CHARLESTON, W. VA. (June 10, 2016) – A West Virginia 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 is now in effect.
A bipartisan coalition of four representatives introduced Senate Bill 416 (SB416) back in January. The legislation gives terminally ill patients access to medicines not yet given final approval for use by the FDA.
The House passed an amended version of SB416 100-0. The Senate originally approved the measure by a vote of 33-0 and then unanimously concurred with House amendments. Gov. Earl Ray Tomblin signed the bill on March 23, and it went into effect last month.
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.
The West Virginia Right to Try law bypasses the FDA expanded access program and allow 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.
“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 law also provides protection to health care providers, with a prohibition against revoking a license or issuing sanctions based on recommendation or issuance of such investigational treatments. SB416 reads, in part:
“Notwithstanding any other law, 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. 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.”
In addition, lawsuits against physicians who comply under the terms specified in SB416 are prohibited:
“This article does not create a private cause of action against a manufacturer of an investigational drug, biological product or device, against a health care provider as defined in section two, article seven-b, chapter fifty-five of this Code, or against any other person or entity 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, so long as the manufacturer, health care provider, or other person or entity is complying in good faith with the terms of this article.”
Although this type of bill 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.
West Virginia joins more than two-dozen other states that have approved Right to Try legislation. The momentum has built very quickly behind this idea, with most of these states passing these laws within the past year alone. This rapid progress shows that Americans from across the political spectrum intuitively understand that these FDA regulations are harmful and must be mitigated through state-level action.
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