FRANKFORT, Ky. (June 29, 2017) – Today, a Kentucky law went into effect that sets the foundation to nullify in practice some Food and Drug Administration (FDA) rules that deny access to experimental treatments by terminally ill patients.
A coalition of three Republicans sponsored Senate Bill 21 (SB21). The legislation gives 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.
SB21 creates a process to bypass the FDA expanded access program and allows 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.
In February, the Kentucky Senate passed SB21 by a 38-0 vote. The House approved the measure in March 87-7. With Gov. Matt Bevin’s signature, the law went into effect June 29.
The legislation includes protections for healthcare providers with a prohibition against revoking a license or issuing sanctions based on recommendation or issuance of investigational treatments. The new law also explicitly prohibits the state from interfering with a patient’s access to covered experimental treatments.
“An official, employee, or agent of the Commonwealth of Kentucky shall not block or attempt to block an eligible patient’s access to an investigational drug, biological product, or device.”
Currently, 37 states have Right to Try laws on the books. Although these laws 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.
“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 Right to Try Act is a no-brainer. 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 take action to nullify the FDA like this.
