HELENA, Mont. (Oct. 1, 2023) – Today, a Montana law that significantly expands the state’s “Right to Try” process went into effect, setting the foundation to nullify in practice Food and Drug Administration (FDA) rules that deny access to experimental treatments to patients in Montana.
As originally enacted, Right to Try enabled terminally ill patients to access medications and treatments that do not have final FDA approval. The enactment of SB422 expands the law to enable any patient to access medications and treatments not yet given final approval for use by the FDA. SB422 simply removes all patient eligibility requirements from the current law.
The Federal Food, Drug, and Cosmetic Act generally prohibits access to experimental drugs. However, under the expanded access provision of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. 360bbb, patients with serious or immediately life-threatening diseases may access experimental drugs after receiving express FDA approval. Right to Try allows terminally ill patients to bypass the expanded access provision and obtain experimental drugs from manufacturers without first obtaining FDA permission.
Congress passed a federal Right to Try law in 2018 after 40 states enacted Right to Try laws allowing terminally ill patients to effectively bypass the FDA and try experimental treatments without federal permission.
The federal government had little choice but to step in after states took the initiative given the success of state Right to Try laws. For instance, after the Texas Right to Try law went into effect, at least 78 patients in Texas received an experimental cancer treatment not allowed by the FDA.
The passage of SB422 to expand on the foundation established by Right to Try for terminally ill patients demonstrates an important strategic point. Passing bills that take a small step forward sets the stage, even if they are limited in scope. Opening the door clears the way for additional steps. You can’t take the second step before you take the first.
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