On May 30, 2018, President Donald Trump signed S.204, the Trickett Wendler, Frank Mongiello, Jordan McLinn and Matthew Bellina Right to Try Act. Right to Try opens a new pathway for terminally ill patients who have exhausted their government-approved options and can’t get into a clinical trial to access treatments. Although 41 states have passed Right to Try laws, the signing of S.204 makes Right to Try the law of the land, creating a uniform system for terminal patients seeking access to investigational treatments.
Who qualifies for Right to Try?
To be eligible for Right to Try, a patient must meet the following conditions:
- Be diagnosed with a life-threatening disease or condition;
- Have exhausted approved treatment options;
- Be unable to participate in a clinical trial involving the eligible investigational drug, as certified by a doctor, who is in good standing with her licensing organization and will not be compensated directly by the manufacturer for so certifying; and
- Give written informed consent regarding the risks associated with taking the investigational treatment.
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What is a life-threatening disease or condition?
Federal law defines a life-threatening disease or condition as: “Diseases or conditions where the likelihood of death is high unless the course of the disease is interrupted” (21 CFR 312.81).
What drugs or treatments qualify for Right to Try?
The treatments available under the law must meet the following conditions:
- Have completed an FDA-approved Phase 1 clinical trial;
- Be in an active clinical trial intended to form the basis of an application for approval or be the subject of an application for approval that has been filed with the FDA; and
- Be in ongoing active development or production and not discontinued by the manufacturer or placed on clinical hold.
I do not live in a state with a Right to Try law. Can I still use Right to Try?
Yes. S.204 makes Right to Try the law of the land. So long as a patient and treatment meet the qualifications of the federal law, Right to Try applies, regardless of whether the patient’s state adopted Right to Try.
Does medical cannabis qualify?
Right to Try only applies to treatments that have completed an FDA-approved Phase 1 clinical trial and remain under study in an active clinical trial. If there is a Phase 2 or 3 clinical trial for medical cannabis as a treatment of an underlying terminal condition, it may qualify.
Does a treatment that is already FDA-approved for something else qualify for Right to Try?
Doctors may already prescribe treatments ‘off-label.’ Off-label means prescribing an FDA approved treatment for a condition, dose, or population other than what the FDA approved. Therefore, no special permission is needed for a physician to prescribe treatments that are approved for other conditions. Right to Try applies to treatments that are being given to patients in clinical trials but are not already FDA approved.
What can companies charge for treatments?
Federal law bans companies from making a profit on any drug or treatment that has not been approved by the FDA, but the law does allow companies to recover the costs that are directly related to providing an individual treatment. Existing regulations govern what can and cannot be included in the calculation for determining the direct costs that can be charged. You can read that formula here.
This means that a patient could be charged for the direct costs of providing their individual treatment, but the company cannot make a profit.
How will payment work?
Just like with the FDA’s existing Expanded Access program, insurance companies and taxpayer-funded healthcare programs like Medicaid or Medicare are not required to cover the cost of investigational treatments, but they may choose to do so. Some insurance companies have covered the costs of investigational treatments used by patients under state Right to Try laws, but others have not. Each patient’s cost situation will be different and determined by their individual insurance company or program and their own financial resources.
How do I initiate a request?
The patient, the patient’s representative, or physician should send a letter to the drug manufacturer’s director of compassionate use or other designated representative to discuss options for access. A sample letter is provided here.
Where can I find a list of potential treatments?
If your physician is not yet aware of investigational treatments, there are several websites that can assist in locating potential treatments:
https://clinicaltrials.gov/
https://platform.emergingmed.com/find-clinical-trials/cri#partnerhome
https://www.cancer.gov/about-cancer/treatment/clinical-trials/search
Is a drug company required to make a treatment available?
No. Drug companies are not required to provide treatments to patients under Right to Try laws. It would not be appropriate to force companies to provide treatments that they do not think are the right fit for a patient or if they do not have enough supply to provide the treatment outside of its clinical trial.
Can I make my doctor submit a request for a treatment I want to try?
No. Doctors have a responsibility to ensure that patients are given treatments that they believe, in their professional opinion, could help them. A doctor who does not think a treatment will help is not obligated to make a request for the treatment. In addition, doctors who pursue treatments under Right to Try must be in good standing with their state licensing or certifying board, and they cannot be compensated for certifying that patients qualify for Right to Try.
How will a company decide if they will give me the treatment?
Each company will develop its own process and procedures for approving Right to Try requests.
5 Reasons for Right To Try
Right To Try is needed because most terminal patients cannot participate in clinical trials.
Most people with a terminal illness are too sick to be selected.
Right To Try is needed because dying people don’t have access to promising treatments once clinical trials are over, even if the drug was successful and will be approved.
For the lucky few terminal patients who get selected for clinical trials, their luck runs out once the trials are over
Right To Try is needed because the FDA compassionate use process doesn’t help enough people.
The application process is complicated, time-consuming, and expensive.
Right To Try is needed because it takes too long for promising treatments to be approved.
On average, it takes more than ten years for drugs to make it through the clinical trial process and receive approval in the U.S.
Right To Try is needed because you shouldn’t have to ask the federal government for permission to try to save your own life.
There is no more fundamental freedom we have than the freedom to try to save our own life.
Video: Everyone Deserves the Right to Try