What Is the Right-to-Try Law for Terminally Ill Patients?

The federal Right-To-Try Act gives terminally ill patients access to experimental medications that are not yet FDA-approved. This law means those diagnosed with a terminal illness have a right to acquire unapproved medications or biologics that may alleviate their specific condition or prolong life. The bill was signed into law by President Donald  Trump on May 30, 2018, granting patients access to investigational drugs when all other treatments or clinical trials have been exhausted. While 38 states had previously passed similar laws, this Right-To-Try law is nationwide.

The law requires that patients meet certain qualifications to be eligible for participation: 

• The patient must be diagnosed with a terminal disease or condition 
• The patient must have exhausted all approved treatment options.
• The patient must be deemed ineligible to participate in clinical trials that might otherwise lessen or cure their disease.
• The experimental drug must have already passed FDA phase 1 clinical testing
• The pharmaceutical manufacturer must approve the use of the drug as an experimental treatment
• A treating physician or health care provider must recommend and approve the use of the drug for the patient.
• The patient must provide written informed consent regarding risks associated with the treatment

It is important to note that Right-To-Try medications do not include those that may be prescribed for off-label use by a physician, as these drugs are already approved by the FDA for other conditions.

Key considerations before you pursue right-to-try medications

Under the Right to Try Act, pharmaceutical companies and physicians are immune from liability. Therefore, patients should have a full understanding of the pros and cons associated with any experimental treatment. The information provided by pharmaceutical companies can often be technical, or contain language that is difficult for the average person to grasp. Patients should always seek advice from their healthcare provider about the risks, benefits and alternatives to any treatment they seek. 

Additionally, while the outcome of experimental therapies may be beneficial or even lifesaving for some terminally ill patients, misconceptions about their projected success rate can foster a false sense of hope. Further, since these therapies have only been tested in small clinical trials, the scope of potential side effects and toxicities is largely unknown. These effects can be significant and potentially worsen a patient’s condition or cause serious detriment to their quality of life. 

Paying for right-to-try medications

According to the FDA, drug companies do have a right to charge for investigational products. Before accessing a right-to-try treatment, patients should check with their health insurance provider to verify what will be covered and what will not. Most often, insurers, including Medicare and Medicaid, do not cover the cost of these medications.

Sources

“S.204 – Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017”. Congress.gov. https://www.congress.gov/bill/115th-congress/senate-bill/204/text

“Development & Approval Process | Drugs”. U.S. Food & Drug Administration. https://www.fda.gov/drugs/development-approval-process-drugs

“What Are “Biologics” Questions and Answers”. U.S. Food & Drug Administration. https://www.fda.gov/about-fda/center-biologics-evaluation-and-research-cber/what-are-biologics-questions-and-answers

“Assessment of the Right-to-Try Law: The Pros and the Cons”. The Journal of Nuclear Medicine. https://jnm.snmjournals.org/content/59/10/1492