BOISE, Idaho (March 25, 2016) – An Idaho bill that would set the foundation to nullify in practice some Food and Drug Administration (FDA) rules that deny access to experimental treatments by terminally ill patients was signed by Gov. Otter on Wednesday
The House of Delegates Health and Welfare Committee introduced House Bill 481 (H481) on Feb. 12. The House passed it by a vote of 66-1 and the Senate by a 34-1 vote. Signed by the Governor this week, the laws goes into effect on July 1, and will allow terminally ill patients access to medicines 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.
H481 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.
H481 “intends only to permit these treatments to terminally ill patients in Idaho” and aims to protect the patient, the manufacturer, and physicians from liabilities for their participation.
“It is not the intent of the legislature to create an obligation but to ensure that all persons or parties availing themselves of this chapter do so voluntarily,” the bill text reads. “Due to the experimental nature of these treatments, it is further the intent of the legislature to protect physicians and other parties from civil, criminal, or professional liability relating to the treatments.”
Under the provisions of the legislation:
An eligible patient may request, and a manufacturer may make available to an eligible patient under the supervision of the patient’s treating physician, the manufacturer’s investigational drug…..which shall be clearly labeled as investigational; provided however, that this chapter does not require that a manufacturer make available an investigational drug to…an eligible patient.
The news law also adds protection to health care providers with a prohibition against revoking a license or issuing sanctions based on recommendation or issuance of such investigational treatments, as well as prohibiting lawsuits against physicians who comply with 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.
Idaho joins twenty-four 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.