California Governor Jerry Brown recently signed legislation allowing terminally ill patients in his state to have access to experimental drugs that have not yet been approved by the United States Food and Drug Administration (“FDA”). This recent stamp of approval stands in stark contrast to his veto last year of a similar bill, then saying that the FDA already has a program in place to allow for the use of experimental drugs and that he wanted to see whether changes in the FDA’s Compassionate Use program would reduce the minimum thirty-day waiting period for experimental drugs.
While the FDA did streamline the process by which patients can apply for expanded access or compassionate use to obtain experimental drugs, the new California law goes even further, allowing patients to entirely circumvent the FDA.
Under the legislation, patients must meet a variety of requirements to qualify for the program, including a requirement that they have only a matter of months to live and that two doctors recommend they try the experimental drug. Additionally, drug makers and device manufacturers would not be required to accommodate a patient’s request for experimental products. It also provides protection for insurers, limiting their liability for outstanding debt related to the treatment if the patient dies.
This legislation is significant, in part because it follows a path that voters in California started twenty years ago: back in 1996, California voters passed Proposition 215 to legalize medical marijuana. According to California Assemblyman Ian Calderon, author of the bill, “terminally ill patients in our state will finally have access to potentially life-saving treatments.”
Around the United States
Right to try legislation has been enacted in thirty-one other states, including Arizona, Colorado, Connecticut, Florida, Georgia, Louisiana, North Carolina, South Carolina, Virginia, and Wyoming, crossing political parties and regional differences. New Mexico is the only state that has not seen a right to try bill introduced. The primary driver behind these laws has been the Goldwater Institute, which offers model legislation to states and their legislators. The model legislation serves as the basis for laws that have been passed in most states.
Tension in the Industry
Though California is the thirty-second state in the United States to enact such legislation, there is still a vocal and tense argument between two camps within the healthcare industry: those who support such legislation, and those who oppose it.
Opposition
Those who oppose such legislation, including oncologists and medical ethicists, believe that access to experimental drugs offers false hope to those with life-threatening illnesses and that experimental drugs have only a limited change of actually working and that pharmaceutical companies have no obligation to offer drugs that are still working their way through trials.
Opposition also notes that Right to Try laws “permit access to experimental drugs after they have passed only Phase 1 trials. At this point in drug development, there is scant evidence about basic safety of the new substance and virtually no data that proves its efficacy in treating the targeted disease. Yet the right to try movement suggests that these early interventions are a magic pill, and that cures are being withheld from dying people solely because of government red-tape or for financial reasons. Even if there were such impediments, the implication that a drug that passes Phase 1 is a cure — and a cure that would not pose substantial risk of pain, injury, or earlier death — is unsupportable.”
Support
Proponents of right to try legislation believe that such laws provide options to patients who cannot wait for drugs to make their way through the FDA’s arduous approval process. According to righttotry.org, “Right to Try Laws give people with terminal illnesses the legal right to use investigational medications years before they might otherwise be on the market. No one can guarantee that a particular treatment will be effective, but these laws return choice and control over treatment options to where it is most effective: with patients and their doctors.”