Two bills in New Jersey would effectively nullify some Food and Drug Administration (FDA) rules that prevent treatments from being used by terminally ill patients.
Assembly Bill 3474 (A3474) and Senate Bill 2186 (S2186), the Right to Try Act, are two of the latest proposed measures of pushback against the FDA and their controversial methodology of approving drugs for mass consumption. Both of the bills contain identical language.
A3474 is sponsored by State Reps. Pamela Lampitt (D-Cherry Hill) and Joseph Lagana (D-Bergen). S2186 is sponsored by State Sens. Diane Allen (R-Burlington), Joseph Vitale (D-Middlesex) and Richard Codey (D-Essex). Once signed into law, these bills will provide compassion and relief from callous federal regulations that have kept potentially life-saving medicine out of the hands of people who need it the most.
The bills state that “a manufacturer of an investigational drug, biological product, or device may make [them] available… to eligible patients pursuant to this act. Nothing in this act shall be construed to require a manufacturer to make an investigational drug, biological product, or device available.”
Patients are eligible for these experimental drugs and procedures if they have “considered all other treatment options currently approved by the United States Food and Drug Administration in consultation with a physician” as well as have “received a prescription or recommendation by a physician” and provided “informed, written consent” with “documentation from the physician indicating the person has met these requirements.” Patients under the age of 18 would need their lawful parent or guardian’s approval before having access to experimental drugs and procedures.
Physicians who prescribe experimental drugs and procedures to patients are shielded from liability under A3474 and S2186. The bill states that “The State Board of Medical Examiners shall not revoke a license, fail to renew a license, or take any other disciplinary action… against a physician solely based on the physician’s recommendation, prescription, or treatment of an eligible patient with an investigational drug, biological product, or device consistent with this act.”
Other provisions in the bills include the proclamation that “any official, employee, or agent of a State or local government who attempts to block or who does block access of an eligible patient to an investigational drug, biological product, or device is a disorderly person.” Public and private insurers may but are not required to provide coverage to experimental drugs and procedures under A3474 and S2186. Manufacturers can provide their experimental drugs and procedures to qualifying patients free of charge, but are not obligated to do so.
A3474 and S2186 make up part of a greater trend promoting medical freedom 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.
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.
Dying dying people should not be deprived of their right to any means that might ease their pain or keep them alive, and it is extremely difficult for opponents to argue that dying people should be forced to use only drugs approved of by bureaucrats who are incapable of empathizing with their possible suffering.
In Louisiana, for example, the law received 80 percent approval, according to one survey. In three of the states that passed “Right to Try” laws, not a single politician voted nay. In Michigan, the entire state House voted yea with no abstentions, while only two senators voted against it.
The cumbersome bureaucratic process deployed by the FDA makes Right to Try laws necessary. It can take more than a decade and a billion dollars to get new medications on the market, according to Lucy Caldwell, communications director for the Goldwater Institute.
Mikaela Knapp provides a compelling real-life example.
According to a World Net Daily report when Knapp was diagnosed with kidney cancer, she and her husband, Keith, launched a social media campaign to lobby drug firms and the FDA to give her access to a new gene therapy. Their efforts gained national attention and generated 200,000 signatures on a petition at Change.org but failed to win access to the treatment. The 25-year-old newlywed died April 24.
The ugly truth is she died waiting for somebody’s permission that never came.
This serves as yet another example of failure in Washington D.C. The FDA shows no inclination to change its rules, and Congress has not made any move to loosen restrictions, despite countless stories like Knapp’s The courts haven’t helped either. In 2003, a federal judge ruled that terminally ill people do not have a right to access to investigational medicine. Not surprisingly, the U.S. Supreme Court declined to consider an appeal on that ruling.
The fact that federal regulatory agencies and federal courts refuse to show compassion for terminally ill patients make state Right to Try bills crucial. A3474 and S2186 would bypass stubborn federal bureaucrats and give hope to those suffering from terminal illness.
A3474 is now in the Assembly Health and Senior Services Committee while S2186 is in the Senate Health, Human Services and Senior Citizens Committee. These bills will have to successfully pass through their committee assignments before they can receive full votes.
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