Right-to-try laws

Right-to-try laws are U.S. state laws that were created to let terminally ill patients try experimental therapies (drugs, biologics, devices) that have completed Phase 1 testing but have not been approved by the Food and Drug Administration (FDA). These laws' value has been called into question on multiple grounds, including the fact that they do not require pharmaceutical manufacturers to provide the therapies that patients are seeking.

In May 2014, Colorado became the first state to pass a right-to-try law. As of May 2017^[update], 37 states have enacted such laws: Alabama, Arizona, Arkansas, California, Colorado, Connecticut, Florida, Georgia, Idaho, Iowa, Illinois, Indiana, Kentucky, Louisiana, Maine, Maryland, Michigan, Minnesota, Mississippi, Missouri, Montana, Nevada, New Hampshire, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, West Virginia, and Wyoming.

The chief advocate of right-to-try laws is the Goldwater Institute, a libertarian think tank based in Arizona, which created the legislation template on which the state laws are modeled. Kurt Altman, national policy adviser for the Institute, has said that right-to-try laws return control of medical decisions "back to a local level". Other proponents include patients and their families, as well as patient advocate groups. Supporters of these laws sometimes describe them as "Dallas Buyers Club" bills, a reference to a movie about an American man with AIDS who smuggled unapproved treatments from foreign countries to fellow patients. Some have likened the efforts of terminally ill patients to procure unapproved drugs in development to those of ACT-UP and other AIDS organizations of the 1980s.

One ethical argument for the right to try unapproved treatments is that if patients have the right to die through physician-assisted suicide or voluntary euthanasia, they should also be afforded the right to try. Some argue that the right to die devalues the lives of people with terminal illness and tacitly encourages them to take their own lives, rather than advocate for them to seek potentially life-saving treatment.

Bioethicists and other scholars have questioned the extent to which right-to-try laws will actually benefit patients. Jonathan Darrow, Arthur Caplan, Alta Charo, Rebecca Dresser, and others have pointed out that the laws do not require physicians to prescribe experimental therapies, do not require insurance companies to pay for them, and do not require manufacturers to provide them. Because the laws do not actually provide a right to receive experimental therapies, they could be considered toothless legislation that offers only false hope to dying people. Even if the laws worked as intended, they would be problematic to critics. Because the laws require only that drugs have completed the first of three phases of clinical testing, there is no data on the efficacy of the drugs, especially in very sick people. There is also no safety data on how they would affect very sick people. This makes true informed consent on the part of the patient impossible, because informed consent entails, first, knowledge of the pros and cons of a proposed treatment and then a decision made in light of those pros and cons. Some states’ right-to-try laws also put patients at risk of losing hospice or home health care, and the costs surrounding treatment can be prohibitive, something right-to-try laws do not fix. Bioethicist Alta Charo called the laws “a simplistic way of going after much more complicated issues.”

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