Tenth Amendment Center: Signed as Law: Nebraska Right to Try Act Rejects Some FDA Restrictions on Terminal Patients

From Tenth Amendment Center

...from Tenth Amendment Center

LINCOLN, Neb. (April 24, 2018) – Last Thursday, Nebraska Gov. Pete Ricketts signed a bill into law setting the foundation to nullify in practice some Food and Drug Administration (FDA) rules that deny access to experimental treatments by terminally ill patients.

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. This procedure directly conflicts with the federal expanded access program and sets the stage to nullify it in practice.

The unicameral legislature approved LB117 by a 35-13 vote. With Gov. Ricketts’ signature, the law goes into effect July 18.

The new law includes legal protections for healthcare providers.

“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 becomes 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.

“Americans shouldn’t have to ask the government for permission to try to save their own lives,” said Darcy Olsen, president of the Goldwater Institute. “They should be able to work with their doctors directly to decide what potentially life-saving treatments they are willing to try. This is exactly what Right To Try does.”

The results show that the 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 regulations would let them die rather than try has got to be one of the most inhumane policies of the federal government. Every state should take action to nullify the FDA like this.

Mike Maharrey
April 24, 2018 at 10:24AM