LITTLE ROCK, Ark. (Mar. 13, 2015) – An Arkansas bill that would nullify in practice some Food and Drug Administration (FDA) rules that prevent terminally ill patients from accessing treatments was signed into law by Governor Asa Hutchinson this week.
State Sen. John Cooper (R-21) introduced Senate Bill 4 (SB4) as the Arkansas Right to Try Act on Jan. 5. Passed unanimously by both houses, the new law is the latest pushback against the FDA and its controversial methodology of withholding experimental treatments from people on their deathbeds.
Right To Try allows terminally-ill Arkansans to try investigational treatments that have not received FDA approval to be on pharmacy shelves. Right To Try expands access to potentially life-saving treatments years before patients would normally be able to access them. The new law effectively nullifies this narrow, but important set of federal restrictions.
It reads, in part:
The standards of the United States Food and Drug Administration for the use of investigational drugs, biological products, and devices may deny the benefits of potentially life-saving treatments to terminally ill patients;
The State of Arkansas recognizes that patients who have a terminal disease have a fundamental right to attempt to pursue the preservation of their own lives by accessing available investigational drugs, biological products, and devices
“This new law 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.”
The law provides protections for physicians who recommend or administer such treatments as well. It prohibits any licensing board from taking action to revoke, suspend, sanction, fail to renew, or take any other action against a physician’s license solely based on such physician’s recommendation, prescription, or treatment of an eligible patient with an investigational product. The law also provides immunity for manufacturers of these investigational drugs or treatments, except in the event of gross negligence or willful misconduct.
Arkansas is one of many states that have taken a bold stand for patients’ rights by passing this type of legislation. During this most recent November election, Arizona residents approved Prop. 303, known as the Arizona Terminal Patients’ Right to Try Referendum. The proposition allows investigational drugs, biological products or devices to be made available to eligible terminally ill patients, not permitted under the FDA.
Legislatures in Colorado, Michigan, Missouri, Wyoming, and Louisiana have already passed Right to Try Laws similar to the Arizona amendment, and more than 20 states are considering such measures in 2015. Governor signatures are likely soon on bills in Virginia, Montana and Mississippi.
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.
Now that it is officially apart of the Arkansas state code, Act 374 represents a positive first step to help terminally-ill patients from FDA restrictions that can kill.
Take the steps to get a similar bill passed in your state at THIS LINK.