Often those with terminal illnesses wish to try new experimental therapies. Now they can if they are willing to accept the risks. On May 30, 2018, President Trump signed into law the Right to Try Act.[1] The Act allows eligible patients to receive drugs that are not FDA-approved but have passed phase I clinical trials. For a patient to be eligible, he or she must be diagnosed with a life-threatening disease or condition, exhausted all other treatment options including being unable to participate in a clinical trial, and give informed consent. Life-threatening diseases and conditions are defined as having a high likelihood of death unless the course of the disease is interrupted, or with potentially fatal outcomes where the end point of clinical trial analysis is survival.[2] The Act protects manufacturers, dispensers and prescribers from liability for providing or administering therapies that comply with the new law.
Companies are already taking advantage of the new law. For example, Therapeutic Solutions International recently announced that it will provide access to its clinical stage cancer immunotherapy product StemVacs.[3] It is hoped that the Right to Try law will benefit patients awaiting FDA approval on promising therapeutics.
Right to try legislation has been discussed in countries outside of the U.S. but relatively few countries have passed it into law. In recent years, Japan and Mexico have enacted right to try laws.[4, 5] This has resulted in several new experimental drugs being used for the first time in terminally ill patients. The opening of a right to try clinic across the U.S. border in Mexico also encouraged “health tourism” for terminally ill U.S. patents who were willing to explore alternative treatments,[6] but if the U.S.’s Right to Try law works as hoped it may decrease the amount of health tourism.
References:
[1] https://www.congress.gov/bill/115th-congress/senate-bill/204/text?format=txt
[2] https://www.law.cornell.edu/cfr/text/21/312.81
[4] https://www.sciencedirect.com/science/article/pii/S2352320416300098
[5] https://www.ncbi.nlm.nih.gov/books/NBK223198/#sec_00038
[6] https://www.nytimes.com/2012/06/28/health/mexicali-lures-american-tourists-with-medical-care.html
