JACKSON, Miss. (Feb. 27, 2016) – A Mississippi bill that would that would improve existing law nullifying in practice some Food and Drug Administration (FDA) rules that deny access to experimental treatments by terminally ill patients passed out of the state Senate Thursday.
Last year, the Mississippi 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 month, Sen. Josh Harkins (R-Flowood) introduced a bill to improve the new law. Senate Bill 2527 (SB2527) would amend the current statute to provide tort immunity to any hospital rendering services to an eligible patient undergoing treatment with an investigational drug under Right to Try. It also clarifies that any health plan or third-party administrator is not liable for outstanding debt related to such treatment.
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.
Mississippi 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.
SB2527 provides additional legal protections for medical facilities and insurers, making it more likely patients will be able to access experimental treatments and medication under Mississippi law.
The bill passed the Senate 49-2 on Thursday.
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.
Twenty-four 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.
SB2527 will now move on to the House for further consideration.
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