BISMARCK, N.D. (Apr. 17, 2015) – A North Dakota bill that would nullify in practice some Food and Drug Administration (FDA) rules that prevent terminally ill patients from accessing treatments was signed into law by Governor Jack Dalrymple this week.
The North Dakota Right to Try Act was introduced by Sen. Tim Mathern (D) and five cosponsors. Senate Bill 2259 (SB2259) serves as pushback against the FDA and its controversial methodology of approving drugs for mass consumption.
It passed through the state Senate with a 32-15 vote, and passed unanimously through the state House with a 91-0 vote. It was signed into law by Gov. Dalrymple on April 15.
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. SB2259 bypasses the FDA expanded access program and allows patients to obtain experimental drugs from manufacturers without obtaining FDA approval. This procedure directly conflicts with the federal expanded access program and effectively nullifies it in practice.
“The Right to Try Act is a no-brainer,” said Mike Maharrey of the Tenth Amendment Center. “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 nullify the FDA like this.”
Health care providers are also protected under the bills, with a prohibition against revoking a license, lawsuits or issuing sanctions based on recommendation or issuance of such investigational treatments. SB2259 reads, in part:
A licensing board may not revoke, fail to renew, suspend, or take any action against a health care provider’s license issued in this state, based solely on the health care provider’s recommendations to an eligible patient regarding access to or treatment with an investigational drug, biological product, or device, if the recommendations are consistent with medical standards of care. Action against a health care provider’s medicare certification based solely on the health care provider’s recommendation that a patient have access to an investigational drug, biological product, or device is prohibited…
This chapter does not create a private cause of action against a manufacturer of an investigational drug, biological product, or device or against any other person involved in the care of an eligible patient using the investigational drug, biological product, or device, for any harm done to the eligible patient resulting from the investigational drug, biological product, or device, if the manufacturer or other person complied in good faith with the terms of this chapter. However, this chapter does not limit a private cause of action against a manufacturer or other person if there was a failure to exercise reasonable care.
SB2259 is an important step in the right direction toward health freedom. Legislatures in thirteen other states have already passed Right to Try Laws similar to this North Dakota bill, and more than 20 states are considering such measures in 2015.
Although these laws only address one small aspect of FDA regulation, they provide us with a clear model demonstrating how to nullify federal statutes that violate the Constitution. The strategy narrows the influence of nullification to limited aspects of the law itself. The strategy works because it focuses on ending specific federal policies large numbers of Americans from across the political spectrum oppose.
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