Right To Try Helps Navy Pilot Improve

Per the FDA, " The Right to Try Act is one way for patients who have been diagnosed with life-threatening diseases or conditions who have tried all approved treatment options and who are unable to participate in a clinical trial to access certain investigational treatment options. FDA’s role in implementing the Right to Try Act is limited to receiving and posting certain information submitted to the agency. 

 

For patients with serious or immediately life-threatening diseases or conditions, FDA remains committed to enhancing access to promising investigational medicines for those unable to access investigational medical products through clinical trials. This is the mission of our Expanded Access program. The agency is dedicated to these purposes, and it has been for more than three decades.

 

The Right to Try Act allows eligible patients to have access to eligible investigational drugs.

A patient who is eligible for Right to Try is a patient who has:

• Been diagnosed with a life-threatening disease or condition;

• Exhausted approved treatment options and is unable to participate in a clinical trial involving the eligible investigational drug (this must be certified by a physician who is in good standing with their licensing organization or board and who will not be compensated directly by the manufacturer for certifying); and

• Provided, or their legally authorized representative has provided, written informed consent regarding the eligible investigational drug to the treating physician.

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An eligible investigational drug is an investigational drug:

• For which a Phase 1 clinical trial has been completed;

• That has not been approved or licensed by FDA for any use;

• For which an application has been filed with FDA or is under investigation in a clinical trial that is intended to form the primary basis of a claim of effectiveness in support of FDA approval and is the subject of an active investigational new drug application (IND) submitted to FDA; and

• Whose active development or production is ongoing, and that has not been discontinued by the manufacturer or placed on clinical hold by FDA.

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If you are interested in Right to Try, you should discuss this pathway with your doctor. Companies who develop and make drugs and biological products can provide information about whether their product is considered an eligible investigational drug and whether they are able to provide the product under the Right to Try Act. Ultimately, companies developing drugs for life-threatening diseases or conditions are responsible for determining whether to make their products available to patients who qualify for access under the law."