LINCOLN, Neb. (April 19, 2018) – On Wednesday, the Nebraska legislature gave final approval to a bill that would set the foundation to nullify in practice some Food and Drug Administration (FDA) rules that deny access to experimental treatments by terminally ill patients.
Sen. Bob Hilkemann (R-Omaha) introduced Legislature Bill 117 (LB117) last year and it carried over into the 2018 session. The legislation would give 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. This procedure directly conflicts with the federal expanded access program and sets the stage to nullify it in practice.
The unicameral legislature approved LB117 by a 35-13 vote. It now heads to Gov. Pete Ricketts’ desk for his consideration.
LB117 provides protection to …
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