ALBANY, N.Y. (Jan. 9, 2017) – Two bills introduced in the New York state legislature would nullify in practice some Food and Drug Administration (FDA) rules that deny access to experimental treatments by terminally ill patients.
Asm. Linda Rosenthal (D-Manhattan) introduced Assembly Bill 3932 (A3932) with 10 co-sponsors while Sens. Kemp Hannon (R-Nassau) and Sen. Kathleen Marchione (R-Saratoga) introduced S2044 to allow 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.
A3932 and S2044 would create a process to 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.
Many states have already passed reforms similar to A3932 and S2044, and the results show that the impact of Right to Try isn’t merely …
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.)