What would you do if you were diagnosed with a terminal illness and told that your only hope for survival is a treatment that you cannot get because it has not been approved by the U.S. Food and Drug Administration (FDA) and you do not qualify for any clinical trials? What if it was your child who was going to die? You would fight tooth and nail to get that treatment. Even though it may not work and could have side effects, you should have the right to take that chance if you are definitely going to die otherwise.
That is the premise of “right to try” laws, and there are very few people who disagree with the idea. But, the legislation currently being pushed at the federal level may not accomplish what patients are hoping for and may actually do more harm than good.
Right to Try Laws
Thirty-three states currently have right to try laws and more are likely to pass them. These laws pass with overwhelming popular support and very few speak out against them. Who would? No one believes that terminally ill patients should be denied potentially life-saving treatments simply because the treatment hasn’t completed the lengthy approval process. “Sorry, folks, you have to just go ahead and die. It’s for your own safety.”
Now we have the Right to Try Act introduced at the federal level. The opposition is starting to speak out on several points. And there is one point in particular that is very concerning.
Withholding Negative Outcomes
If the federal right to try legislation passes in its current form, the FDA will not be able to use negative outcomes in the approval process. If someone tries an experimental treatment under the law, and the treatment injures or kills them, that information cannot be used or considered when regulators are deciding if the drug or product should ultimately be approved.
If right to try legislation is ultimately passed, there will still be hurdles for patients. Insurance companies typically do not pay for experimental treatments. Learn more by reading Top 5 Treatments Not Covered by Health Insurance.