COLUMBIA, S.C. (June 5, 2016) – On Friday, South Carolina Gov. Nikki Haley signed into law a bill that sets the foundation to nullify in practice some Food and Drug Administration (FDA) rules that deny access to experimental treatments by terminally-ill patients.
A bipartisan coalition of seven Representatives sponsored House Bill 4542 (H.4542). The new law gives terminally ill patients a path to some treatments that have not been 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.
H.4542 would bypass 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.
The House passed the measure 71-25 back in March. Meanwhile, the Senate unanimously passed a similar bill (S.929) in February. On May 31, the Senate took up the House bill and passed an amended version 42-0. The House concurred with the amendments 78-17 the following day.
Haley signed the bill on Friday.
H.4542 prohibits any state agency from interfering with access to experimental treatments.
“No official, employee, or agent of this State shall block or attempt to block an eligible patient’s lawful access to an investigational drug, biological product, or…