OKLAHOMA CITY (Apr. 21, 2015) – A bill that would nullify in practice certain Food and Drug Administration (FDA) rules that prevent terminally ill patients from accessing treatments was signed into law by Gov. Fallin today. Oklahoma is now the 15th state to pass such a bill into law.
Rep. Richard Morrissette (D-92), along with a bipartisan group of five other representatives, introduced House Bill 1074 (HB1074) on Feb. 2. The Oklahoma Right to Try Act pushes back against the FDA and their controversial methodology of withholding experimental treatments from people on their deathbed.
It passed through the state House with a unanimous 96-0 vote 3, and passed through the state Senate with a unanimous 44-0 vote.
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. HB1074 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 who prescribe these drugs to patients are shielded from liability under HB1074. The text of the bill states that “a licensing board may not revoke, fail to renew, suspend or take any action against a health care provider’s license, 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, as long as the recommendations are consistent with medical standards of care.” The legislation also prohibits action against a health care provider’s Medicare certification based solely on the recommendation that a patient have access to an experimental medical treatment.
Manufacturers receive some protection from liability under the proposed law. HB1074 states that the law would not create a “private cause of action” against a manufacturer or others involved in care as long as they comply in good faith with the terms of the act.
Legislatures in fourteen other states have already passed Right to Try Laws similar to this Oklahoma 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.
The bill represents a positive first step to help terminally-ill patients from FDA restrictions that can kill.
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