You Have The Legal Right To Try

The Right to Try Act was signed into law in 2018, providing terminally ill patients with the right to utilize experimental medications that are still pending Food and Drug Administration (FDA) approval.

In the United States, all pharmaceuticals are regulated by the FDA. For a medication to be prescribed to a patient by a physician, it must meet with FDA approval standards. To achieve this approval, pharmaceutical companies must go through a lengthy, three-phase process. The FDA approval process centers around rigorous clinical trials, in order to scientifically prove that the drug safely and effectively treats the condition.

The Right to Try Act was enacted thanks to advocates who made and effective argument that people with terminal illnesses could be receiving life-saving medications that are not yet available because the human clinical trials being conducted for FDA approval are not yet completed. The act allows physicians to prescribe medications that are in the FDA Phase 1 clinical trials.

While the Act allows physicians to treat their patients with experimental medications in development, it does not give them the actual right to freely access them and obtain coverage through traditional insurance. This is not to say that experimental drugs and therapies will not be required to achieve FDA approval. It simply means that someone with a terminal illness, who have tried and failed traditional, FDA approved therapy, has a chance to extend their life – or even be cured of their disease.

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.

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).

We invite anyone diagnosed with a life-threatening disease or condition, who has exhausted approved treatment conditions, to contact Seraph Medical.