LITTLE ROCK, Ark. (March 6, 2015) – A bill that would nullify in practice some Food and Drug Administration (FDA) rules that prevent terminally ill patients from accessing treatments unanimously passed both the House and the Senate and was sent to the governor’s desk for a signature yesterday.
Sen. John Cooper introduced Senate Bill 4 (SB4) as the Arkansas Right to Try Act on Jan. 5. The bill represents the latest pushback against the FDA and its controversial methodology of withholding experimental treatments from people on their deathbeds.
SB4 cleared the Senate 31-0 on Feb. 5, and passed the House with amendments 96-0 on Feb. 24.The Senate gave final approval to the House version 33-0 on March 5, sending the bill on to the governor’s office.
Gov. Asa Hutchinson has until Wednesday, March 11, to sign or veto the bill. If he takes no action, it will automatically become law.
If the governor does not veto the legislation, a patient suffering from a terminal disease, as attested to by a physician, who has considered all other approved treatment options, would be able to try experimental treatments or drugs not yet approved by the FDA. The law would effectively nullify this narrow, but important set of federal restrictions.
The Arkansas legislature based the bill on two fundamental principles as declared in the bill.
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
The legislation provides protections for physicians who recommend or administer such treatments. SB4 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 bill also provides immunity for manufacturers of these investigational drugs or treatments, except in the event of gross negligence or willful misconduct.
SB4 makes up part of a greater trend sweeping the nation. 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, 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. A similar bill passed the Virginia legislature this month and awaits a signing decision by the governor.
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.
The bill represents a positive first step to help terminally-ill patients from FDA restrictions that can kill.
ACTION ITEMS
In Arkansas: Support this bill by following the action steps at THIS LINK
In Other States: Take the steps to get a similar bill passed in your state at this link.
