BATON ROUGE, La. (May 24, 2016) – Yesterday, the Louisiana Senate passed a bill that would expand the state’s current “Right to Try” law. It now goes on to the governor’s desk for his signature.
Last year, the Louisiana legislature passed, and the governor signed,“Right to Try” legislation giving terminally ill patients access to medicines not yet given final approval for use by the FDA. Earlier this year, Rep. Julie Stokes (R-Kenner) introduced a bill to improve the new law.
House Bill 232 (HB232) would add a limits of liability provision to the state’s current “Right to Try” law. Passage would provide additional legal protections for manufacturers and healthcare workers.
“Nothing in this section shall be construed as creating a cause of action by or on behalf of any person against a manufacturer of an investigational drug, biological product, or device, or against any person or entity involved in the care of an eligible patient using and investigational drug, biological product, or device, for any harm done to the eligible patient resulting from the investigational drug, biological product, or device.”
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.
Louisiana Right to Try bypasses the FDA expanded access program and allows patients to obtain experimental drugs from manufacturers without first obtaining…