TRENTON, N.J. (March 9, 2022) – A bill introduced in the New Jersey House would give terminally ill patients the “right to try” experimental treatments not given final approval by the FDA along with off-label treatments.
Rep. Ronald Dancer (R) introduced Assembly Bill 3487 (A3487) on March 8. Titled the “Right to Try-Plus Act,” the legislation would create a state process to give terminally ill patients access to medicines not yet given final approval for use by the FDA. It would also allow terminally ill patients to use “off-label” medications. These are drugs that have been approved by the FDA but not for the patient’s particular illness.
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. A3487 creates a process to bypass the FDA expanded access program and allows patients to obtain experimental drugs from manufacturers without first obtaining FDA approval.
Additionally, the FDA effectively blocked the use of some treatments for coronavirus during the coronavirus pandemic, including ivermectin and chloroquine. The passage of A3487 would open the door for doctors to prescribe such treatments in New Jersey regardless of federal policy. As legislative findings in A3487 state, “Approximately 50 percent of cancer patients receive some type of ‘off label’ drug in their treatment.”
On May 30, 2018, President Donald Trump signed a federal Right to Try Act into law. At the time Trump inked his signature on the bill, patients in 39 U.S. states already had access to experimental treatments thanks to state Right to Try laws. The federal Right to Try Act is an example of the feds arriving late to a party. The movement started nearly five years ago when Colorado Gov. John Hickenlooper signed the first state Right to Try bill into law. State action drove this change, and it’s almost certain Congress would have never passed Right to Try if the states hadn’t acted first.
The new federal law does not render the state right to try laws irrelevant. In the first place, the federal government could change the last or enact restrictions at any time. The passage of a state law would ensure the right to try continues unhindered in Rhode Island no matter what Congress does. And while the federal law creates a uniform standard, state laws provide doctors, drug manufacturers and patients important protections. As Goldwater Institute spokesperson Jennifer Tiedemamm pointed out, states have their own standards for tort liability, medical licensure, and other legal issues that federal law does not address.
For instance, A3487 includes important legal protections for medical practitioners who administer experimental treatments.
“Except in the case of gross negligence, recklessness, or willful misconduct, a hospital, a health care practitioner or staff member providing services at or through the hospital, and any physician unaffiliated with the hospital, who assists a patient with a request for, or who furnishes or administers, a drug, biological product, or device to a patient pursuant to this section, shall not be liable in any criminal or civil action or subject to adverse licensure or other administrative disciplinary action for adverse consequences resulting from acts or omissions taken by the hospital, health care practitioner, staff member, or physician consistent with the provisions of this section.”
It also specifically prohibits any state agent from blocking a patient’s access to investigational treatments.
Although “right to try” 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. And when enough states defy the feds, Congress will eventually follow along. This demonstrates the effectiveness of a bottom-up strategy for limiting federal power.
The results show that the practical impact of Right to Try isn’t merely theoretical.
Since the Texas Right to Try law went into effect in June 2015, at least 78 patients in the Lone Star State have received an experimental cancer treatment not allowed by the FDA. While the FDA would have allowed these patients to die, Houston-based oncologist, Dr. Ebrahim Delpassand, continued their treatment through the Texas law. (Watch a video about Dr. Delpassand here.)
The Right to Try Act is a no-brainer. When someone is on their deathbed, the fact that FDA ever maintained regulations would let them die rather than try has got to be one of the most inhumane policies of the federal government.
A3487 was referred to the Assembly Health Committee where it must get a hearing and pass by a majority vote before moving forward in the legislative process.