Most of the time, drug trials take longer than this. If people with terminal illnesses are allowed to try treatments, they could live longer and possibly live long enough for a cure to be found. Please pass this bill!
    Like (28)
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    Just like a woman should be able to have control over her own body, a terminally ill patient should be able to make their own decisions that affect their health. As a hospice nurse, I support and encourage my patients to do what is right for them as they see fit.
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    If nothing else works, yes. Also, 1) Nobody can be sued for any outcome 2) Should be free since it's experimental. Maybe insurance, drug company, or government grants (If government funds though, they must receive profits later on)
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    My body my choice Butt out
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    If you're terminally ill, what have you got to lose.
    Like (13)
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    It's precisely not the government's job to protect people from themselves. Let people pursue whatever treatments they want, and let the buyer beware. How patronizing do you have to be to say "You're too dumb to make a decision in your own best interest, so I, who know better than you what is good for you, will prevent you." Get your arrogant self out of the way and stop patting yourself on the back for imposing your will on an autonomous human being! They're free to make their own decisions, for better or worse!
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    My husband had small cell carcinoma lung cancer. There was no cure. We wanted to try everything, anything. He had chemo therapy to no avail. It was the most excrutiating time of my liife when I lost him. He was my husband, true love, my best friend and my whole support system. If he was going to die, what difference would it have made if he undergone some experimental drug. If it worked, we could have rejoiced. If not, well..... he died anyway. Yes. I see as long as no harm is done to further the death of a loved one, why not?
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    People covered by this bill have nothing left to loose. It is no longer about quality of life, but a fighting chance at it. What's more, insurance should cover these treatments.
    Like (8)
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    Why do we keep having these terrible bills that are obviously meant to allow unscrupulous businesses to take advantage of vulnerable populations? No, Snake Oil Salesman should not be able to market their garbage that has not been proven to work to someone who is dying and desperate.
    Like (7)
    Follow
    Share
    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. Terminally ill people deserve the right to keep fighting for a chance to survive.
    Like (7)
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    Having walked with my husband through a terminal illness, yes, unequivocally yes, a person should have access to whatever treatment they and their doctors decide is best.
    Like (6)
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    Of course, but people will lose that choice if single payer is passed.
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