HELENA, Mont. (March 7, 2023) – Last week the Montana Senate passed a bill that would significantly expand the state’s “Right to Try” law, setting the foundation to nullify in practice additional Food and Drug Administration (FDA) rules that deny access to experimental treatments to patients in Montana.
Sen. Kenneth Bogner (R) introduced Senate Bill 422 (SB422) on Feb. 20. The legislation would expand the Montana Right to Try law that was passed in March 2015. This law currently enables terminally ill patients to access medications and treatments that do not have final FDA approval.
The enactment of SB422 would expand the law to enable any patient to access medications and treatments not yet given final approval for use by the FDA. SB422 would simply remove all patient eligibility requirements from the current law.
On March 2, the Senate passed SB422 by a 38-12 vote.
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 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 introduction 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 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.
SB422 will move to the House for further consideration. At the time of this report, it had not been referred to a House committee. Once it receives a committee assignment, it will need to get a hearing and pass by a majority vote before moving forward in the legislative process.
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