ATLANTA, Ga. (July 1, 2025) – Today, a new law that significantly expands the state’s “Right to Try” process went into effect, 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As originally enacted in 2016, the Georgia Right to Try enabled terminally ill patients to access medications and treatments that do not have final FDA approval. Sponsored by Matt Brass and a large coalition of cosponsors, Senate Bill 72 (SB72) expands the law to allow non-FDA-approved treatment options for patients suffering from severely debilitating or life-threatening illnesses.
The Senate passed SB72 by a 56-0 vote. The House approved the measures 161-0. With Gov. Brian Kemp’s signature, the law went into effect July 1.
Under the new law, qualified patients can access individualized investigational treatments that have not been approved by the FDA. This includes individualized gene-based and biologic treatments, neoantigen therapies, and some perinatal-derived biologics. 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, Georgia patients will be able to access a broader range of treatment options without dealing with FDA bureaucratic red tape.
While SB72 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 Georgia, meaning SB72 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.
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 SB72 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.
