BATON ROUGE, La. (Aug. 3, 2016) – On Monday, a new law that strengthens Louisiana’s Right to Try Act went into effect.
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) adds a limits of liability provision to the state’s existing “Right to Try” law. The revisions strengthens Right to Try by 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 FDA approval. This procedure directly conflicts with the federal expanded access program and sets the stage to nullify it in practice.
The additional legal protections offered by the new lawmakes it more likely that patients will be able to access experimental treatments and medication under Louisiana law.
Although Right to Try only addresses one small aspect of FDA regulation, it provides a clear model that demonstrates how to nullify federal statutes that violate the Constitution. The strategy narrows the influence of nullification to limited aspects of the law itself, which has proven to be very effective.
More than two-dozen states currently have Right to Try in place. The rapid progress of this legislation and the Mississippi legislature’s efforts to improve its law shows that Americans from across the political spectrum intuitively understand that these FDA regulations are harmful and must be mitigated through state-level action.