The Right to Try Act, or the Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act, was signed into law May 30, 2018. This law is another 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 unapproved treatments.

Treatment with a drug or biologic under the Right to Try Act is different than a clinical trial or the FDA’s expanded access program.  Drugs received under the Right to Try Act do not fall under the oversight of research though the drugs eligible are those still under clinical trial investigation (i.e. not approved by the FDA).  Per the FDA, a Right to Try drug does not require IRB review and/or approval.  Additionally, the FDA does not review or approve requests for Right to Try Act drug use. 

Insurance companies and healthcare programs like Medicaid or Medicare are not required to pay for the cost of an investigational treatment, but they may elect to do so. Some have and some have not covered the costs of investigational treatments used by patients under the Right to Try law.  The patient may be responsible for the full cost of the drug.  This cost should be outlined within the informed consent and the possibility the patient may be responsible for the cost.

Please review this Fact Sheet for more information.

Physicians interested in using a drug or biologic under the Right to Try should discuss it with their entity’s Chief Medical Officer.