On June 10, 2016, A West Virginia law setting the foundation to nullify in practice some Food and Drug Administration (FDA) rules that deny access to experimental treatments by terminally ill patients went into effect.
A bipartisan coalition of four representatives introduced Senate Bill 416 (SB416) back in January. The legislation gives terminally ill patients access to medicines not yet given final approval for use by the FDA.
The House passed an amended version of SB416 100-0. The Senate originally approved the measure by a vote of 33-0 and then unanimously concurred with House amendments. Gov. Earl Ray Tomblin signed the bill on March 23, and it went into effect last month.
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.
The West Virginia Right to Try law bypasses the FDA expanded access program and allow 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.