RIGHT TO TRY

The federal Right-to-Try law was passed in 2017. This law allows for terminally ill patients to receive experimental drugs in an attempt to prolong their lives as long as the patient and the trial medication both meet specific requirements.

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The Right-to-Try laws give terminally ill patients one last chance to attempt to save their own lives by applying to trail drugs that have not yet been FDA approved. Although similar, this law differs from the already standing expanded access law in that for expanded access, FDA permission is required.

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 The first patient to enact the right to try law was a man suffering from stage 4 glioblastoma. The patient applied to test the experimental medication, Gilovac, from the University of California, Irvine. During the trial, there was a visible decrease in the size of the brain tumor and the patient was able to prolong his life for 7 months. Later the university stated that this patient was in poor health to begin with and that another patient after had shown signs of remission using this medication as of November 2019. However, although these two patients had the chance to try this medication, not many patients are quite as lucky.

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 Patients who enact this law and apply for medications that have not yet been approved by the FDA, are not guaranteed the medication, it is entirely up to the manufacturer whether or not the patient gets approved. If the manufacturer feels as though the results or outcome of the trial patient could affect the overall outlook of the drug, the company may reject them. Since the FDA has not approved of these investigational medications, this also means that there is little known to the researchers and to the patients about what side effects the medications may have. The FDA also in this case is not able to offer safer alternatives to investigational drugs because they are not involved in any of the process with this law. Since the FDA is removed as a mediator during this process, there is greater chance for illegitimate companies to pop up and offer investigational drugs to vulnerable patients. Though they may be actively involved in research, they are also seeking monetary gain and may not be truly concerned with the potential harm that could come to the patient.

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A lot of people also do not realize the cost of receiving these medications. Some of these medications and trials can cost them millions of dollars. Most people do not have that kind of money, especially those who are terminally ill and are riddled with medical bills. People who do not have access to health care and those who are uneducated are also at a disadvantage because they are usually unaware of what kind of experimental drugs and treatments are out there and they don’t really have a way to find out. Most uneducated people will also be unable to complete the application process.

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Sources

“Right to Try.” U.S. Food & Drug Administration (January 14, 2020).

“The Realities of “Right to Try.”” ASH Clinical News (October 1, 2018).

Caplan, Arthur. “’Right-to-Try’ laws provide little access to investigational drugs. We created a process that does.” STAT News (June 3, 2019).

Coughlin, Christine, Nancy King, and Melissa McKinney. “Regenerative Medicine and the Right to Try.” Wake Forrest Journal of Business and Intellectual Property Law, Vol. 18, No. 4 (June 2018): 590-594

Howard, Jacqueline. “What you need to know about right-to-try legislation.” CNN Health (May 29, 2018).

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