LINCOLN, Neb. (July 19, 2018) – Today, a Nebraska law went into effect that allows terminally ill patients to bypass some Food and Drug Administration (FDA) rules that deny access to experimental treatments.
Sen. Bob Hilkemann (R-Omaha) introduced Legislature Bill 117 (LB117) last year and it carried over into the 2018 session. The new law gives terminally ill patients access to medicines not yet given final approval for use by the FDA.
The Federal Food, Drug, and Cosmetic Act prohibits general 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. LB117 creates a process to bypass the FDA expanded access program and allows patients to obtain experimental drugs from manufacturers without first obtaining FDA approval.
On May 30, 2018, Pres. Donald Trump signed a federal Right to Try Act into law. At the time Trump inked his signature on the bill, patients in 39 U.S. states already had access to experimental treatments thanks to state Right to Try laws. The federal Right to Try Act is an example of …
Read more at The Tenth Amendment Center
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