From Tenth Amendment Center
LINCOLN, Neb. (July 19, 2018) – Today, a Nebraska law went into effect that allows terminally ill patients to bypass some Food and Drug Administration (FDA) rules that deny access to experimental treatments.
Sen. Bob Hilkemann (R-Omaha) introduced Legislature Bill 117 (LB117) last year and it carried over into the 2018 session. The new law gives 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. LB117 creates a process to bypass the FDA expanded access program and allows patients to obtain experimental drugs from manufacturers without first obtaining FDA approval.
On May 30, 2018, Pres. Donald Trump signed a federal Right to Try Act into law. At the time Trump inked his signature on the bill, patients in 39 U.S. states already had access to experimental treatments thanks to state Right to Try laws. The federal Right to Try Act is an example of the feds arriving late to a party. The movement started nearly five years ago when Colorado Gov. John Hickenlooper signed the first state Right to Try bill into law. State action drove this change, and it’s almost certain Congress would have never passed Right to Try if the states hadn’t acted first.
The new federal law does not render the state right to try irrelevant. While the federal law creates a uniform standard, state laws provide doctors, drug manufacturers and patients important protections. As Goldwater Institute spokesperson Jennifer Tiedemamm pointed out, states have their own standards for tort liability, medical licensure, and other legal issues that the federal law does not address.
For instance, the new Nebraska law includes legal protections for healthcare providers under state law.
“A good-faith recommendation to an eligible patient regarding access to treatment with an investigational drug, biological product, or device shall not subject the health care provider to discipline or an adverse licensure action.”
It also specifically prohibits any state agent from blocking a patient’s access to investigational treatments.
No official, employee, or agent of this state may block or attempt to block an eligible patient’s access to an investigational drug, biological product, or device. Counseling, advice, or recommendations consistent with medical standards of care from a licensed health care provider is not a violation of this section.
Nebraska was the 40th state put a Right to Try law on the books. Although these laws only address one small aspect of FDA regulation, they provide 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. And when enough states defy the feds, Congress will eventually follow along. This demonstrates the effectiveness of a bottom-up strategy for limiting federal power.
The results show that the practical impact of Right to Try isn’t merely theoretical.
Since the Texas Right to Try law went into effect in June 2015, at least 78 patients in the Lone Star State have received an experimental cancer treatment not allowed by the FDA. While the FDA would have allowed these patients to die, Houston-based oncologist Dr. Ebrahim Delpassand continued their treatment through the Texas law. (Watch a video about Dr. Delpassand here.)
The Right to Try Act is a no-brainer. When someone is on their deathbed, the fact that FDA ever maintained regulations would let them die rather than try has got to be one of the most inhumane policies of the federal government.
Mike Maharrey
July 19, 2018 at 01:39PM
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