HARRISBURG, Pa. (Oct. 12, 2017) – Yesterday, Pennsylvania Gov. Tom Wolf signed a bill into law 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.
Rep. Robert Godshall (R-Hatfield) sponsored House Bill 45 (HB45), along with nearly 40 cosponsors. The new law gives terminally ill patients access to medicines and treatments 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.
HB45 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.
Read more at The Tenth Amendment Center
(The opinions in this article are the opinions of the author and do not necessarily represent the views of Southern Nation News or SN.O.)