TRENTON, N.J. (Feb. 22, 2018) – Two bills introduced in the New Jersey state legislature 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. Joseph Vitale (D-Middlesex) introduced Senate Bill 955 (S955) and Rep. Pamela Lampitt (D-Cherry Hill) introduced Assembly Bill 1830 (A1830) with three bipartisan co-sponsors. Both bills are continuations from initiatives that were pursued during the previous legislative session. The bills 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.
S955 and A1830 would create 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 proposed laws would …
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.)