Some more good news from the Tenth Amendment Center.
‘An Iowa bill that would nullify in practice some Food and Drug Administration (FDA) rules that deny access to experimental treatments by terminally ill patients unanimously passed the Senate today.
The Senate State Government Committee introduced Senate Bill 2198 (SF2198) and issued a report approving the legislation on Feb. 16. The bill would enable terminally ill patients to access to medications and treatments 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.
SF2198 would bypass 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.
The Senate passed SF2198 by a 50-0 vote.
A section of the bill’s text reads:
A manufacturer of an investigational drug, biological product, or device may make available and an eligible patient may request the manufacturer’s investigational drug, biological product, or device under this chapter. This chapter does not require a manufacturer of an investigational product, or device to provide or otherwise make available the investigational drug, biological product, or device to an eligible patient.
Under the proposed law, a manufacturer would not be required to charge the patient, though it may do so. It does not require insurance providers to cover the cost, nor does it prohibit them from doing so. 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. It also prohibits lawsuits against physicians who comply with the terms specified in the law.
Although these type of bills 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.‘