DENVER, Colo. (June 30, 2025) – A Colorado law that significantly expands the state’s “Right to Try” process went into effect last month, setting the foundation to further nullify in practice Food and Drug Administration (FDA) rules that limit or deny access to experimental treatments.
As originally enacted in 2014, the Colorado Right to Try enabled terminally ill patients to access medications and treatments that do not have final FDA approval. Sponsored by Rep. Rose Pugliese, Rep. Lindsay Gilchrist and a large coalition of cosponsors, House Bill 1270 (HB270) expands the law to allow non-FDA-approved treatment options for patients suffering from severely debilitating or life-threatening illnesses.
The House passed HB270 by a 64-0 vote. The Senate approved the measure by a 33-0 vote. With Gov. Jared Polis’s signature on May 19, the law went into immediate effect.
Under the new law, qualified patients can access individualized investigational treatments that have not been approved by the FDA. This includes drugs, biological products, or devices that are unique and produced exclusively for use by an individual patient based on their own genetic profile, such as gene therapy, antisense oligonucleotides, and neoantigen vaccines. The law does not even require that the treatments be in clinical trials.
This state law goes beyond the FDA’s “expanded access” compassionate use policy, which is more narrowly regulated and requires FDA authorization on a case-by-case basis. In practice, Colorado patients will be able to access a broader range of treatment options without dealing with FDA bureaucratic red tape.
While HB270 does not override federal law and the FDA could theoretically intervene, the new law explicitly removes state-level barriers and enforcement. The FDA does not have the personnel or resources to police Colorado, meaning HB270 will effectively nullify FDA regulations.
Based on James Madison’s advice for states and individuals in Federalist #46, a “refusal to cooperate with officers of the Union” provides an extremely effective method to render federal laws effectively unenforceable because most enforcement actions rely on help, support, and leadership from the states.
The federal government relies heavily on state cooperation to implement and enforce almost all of its laws, regulations, and acts. By simply withdrawing this necessary cooperation, states can nullify, in effect, many federal actions. As noted by the National Governors Association during the partial government shutdown of 2013, “states are partners with the federal government on most federal programs.”
BACKGROUND
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.
Colorado was the first state to pass right to try back in 2014.
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 HB270 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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