On May 30, 2018, the Right to Try Act was signed into federal law. This legislation gives terminally ill patients direct access to experimental treatments and eliminates Federal Drug Administration (FDA) application requirements. Nearly 40 states have already passed some version of Right to Try (RTT) over the last four years and the federal law is similar to the state laws.
Since 2009, there has been a process in place for terminally ill patients to access experimental treatments outside clinical trials (“expanded-access policies” or “compassionate use”). In this program, after all available treatment options have been exhausted, patients and their physician request access to experimental drugs from the FDA and drug manufacturers. By some estimates, the FDA has approved nearly 99% of Expanded Access requests. RTT is meant to be an alternative process for patients who do not qualify under the current FDA Expanded Access program.
RTT permits access to experimental drug therapies that have successfully completed an FDA Phase I clinical trial. (it is estimated that 11% of drugs that pass Phase 1 clinical trials ultimately get FDA approval) If the physician approves use of the experimental drug, a request is sent to the drug manufacturer petitioning for approval to use the treatment on behalf of the patient. Since the drug manufacturer is under no obligation to provide access to an experiment drug, they can approve or deny the request.
If approved, the manufacturer provides a price to the patient (actual cost plus shipping of the drug). Insurers are not mandated to cover drug costs nor the costs associated with complications, including hospitalization. If a patient participates in an employer-sponsored plan, they can decide to cover such costs if outlined in the plan document. There is no federal funding for this program. All costs are solely out- of-pocket and 100% at risk for the patient; liability has been waived for physicians and manufacturers of the drug/treatment. In some states with right-to-try laws, insurers can deny hospice care to patients who have used an experimental drug. Patient advocacy groups are concerned with patient safety due to the lack of safeguards.
The essence of the Bill can be viewed at: https://www.congress.gov/115/bills/hr878/BILLS-115hr878ih.xml